(66 days)
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 Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected form accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997.
The provided text is a 510(k) submission for a medical device, the VanishPoint™ Syringe, seeking clearance from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics as might be found for a novel device.
Therefore, the information required for items 1 through 9 in your request is largely not present in the provided document, as it's not typically part of a 510(k) summary focused on substantial equivalence for a Class II device like a syringe.
Here's a breakdown based on the given text:
1. A table of acceptance criteria and the reported device performance
- Absent. This document does not detail specific acceptance criteria or quantitative performance metrics for the device. The "Safety and Effectiveness" section states: "No new issues of safety or effectiveness when prepared. The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997." This indicates a claim of equivalence rather than a report of specific test results against predefined criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Absent. No information is provided regarding a test set, sample sizes, or data provenance. The substantial equivalence argument relies on the existing predicate devices.
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)
- Absent. Ground truth establishment by experts is not described, as the submission does not detail a clinical study where such an assessment would be necessary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Absent. No adjudication method is mentioned.
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
- Absent. This is not relevant to a syringe device. MRMC studies are typically for diagnostic imaging devices involving interpretation by multiple readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Absent. This is not relevant to a syringe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Absent. No ground truth is described for the device performance. The "ground truth" for this submission concerns the functionality and safety profile of similar, already cleared devices, suggesting that the new device has "no new issues of safety or effectiveness."
8. The sample size for the training set
- Absent. No training set is mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Absent. Not applicable.
Summary of what the document does provide regarding acceptance/equivalence:
The core of this 510(k) submission is the assertion of substantial equivalence to existing predicate devices.
-
Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria in a 510(k) relevant to device safety and effectiveness are that the new device (1cc VanishPoint™ Syringe) does not raise new issues of safety or effectiveness compared to its predicate devices, and that it has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
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Study Proving Equivalence (Described implicitly): The "study" is the comparison to the predicate devices.
- The 1cc VanishPoint® Syringe is stated to be a "smaller version" of the original 3cc VanishPoint® (introduced Dec 1995), and also compared to 5cc and 10cc VanishPoint® Syringes (introduced May 1997).
- The document states: "No new issues of safety or effectiveness when prepared."
In essence, for this type of device and submission, the "proof" is the demonstrated similarity and lack of new risks compared to already cleared devices on the market. Clinical trials or detailed performance studies with explicit acceptance criteria are generally not required for such 510(k) submissions unless the device has novel technology or raises new safety/effectiveness concerns.
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NOV - 7 1997
October 13, 1997
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: | Anti-Stick Syringe with Integral Hypodermic Needle |
|---|---|
| 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 VanishPoint® Syringe is a smaller version and issubstantially equivalent to the original 3cc VanishPoint® whichwas introduced into the market in December 1995, and the 5cc and10ccVanishPoint® Syringes which were introduced May 1997. |
| 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 form 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.
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510(k) SAFETY and EFFECTIVENESS SUMMARY ___page 2 of 2
:
| Substantial Equivalence | The 1 cc VanishPoint® is a smaller version of the original3 cc VanishPoint® originally called a Pop n' Lok Syringe | |
|---|---|---|
| Contact Information: | ||
| Name: | Terance GrissoDirector, 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 |
: 上一篇:
100 - 100 - 100
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Image /page/2/Picture/2 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's head in profile, with three human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terance Grisso Director, Regulatory Affairs and Quality Retractable Technologies, Incorporated 511 Lobo Lane Little Elm, Texas 75068
NOV - 7 1997
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K973301 Re : VanishPoint® Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: August 28, 1997 Received: September 2, 1997
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
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Page 2 - Mr. Grisso
through 542 of the Act for devices under the Electronic enroagn Badiation 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 markets premits 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) 594-4618. 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" (21 CFR 807.97) . Other gener 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.fya.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timothy A Ulatows Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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INDICATIONS FOR USE
510 (k) Number (if known):
VanishPoint ® Syringe Device Name:
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 needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Patricia Cucerite
(Division Sign Division of C and General H E i Oik) Numb
Prescription Use /
Over-The-Counter Use _/
_
For allergy syringes
The-Counter Use __
for Insulin syringes
(Optional Format 1-2-96)
§ 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).