(84 days)
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Not Found
No
The 510(k) summary describes a standard syringe and contains no mention of AI, ML, or related concepts.
No
Explanation: The device is a syringe, which is used for injection of medication, not for direct therapeutic treatment itself.
No
The device, a 3cc syringe, is indicated for the injection of medication, which is a treatment modality, not a diagnostic one.
No
The device is described as a "3cc Syringe," which is a physical medical device used for injection. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the injection of medication into a patient." This describes a device used on a patient for therapeutic purposes (delivering medication), not a device used on a sample taken from a patient for diagnostic purposes (testing the sample).
- Lack of IVD Indicators: The description does not mention anything related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing diseases or conditions
- Determining the state of health
- Screening for diseases
- Monitoring treatment
IVDs are specifically designed to perform tests on samples taken from the body to provide information about a person's health. A syringe used for injecting medication is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient.
Product codes
FMF, FMF, FMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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.
1
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
2
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