BLUNT SYRINGE CANNULA

K971924 · B.Braun Medical, Inc. · FMI · Sep 25, 1998 · General Hospital

Device Facts

• Record ID: K971924
• Device Name: BLUNT SYRINGE CANNULA
• Applicant: B.Braun Medical, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

To be used with a syringe to pierce a pre-split rubber injection site.

Device Story

Blunt Syringe Cannula; used with syringe to access pre-split rubber injection sites; designed for needleless access; functions as interface between syringe and injection port; used in clinical settings; enables fluid transfer while minimizing needle-stick risk; provides mechanical access to medication delivery systems.

Clinical Evidence

No clinical data. Bench testing only, including sterility, pyrogenicity (LAL method), physical testing, and visual examination per established Quality Control Test Procedures.

Technological Characteristics

Blunt cannula design for pre-split rubber injection sites. Materials meet biocompatibility requirements per Tripartite Guidance. Sterilization and physical testing conform to GMP and internal design specifications.

Indications for Use

Indicated for use with a syringe to pierce pre-split rubber injection sites.

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.

Predicate Devices

• InterLink Syringe Cannula (K920422)
• SafeLine System (K913177)

Submission Summary (Full Text)

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K971924

May 20, 1997

# SEP 2 5 1998

#### II 510 (k) Summary

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 [phone]

Requlatory Affairs Manager Mark S. Alsberge, CONTACT:

PRODUCT NAME: Blunt Syringe Cannula

TRADE NAME: Blunt Syringe Cannula

CLASSIFICATION NAME:

General Hospital Class II,FMF, Piston Syringe 21 CFR. 880.5860

SUBSTANTIAL EQUIVALENCE, TO:

| 510 (k) number | Name | Applicant |
|----------------|------------------------------|------------------------|
| K920422 | InterLink Syringe<br>Cannula | Becton Dickinson, Inc. |
| K913177 | SafeLine System | McGaw, Inc. |

DEVICE DESCRIPTION:

B. Braun Medical Inc. intends to introduce into interstate commerce the Blunt Syringe Cannula. These have the same design and performance characteristics as the InterLink Syringe Cannnula currently marketed by Becton Dickinson and covered under K920422. It is also similar to McGaw's SafeLine System covered under K913177. The intended use is to be used with a syringe to pierce a pre-split rubber injection site.

+ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without

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premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.

### MATERIAL:

B. Braun Medical certifies that the biocompatibilty tests 'recommended in the Tripartite Guidance for this category of contact duration will be completed for all the materials used in the manufacture of the device.

## SUBSTANTIAL EQUIVALENCE:

The Blunt Syringe Cannula is equivalent in materials, form, and intended use to the InterLink Syringe Cannula currently marketed by Becton Dickinson, covered under K920422. There are no new issues of safety or effectiveness raised by the Blunt Syringe Cannula.

#### SAFETY AND EFFECTIVENESS:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually . required procedures are approved, released, distributed and revised in accordance with document control GMP"s.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 25 1998

Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 824 12th Avenue Bethlehem, Pennsylvania 18018-0027

K971924 Re: Trade Name: Blunt Syringe Cannula Regulatory Class: II Product Code: FMI Dated: August 26, 1998 Received: Auqust 31, 1998

Dear Mr. Alsberge:

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 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 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 regulation 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 - Mr. Alsberge

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 leqally 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 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.qov/cdrh/dsmamain.html",

Sincerely yours,

Susan Rumm

tw 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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1497 924 510(k) Number (if known): annula Device Name: Indications For Use: presslit SafeLine pierce To be used with rubber in iction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palazzo Puccerite

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

510(k) Number 4971924

Prescription Use
(Per 21 CFR 801.109)

:

OR

Over-The-Counter Use

(Optional Format 1-2-96)