BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

K062852 · Onset Medical Corporation · DYB · Feb 23, 2007 · Cardiovascular

Device Facts

• Record ID: K062852
• Device Name: BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
• Applicant: Onset Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

Device Story

The Onset Balloon Expandable Transseptal Introducer (BETI) is a catheter-based device designed to facilitate access to the left atrium. It functions by creating a conduit through the inter-atrial septum. The device utilizes a balloon-expandable mechanism to dilate the septal puncture, allowing for the subsequent introduction of various cardiovascular catheters. It is intended for use by physicians in a clinical or hospital setting during cardiovascular procedures. By providing a stable conduit, the device assists clinicians in performing diagnostic or therapeutic interventions within the left heart chambers.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Balloon-expandable catheter system designed for transseptal access. Materials and dimensions are consistent with standard cardiovascular introducer catheters. The device is a mechanical system; no software, electronics, or energy sources are utilized.

Indications for Use

Indicated for patients requiring transseptal access to the left side of the heart for the introduction of cardiovascular catheters.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2007

Onset Medical Corporation c/o Albert Rego, PhD 27001 La Paz Suite 312 Mission Viejo, CA 92691

Re: K062852

Onset Expandable Transseptal Introducer (BETI) Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: II Product Code: DYB Dated: January 18, 2007 Received: January 23, 2007

Dear Dr. Rego:

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.

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Page 2 - Albert Rego, PhD

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. 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 Office 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 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,

Duna D. W. Danes

3Bram 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

510(k) Number (if known):_Unknown KD6285V

Device Name: Onset Medical Balloon Expandable Transseptal Inroducer

Indications For Use:

The Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Lachine
(Print Name)

(Division Sign-Off) Division of Cardion of Cardion

510(k) Number_ K062852

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