The Gettig Disposable Syringe, with or without a hypodermic single lumen needle, is intended to inject fluids into, or withdraw fluids from, the body. The syringe is designed for manual use.

Device Description

The Gettig Disposable Syringe is a standard piston syringe. It consists of a calibrated hollow barrel and a moveable plunger. At one end of the barrel there is a male connector (nozzle) for the female connector (hub) of a hypodermic single lumen needle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gettig Disposable Syringe:

Note: The provided document is a 510(k) summary for a medical device (syringe). For this type of device, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to predicate devices through compliance with established industry standards, rather than clinical efficacy studies often seen for diagnostic or therapeutic AI/ML devices. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, standalone performance with AI, etc.) is not applicable or not present in this type of submission.

Acceptance Criteria and Device Performance Study for Gettig Disposable Syringe (K022495)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 7886-1:1993 (Sterile Hypodermic Syringes for Single Use)	Device found compliant through testing
ISO 594-1:1986 (Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment, Part 1 General Requirements)	Device found compliant through testing
ISO 594-2:1991 (Conical Fitting With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment, Part 2 Lock Fittings)	Device found compliant through testing

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

Sample Size: The document does not specify the exact sample size (number of syringes) used for "standards testing." However, such testing typically involves a statistically relevant number of units to ensure product consistency and compliance.
Data Provenance: The testing was conducted "on the Gettig Disposable Syringe and the predicate devices." This implies internal (manufacturer-sponsored) testing. The country of origin for the data is not explicitly stated, but since the submission is to the US FDA, the testing would generally adhere to international standards recognized by the FDA. The testing is prospective in the sense that it was performed on new devices manufactured for the purpose of demonstrating conformity to standards.

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

This information is not applicable to this type of device submission. The "ground truth" for a mechanical device like a syringe is its physical and functional compliance with established international standards (ISO standards). The "experts" involved would be the engineers and technicians performing the tests and comparing results against the standard's specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. The "adjudication method" as described typically refers to a process of resolving discrepancies in expert interpretations, which is relevant for subjective assessments (e.g., medical image interpretation). For compliance testing against objective engineering standards, the results are typically pass/fail based on objective measurements against defined thresholds.

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 is not applicable. This submission is for a medical device (a syringe), not an AI/ML-driven diagnostic or therapeutic system. Therefore, no MRMC study or AI-related comparative effectiveness was performed or presented.

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

This is not applicable. This submission is for a medical device (a syringe), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is compliance with established international engineering standards (ISO 7886-1, ISO 594-1, ISO 594-2). These standards define objective criteria for syringe performance, such as leakage, force to operate plunger, Luer taper dimensions, etc.

8. The Sample Size for the Training Set:

This is not applicable. This device is a traditional mechanical medical device, not an AI/ML system that requires a "training set."

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

This is not applicable. As stated above, there is no "training set" for this type of device.

Summary

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510(k) SUMMARY

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

The assigned 510(k) number is K022495

1. Submitter's Identification:
  Gettig Pharmaceutical Instrument Company 1 Streamside Place West P. O. Box 85 Spring Mills, PA 16875

Date Summary Prepared:

July 25, 2002

1. Name of the Device:
  Trade Name: Gettig Disposable Syringe

Common Name: Piston Syringe

Classification Name: Piston Syringe

1. Predicate Device Information:
- A. Becton Dickinson Syringe (K#941562)
- B. Terumo Disposable Syringe (K#980181)
1. Device Description:

1. Intended Use:
  The intended use of the Gettig Disposable Syringe is to inject fluids into, or withdraw fluids from, the body.
1. Summary of Technological Characteristics:
  The Gettig Disposable Syringe has the same intended use as the predicate devices. All are operated manually. The materials used for the Gettig Disposable Syringe (polycarbonate

Image /page/0/Picture/23 description: The image shows a logo with the word "GETTIG" written in capital letters above a graphic. The graphic is a stylized design featuring a combination of geometric shapes, including a partial oval and a rectangular form. The left side of the oval is white, while the upper and right portions of the graphic are filled in with black.

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and Santoprene) are the same as the Polycarbonate used in the Becton Dickinson Syringe and the Santoprene used in both mentioned predicate devices.

1. Non-Clinical Tests Performed for Determination of Substantial Equivalence:
  The following standards testing were conducted on the Gettig Disposable Syringe and the predicate devices:
A. ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use
B. ISO 594-1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment, Part 1 General Requirements
C. ISO 594-2:1991 Conical Fitting With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment, Part 2 Lock Fittings

The testing results revealed the Gettig Disposable syringe to be substantially equivalent to the predicate devices.

1. Conclusion:
  The Gettig Disposable Syringe has the same intended use and similar technological characteristics as the Terumo Disposable Syringe and Becton Dickinson Syringe. There are no new technological characteristics that raise any new questions of safety and effectiveness. Thus, the Gettig Disposable Syringe is substantially equivalent to the predicate devices.

Image /page/1/Picture/9 description: The image shows a logo with the word "GETTIG" written above a graphic. The graphic is a stylized oval shape that is divided into sections. The upper left section of the oval is filled in with black, while the rest of the left half is white. The right half of the oval is divided into two sections, with the upper section being black and the lower section being white.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right.

Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. James A. Benz Gettig Pharmaceutical Instrument Company One Streamside Place, West Spring Mills, Pennsylvania 16875-0085

Re: K022495

Trade/Device Name: Gettig Disposable Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 25, 2002 Received: July 29, 2002

Dear Mr. Benz:

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.

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Page 2 - Mr. Benz

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 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.gov/cdrh/dsmamain.html

Sincerely,

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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Exhibit B

Page

510(k) Number (if known): K022495

Gettig Disposable Syringe Device Name

Indications For Use:

The Gettig Disposable Syringe, with or without a hypodermic single lumen The Gettig Disposable Syringe, with or without a myportune of the body. The syringe is designed for manual use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrea Cucurite

sthesio

510(k) Number: KC22495

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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).