(80 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (syringe) and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a general-purpose single-use piston syringe used for withdrawing or injecting fluids, not for delivering a therapeutic agent itself or providing a therapeutic effect.
No
Explanation: The "Intended Use" states that the device is "used to withdraw or inject first into the body." There is no mention of analysis, diagnosis, or assessment of a condition based on the withdrawn or injected substance (or anything else). It functions as a delivery or collection tool, not a diagnostic one.
No
The device description clearly states it is a "Piston Syringe," which is a physical hardware device used for injection or withdrawal of substances.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "withdraw or inject first into the body." This describes a device used on the body, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: A "Piston Syringe" is a tool for administering or withdrawing substances from the body, not for performing in vitro tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic, prognostic, or screening information
Therefore, this device falls under the category of a general medical device used for administering or withdrawing substances, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
General purpose single use piston syringe used to withdraw or inject first into the body. The device is sold as a sold as a sold as a sold and in a sold and is monther is sold device is sold device is not of The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle . attached and ready for use.
Product codes
FMF
Device Description
RAMY Piston Syringe
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
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
Image /page/0/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 abstract symbol resembling a human figure in profile, with flowing lines suggesting movement or connection. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Milton N. Beneke Jr. Official Correspondent Alshifa Medical Syringes Manufacturing Company, Ltd. C/O MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Jul 25 1997
Re : K971664 Trade Name: Ramy Syringe Regulatory Class: II Product Code: FMF Dated: May 2, 1997 Received: May 6, 1997
Dear Mr. Beneke Jr .:
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, qood 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. 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
1
Page 2 - Mr. Beneke Jr.
through 542 of the Act for devices under the Electronic through 542 or the nee al 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 described in your 510\n promatence of your device to a legally rinding of bubbeancial oquresults in a classification for your marketed predicate actro 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 ritro 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 che promotion and liance at (301) 594-4639. Also, please note the organs on centitled, "Misbranding by reference to che regaracion chororoa, (21 CFR 807.97) Other general information on your responsibilities under the Act may be Information on Jourision of Small Manufacturers Assistance obtained from enomber (800) 638-2041 or (301) 443-6597 or at at its corr free namber (6:1/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
EXHIBIT 1 Page_1__of__1_
510(k) Number (if known): 上971464
Device Name:RAMY_Piston_Syringe_____________________________________________________________________________________________________________________________________________
Indications For Use:
General purpose single use piston syringe used to withdraw or inject first into the body. The device is sold as a sold as a sold as a sold and in a sold and is monther is sold device is sold device is not of The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle . attached and ready for use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Patricia Cucovich |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971664 |
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)