(25 days)
Not Found
No
The summary describes a standard PTA catheter with no mention of AI or ML capabilities.
Yes
The device is described as a PTA Catheter intended for dilatation of lesions in various arteries and arteriovenous dialysis fistulae, which is a therapeutic intervention.
No
The device is a Fox SV PTA Catheter, which is explicitly stated as being "intended for dilatation of lesions." This indicates a therapeutic function (dilatation) rather than a diagnostic one (identifying or characterizing a condition).
No
The device description clearly describes a physical catheter with a balloon and lumens, indicating it is a hardware 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.
- Device Function: The Fox SV PTA Catheter is a device used inside the body (in vivo) for a therapeutic procedure (dilatation of blood vessels). It is a physical tool used to treat a condition, not to analyze a sample for diagnostic purposes.
- Intended Use: The intended use clearly states it's for "dilatation of lesions," which is a treatment, not a diagnostic test.
The information provided about the device description, anatomical site, and performance studies all support its classification as an interventional medical device used for treatment, not an IVD.
N/A
Intended Use / Indications for Use
The Fox SV 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 delivery or expansion of stents.
Product codes
LIT
Device Description
The Fox SV 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 0.018"). The balloon material expands to a known diameter at specific pressure.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was confirmed through non-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fox SV PTA Catheter (K051519)
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).
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APPENDIX A. 510(k) SUMMARY
:
| Sponsor/Submitter: | Abbott Laboratories
Abbott Vascular Inc.
400 Saginaw Drive
Redwood City, CA 94063 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathryn Marchel
Regulatory Affairs Coordinator
Phone:(650) 474-6341
Fax:(650) 474-3041 |
| Date of Submission: | September 21, 2006 |
| Device Trade Name: | Fox SV PTA Catheter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| Classification Name: | Percutaneous Transluminal Angioplasty Catheter |
| Product Code: | LIT |
| Predicate Device: | Fox SV PTA Catheter (K051519) |
| Intended Use: | The Fox SV 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 delivery or expansion of stents. |
| Device Description: | The Fox SV 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 0.018"). The balloon material expands to a known
diameter at specific pressure. |
| Summary of Substantial
Equivalence: | The Fox SV PTA Catheter is substantially equivalent to the
predicate device. Substantial equivalence was confirmed through
non-clinical testing. |
| OCT 17 2006 | |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 17 2006
Kathryn Marchel Regulatory Affairs Coordinator 500 Saginaw Drive Redwood City. CA 9406 Ph: 650-474-6341 Fax: 650-474-3041
Re: K062843
Trade/Device Name: Fox SV PTA Transluminal Angioplasty Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Angioplasty Catheter Regulatory Class: II (two) Product Code: LIT Dated: September 21, 2006 Received: September 22, 2006
Dear Ms. Marchel:
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 itestate 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, Or e. 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. Marchel
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dmna R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
APPENDIX B. INDICATIONS FOR USE STATEMENT
- Ko62843 510(k) Number (if known):
Device Name:
Fox SV PTA Catheter
Indications For Use:
The Fox SV 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use [] (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dma R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KO 6 2