BKMI DISPOSABLE SYRINGE

K971487 · Sumi Salud C.A. · FMI · Sep 4, 1997 · General Hospital

Device Facts

• Record ID: K971487
• Device Name: BKMI DISPOSABLE SYRINGE
• Applicant: Sumi Salud C.A.
• Product Code: FMI · General Hospital
• Decision Date: Sep 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

BKMI's Disposable Syringes, with or without attached BKMI disposable single lumen hypodermic needles, are intended to be sterile, single use, disposable, nonpyrogenic, nontoxic, calibrated, piston syringes intended for injecting fluids into, or withdrawing fluids out of, the body via a single lumen stainless steel hypodermic needle.

Device Story

BKMI Disposable Piston Syringe is a sterile, single-use, nonpyrogenic, nontoxic, calibrated manual syringe. Device consists of a piston-style barrel and plunger, optionally supplied with an attached stainless steel single lumen hypodermic needle. Used by clinicians or patients (for insulin) to inject fluids into or withdraw fluids from the body. Operation is purely mechanical; user manually depresses or retracts the plunger to create pressure differentials for fluid transfer. Benefits include sterile, disposable fluid delivery/aspiration, reducing cross-contamination risks associated with reusable devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual piston-style syringe; materials include plastic barrel/plunger and stainless steel needle. Sterile, single-use, nonpyrogenic, nontoxic. No electronic components or software.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body via single lumen stainless steel hypodermic needle. Intended for prescription use; also indicated for over-the-counter use as an insulin syringe.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 1997

Suzanne Parisian, M.D. Consultant & President Medical Device Assistance, Incorporated ...... P.O. Box 296 """" "" Front Royal, Virginia 22630

K971487 Re : BKMI Disposable Syringe Trade Name: Regulatory Class: İI Product Code: FMI Dated: August 7, 1997 Received: August 8, 1997

Dear Dr. Parisian:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

{1}------------------------------------------------

## Page 2 - Dr. Parisian

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control 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 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,

Richard

Timo hv A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## SECTION VI. INDICATIONS STATEMENT

510K Number (if known): K97/487

## Device Name: BKMI Disposable Piston Syringes With and Without Disposable Stainless Steel Single Lumen Hypodermic Needles

Indications for Use:

BKMI's Disposable Syringes, with or without attached BKMI disposable single lumen hypodermic needles, are intended to be sterile, single use, disposable, nonpyrogenic, nontoxic, calibrated, piston syringes intended for injecting fluids into, or withdrawing fluids out of, the body via a single lumen stainless steel hypodermic needle.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------------------|--------------------------------------|
| (Division Sign-Off) | Patricia Cucente |
| Division of Dental, Infection Control,<br>and General Hospital Devices | |
| 510(k) Number | K971487 |
| Prescription Use | V |
| OR | Over-the-counter Use Insulin Syringe |
| (Per 21 CFR 801.109) | (Optional Format 1-2-95) |