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K Number
K022495
Device Name
GETTIG DISPOSABLE SYRINGES
Manufacturer
GETTIG PHARMACEUTICAL INSTRUMENT CO.
Date Cleared
2002-10-08

(71 days)

Product Code
FMF
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

K#941562,K#980181

K#941562,K#980181

No
The device description and performance studies focus on the mechanical aspects and standard testing of a disposable syringe, with no mention of AI or ML.

No
The Gettig Disposable Syringe is intended for injecting or withdrawing fluids, which is a diagnostic or procedural function, rather than directly treating a disease or condition.

No

The device is a syringe, which is used for injecting or withdrawing fluids, not for diagnosing medical conditions.

No

The device description clearly indicates a physical syringe with a barrel, plunger, and connectors, which are hardware components. The performance studies also focus on physical standards for syringes and fittings.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, the body." This describes a device used on the body for therapeutic or diagnostic procedures, not a device used to examine specimens outside the body.
  • Device Description: The description of a standard piston syringe with a barrel, plunger, and connector for a needle aligns with a device for administering or collecting substances directly from a living organism.
  • Lack of IVD Characteristics: There is no mention of analyzing biological specimens (like blood, urine, tissue), reagents, or any process that would involve testing samples in vitro (in a lab setting).

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Gettig Disposable Syringe is a tool for delivering or collecting substances, not for analyzing them.

N/A

Intended Use / Indications for Use

The intended use of the Gettig Disposable Syringe is to inject fluids into, or withdraw fluids from, the body.
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.

Product codes

FMF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

  • A. Becton Dickinson Syringe (K#941562)
  • B. Terumo Disposable Syringe (K#980181)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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:

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.

    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.

2

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

4

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)

OR

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