(83 days)
The Introducer Sheath with hemostasis valve is indicated for patients requiring introduction of catheters. It is intended for the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ Catheter.
Not Found
This document does not contain information about acceptance criteria, device performance, ground truth, or study details such as sample size, expert qualifications, or adjudication methods for a medical device.
The provided text is a 510(k) summary for the Heartport® Introducer Sheath from 1997. It explicitly states that "Performance testing of the subject device was not deemed necessary based on equivalence to the predicate device." This means that no specific performance study was conducted to establish acceptance criteria for the new device as its safety and effectiveness were established by demonstrating substantial equivalence to an already marketed predicate device (Heartport® Endoarterial Return™ Cannula).
Therefore, I cannot fulfill the request to provide the tables and information requested, as it is not present in the provided text.
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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _
Applicant Information:
Date Prepared: July 9, 1997 Heartport, Inc. Name: 200 Chesapeake Drive Address: Redwood City, CA 94063 OCT - 1 1997
Contact Person: Marianne C. Drennan Phone Number: (415) 482-4405 (415) 482-4346 Fax Number:
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport® Introducer Sheath |
| Common Name: | Cardiovascular Surgical Devices - Catheter introducer21 CFR 870.1340 |
Equivalent Devices:
The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport® Endoarterial Return™ Cannula.
Intended Use:
The Introducer Sheath with hemostasis valve is indicated for patients requiring introduction of catheters. It is intended for the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ Catheter.
Non-Clinical Test Results:
Performance testing of the subject device was not deemed necessary based on equivalence to the predicate device. The materials used in the subject device have proven biocompatibility.
Summary:
Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10.1 - 1
Ms. Marianne C. Drennan Heartport, Inc. 200 Chesapeake Drive Redwood City, California 94063
Re: K972570 Heartport® Introducer Sheath Regulatory Class: II (two) Product Code: 74 DYB August 20, 1997 Dated: Received: August 22, 1997
Dear Ms. Drennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Marianne C. Drennan
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4639. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet
Sincerely yours,
address "http://www.fda.gov/cdrh/dsmamain.html".
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health · · · ·
Enclosure
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Indications for Use
XG72570 510(k) Number (if known): _
Heartport® Introducer Sheath with Hemostasis Valve Device Name:
Indications for Use:
本日本最重要 - 2017-08-28 10:48:
The Introducer Sheath with hemostasis valve is indicated for patients requiring introduction of catheters. It is intended for the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ Catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tia A R
Prescription Use (Per 21 CFR 801.109)
OR
Over- The Counter Use (Optional Format 1-2-96)
§ 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).