(102 days)
The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:
- Balloon dilatation of the stenotic portion of an arterial lesion
- Post-delivery expansion of balloon expandable stents
- Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.
Not Found
This document is a 510(k) clearance letter for the Metricath Gemini-P System. It is a regulatory document and does not contain information on acceptance criteria or a study proving device performance against such criteria. Therefore, I cannot provide the requested information based solely on the provided text.
Specifically, the document:
- States that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices.
- Lists the indications for use of the device: balloon dilatation, post-delivery expansion of balloon expandable stents, and measurement of arterial lumen cross-sectional area and diameter.
- Provides regulatory details such as regulation number, name, class, and product code.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts used to establish ground truth or adjudication methods for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
- A standalone performance study of the algorithm (as this is a medical device, not an AI/algorithm-based one in the context of typical standalone performance studies for AI).
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
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Mr. Tim Verspagen Regulatory Affairs Manager Angiometrx Inc. 1099 8th Avenue West, Suite 107 Vancouver, British Columbia Canada V6H-1C3
K051042 Re: Metricath Gemini-P System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: July 8, 2005 Received: July 10, 2005
Dear Mr. Verspagen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becomined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actuation the Medical Device Amendments, or to conninered prial to May 20, 1978, the exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (7107 market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controlo provisions 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 If your device is etablined (occare) ols. Existing major regulations affecting your device can thay be subject to suen additional connections, 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 - Mr. Tim Verspagen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Drissian that your device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must of any I cacal success and regaranents, 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. production of the or probegin marketing your device as described in your Section 510(k) I mis icter will anow you'll begin finding of substantial equivalence of your device to a legally premits to the month 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, Connact the Office of Company of Crification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general microal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna R. bo dines
GA 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
510(k) Number (if known): K051042
Device Name: The Metricath Gemini-P System
… 、 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ Indications For Use:
تحت تحت ترتان تيمي
The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:
- Balloon dilatation of the stenotic portion of an arterial lesion �
- Post-delivery expansion of balloon expandable stents .
- Measurement of arterial lumen cross sectional area and diameter proximal to a ● lesion, or within a stented section of artery.
× 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)
Dmma R. Vochner
Division Sign-Off)
Division of Cardiovascular Devices
ાંકા Number Kostoday
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).