(84 days)
The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the American Syringe Company's 1cc and 3cc Syringe with Needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.
This type of submission does not typically include detailed performance data, acceptance criteria, or clinical study results in the way that, for example, a submission for a new AI-powered diagnostic device would. For syringes, equivalence is often established primarily through design specifications, material conformance to ISO standards, and sometimes physical performance testing against predicate devices, rather than clinical efficacy studies with expert consensus ground truth.
Therefore, many of the requested details are not present in this document. Based on the information available, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance for the American Syringe Company's 1cc and 3cc Syringe with Needle. For this type of device, acceptance criteria would typically relate to factors like:
- Dimensional conformity: Meeting specified lengths, diameters, and volumes.
- Material compatibility: Ensuring materials are non-toxic and compatible with intended medications.
- Sterility: Ability to maintain sterility until use.
- Functionality: Smooth plunger movement, secure needle attachment, accurate dose delivery markings, no leakage, sufficient needle sharpness and strength.
- Biocompatibility: Absence of adverse reactions.
- Packaging integrity.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided in this document. The 510(k) pathway for a basic device like a syringe often relies on established standards and predicate device comparisons rather than extensive clinical testing with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth in the context of expert review for medical imaging or diagnostics is not relevant for a simple medical device like a syringe.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable. This device is a syringe, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable in the conventional sense. For a syringe, "ground truth" would relate to its physical and functional specifications as verified through engineering tests against recognized standards (e.g., ISO standards for syringes and needles), rather than expert consensus or pathology on biological samples.
8. The sample size for the training set
Not applicable. There is no machine learning model or "training set" for a syringe.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2003
Mr. David M. Garvin President American Syringe Company 1200 Brickell Avenue, Suite 1480 Miami. Florida 33131
Re: K031394
Trade/Device Name: American Syringe Company 1cc and 3CC Syringe with Needle Regulation Number: 880.5860, 880. 5570 Regulation Name: Piston Syringe, Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF, FMF, FMI Dated: May 1, 2003 Received: May 2, 2003
Dear Mr. Garvin:
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 vour 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. Garvin
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/dsma/dsmamain.html
Sincerely yours,
fer
Susan Runner, DDDS, MA Interim 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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ins
INDICATIONS FOR USE
| 510(k) Number: | K031394 (To be assigned by FDA) |
|---|---|
| Device Name: | American Syringe Company 3cc Syringe with Needle |
| Indications For Use: | The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDLED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓ | OR Over - The - Counter Use ✓ |
|---|---|
| --------------------------------------------------------------------- | -------------------------------------------------------------------------------- |
(Per 21 CFR 801.109)
Patricia Cucenito
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number: K031394
§ 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).