(613 days)
To be used to administer medication or draw sample. To be used in applications that require clarity that only glass can offer or applications that require smooth plunger movement / control that is not possible with plastic syringe. Also to be used in applications where use of plastic syringe may cause contamination due to reaction of plastic with dispensed substance. May also be used in applications that require stability at extreme temperature.
"GlassVan" Glass Syringe
There's a critical misunderstanding here. The provided text is a 510(k) clearance letter from the FDA for a medical device: "Glass Van" Glass Syringes.
This document does not contain any information about a study proving the device meets acceptance criteria in the way you've described for an AI/algorithm-based device.
Instead, a 510(k) clearance is based on demonstrating substantial equivalence to a predicate, legally marketed device. This typically involves showing that the new device has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, that those differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the information requested in your bullet points because the input document does not contain that type of data.
To be clear:
- There's no mention of acceptance criteria in terms of accuracy, sensitivity, specificity, etc., as typically applied to performance studies of diagnostic algorithms.
- There's no study described with a test set, training set, experts, ground truth, or MRMC study.
The FDA letter confirms that the "Glass Van" Glass Syringes are substantially equivalent to a previously marketed device, allowing them to be marketed. This is a regulatory pathway, not a performance study report for an AI or algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1638 MAY
Mr. Sanjiv Kumar ·President Myco Medical Supplies, Incorporated 101 Rose Valley Woods Drive Cary, North Carolina 27513, USA
Re : K963364 Trade Name: "Glass Van" Glass Syringes Regulatory Class: II Product Code: FMF Dated: January 31, 1998 Received: February 12, 1998
Dear Mr. Kumar:
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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Mr. Kumar
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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) 594-4692. 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 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.gpv/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) Number (if known): _ K963364
"GlassVan" Glass Syringe Device Name: _________________________________________________________________________________________________________________________________________________________________
Indication For Use:
To be used to administer medication or draw sample. To be used in applications that require clarity that only glass can offer or applications that require smooth plunger movement / control that is not possible with plastic syringe. Also to be used in applications where use of plastic syringe may cause contamination due to reaction of plastic with dispensed substance. May also be used in applications that require stability at extreme temperature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Brimh Bakker
(Division Sign-Off) Division of Dental, Infection On ntrol, and General Hospital t 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use √ Insulin Syringe
only
(Optional Format 1-2-96)
(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).