AVALON ELITE VASCULAR ACCESS KIT

K081940 · Avalon Laboratories, LLC · DRE · Nov 18, 2008 · Cardiovascular

Device Facts

• Record ID: K081940
• Device Name: AVALON ELITE VASCULAR ACCESS KIT
• Applicant: Avalon Laboratories, LLC
• Product Code: DRE · Cardiovascular
• Decision Date: Nov 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

Intended for single use by trained physician to assist in vessel cannulation.

Device Story

Avalon Elite Vascular Access Kit is a procedural kit containing dilators, guide wire, scalpel, introducer needle, and syringe. Used by trained physicians in clinical settings to facilitate vessel cannulation. The kit provides the necessary mechanical components to gain vascular access for subsequent catheterization procedures. It is a single-use device.

Clinical Evidence

No clinical data. Performance established via bench testing including biocompatibility, packaging integrity, transportation integrity, sterilization validation, and functional testing.

Technological Characteristics

Kit includes dilators, guide wire, scalpel, introducer needle, and syringe. Mechanical device for percutaneous access. Sterilized for single use. No electronic or software components.

Indications for Use

Indicated for use by trained physicians to assist in vessel cannulation for single-use procedures.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Estech Percutaneous Insertion Dilator Kit (K070749)

Submission Summary (Full Text)

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K081940

## NOV 1 8 2008

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510(k) Summary As required by Section 807.92 (c)

| Owner's Name: | Avalon Laboratories, LLC |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2610 E. Homestead Place<br>Rancho Dominguez, CA 90220<br>USA |
| Phone: | 310 761-8660 |
| Fax: | 310 761-8665 |
| Contact Person: | Lee Wirth/Director of Quality Assurance and Regulatory Affairs |
| Summary Prepared: | July 3, 2008 |
| Name of device: | Vascular Access Kit |
| Trade/Proprietary Name: | Avalon Elite Vascular Access Kit |
| Classification Name: | 21 CFR 870.1310 - Dilator |
| Product Code: | DRE |
| Substantially Equivalent: | K070749 Estech Percutaneous Insertion Dilator Kit |
| Description: | Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe. |
| Intended Use: | Intended for single use by trained physician to assist in vessel cannulation. |
| Comparison to Predicate: | Similar in terms of design (physical characteristics), materials, content, intended use, performance characteristics, packaging, and sterilization. |
| Supporting Data: | Validation Testing was used to establish the performance characteristics of the Vascular Access Kit as follows:<br>● Biocompatibility<br>● Packaging Integrity<br>● Transportation Integrity<br>● Sterilization Validation<br>● Functional Testing |
| Conclusions: | The results of these validation tests demonstrate the kit is as safe and effective as the legally marketed predicate device. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 8 2008

Avalon Laboratories, LLC c/o Mr. Lee Wirth Director, QA/RA 2610 E. Homestead Place Rancho Dominquez, CA 90220

Re: K081940

> Trade/Device Name: Avalon Elite Vascular Access Kit Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: September 23, 2008 Received: September 26, 2008

Dear Mr. Wirth:

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 agencics. 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

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Page 2 - Mr. Lee Wirth

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

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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## Indications for Use

K 081940 510(k) Number (if known):

Device Name: Avalon Elite Vascular Access Kit

Indications For Use: intended for single use by trained physician to assist in vessel cannulation.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

(Division Sign-Off)

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