(54 days)
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
This catheter is not intended for the expansion or delivery of stents.
The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
Here's an analysis of the provided text regarding the Fox™ Plus PTA Catheter (K080264). Unfortunately, the document does not contain the specific information requested about acceptance criteria and a study proving device performance, as it pertains to AI/ML device evaluations. This document is a traditional 510(k) premarket notification for a medical device that relies on substantial equivalence to predicate devices, rather than a performance study against specific acceptance criteria for an AI algorithm.
The request asks for details typically associated with the evaluation of AI/ML-driven medical devices, especially for topics like:
- Acceptance criteria table with reported device performance for an AI
- Sample size for a test set and data provenance for an AI
- Number and qualifications of experts for ground truth establishment for an AI
- Adjudication method for an AI test set
- MRMC comparative effectiveness study for an AI
- Standalone performance for an AI
- Type of ground truth used for an AI
- Sample size for the training set for an AI
- How ground truth for the training set was established for an AI
Since this is a conventional medical device submission (PTA Catheter), these AI/ML- specific details are not applicable and are therefore not present in the provided text.
The document focuses on:
- Device Description: What the catheter is and its components.
- Intended Use: The medical conditions and procedures for which the catheter is designed.
- Predicate Devices: Previously cleared devices to which the current device is compared for substantial equivalence.
- Technological Characteristics Comparison: How the new device is similar to or different from predicate devices (mostly identical, with minor balloon length changes).
- Substantial Equivalence Justification: Stating that in vitro bench tests, analyses, and biocompatibility testing demonstrate the safety and effectiveness, leading to substantial equivalence to predicate devices.
There is no "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The "acceptance" here is the FDA's determination of substantial equivalence based on the provided engineering and biocompatibility data compared to predicate devices, not specific performance metrics for an AI algorithm.
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any lit 2
MAR 2 6 2008
510(k) Summary
Summary Information
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name: Abbott Vascular
Submitter's Address: 3200 Lakeside Drive Santa Clara, CA 95054
Telephone: 408-845-0682
Fax: 408-845-0921
Contact Person: Ivalee Cohen
Manager, Regulatory Affairs
Date Prepared:
Device Trade Name: Device Common Name: Device Classification: Device Classification Number: Device Product Code:
January 31, 2008
Fox™ Plus PTA Catheter PTA Catheter Class II 21 CFR 870.1250 LIT
Predicate Devices
The subject device is substantially equivalent to the Fox Plus PTA Catheter predicate device (K040954, cleared on May 11, 2004) and to the Sailor™ Plus PTA Balloon Dilatation Catheter predicate device (K042538, cleared on November 8, 2004).
Device Description
The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
Intended Use
The intended use for the device has not changed as a result of the modification.
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The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, illiac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
Summary of Technological Characteristics Compared to Predicate Devices
The Fox™ Plus PTA Catheter subject device is identical in technological characteristics, with the exception of balloon lengths, to the Fox Plus PTA Catheter predicate device. The subject device is also substantially equivalent to the Sailor™ Plus PTA Balloon Dilatation Catheter with respect to product code, classification section, classification name, intended use, catheter length, balloon diameters and lengths, introducer sheath size, and guidewire compatibility.
Summary of Substantial Equivalence
The Fox Plus PTA Catheter subject device is substantially equivalent to the predicate devices. The results of the in vitro bench tests and analyses and biocompatibility testing demonstrate the safety and effectiveness of the Fox Plus PTA Catheter subject device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2008
Abbott Vascular c/o Ms. Ivalee Cohen 3200 Lakeside Drive Santa Clara, CA 95054
Re: K080264
Trade Name: Fox 1M Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Transluminal Angioplasty Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: January 31, 2008 Received: February 1, 2008
Dear Ms. Cohen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Ivalee Cohen
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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 Statement
510(k) Number (if known): K080264
Device Name: Fox™ Plus PTA Catheter
Indications for Use:
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
This catheter is not intended for the expansion or delivery of stents.
OR
Prescription Use × (Per 21 CFR 801.109)
Over-The-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number
§ 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).