(50 days)
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Angiometrix Inc. Metricath System, dated November 18, 2004. This type of document primarily confirms that a medical device is substantially equivalent to a predicate device already on the market and describes its intended use. It does not typically contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way a clinical study report or a technical design document would.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The letter does not specify quantitative acceptance criteria or detailed performance results. It only states that the device is "substantially equivalent."
- Sample size used for the test set and the data provenance: No information on test set size or data origin (e.g., country, retrospective/prospective) is present.
- Number of experts used to establish the ground truth for the test set and their qualifications: No details about ground truth establishment or expert involvement are provided.
- Adjudication method: The document does not describe any adjudication process.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study or any associated effect size.
- Standalone (algorithm only) performance: This device is a physical catheter system, not a software algorithm, so standalone performance in the sense of AI models is not applicable.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not applicable for this type of device and document.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is:
- Device Name: The Metricath System
- Indications for Use: "The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery."
- Regulatory Classification: Class II (two), Product Code: DQO, Regulation Number: 21 CFR 870.1200 (Diagnostic Intravascular Catheter)
- Predicate Device: Not explicitly named, but the letter states the device is substantially equivalent to "legally marketed predicate devices."
- Date of Clearance: November 18, 2004
To get the specific information requested in the prompt, one would need to review the original 510(k) submission (K042685) itself, which would contain the technical data and study reports submitted to the FDA to demonstrate substantial equivalence. The clearance letter only summarizes the FDA's decision.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Angiometrix Inc. c/o Mr. Tim Verspagen Regulatory Affairs Manager 107-1099 8th Avenue West Vancouver. BC Canada V6H 103
Re: K042685 Metricath System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: September 27, 2004 Received: September 29, 2004
Dear Mr. Verspagen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat nave been receasined in quire approval of a premarket approval application (PMA). alle Costience Act (11ct) that as not require appear al controls provisions of the Act. The I ou may, merclore, mailer of the Act include requirements for annual registration, listing of general controls provider and prohibitions 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 blubsition (600 a00 m) ols. Existing major regulations affecting your device can may be subject to back as a success 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 - Mr. Tim Verspagen
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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Va. Aanes
Image /page/1/Picture/6 description: The image contains what appears to be a signature. The signature is composed of a few strokes, with a loop-like structure on the left side and a more angular line extending to the right. The overall impression is that of a quick, stylized autograph.
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): K042685
Device Name: The Metricath System
Indications For Use:
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.
Prescription Use x (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)
Duma P. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
010(K) Number_K0426 85
Page 1 of 1
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).