GLASS VAN GLASS SYRINGES

K963364 · Myco Medical Supplies, Inc. · FMF · May 1, 1998 · General Hospital

Device Facts

• Record ID: K963364
• Device Name: GLASS VAN GLASS SYRINGES
• Applicant: Myco Medical Supplies, Inc.
• Product Code: FMF · General Hospital
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

GlassVan glass syringe; manual device for medication administration or sample collection. Provides high clarity, smooth plunger movement, chemical resistance, and thermal stability compared to plastic alternatives. Used by clinicians or patients (insulin) in clinical or home settings. Simple mechanical operation; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Glass syringe; manual operation; provides chemical inertness and thermal stability. No electronic components, software, or connectivity.

Indications for Use

Indicated for administration of medication or sample collection in clinical or home settings where glass material properties (clarity, smooth plunger movement, chemical inertness, or thermal stability) are required. Includes prescription use and OTC use for insulin syringes.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 1 1998

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 Regulations, Title 21, Parts 800 to 895. A 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
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

Device Name: "GlassVan" Glass Syringe

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)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Office
510(k) Number K963364

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑ Insulin Syringe Only
(Optional Format 1-2-96)