(29 days)
Fox sv PTA Catheter, Fox Cross PTA Catheter
Fox sv PTA Catheter, Fox Cross PTA Catheter
No
The description focuses on the mechanical aspects of a standard PTA catheter and does not mention any AI/ML components or functionalities.
Yes
The device is intended for the dilatation of lesions in several arteries, which directly addresses a medical condition (stenosis) by widening the narrowed vessels. This active intervention to treat a disease makes it a therapeutic device.
No
Explanation: The device description states its purpose is for "dilatation of lesions" and mentions a "balloon located near the distal tip" used for inflation and expansion. This indicates a therapeutic function (angioplasty) rather than gathering information or identifying a condition, which are characteristics of a diagnostic device.
No
The device description clearly describes a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon for mechanical dilatation. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body, which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The Fox sy PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries.
This catheter is not intended for the expansion or delivery 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 and is accessed via the side leg port. The balloon material expands to a known diameter at specific pressure. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. 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
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)
The Fox sy PTA Catheter subject device is substantially equivalent to the predicate devices, Fox sv PTA Catheter and Fox Cross PTA Catheter, as demonstrated by the results of the in vitro bench tests, analyses and biocompatibility data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fox sv PTA Catheter, Fox Cross 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
1092286
Abbott Vascular
AUG 2-7 2009
Fox sv PTA Catheter Special 510(k)
510(k) SUMMARY
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: | 951-914-3311 |
| Fax: | 951-914-0339 |
| Contact Person: | Nadine Smith |
| Date Prepared: | July 22, 2009 |
| Device Trade Name: | Fox sv PTA Catheter |
| Device Common Name: | PTA Catheter |
| Device Classification Name: | Catheter |
| Device Classification No .: | 21 CFR 870.1250 |
| Device Classification: | Class II |
| Device Product Code: | LIT |
Summary of Substantial Equivalence
The Fox sy PTA Catheter subject device is substantially equivalent to the predicate devices, Fox sv PTA Catheter and Fox Cross PTA Catheter, as demonstrated by the results of the in vitro bench tests, analyses and biocompatibility data.
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 and is accessed via the side leg port. The balloon material expands to a known diameter at specific pressure. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. 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 Fox sy PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries.
This catheter is not intended for the expansion or delivery of stents.
Summary of Technological Characteristics Compared to Predicate Device
The subject Fox sv PTA Catheter (line extension) is identical in technological characteristics to the Fox sv PTA Catheter, with respect to product code, classification section, classification name, intended use, catheter lengths, introducer sheath size, and guide wire compatibility. The subject PTA Catheter (line extension) is also substantially equivalent to the FoxCross PTA catheter with similar balloon diameters of 5.0 mm and 6.0 mm devices with balloon lengths of 20mm, 40 mm, 60 mm, 80 mm, 100mm and 120 mm.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the left.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 7 2009
Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054
Re: K092286
Trade/Device Name: Fox sv PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: July 27, 2009 Received: July 29, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/Resourcesfor.You/Industry/default.htm.
Sincerely yours,
simna R. kahner
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
510(k) Number (if known)
KO9ZZ86
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.
This catheter is not intended for the expansion or delivery of stents.
Prescription Use X (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)
smmer D. be. Ames
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko 92286
Page 51