(151 days)
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.
Onset Expandable Transseptal Introducer (BETI)
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the Onset Medical Corporation's Onset Expandable Transseptal Introducer (BETI), confirming its substantial equivalence to a predicate device. It defines the device’s indications for use but does not detail any studies or performance metrics the manufacturer may have submitted as part of their 510(k) application.
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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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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0029
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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§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).