(218 days)
The IVT 0.014" PTFE-Coated Trackwire is indicated for use in coronary and peripheral vessels to facilitate the navigation and placement of angioplasty interventional catheters. The 0.014" Trackwire is not indicated for cerebrovascular use.
The IVT 0.014" PTFE-Coated Trackwires have a nominal diameter of 0.014 inches and nominal lengths from 175 to 300 centimeters. The distal 1-3 centimeters of the Trackwire is shapeable. The distal 2-6 centimeters contains a radiopaque coil. The proximal section of the Trackwire is coated with a fluorinated polymer.
The provided document is a 510(k) summary for a medical device, the IVT 0.014" PTFE-Coated Trackwire. It relates to a premarket notification to the FDA for a medical device and not an AI/ML powered device. This type of document is about demonstrating substantial equivalence to existing predicate devices, primarily through physical performance testing and biocompatibility. As such, it does not contain the information requested in your prompt regarding acceptance criteria and studies that prove an AI/ML device meets them.
Specifically, the document does not contain any of the following information:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample size used for the test set or data provenance for an AI/ML model.
- Number of experts used to establish ground truth or their qualifications for an AI/ML model.
- Adjudication method for an AI/ML model test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How the ground truth for an AI/ML training set was established.
The document details the device's description, intended use, and substantial equivalence to physical predicate devices, based on physical performance testing and biocompatibility. It's a regulatory submission for a physical medical product, not a software or AI/ML algorithm.
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Section 2 – 510(k) Summary
In accordance with 21 CFR §807.92, a 510(k) Summary for the IVT 0.014" PTFE-Coated Trackwire is presented on the following page.
DEC | | |997
510(k) Notification -- PTFE-Coated Trackwire (Rev 05/05/97)
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510(k) Summary
| Date: | May 5, 1997 | |
|---|---|---|
| Submitter: | InterVentional Technologies, Inc.3574 Ruffin RoadSan Diego, CA 92123Tel: (619) 268-4488 | DEC 1 1997 |
| Contact Person: | Kevin E. DalyDirector, Regulatory Affairs/Compliance Standards | |
| Device Proprietary Name: | IVT 0.014" PTFE-Coated Trackwire | |
| Device Common Name: | Catheter Guide Wire (§870.1330) | |
| Predicate Devices: | IVT 0.014" Trackwire;ACS Hi-Torque Guide Wires with Microglide Coating;Cordis Stabilizer Guidewires with Duraglide PTFE Coating. | |
| Device Description: | The IVT 0.014" PTFE-Coated Trackwires have a nominal diameter of 0.014inches and nominal lengths from 175 to 300 centimeters. The distal 1-3centimeters of the Trackwire is shapeable. The distal 2-6 centimeterscontains a radiopaque coil. The proximal section of the Trackwire is coatedwith a fluorinated polymer. | |
| Intended Use: | The IVT 0.014" Trackwire is recommended for use to facilitate thenavigation and placement of angioplasty interventional catheters throughcoronary and peripheral vessels. The 0.014" Trackwire is not indicated forcerebrovascular use. | |
| Substantial Equivalence: | The IVT 0.014" Trackwire is substantially equivalent to predicate 0.014"catheter guidewires. The technical characteristics of the 0.014" Trackwire donot introduce new questions regarding device safety and effectiveness.Biocompatibility and physical performance testing demonstrate that the IVT0.014" Trackwire is suitable for its intended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Rockville MD 20857
DEC I I 1997
Mr. Kevin E. Daly Director, Requlatory Affairs/Compliance Standards InterVentional Technoloqies, Inc. 3574 Ruffin Road San Diego, California 92123
Re: K971688 IVT 0.014" PTFE-Coated Trackwire Regulatory Class: II (two) Product Code: DOX Dated: September 11, 1997 Received: September 15, 1997
Dear Mr. Daly:
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, Drug, 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 aqainst 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 requlations affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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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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 (301) 594-4648. Additionally, for questions on the promotion and 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 address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ IVT 0.014" PTFE-Coated Trackwire ___
Indications for Use: The IVT 0.014" PTFE-Coated Trackwire is indicated for use in coronary and peripheral vessels to facilitate the navigation and placement of angioplasty interventional catheters. The 0.014" Trackwire is not indicated for cerebrovascular use.
Taco A. Rue
(Division Sign-Off) Division of Cardiovascular, Res. 1 nd Neurological Devices K971688 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use __________
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.