UNIFINE

K983994 · Owen Mumford USA, Inc. · FMF · Jan 8, 1999 · General Hospital

Device Facts

• Record ID: K983994
• Device Name: UNIFINE
• Applicant: Owen Mumford USA, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The device is for the subcuraneous injection of insulin.

Device Story

Unifine syringes are piston-style insulin syringes used for subcutaneous insulin delivery. The device is identical to the Omnican range of syringes manufactured by B Braun. Owen Mumford distributes these syringes without modification, re-packaging, or reworking. Syringes are supplied in 0.3ml and 0.5ml sizes, individually packaged in peel pouches, and sterilized via ethylene oxide. The device is intended for use by patients or healthcare providers for insulin administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston syringe for subcutaneous insulin injection. Available in 0.3ml and 0.5ml volumes. Sterilized using ethylene oxide. Supplied in peel pouches.

Indications for Use

Indicated for subcutaneous injection of insulin in patients requiring insulin therapy.

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.

Predicate Devices

• Omnican Insulin Syringe (K962084)

Submission Summary (Full Text)

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K983994

8 1999 JAN

## 510(k) SUMMARY

| DATE OF APPLICATION: | 1ª August 1998 |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| APPLICANTS ADDRESS: | Owen Mumford Inc<br>849 Pickens Industrial Drive<br>Suite 14<br>Marietta<br>GA 30062<br>USA |
| CONTACT: | Mr Robert Shaw |
| POSITION: | Director |
| TEL: | 770 425 5138 |
| FAX: | 770 426 5365 |
| REGISTRATION No: | 1058602 |
| TRADE NAME | Unifine |
| COMMON NAME: | Insulin syringes |
| CLASSIFICATION NAME: | Piston Syringe |
| CLASS: | 2 |
| CLASSIFICTION PANEL: | General Hospital |
| PANEL CODE: | 80 HO |
| CFR NUMBER: | 880.5860 |
| SUBSTANTIAL EQUIVALENCE | The product is substantially equ<br>Omnican Insulin Syringe manuf<br>distributed by B Braun (K96208 |

### rivalent to the factured and distributed by B Braun (K962084).

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# DEVICE DESCRIPTION

The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.

#### STATEMENT OF INTENDED USE

The device is for the subcuraneous injection of insulin.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 JAN

Mr. Robert E. Shaw Owen Mumford, Incorporated 849 Pickens Industrial Drive Suite 14 30062-3165 Marletta, Georgia

Re : K983994 Trade Name: Unifine Requlatory Class: II Product Code: FMF November 6, 1998 Dated: November 9, 1998 Received:

Dear Mr. Shaw:

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 legally marketed predicate 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 The general controls controls provisions of the Act. 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. ਬੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Shaw

through 542 of 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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# UNIFINE SYRINGES 510(k) SUBMISSION

510(k) Number: Not Known

Device Name: Unifine

Indications for Use:

The Unifine range of Syringes is designed for the subcutaneous injection of insulin.

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ Qver-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21CFR 801.109) ivision Sign-Off ivision 1 Theat Informon Control, and General 14.0 period Devices 6 510(k) Number _ Page 8 of 9