INTROCAN SAFETY IV CATHETER

K020785 · B.Braun Medical, Inc. · FOZ · Aug 28, 2002 · General Hospital

Device Facts

• Record ID: K020785
• Device Name: INTROCAN SAFETY IV CATHETER
• Applicant: B.Braun Medical, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

Device Story

Passive needle stick prevention device; provides venous or arterial access for infusion of fluids, drugs, or blood components. Available in 14-24 gauge sizes; includes winged and non-winged versions. 14-22 gauge models compatible with power injectors (max 300 psi). Used in clinical settings by healthcare professionals. Device design incorporates safety mechanism to prevent needle stick injuries during insertion. Output is established vascular access for therapeutic delivery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive safety IV catheter; 14-24 gauge; winged and non-winged configurations. Materials and design identical to predicate K982805. Compatible with power injectors up to 300 psi for 14-22 gauge sizes.

Indications for Use

Indicated for patients requiring venous or arterial access for infusion of fluids, drugs, or blood components. 14-22 gauge catheters are compatible with power injectors up to 300 psi.

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

• Introcan Safety IV Catheter (K982805)
• JELCO™, JELCO-W™ and JELCO Plus I™ (K990236)
• INSYTE®, INSYTE-W® and INSYTE® AUTOGUARD II catheters (K971339)

Submission Summary (Full Text)

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## AUG 2 8 2002

## 7.0 510(k) Summary

:

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2579<br><br>Contact: Amy S. Krall, RA Specialist |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Introcan ® Safety™ IV Catheter |
| COMMON OR USUAL NAME: | Safety Intravascular Catheter |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 880.5200: Intravascular Catheter and<br>880.5440: Intravascular Administration Set |
| PREDICATE DEVICE: | B. Braun Medical Inc.<br>Introcan Safety IV Catheter, K982805.<br>Johnson and Johnson<br>JELCO™, JELCO-W™ and JELCO Plus I™, K990236<br>Becton Dickinson<br>INSYTE®, INSYTE-W® and INSYTE® AUTOGUARD II catheters, K971339 |
| DESCRIPTION: | B. Braun Medical's Introcan Safety IV Catheter is a passive<br>needle stick prevention device used for arterial and venous<br>access for the infusion of fluids, drugs and/or blood<br>components. 14 - 22 gauge catheters may be used with<br>power injectors for which the maximum pressure setting is<br>300 psi.<br><br>The Introcan Safety IV Catheter is available in 14 - 24<br>gauge sizes, and both winged and non-winged versions. |
| INTENDED USE: | Passive anti-needle stick device for venous or arterial<br>access for the infusion of fluids, drugs, and/or blood<br>components. 14 - 22 gauge catheters may be used with<br>power injectors for which the maximum pressure setting is<br>300 psi. |
| SUBSTANTIAL EQUIVALENCE: | The Introcan Safety IV Catheter is identical in materials<br>and design to B. Braun Medical's premarket notification,<br>Introcan Safety IV Catheter, K982805. The Introcan Safety |
| 000014 | |

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IV Catheter is similar in indications for use to Johnson and Johnson Jelco™ catheters, K990236 and Becton Dickinson INSYTE® catheters, K971339. Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use
for the Introcan® Safety™ IV Catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble an abstract human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2002

Ms. Amv S. Krall Regulatory Affairs Specialist B. Braun Medical, Incorporated 824 Twelfth Avenue Bethlehem, Pennsylvania 18018

Re: K020785

Trade/Device Name: Introcan SafetyTM IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 18, 2002 Received: June 19, 2002

Dear Ms. Krall:

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.

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Page 2 - Ms. Krall

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 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,

Timothy A. Ulatowski

Timo 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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## 2.0 Indications for Use Statement

-Page

| 510(k) Number (if known): | K020785 |
|---------------------------|---------|
|---------------------------|---------|

Introcan® Safety™ IV Catheter Device Name:

Indications For Use:

Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

(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

Pactrice Cuenito
(Division Sign-Off)

ision of Anesthesiology, General Hospital, Infection Control, Dent

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510(k) Number: K020785