INTROCAN SAFETY IV CATHETER

K982805 · B.Braun Medical, Inc. · FOZ · Jan 14, 1999 · General Hospital

Device Facts

• Record ID: K982805
• Device Name: INTROCAN SAFETY IV CATHETER
• Applicant: B.Braun Medical, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

Device Story

Introcan Safety I.V. Catheter is a passive anti-needle stick peripheral intravenous catheter. It is used in clinical settings for the infusion of fluids, drugs, and blood components. The device functions as a standard catheter with an integrated safety mechanism to prevent needle stick injuries during insertion. It is operated by healthcare professionals. The device provides a secure venous access point, benefiting patients by facilitating therapy delivery while protecting clinicians from accidental needle sticks.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination in accordance with established Quality Control Test Procedure documents and cGMP requirements to ensure compliance with design specifications.

Technological Characteristics

Peripheral I.V. catheter with passive anti-needle stick safety mechanism. Materials tested per ISO 10993. Device is a sterile, single-use medical device.

Indications for Use

Indicated for use as a passive anti-needle stick device for placement in a peripheral vein for the infusion of fluids, drugs, and/or blood components.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Microcath™ Intravenous Catheter Placement Unit and Catheter (K801941)

Submission Summary (Full Text)

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K98.2805

August 4, 1998

JAN 1 4 1999

# II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

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

Mark S. Alsberge, Regulatory Affairs Director Contact:

Introcan Safety I.V. Catheter Product Name:

Trade Name: Catheter, Intravascular, Short Term

Classification name:

Hospital Class II, 80FOZ 21 CFR 880.5200

## SUBSTANTIAL EQUIVALENCE1 TO:

| 510(k) number | Name | Applicant |
|---------------|----------------------------------------------------------------------|---------------------|
| K801941 | "Microcath" ™ Intravenous<br>Catheter Placement Unit and<br>Catheter | Burron Medical Inc. |

#### Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Introcan Safety I.V. Catheter which is a passive antineedle stick device. The device is to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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### Material:

The Introcan Safety I.V Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.

#### Substantial equivalence:

The Safety I. V. Catheter is similar in materials, form and intended use to the Microcath™ cleared by B. Braun Medical Inc. formally known as Burron Medical. There are no new issues of safety or effectiveness raised by The Safety I.V. Catheter.

### 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; 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 cGMP"s.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

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

K982805 Re : Trade Name: Introcan Safety I.V. Catheter Regulatory Class: II Product Code: FOZ Dated: November 9, 1998 Received: November 12, 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 The general controls provisions of the Act 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. A 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 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 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/gov/cdrh/dsmamain.html".

Sincerely yours

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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510(k) Number (if known): I.V. Ca the fer afety strocan Device Name: anti-needle Stick device to be Indications For Use: Dassive antify frem.
Specipheral vein for the infusion of

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Snucenik

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

510(k) Number 49782805

Prescription Use
(Per 21 CFR 801.109)

。

OR

Over-The-Counter Use

(Optional Forrazt 1-2-96)