(78 days)
Not Found
Not Found
No
The summary describes a simple mechanical syringe and explicitly states that AI, DNN, or ML were not found in the description.
No
The device is a syringe used to inject fluids, which is a delivery mechanism rather than a therapeutic treatment itself.
No
The device is described as a piston syringe used to inject fluids into the body, which is a therapeutic or delivery function, not a diagnostic one. There is no mention of measurement, analysis, or detection of a disease or condition.
No
The device description clearly states it is a "Single use piston syringe," which is a physical hardware device used for injecting fluids. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into the body." This is a direct interaction with the patient's body for therapeutic or diagnostic purposes (like administering medication or contrast agents), not for testing samples in vitro (outside the body).
- Device Description: A piston syringe is a tool for delivering substances into the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for clinical purposes. This syringe is used to introduce substances into the body.
N/A
Intended Use / Indications for Use
Single use piston syringe used to inject fluids into the body. The device has an integrated attached needle and can be sold for prescription or non-prescription use. The tuberculin syringe is for prescription use and the insulin syringe can be sold for non-prescription use. The syringes are sold sterile and are also non-pyrogenic and non-toxic.
Product codes
FMF
Device Description
Single use piston syringe with an integrated attached needle.
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 seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a bird with three human profiles inside of it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Milton N. Beneke, Jr. ·Official Correspondent Alshifa Medical Syringes Manufacturing Company, Itd. C/O MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re : K972452 JUL 2 4 1997 Trade Name: Ramy Syringe Regulatory Class: II Product Code: FMF Dated: May 5, 1997 Received: May 7, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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
1
Page 2 - Mr. Beneke, Jr.
through 542 of the Act for devices under the Electronic enrough Siz or chorol 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 findinq 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 ene regaracion chorosod) Missianalir by Dother 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,
Clivatast
Timoty A. Ulatowski 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):- K 9 72 4 5 2
Device Name: RAMY PISTON SYRINGE ·
Indications For Usc:
Single use piston syringe used to inject fluids into the body. The device has an integrated attached needle and can be sold for prescription or non-prescription use. The tuberculin syringe is for prescription use and the insulin syringe can be sold for non-prescription use. The syringes are sold sterile and are also non-pyrogenic and non-toxic.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Fabriccia Cccentr
Division of Dental, Infection Control,
and General Hospital Device
510(k) Number K972452
Prescription Use (Per 21 CFR 801.109)
ਾਲ
Over-The Counter Use Insulin
(Options) Forced 1-2-96)