(26 days)
Not Found
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 various arteries and arteriovenous dialysis fistulae, which is a therapeutic intervention.
No
Explanation: The device is a PTA (percutaneous transluminal angioplasty) catheter intended for dilatation of lesions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical catheter with a balloon and lumens, 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 clearly states that the device is 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 directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon for mechanical dilatation. This is a medical device used for intervention, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are 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 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.
Product codes
LIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, renal, illiac, 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)
The results of the aging tests demonstrate that the Fox Plus PTA Catheter subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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.
1
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.
2
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.
3
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
4
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 |
|---|---|
| --------------- | --------- |