Becton Dickinson and Company Meriam Youssef 1 Becton Drive

Preparing to load PDF file. please wait...

0 of 0
100%
Becton Dickinson and Company Meriam Youssef 1 Becton Drive

Transcript Of Becton Dickinson and Company Meriam Youssef 1 Becton Drive

October 21, 2019 Becton Dickinson and Company Meriam Youssef Senior Manager Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K190054 Trade/Device Name: BD Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: September 19, 2019 Received: September 23, 2019
Dear Meriam Youssef:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

Doc ID# 04017.04.08

K190054 - Meriam Youssef

Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rumi

Rumi Young -S c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Rumi Young -S,

Young -S 0.9.2342.19200300.100.1.1=20024

For CAPT Alan M. Stevens67913

Assistant Director

2019.10.21 13:36:29 -04'00'

DHT3C: Division of Drug Delivery and

General Hospital Devices,

and Human Factors

OHT3: Office of Gastrorenal, ObGyn,

General Hospital and Urology Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

K190054 510(k) Summary

Submitted By:
Date Prepared: Device Name:

Meriam Youssef Sr. Manager Regulatory Affairs, BD Medical- Diabetes Care 1 Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 6557 Fax: 201 847 5307

September 19, 2019

Trade Name: Common Name: Regulation Name: Regulation: Product Code:

BD Insulin Syringe™ Syringe, Piston Piston syringe 21 CFR 880.5860 FMF

Legally marketed predicate device to which substantial equivalence is being claimed:
• BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle (K170386)

Device Description:
The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100 insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.

The BD Insulin Syringes are offered in the following sizes:

Syringe size (mL) 0.3mL 0.3mL 0.3mL 0.3mL 0.3mL 0.5mL 0.5mL 0.5mL 0.5mL 0.5mL 1mL 1mL 1mL 1mL 1mL 1mL 1mL 1mL

Bevel 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

Cannula length (mm) 12.7mm 12.7mm 8mm 8mm 6mm 12.7mm 12.7mm 12.7mm 8mm 6mm 16mm 12.7mm 12.7mm 12.7mm 8mm 8mm 6mm 16mm

Gauge (G) 29G 30G 29G 31G 31G 28G 29G 30G 31G 31G 27G 28G 29G 30G 30G 31G 31G 27G

Indications for Use: Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins.

Differences in Indications for use: The indications for use are the same as the predicate.

Substantial Equivalence Discussion:

General Information Feature

Subject Device: BD Insulin Syringe

510(k) Number Device Classification Regulation Number Product Code Indications of Use Specific Drug Use Capacity
Bevel Cannula Gauge Size(s)
Nozzle Tip Type
Scale Markings

K190054
Syringe Piston
880.586 FMF Becton Dickinson insulin syringes are intended for subcutaneous injection of U 100 insulins
U-100 Insulin
1mL, 0.5mL, 0.3mL
3
27G, 28G, 29G, 30G, 31G
Snap fit needle hub for 0.3mL and 0.5mL designs for permanently attached needles Integral barrel for 1mL design for permanently attached needles 1 unit increments and ½ unit increments (0.3mL) 1 unit increments (0.5mL) 2 units increments (1mL)

Predicate Device
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
K170386
Same
Same Same Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins.
Same
1mL

Comparison
N/A Same Same Same Same
Same The subject device includes a 0.5mL and 0.3ml model.

3 27G, 28G, 29G, 30G, 31G

Dimensional modifications to primary bevel of cannula
Same

Integral barrel for 1mL design for permanently attached needles

Introduction of one glue well design for 1mL barrel configuration

2 units increments (1mL)

Addition of ½ unit scale mark increments

General Information Feature
Packaging Configuration
Cannula Length Size(s) Cannula (Needle) material Cannula (Needle) shield material and Cap (for plunger rod) material Cannula cover color Lubricant Cannula bonding adhesive (UV cured) Scale marking ink
Plunger rod material Plunger tip (stopper) material Barrel and Hub Material Single Use Only Non-Pyrogenic Sterile (10-6)

Subject Device: BD Insulin Syringe
Polybag for self-contained syringe and blister pack (multiple blister packs per perforated sheet) offerings
6mm, 8mm, 12.7mm, 16mm 304 Stainless Steel Polyethylene
Orange Medical Grade Silicone
UV Cured Adhesive Solvent based Markem black colored ink Polystyrene
Rubber stopper Polypropylene
YES YES YES

Predicate Device BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
Polybag for self-contained syringe and blister pack (individual blister pack) offerings
6mm, 8mm, 12.7mm, 16mm 304 Stainless Steel
Polyethylene
Orange
Medical Grade Silicone
UV Cured Adhesive

Comparison
Addition of retention ring to 1mL self-contained insulin syringe Multiple blister packs per perforated sheet
Same
Same Modification to the comonomer of polyethylene material Same Modification to lubricant formulation carrier solvent New 0.3mL & 0.5mL UV Cured Adhesive

Solvent based Markem black colored ink
Polystyrene
Rubber stopper

Same
Remove colorant additive from the plunger rod component Same

Polypropylene
YES YES YES

New material formulation of polypropylene
Same
Same
Same

Discussion: Apart from the above mentioned modifications to the design and materials, there are no technological differences between the subject and the predicate devices. The design modifications were assessed through performance testing per ISO 8537 and ISO 9626. The material changes were evaluated per ISO 10993-1. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
Non-Clinical Testing: Following BD’s Quality System processes, required testing was conducted to validate the cumulative modifications made to the subject devices.
Substantial Equivalence is being supported with full performance testing representing the current BD Insulin Syringe devices currently marketed.
Bench functional performance • Testing was conducted according to ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin, and ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. This testing included Air Leakage, Cannula Pull Force, Cap Pull Force, Hub Pull Force, Liquid Leakage, Needle Break-Off Force, Penetration Force, Scale Print Permanency, Shield Pull Force, Syringe Filling Force, Syringe Injection Force (Force to Expel Water), Volumetric Accuracy, Dead Space and Corrosion Resistance.
Biocompatibility testing • Testing was conducted according to relevant sections of ISO 10993:2019 Biological evaluation of medical devices. This testing included Cytotoxicity, Sensitization (GP Max), Sensitization, Intracutaneous Reactivity, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Hemocompatibility, and Genotoxicity (Bacterial and Mammalian). The medical device is classified as: externally communicating, blood path indirect, with prolonged contact duration.
Additional Testing: ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA), ISO 11137-1:2006/Amd 2013(E) Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, ISO 11137-2:2013(E) Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose, ISO 11137-3: 2017(E) Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control, and ISO 11737-1:2018(E) Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products .
Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use and is as safe and effective as its predicate device.
Clinical Testing: Not Applicable
Conclusion: The modifications to the design, dimensions, and materials of the subject device met the requirements of the standards. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
The BD Insulin Syringes are substantially equivalent to the BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle cleared under K170386 with respect to the indications for use, target populations, treatment method, use environment and technological characteristics.
DeviceDevicesForceDifferencesSubject Device