SWFIPS is a combination product intended to be used by patients, pharmacists or physicians for the reconstitution and administration of approved prescription drug products.

SWFIPS is not labeled or intended for stand alone use. The indications for use of the reconstituted drug or biologic are contained in the package insert for each product.

Device Description

SWFIPS is a glass piston syringe filled with USP Sterile Water for Injection.

SWFIPS is composed of an assembled glass piston syringe filled with a diluent, Sterile Water for Iniection. USP.

SWFIPS is used for the reconstitution of non-liquid injectable drugs, in containers, and subsequent injection, according to their labeling.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called SWFIPS (Sterile Water for Injection Prefilled Syringe). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or performance study in the way a new, non-equivalent device might.

Therefore, the sections of your request regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth for training are not directly applicable or available in the typical 510(k) summary. The document focuses on comparing the new device to a predicate device to establish substantial equivalence.

Here's an analysis based on the information available in the provided text, addressing your points where possible and explaining why others are not present:

1. Table of Acceptance Criteria and the Reported Device Performance

This 510(k) summary does not present a table of specific acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) and corresponding reported device performance for the SWFIPS device in the way a diagnostic or therapeutic device might.

Instead, the "performance" described relates to its characteristics, intended use, and conformance to existing standards for its components and contents, primarily to establish substantial equivalence to a predicate device.

The document states:

"The Sterile Water for Injection contained in the syringe conforms to USP monograph specifications at release and throughout the shelf life."
"The glass and the elastomeric closures meet USP requirements."
"The SWFIPS has been tested according to a stability protocol designed to support the shelf life claim."

These statements imply that the performance (e.g., sterility, chemical composition of water, integrity of materials) meets relevant USP (United States Pharmacopeia) standards and internal stability protocols. However, no quantitative performance metrics or specific acceptance criteria are provided in a table format.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document describes a comparison to a predicate device and mentions stability testing, but it does not detail any specific "test set" in terms of patient data or clinical samples. The "tested according to a stability protocol" likely refers to in-house laboratory testing of the product itself, not a study involving human subjects or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. SWFIPS is a prefilled syringe with sterile water, not a device that generates data requiring expert interpretation or "ground truth" establishment in a diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Similar to point 3, the device type does not involve an adjudication process for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. MRMC studies are typically for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. This device is a prefilled syringe for drug reconstitution and administration, with no AI component or human interpretation task.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided. The device is a physical medical product (a syringe with sterile water), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable in the traditional sense for this device. The "ground truth" for components like the Sterile Water for Injection is its conformance to USP monograph specifications, which are established chemical and physical standards. For the physical components (glass, closures), it's conformance to USP requirements. This is a form of "ground truth" based on established scientific and regulatory standards for chemical purity and material properties, rather than clinical outcomes or diagnostic certainty.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided. As above, there is no "training set" for this device.

Summary of Device Comparison for Substantial Equivalence:

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the BD® GLASPAK® syringe. The substantial equivalence argument is based on:

Intended Use: Both used for reconstitution of non-liquid drugs and injection of drug solutions.
Material Compatibility: Both container materials are biocompatible and chemically compatible with Sterile Water for Injection.
Syringe Tip Compatibility: Both syringe tips are compatible with a female Luer fitting.
Technological Characteristics: Both employ the same technological characteristics, with the key difference being that SWFIPS is pre-filled.

Differences noted, without adverse effect to safety or efficacy:

SWFIPS is filled with 1 mL Sterile Water for Injection (predicate is empty).
SWFIPS is terminally sterilized by steam (predicate by ethylene oxide).

The 510(k) states that these differences do not adversely affect safety or efficacy, therefore supporting the claim of substantial equivalence. The "performance" described relates to the components meeting USP standards and stability protocols, which implicitly demonstrate that the device is safe and effective for its stated intended use and is equivalent to an already marketed device.

Summary

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The 1 5 1998

K972728

510(k) SUMMARY

Date of preparation: July 18, 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

A. REASON FOR 510(k): Introduction of a new product.
B. NAME OF DEVICE:

Piston syringe Classification Name: Sterile Water for Injection Prefilled Syringe (SWFIPS) Common Name: Proprietary Name: not established

். CLASSIFICATION:
Name/Class: 21 CFR 880.5860 Piston syringe / Class II General Hospital, Panel 80 Panel:
D. ESTABLISHMENT REGISTRATION NUMBER: 8023072
E. SUBMITTER'S NAME AND ADDRESS:

Becton Dickinson and Company Pharmaceutical Systems Division 1 Becton Drive Franklin Lakes, New Jersey 07417-1886

Contact person:

Michael Gross, Ph.D. 201-847-5930 Tel : Fax : 201-847-4854

F. MANUFACTURING AND STERILIZATION FACILITIES:
Vetter Pharma-Fertigung GmbH & Co KG Schützenstrasse 99-101 88212 Ravensburg, Germany
PERFORMANCE STANDARD(S): G.
No performance standard applicable to this device have been promulgated under Section 514 of the Food, Drug and cosmetic Act.

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DEVICE DESCRIPTION AND INTENDED USE : H.

SWFIPS is a glass piston syringe filled with USP Sterile Water for Injection.

SWFIPS is composed of an assembled glass piston syringe filled with a diluent, Sterile Water for Iniection. USP.

SWFIPS is used for the reconstitution of non-liquid injectable drugs, in containers, and subsequent injection, according to their labeling. In the reconstitution of non-liquid drugs packaged in vials or ampules, a health care provider uses a syringe-needle assembly to remove a specified volume of diluent (e.g., Sterile Water for Injection) from a separate container and transfer it by injection into another vial or ampule containing the drug. A specific volume of drug is then removed and injected into the patient. By providing the Sterile Water for Injection prefilled in a Syringe, SWFIPS eliminates a number of reconstitution manipulations, reduces medical waste and reduces the possibility of microbial and/or particulate contamination. When SWFIPS is used to reconstitute, a needle is affixed to the syringe tip and is used to enter a vial or ampule containing a drug. The syringe contents (i.e., Sterile Water for Injection) are then expressed into the container dissolving the drug. All or part of drug solution is then withdrawn according to labeling. The needle-syringe assembly is then ready for injection through the skin or, depending on medical preference, the needle may be replaced with a fresh needle before iniection into the patient occurs.

The Sterile Water for Injection contained in the syringe conforms to USP monograph specifications at release and throughout the shelf life. The glass and the elastomeric closures meet USP requirements. The SWFIPS has been tested according to a stability protocol designed to support the shelf life claim.

SUBSTANTIAL EQUIVALENCE ﻨﺴ

SWFIPS is substantially equivalent to the BD® GLASPAK® syringe, a legally marketed device.

The term « substantial equivalence » as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the court.

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SWFIPS is substantially equivalent to the predicate device in that:

both can be used for the reconstitution of a non liquid drug and for the injection of a a) drug solution.
both container materials are biocompatible and chemically compatible with the Sterile b) Water for Injection.
C) both syringe tips are compatible with a female Luer fitting
both employ the same tehnological characteristics with the exception that SWFIPS is d) filled.

SWFIPS is different from the predicate device, without adverse effect to safety or efficacy, in that:

it is filled with 1 mL Sterile Water for Injection whereas the predicate device is empty. a)
b) it is terminally sterilized by steam whereas the predicate device is sterilized by ethylene oxide.

[END OF SUMMARY]

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

Michael Gross, Ph.D. 'Director, Corporate Regulatory Affairs Pharmaceutical Systems Division Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1886

K972728 Re : Sterile Water for Injection Prefilled Trade Name: Syringe Regulatory Class: II Product Code: FMF Dated: April 20, 1998 Received: April 22, 1998

Dear Dr. Gross:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Gross

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Susan Rummer

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

Enclosure__________.

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510(k) Number (if known):

Sterile Water for Injection Prefilled Syringe, USP (SWFIPS) Device Name:

Indications for Use:

SWFIPS is a combination product intended to be used by patients, pharmacists or physicians for the reconstitution and administration of approved prescription drug products.

SWFIPS is not labeled or intended for stand alone use. The indications for use of the reconstituted drug or biologic are contained in the package insert for each product.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

. .

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CRF 801.109)

(Optional Format 1-2-96)

Patricia Cucanto

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

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).