AIRGUARD VALVED INTRODUCER

K042036 · C.R. Bard, Inc. · DYB · Aug 23, 2004 · Cardiovascular

Device Facts

• Record ID: K042036
• Device Name: AIRGUARD VALVED INTRODUCER
• Applicant: C.R. Bard, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The AirGuard™ Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system.

Device Story

AirGuard™ Valved Introducer is a catheter introducer featuring a passive valve design. It is used during percutaneous catheter placement to reduce air and blood leakage. The device consists of a PTFE sheath and is available in 15Fr and 16.5Fr sizes with lengths of 13cm and 18cm. It is intended for clinical use by healthcare professionals for venous access procedures.

Clinical Evidence

Bench testing only. Design verification testing was conducted in accordance with AAMI/ANSI/ISO-10993-1 (biocompatibility), AAMI/ANSI/ISO 11135 (sterilization), and ISO 11070 (sterile single-use intravascular catheter introducers). Results confirmed the device meets all performance criteria and is substantially equivalent to the predicate.

Technological Characteristics

Materials: PTFE sheath. Design: Passive valve for air/blood leakage reduction. Sizes: 15Fr and 16.5Fr; Lengths: 13cm and 18cm. Standards: AAMI/ANSI/ISO-10993-1, AAMI/ANSI/ISO 11135, ISO 11070. Sterilization: Ethylene oxide.

Indications for Use

Indicated for percutaneous insertion of catheters into the venous 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

• MedAmicus FlowGuard™Peelable Introducer (K040150)

Submission Summary (Full Text)

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K042036

AUG 2 3 2004

AirCinard 510(k)

# AirGuard™ Valved Introducer 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).

### General Information:

| Submitter Name: | Bard Access Systems, Inc. (BAS)<br>[Wholly owned Subsidiary of C. R. Bard, Inc.] |
|----------------------|----------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive<br>Salt Lake City, UT 84116 |
| Telephone Number: | [phone] ext. 5525 |
| Fax Number: | [phone] |
| Contact Person: | Glenn Norton |
| Date of Preparation: | August 20, 2004 |

### Device Information:

| Device Name: | AirGuard™ Valved Introducer |
|-----------------------|------------------------------------------------------------|
| Trade Name: | AirGuard™ |
| Common/Usual Name: | Catheter Introducer |
| Classification Name: | 74DYB - Introducer, Catheter<br>21 CFR 870.1340 - Class II |
| Classification Panel: | Cardiovascular and Respiratory Devices |

#### Predicate Device:

MedAmicus FlowGuard™Peelable Introducer, 510(k) K040150, FDA clearance date 02/18/2004

### Summary of Change:

The modification to the MedAmicus FlowGuard™Peelable Introducer is a passive valve design for improved reduction of air and blood leakage during percutaneous catheter placement.

### Device Description:

AirGuard™ Valved Introducers have a PTFE sheath and are available in 15Fr and 16.5Fr sizes, and in lengths of 13cm and 18cm.

### Intended Use of Devices:

AirGuard is recommended for use in the percutaneous insertion of cathelers in the venous system.

### Technological Comparison to Predicate Devices:

The technological characteristics of the AirGuard Valved Introducer are substantially equivalent to those of the predicate FlowGuard Peelable Introducer in terms of intended use, application, user population, basic design, performance, labeling, packaging, and sterilization method. Bench performance test results met all requirements and were comparable to the predicate device.

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Air Juarc 510(k)

### Non-Clinical Performance Data

Design verification testing was conducted in conformance to in-house protocols, and performed or evaluated based on the following standards:

- AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation . and testing, and the FDA Modified ISO 10993 Test Profile
- . AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of elhylene oxide sterilization
- . ISO 11070:1998(E), Sterile single-use intravascular catheter introducers

Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating, direct blood-contacting, limited-exposure devices.

All test results confirm the subject device to be substantially equivalent to the predicate device.

### Conclusion

AirGuard Valved Introducers met all performance criteria of design verification as specified by applicable standards, test protocols and/or customer inputs. Based on FDA's decision trees, the AirGuard Valved Introducer is substantially equivalent to the legally marketed predicate device, the MedAmicus FlowGuard™ Peelable Introducer, 510(k)# K040150, clearance date 02/18/2004.

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Public Health Service

AUG 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Access Systems, Inc. (BAS) c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

- Re: K042036
Trade/Device Name: AirGuard™ Valved Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: July 27, 2004 Received: July 29, 2004

Dear Mr. Mosenkis:

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 for associous 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 (IPMA). 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 I rease of a novel 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

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# Page 2 - Mr. Robert Mosenkis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rend wt 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) I ms lotter will and in yourse finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and th . . 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 in you a some 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 other generalional 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,

p

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Section 1-B

### AirGuard™ Valved Introduccr 510(K)

## INDICATION(S) FOR USE STATEMENT*

I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the AirGuard™ Valved Introducer is indicated for the following:

"The AirGuard™ Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system."

Signature of 510(k) Submitter:

Printed Name of Submitter:

Glenn Norton

Date:

7-7-04

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801. 4 of the Code of Federal Regulations, Title 21.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number

510(k) Number

Division Sign-Off
Office of Device Evaluation

000005