INJEKT SYRINGE

K063280 · B.Braun Medical, Inc. · FMF · Nov 17, 2006 · General Hospital

Device Facts

• Record ID: K063280
• Device Name: INJEKT SYRINGE
• Applicant: B.Braun Medical, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B. Braun Injekt® piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.

Device Story

B. Braun Injekt® Piston Syringe is a 2-piece manual device consisting of a calibrated hollow barrel and a movable plunger. Device lacks a plunger tip. Features male nozzle connectors (luer lock or luer slip) in centric or eccentric configurations. Used by clinicians to inject or withdraw fluids from the body. Operation is manual; device functions as a standard piston syringe for fluid transfer. No electronic, software, or automated components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

2-piece piston syringe design; calibrated hollow barrel; movable plunger without plunger tip. Available with luer lock or luer slip nozzles (centric/eccentric). Manual operation. No energy source. Non-electronic.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body. No specific patient population, age, or gender restrictions provided.

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

• NIPRO disposable hypodermic syringes with or without needle (K051574)

Submission Summary (Full Text)

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

## K063280

NOV 17 2006

## 5. 510(k) Summary

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>Contact: Christine Ford, Regulatory Affairs Specialist<br>phone [phone] fax [phone] |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Injekt® Piston Syringe |
| COMMON OR USUAL<br>NAME: | Piston Syringe |
| DEVICE<br>CLASSIFICATION: | Piston Syringe<br>Class II, CFR Title 21 § 880.5860 |
| PREDICATE DEVICE: | NIPRO disposable hypodermic syringes with or without<br>needle (K051574) |
| DESCRIPTION: | The B. Braun piston syringe is a 2-piece syringe consisting<br>of a calibrated hollow barrel and a movable plunger without<br>a plunger tip. One end of the barrel has a male connector<br>(nozzle), which permits attachment to a female connector<br>(hub). Both luer lock and luer slip nozzles are available,<br>with centric and eccentric configurations. |
| INTENDED USE: | The B. Braun Piston Syringes are intended to be used to<br>inject fluid into, or withdraw fluids from, the body. |
| SUBSTANTIAL<br>EQUIVALENCE: | The B. Braun Piston Syringes have the same intended use,<br>operation, and similar design as the stated predicate device,<br>the NIPRO disposable hypodermic syringes with or<br>without needle (K051574). There are no differences<br>between the predicate and proposed devices that raise new<br>issues of safety and effectiveness. |

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all caps and is evenly spaced around the circle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine Ford Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

NOV 17 2006

Re: K063280

Trade/Device Name: B. Braun Injekt® Piston Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 27, 2006 Received: October 31, 2006

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.

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

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 yours.

Suite Y. Michael Omis

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

{3}------------------------------------------------

## Indications for Use Statement 4.

Page

510(k) Number (if known): K063280

Device Name:

B. Braun Injekt® Piston Syringes

Indications For Use:

The B. Braun Injekt® piston syringes are intended to be used 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)

Ris C. Chaym for Apu 11/7/2000

nesthesiology, General Hospital, trol, Dental Dev

) Number. Ko632jo