(83 days)
Not Found
Not Found
No
The 510(k) summary describes a simple mechanical introducer sheath and does not mention any AI or ML related terms, image processing, or performance studies typically associated with AI/ML devices.
No.
The device is an introducer sheath used for the introduction and removal of vascular catheters, which is a procedural accessory rather than a device designed to directly treat a medical condition.
No
The device is described as an "introducer sheath" used for the "introduction and removal of vascular catheters." Its stated purpose is related to access and hemostasis, not the diagnosis of a condition.
No
The device description and intended use clearly describe a physical medical device (Introducer Sheath with hemostasis valve) used for introducing catheters, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction and removal of vascular catheters". This is a procedure performed in vivo (within the living body) to access blood vessels.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Reagents, calibrators, or controls used for testing.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool used during a medical procedure, not for analyzing samples.
N/A
Intended Use / Indications for 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.
Product codes
74 DYB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Heartport® Endoarterial Return™ Cannula
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 introducer |
| 21 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.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles a caduceus, a traditional symbol of medicine, with a staff and intertwined snakes.
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
3
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)