(15 days)
Not Found
No
The summary describes a standard mechanical PTA catheter with no mention of AI/ML features or image processing capabilities.
Yes
The device is intended for "dilatation of lesions," which is a therapeutic intervention aimed at treating a medical condition rather than just diagnosing it.
No
Explanation: The device is a PTA catheter intended for dilating lesions, which is a therapeutic rather than a diagnostic function. It is used to treat blockages, not to identify or characterize them.
No
The device description clearly details a physical catheter with a balloon and lumens, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- FoxCross PTA Catheter Function: The description clearly states the FoxCross PTA Catheter is used for "dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae." This is a therapeutic procedure performed inside the body to open narrowed blood vessels.
The device description focuses on the physical characteristics of the catheter and its use in a medical procedure, not on analyzing biological samples.
N/A
Intended Use / 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 fistulae. This catheter is not intended for the expansion or delivery of stents.
Product codes
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The FoxCross PTA Catheter, subject device, is substantially equivalent to the FoxPlus PTA Catheter, predicate device, as demonstrated by the results of the in vitro bench tests, analyses, and biocompatibility data.
Key Metrics
Not Found
Predicate Device(s)
FoxPlus PTA Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Vascular
3200 Lakeside Drive
Santa Clara, CA 95054 |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | Telephone:
Fax: | 951-914-2292
951-914-1069 |
| | Contact Person: | Nadine Smith |
| | Date Prepared: | May 19, 2005 |
| | Device Trade Name:
Device Common Name:
Device Classification Name: | FoxCross PTA Catheter
PTA Catheter
Catheter |
| | Device Classification No .:
Device Classification:
Device Product Code: | 21 CFR 870.1250
Class II
LIT |
| Device
Description | 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. | |
| Intended
Use | 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 synthetic
arteriovenous dialysis fistulae. This catheter is not intended for the expansion or
delivery of stents. | |
| Summary of
Technological
Characteristics
Compared to
Predicate
Device | The FoxCross PTA Catheter, subject device, is identical in technological
characteristics, to the FoxPlus PTA Catheter, predicate device, with respect to
product code, classification section, classification name, intended use, catheter
length, balloon diameters and lengths, introducer sheath size, and guide wire
compatibility. | |
| | Minor changes were to the FoxCross, including a different color for the shaft and
tip, coating on the balloon, adhesive used, and removal of shrink tubing on the
strain relief. | |
| Summary of
Substantial
Equivalence | The FoxCross PTA Catheter, subject device, is substantially equivalent to the
FoxPlus PTA Catheter, predicate device, as demonstrated by the results of the
in vitro bench tests, analyses, and biocompatibility data. | |
1
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.
2
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
3
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