(26 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.
This document is a 510(k) summary for the Fox™ Plus PTA Catheter. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It typically does not involve clinical studies designed to prove performance against specific acceptance criteria in the way that novel devices might. Instead, the focus is on demonstrating equivalence to an existing, legally marketed device.
Therefore, many of the requested elements of your query are not applicable to a 510(k) submission for substantial equivalence based on identical technological characteristics and aging tests.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device: The subject device must be identical in technological characteristics to the predicate device. | The Fox™ Plus PTA Catheter subject device is identical in technological characteristics to the Fox Plus PTA Catheter predicate device. |
| Aging Test Results: The device must demonstrate substantial equivalence to the predicate device based on aging tests. | The results of the aging tests demonstrate that the Fox Plus PTA Catheter subject device is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable/not provided. The document primarily relies on demonstrating identical technological characteristics and aging test results, not a clinical test set in the traditional sense.
- Data provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for a clinical test set is not established in this type of submission. The "ground truth" here is the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical catheter, not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the safety and efficacy profile of the previously cleared predicate device, to which the subject device is deemed substantially equivalent. The substantial equivalence is demonstrated through identical technical characteristics and performance in non-clinical tests (like aging tests).
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
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510(k) Summary
APR 2 8 2008
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
Ivalee Cohen Contact Person:
Manager, Regulatory Affairs
Date Prepared:
Device Trade Name: Device Common Name: Device Classification: Device Classification Number: Device Product Code:
March 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 (K080264, cleared on March 26, 2008).
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.
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.
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Summary of Technological Characteristics Compared to Predicate Devices
The Fox™ Plus PTA Catheter subject device is identical in technological characteristics to the Fox Plus PTA Catheter predicate device.
Summary of Substantial Equivalence
The results of the aging tests demonstrate that the Fox Plus PTA Catheter subject device is substantially equivalent to the predicate device.
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Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2008
Abbott Vascular c/o Mr. Ivalee Cohen Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054
Re: K080925
Fox Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: April 1, 2008 Received: April 2, 2008
Dear Mr. 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 - Mr. 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,
R. bohner
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): KO00925
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K080925 |
|---|---|
| --------------- | --------- |
§ 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).