B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES

K071459 · B.Braun Medical, Inc. · FMF · Aug 16, 2007 · General Hospital

Device Facts

• Record ID: K071459
• Device Name: B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
• Applicant: B.Braun Medical, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Aug 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnifix piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body. The Omnican and Omnifix insulin syringes are intended for subcutaneous injection of insulin.

Device Story

Omnifix piston syringes and Omnican/Omnifix insulin syringes are manual medical devices. Omnifix syringes consist of a graduated hollow barrel and a movable plunger with a plunger tip, featuring luer lock or luer slip nozzles (centric or eccentric). Omnican insulin syringes feature an integrated needle bonded to the nozzle. Used by clinicians or patients for fluid injection or withdrawal. Omnican/Omnifix insulin syringes are specifically for subcutaneous insulin delivery. Devices are operated manually; no electronic or automated components. Benefit includes precise fluid delivery or withdrawal.

Clinical Evidence

Bench testing only. Biocompatibility and functional testing performed to verify safety and effectiveness.

Technological Characteristics

Piston syringe design; graduated hollow barrel; movable plunger with tip; luer lock or luer slip nozzles; integrated needle for insulin variants. Available in volumes 0.5 mL to 50 mL. Manual operation.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection or general fluid injection/withdrawal from the body.

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

• B. Braun Injekt Piston Syringe (K063280)
• NIPRO disposable hypodermic syringes with or without needle (K051574)
• BD Ultra Fine II, Micro Fine and Short Needle Insulin Syringes (K955235 and K024112)

Submission Summary (Full Text)

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K071459

Page 1 of 2

### 5. 510(k) Summary

AUG 1 6 2007

| | AUG 16 200 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341 |
| | Contact: Christine Ford, Regulatory Affairs Specialist<br>phone [phone] fax [phone] |
| DEVICE NAME: | Omnifix ^® Syringes, Omnican ^® and Omnifix Insulin<br>Syringes |
| COMMON OR USUAL<br>NAME: | Piston Syringes, Insulin syringes |
| DEVICE<br>CLASSIFICATION: | Piston Syringe<br>Class II, CFR Title 21 § 880.5860 |
| PREDICATE DEVICES: | B. Braun Injekt ^® Piston Syringe (K063280) |
| | NIPRO disposable hypodermic syringes with or without<br>needle (K051574) |
| | BD Ultra Fine II, Micro Fine and Short Needle Insulin<br>Syringes (K955235 and K024112) |
| DESCRIPTION: | The Omnifix piston syringes consist of a graduated hollow<br>barrel and a movable plunger with a plunger tip. One end of<br>the barrel has a male connector (nozzle), which permits<br>attachment to a female connector (hub). Both luer lock and<br>luer slip nozzles are available, with centric and eccentric<br>configurations. The Omnifix syringes will be available in<br>1 mL, 2 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL,<br>and 50 mL volume sizes, and as a 1 mL insulin syringe.<br>The Omnican insulin syringes have an integrated needle<br>bonded to the nozzle end of the syringes and are graduated<br>in units of insulin. The Omnican insulin syringes will be<br>available in sizes of 0.5 mL and 1 mL, and with a 30 gauge<br>needle in lengths of 8 mm and 12 mm. |
| INTENDED USE: | The Omnifix piston syringes are intended to be used to<br>inject fluid into, or withdraw fluids from, the body. The<br>Omnican and Omnifiy insulin curings |

Omnican and Omnifix insulin syringes are intended for

subcutaneous injection of insulin.

. . . . . . .

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# KD71459

page 2 of 2

### SUBSTANTIAL EQUIVALENCE:

The Omnifix® piston syringes and Omnican® and Omnifix insulin syringes have the same intended use, operation, and similar design and materials as the stated predicate devices, the B. Braun Injekt piston syringe, the NIPRO disposable hypodermic syringes with or without needle, and the BD Ultra Fine II, Micro Fine and Short Needle Insulin Syringes. Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Omnifix and Omnican syringes. There are no differences between the predicate and proposed devices that raise new issues of safety and effectiveness.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES. USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 6 2007

Ms. Christine Ford Regulatory Affairs Specialist B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K071459

Trade/Device Name: B. Braun Omnifix® Piston Syringes B.Braun Omnican® and Omnifix® Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 24, 2007 Received: May 25, 2007

Dear Ms. Ford:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Ford

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chris Lino, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement 4.

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K071459

Device Names: B. Braun Omnican® and Omnifix® Insulin Syringes

Indications For Use:

The B. Braun Omnican® and Omnifix® Insulin Syringes are intended for subcutaneous injection of insulin.

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Craton 2011

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

510(k) Number: __ Loggy S 9

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### Indications for Use Statement 4.

Page

510(k) Number (if known): K071459

Device Names: B. Braun Omnifix® Piston Syringes

Indications For Use:

The B. Braun Omnifix® Piston Syringes are intended to inject fluid into, or withdraw fluids from, the body.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clues

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

510(k) Number: K071459