The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

Device Description

The 1cc Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997 and the 1cc Allergy and Insulin Syringes were introduced in November 1997. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user.

AI/ML Overview

The provided text describes a 510(k) submission for the VanishPoint® Syringe, a safety syringe designed to prevent needlestick injuries. However, the document does not contain specific acceptance criteria or the details of a study with numerical performance data for this device.

Instead, the submission primarily focuses on establishing "substantial equivalence" of the 1cc Tuberculin VanishPoint® Syringe to previously marketed versions of the VanishPoint® Syringe (3cc, 5cc, 10cc, 1cc Allergy and Insulin). This is a common pathway for medical devices seeking FDA clearance, where the device's safety and effectiveness are demonstrated by showing it is as safe and effective as a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the available information, here's what can be gathered, with many fields explicitly marked as "Not provided in the text" due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not formally stated. The submission focuses on substantial equivalence to predicate devices.	The device functions like a conventional hypodermic syringe but with the added ability to retract the contaminated needle inside the syringe immediately after use, activated by the user. This retraction is intended to protect the user from accidental needlesticks that would occur between removing the needle from the patient and disposing of the syringe.

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

Sample size for test set: Not provided in the text.
Data provenance: Not provided in the text. The submission relies on the established safety and effectiveness of predicate devices.

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

Number of experts: Not applicable/Not provided in the text. This type of information is typically found in performance studies, which are not detailed in this 510(k) summary.
Qualifications of experts: Not applicable/Not provided in the text.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not provided in the text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

MRMC study: Not provided in the text. This type of study is more common for diagnostic imaging AI systems comparing human reader performance.
Effect size: Not applicable/Not provided.

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

Standalone performance study: Not applicable/Not provided in the text. This device is a mechanical syringe, not an algorithm. Its operation inherently involves human interaction.

7. The Type of Ground Truth Used

Type of ground truth: Not applicable in the context of this 510(k) summary. For devices relying on substantial equivalence, the "ground truth" is essentially the demonstrated safety and effectiveness of the predicate device(s) as cleared by the FDA. The safety claim for this specific device is "protection from accidental needlesticks" through needle retraction.

8. The Sample Size for the Training Set

Training set sample size: Not applicable/Not provided in the text. This is a mechanical device, not an AI/ML algorithm that requires training data.

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

Ground truth for training set: Not applicable/Not provided in the text.

Study Description (as inferred from the 510(k) Summary):

The "study" that proves the device meets its (unstated) acceptance criteria is based on the concept of Substantial Equivalence. The submission argues that the 1cc Tuberculin VanishPoint® Syringe is simply a "smaller version" of existing, previously cleared VanishPoint® syringes (3cc, 5cc, 10cc, and 1cc Allergy and Insulin versions). The implicit assumption (and the basis of the FDA clearance) is that if the design and function are sufficiently similar to devices already on the market and deemed safe and effective, then the new device also meets those standards without requiring new, extensive performance studies.

The document states: "No new issues of safety or effectiveness when prepared. The 1cc Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint®... the 5cc and 10cc VanishPoint® Syringes... and the 1cc Allergy and Insulin Syringes..."

This indicates that the "proof" is a comparative analysis to already-cleared devices, rather than a de novo performance study with specific acceptance criteria and detailed quantitative results.

Summary

{0}------------------------------------------------

K980069

January 15, 1998

510(k) SAFETY and EFFECTIVENESS SUMMARY page 1 of 2 Re:

Pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, Safety and Effectiveness information is enclosed for the following device:

Device Name:	Automated Retractable VanishPoint Syringe
Trade Name:	VanishPoint® Syringe
Common Name:	Safety Syringe
Classification Name:	Piston Syringe/Anti-Stick Syringe
Device Class:	Class II Medical Device
Classification Panel:	Panel 80 (General Hospital and Personal Use)
	Procode: MEG - Anti-Stick Syringe
Performance Standard:	None established for hypodermic syringes.
Safety and Effectiveness:	No new issues of safety or effectiveness when prepared.The 1cc Tuberculin VanishPoint® Syringe is a smaller version andis substantially equivalent to the original 3cc VanishPoint® whichwas introduced into the market in December 1995, the 5cc and10ccVanishPoint® Syringes which were introduced May 1997 andthe 1cc Allergy and Insulin Syringes were introduced in November1997.
Facility Address:	Retractable Technologies, Inc.511 Lobo Lane, P.O. Box 9Little Elm, TX 75068-0009

Establishment Registration Number: 1647137

Indications for Use: The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needle sticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

{1}------------------------------------------------

510(k) SAFETY and EFFECTIVENESS SUMMARY __page 2 of 2

4年 10月 10月 18:58:58 AM 10:00 10:00 1

Substantial Equivalence The 1 cc Tuberculin VanishPoint® is a smaller version of the original 3 cc VanishPoint® originally called a Pop n' Lok Syringe.

Contact Information:
Name:	Terance Grisso
	Director, Regulatory Affairs and Quality
Address:	Retractable Technologies, Inc.511 Lobo Lane, P.O. Box 9Little Elm, TX 75068-0009
Telephone:	(972) 294-1010
Facsimile:	(972) 294-4400

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

294-4400

The 1 cc Tuberculin Vanis
nt® originally called a Pop n

MARY page 2 of 2

{2}------------------------------------------------

Image /page/2/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 image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB | 2 |998

Mr. Terance Grisso Director of Regulatory Affairs and Quality Retractable Technologies, Incorporated 511 Lobo Lane 75068 Little Elm, Texas

Re : K980069 Trade Name: Vanishpoint Syringe Regulatory Class: II Product Code: MEG Dated: January 7, 1998 Received: January 8, 1998

Dear Mr. Grisso:

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 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 The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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

{3}------------------------------------------------

Page 2 - Mr. Grisso

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 described in your 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 requlation (21 CFR Part 801 and additionally 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 one began and fication" (21 CFR 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/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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

Enclosure

{4}------------------------------------------------

K980069

INDICATIONS FOR USE

510 (k) Number (if known):

Device Name:

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pataria Crescenti

510(k) Numb

Prescription Use

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).