LITE-TOUCH SYRINGE

K983430 · Medicore, Inc. · FMF · Feb 9, 1999 · General Hospital

Device Facts

• Record ID: K983430
• Device Name: LITE-TOUCH SYRINGE
• Applicant: Medicore, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For use in hospitals, clinics, home use for the delivery of insulin to diabetics.

Device Story

Lite-Touch Syringe is a manual medical device designed for the subcutaneous delivery of insulin. It is intended for use by patients or healthcare providers in clinical or home environments. The device functions as a standard syringe to draw and inject insulin doses. It provides a mechanical means for insulin administration, aiding in the management of diabetes. No electronic, software, or algorithmic components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual syringe for insulin delivery. No electronic components, software, or energy sources. Materials and specifications are consistent with standard medical syringe requirements.

Indications for Use

Indicated for the delivery of insulin to diabetic patients in hospital, clinic, or home settings.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Ms. Bonnie Kaplan Medicore™ 2647 West 81ªt Street Hialeah, Florida 33016

K983430 Re : Lite-Touch Syringe Trade Name: Regulatory Class: II Product Code: FMF November 13, 1998 Dated: Received: November 17, 1998

Dear Ms. Kaplan:

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, 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. ਸੇ 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 requlation 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 - Ms. Kaplan

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 [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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applying 510(k) Number (if known):

Device Name: Lite Touch Syringes

Indications For Use:

For use in hospitals, clinics, home use for the delivery of insulin to diabetics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Caceres

(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices

510(k) Number K983150

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X