This document describes a 510(k) premarket notification for a change in the formulation of the lubricant carrier for BD needle products. The primary goal of the submission is to demonstrate that the modified devices are substantially equivalent to their predicate devices, meaning they have the same intended use and performance characteristics, despite the change in lubricant carrier.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or measurable format for specific performance metrics. Instead, the entire submission hinges on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it remains identical to the predicate.

Element of Comparison	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Intended Use	Must be identical to predicate devices.	Identical to predicate devices.
Sterility	Sterile fluid path, identical to predicate devices.	Sterile fluid path, identical.
Sterilization	Gamma or EtO, unchanged from predicate devices.	Gamma or EtO, unchanged.
Design	Unchanged from predicate devices.	Unchanged.
Needle Material	Unchanged from predicate devices.	Unchanged.
Packaging	Unchanged from predicate devices.	Unchanged.
Silicone Proportions	Unchanged from predicate devices.	Unchanged.
Labeling	Unchanged from predicate devices.	Unchanged.
Product Claims	Unchanged from predicate devices.	Unchanged.
Performance	Unaffected by lubricant carrier change, equivalent to predicate.	Unaffected, equivalent.
Physical/Mechanical/Biological Specifications	Unaffected by lubricant carrier change, equivalent to predicate.	Unaffected, equivalent.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a test set sample size or the data provenance (e.g., country of origin, retrospective/prospective). This submission is for a material change (lubricant carrier) where the argument for substantial equivalence relies on the fact that the carrier evaporates, leaving the same silicone lubricant in the same proportions as the predicate device. Therefore, new extensive performance testing of physical/mechanical/biological specifications might have been conducted by the manufacturer but is not detailed as a "test set" in this summary. The focus is on the impact of the carrier change, which is argued to be negligible on the final product.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. Given the nature of the submission (change in excipient/carrier), it's unlikely that "ground truth" in the sense of expert consensus on diagnostic interpretations (as would be the case for imaging AI) was required or established. The ground truth here is the established performance and safety of the predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. There's no mention of a "test set" requiring adjudication in the context of this submission. The evaluation is based on a comparison to predicate devices and the scientific rationale that the carrier's evaporation renders its change inconsequential to the final product's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices, particularly AI-driven ones where human readers' performance is being evaluated with and without AI assistance. This submission is for a medical device (needles, syringes) with a material change to a non-active component, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone performance study (in the context of an algorithm) was not done. This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established performance and safety profiles of the predicate devices. The entire argument for substantial equivalence rests on the modified devices being equivalent to these already-cleared, safe, and effective predicates. The claim is that the change in the lubricant carrier does not alter these established characteristics.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. There is no "training set" in the context of an AI algorithm for this type of submission.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided. As there is no training set for an AI algorithm, there is no ground truth establishment for it.

Summary

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BD Medical Systems 1 Becton Drive Franklın Lakes, New Jersey 07417 tel. 201.847.6800 fax: 201.847 4896 www.bd com

KO21475

JUL 1 9 2002

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Indispensable to human health

్లాలు

గ్రామం

Change to the Formulation of the Lube Carrier for Needle Products

Summary of Safety and Effectiveness

1 BD Contact person: Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847-4513 Fax (201) 847-4855

2 Device Name: BD Single Lumen Needle, Syringe and Blood Collection Set

3 Predicate Device(s):

Predicate Devices	510(k) Number
BD Hypodermic Needles	Pre-Amendment
BD Ultra Fine II, Micro Fine + Short NeedleInsulin	K955235
BD Intravascular Catheters	K013073
BD Pen Needles	K002938; K970737; K950466
BD Introcyte Introducers	K013304
Eclipse Safety Needle	K982541
SafetyGlide Needle	K951254
Blood Collection Syringe	K982922
Safety-Lok Blood Collection Set	K931367
	K965202
	K972404
	K980414
Passive Shielding Blood Collection Needle	K003461
Push Button Blood Collection Set	K011984

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4 Product Description / Function: This change in needle lubricant carrier is across the BD product lines.
Intended Uses: These needles are intended for general purpose fluid 5 injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
6 Comparison of Modified and Predicate Device:

The table provides a comparison of the single lumen needles, insulin syringes and blood collection set with the predicate devices:

Element ofComparison	Single lumen needles, insulinsyringes and blood collection set	Similarity toPredicate Devices
Intended Use	These needles are intended forgeneral purpose fluidinjection/aspiration, infusion,venipuncture to obtain blood collectionand insulin injection	Predicate devices identical
Sterility	Sterile fluid path	Predicate devices identical
Sterilization	Gamma or EtO. Remains unchanged	Predicate devices identical
Design	Design remains unchanged	Predicate devices identical
Needle Material	Needle materials remain unchanged	Predicate devices identical
Packaging	Packaging remains unchanged	Predicate devices identical

7 Equivalence determination:
Single lumen needles, insulin syringes and blood collection sets are being compared to themselves. The indications for use, components, silicone proportions in the lubricants, labeling, performance and product claims remain the same. The only product modification is in the carrier used to disperse the silicone. Since the carrier evaporates, leaving only the silicone on the device, the modified devices are substantially equivalent to the currently marketed devices.

Intended uses: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

Materials: The needle materials remain unchanged. Predicate device is identical.

Physical, Mechanical, and Biological Specifications: These specifications are unaffected by the lubricant carrier formulation change and the predicate device are equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles embedded within the eagle's body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville .MD 20850

JUL 1 9 2002

Mr. Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical 1 Becton Drive MC 226 Franklin Lakes, New Jersey 07417

Re: K021475

Trade/Device Name: BD Single Lumen Needle, Syringe and Blood Collection Set Regulation Number: 880.5570, 880.5860 and 862.1675 Regulation Name: Hypodermic Single Lumen Needle, Piston Syringe and Blood Specimen Collection Device Regulatory Class: II Product Code: FMF, FMF, FMI and JKA Dated: May 6, 2002 Received: May 8, 2002

Dear Mr. Amato:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.

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Page 2 - Mr. Amato

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qoy/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runpp

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement.

510(k) Number (if known): ূ长 0214 75

Device Name: BD Single Lumen Needle, Syringe and Blood Collection Set

Indications for Use:

The needles are intended for general purpose fluid injection/aspiration, infusion, venipucture to obtain blood collection and insulin injection.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Insulin
Syringes/Needles

Pasture Crescent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).