INTROCAN SAFETY IV CATHETER

K021094 · B.Braun Medical, Inc. · DYB · Jul 3, 2002 · Cardiovascular

Device Facts

• Record ID: K021094
• Device Name: INTROCAN SAFETY IV CATHETER
• Applicant: B.Braun Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Introcan Safety IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

Device Story

Over-the-needle catheter with integrated passive safety clip mechanism; designed to prevent needle stick injuries. Upon needle withdrawal, safety clip automatically secures needle tip as it exits catheter hub. Available in 14G to 24G sizes. Used by clinicians for venous/arterial access or as an introducer for other vascular access devices. Passive safety feature activates automatically without user intervention, reducing risk of accidental needle sticks during clinical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Over-the-needle catheter; passive safety clip mechanism; sizes 14G-24G. Mechanical design for vascular access and introducer functionality.

Indications for Use

Indicated for patients requiring venous or arterial access for fluid, drug, or blood component infusion, or for the placement of vascular access devices (guidewires, central venous catheters, PICCs, midline catheters) into the vascular system.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• B. Braun Medical Inc. Introcan Safety IV Catheter (K982805)
• B. Braun Medical Inc. Introducer Catheter (K810460 / K810461)
• Becton Dickinson Infusion Therapy Systems Inc., BD Introsyte™ Autoguard™ Shielded Introducer (K013304)

Submission Summary (Full Text)

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## JUL 3 2002

| 7.0 | 510(k) Summary |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2280<br><br>Contact: Patricia D. Wilson, Regulatory Affairs Specialist |
| | |
| DEVICE NAME: | Introcan® Safety™ IV Catheter |
| COMMON OR USUAL<br>NAME: | Safety Intravascular Catheter / Safety Introducer Catheter |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR § 880.5200: Intravascular Catheter and<br>21 CFR § 870.1340: Catheter Introducer |
| PREDICATE DEVICE: | B. Braun Medical Inc. Introcan Safety IV Catheter (K982805)<br>B. Braun Medical Inc. Introducer Catheter (Kit component of<br>K810460 / K810461)<br>Becton Dickinson Infusion Therapy Systems Inc., BD Introsyte™<br>Autoguard™ Shielded Introducer (K013304) |
| DESCRIPTION: | The Introcan Safety IV Catheter consists of an over-the-needle<br>catheter with a safety clip feature. Upon removal of the needle<br>from the catheter, the safety clip is automatically secured over the<br>needle tip as it exits the catheter hub. The Introcan Safety IV<br>Catheter is available in sizes ranging from 14 Gauge through 24<br>Gauge. |
| INTENDED USE: | The Introcan Safety IV Catheter is a passive anti-needle stick<br>device to provide venous or arterial access for the infusion of<br>fluids, drugs, and/or blood components, or to facilitate the<br>placement of Vascular Access devices such as guidewires,<br>indwelling central venous catheters, peripherally inserted central<br>catheters, and midline catheters into the vascular system. |
| SUBSTANTIAL<br>EQUIVALENCE: | The Introcan Safety IV Catheter includes the same materials,<br>construction, design, and safety clip feature as the Introcan Safety<br>IV Catheter previously cleared under the B. Braun Medical Inc.<br>Premarket Notification, K982805. The Introcan Safety IV Catheter<br>is also similar in materials and design, with the exception of the<br>safety clip feature, as the introducer catheter previously cleared as<br>a kit component under the B. Braun Medical Inc. Premarket |

B Braun Medical Inc.
510(k) Premarket Notification
Introcan Safety IV Catheter

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Notifications, Burron Percutaneous Introducer Set (K810460) and Burron Central Vein Catherization Kit (K810461). The new indication for the Introcan Safety IV Catheter, for use as an introducer catheter, is the same indication previously cleared for Becton Dickinson Infusion Therapy Systems Inc.'s Premarket Notification, BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, K013304.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 3 - 2002 JUL

B. Braun Medical, Inc c/o Ms. Patricia D. Wilson Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, PA 18109-9341

K021094 Re: Introcan® Safety™ IV Catheter Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II (two) Product Code: 74 DYB Dated: April 3, 2002 Received: April 4, 2002

Dear Ms. Wilson:

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.

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.

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Page 2 - Ms. Patricia D. Wilson

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Dale Tuh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 2.0

Page ·

| 510(k) Number (if known): | K021094 |
|---------------------------|---------|
|---------------------------|---------|

Introcan® Safety™ IV Catheter Device Name:

Indications For Use:

The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

n Sign-Off vision of Cardiovascular and Respiratory Dev

510(k) Number

B. Braun Medical Inc. 510(k) Premarket Notification Introcan Safety IV Catheter

000005