(15 days)
The FoxCross 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 FoxCross 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 guide wire 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.
The provided text describes a 510(k) submission for the Abbott Vascular FoxCross PTA Catheter, asserting its substantial equivalence to a predicate device, the FoxPlus PTA Catheter. This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, the submission focuses on demonstrating substantial equivalence based on technological characteristics and in vitro bench tests, analyses, and biocompatibility data compared to a previously cleared device. It does not present a clinical study with performance metrics or acceptance criteria for a new device's efficacy or safety.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent in the provided text.
Here's a breakdown of why each specific point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not available. The document states "Summary of Substantial Equivalence: The FoxCross PTA Catheter...is substantially equivalent to the FoxPlus PTA Catheter...as demonstrated by the results of the in vitro bench tests, analyses, and biocompatibility data." No specific criteria or performance values are given.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. The testing mentioned is "in vitro bench tests," which typically refers to laboratory testing, not human subject data. Therefore, details like data provenance or sample size of a test set are not applicable in the context of clinical data.
- 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, as there's no clinical test set or ground truth established by experts mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set or adjudication process is mentioned.
- 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 device is a PTA catheter, a physical medical device, not an AI software or a device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth is established or discussed.
- The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. There is no mention of a "training set" or ground truth for it.
In summary, the provided documentation is a 510(k) summary for a physical medical device, focusing on substantial equivalence to a predicate device via bench testing. It does not provide the type of performance study details requested for AI or diagnostic devices.
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K081417 Page lot 1
Abbott Vascular
FoxCross PTA Catheter Special 510(k)
Appendix A – 510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.93UN ~ 4 2008
| Submitter's Name:Submitter's Address: | Abbott Vascular3200 Lakeside DriveSanta Clara, CA 95054 | |
|---|---|---|
| Telephone:Fax: | 951-914-2292951-914-1069 | |
| Contact Person: | Nadine Smith | |
| Date Prepared: | May 19, 2005 | |
| Device Trade Name:Device Common Name:Device Classification Name: | FoxCross PTA CatheterPTA CatheterCatheter | |
| Device Classification No .:Device Classification:Device Product Code: | 21 CFR 870.1250Class IILIT | |
| DeviceDescription | The FoxCross PTA Catheter is a standard over-the-wire PTA catheter. The doublelumen catheter has a balloon located near the distal tip. One lumen is used forinflation of the balloon, while the second lumen allows access to the distal tip ofthe catheter for guide wire insertion (max 0.035"). The balloon has two radiopaquemarkers for positioning the balloon relative to the stenosis. The balloon materialexpands to a known diameter at specific pressures. | |
| IntendedUse | The intended use for the device has not changed as a result of the modification.The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral,renal, iliac, popliteal, peroneal, and profunda arteries and native or syntheticarteriovenous dialysis fistulae. This catheter is not intended for the expansion ordelivery of stents. | |
| Summary ofTechnologicalCharacteristicsCompared toPredicateDevice | The FoxCross PTA Catheter, subject device, is identical in technologicalcharacteristics, to the FoxPlus PTA Catheter, predicate device, with respect toproduct code, classification section, classification name, intended use, catheterlength, balloon diameters and lengths, introducer sheath size, and guide wirecompatibility. | |
| Minor changes were to the FoxCross, including a different color for the shaft andtip, coating on the balloon, adhesive used, and removal of shrink tubing on thestrain relief. | ||
| Summary ofSubstantialEquivalence | The FoxCross PTA Catheter, subject device, is substantially equivalent to theFoxPlus PTA Catheter, predicate device, as demonstrated by the results of thein vitro bench tests, analyses, and biocompatibility data. |
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Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs 26531 Ynez Road Temecula, CA 92591
Re: K081417
FoxCross PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: May 19, 2008 Received: May 20, 2008
Dear Ms. Smith:
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. Nadine Smith
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 (OS) 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 vours.
R. vodinel
A. 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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Appendix A - Indications for Use
K 381417 510(k) Number (if known)
Device Name FoxCross PTA Catheter
Indications for Use The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistula.
This catheter is not intended for the expansion or delivery of stents.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duna R. Vuhner
vision Sign-Off) Ision of Cardiovascular Devices
01K) Number_K081417
§ 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).