(613 days)
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No
The summary describes a glass syringe and its intended uses, focusing on material properties and function. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is described as a "GlassVan" Glass Syringe used to administer medication or draw samples, which are functions of a delivery or diagnostic tool rather than a therapeutic one.
No
The description states the device is used to "administer medication or draw sample," which are primarily therapeutic or sample collection functions, not diagnostic ones. There is no mention of analysis or diagnosis based on the sample or the device's function.
No
The device description clearly states "GlassVan" Glass Syringe, indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer medication or draw sample." This describes a device used for direct interaction with a patient's body (administering medication) or collecting a sample from a patient's body (drawing sample).
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Activities: The description does not mention any analysis or testing of samples in vitro (in a lab setting). It focuses on the physical act of administering or collecting.
Therefore, the "GlassVan" Glass Syringe, as described, is a medical device used for patient care, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
FMF
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 & 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
1
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)