(22 days)
Not Found
Not Found
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a PTA catheter used for dilating arterial lesions, which is a therapeutic intervention.
No
Explanation: The device is an angioplasty catheter used for dilating arterial lesions, which is a therapeutic function, not a diagnostic one. It is used to treat existing conditions rather than to identify or characterize them.
No
The device description clearly describes a physical catheter with a balloon and lumens, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- FoxCross PTA Catheter Function: The description clearly states the FoxCross PTA Catheter is used for dilatation of lesions within blood vessels. This is a therapeutic procedure performed directly on the patient's body, not an examination of a specimen outside the body.
- Lack of Specimen Analysis: The device description and intended use do not mention any analysis of biological specimens.
Therefore, based on the provided information, the FoxCross PTA Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
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
DQY
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 results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension.
Key Metrics
Not Found
Predicate Device(s)
FoxCross PTA Catheter, Agiltrac .035 PT A 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
K090509 page 1 of 1
FoxCross 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 | MAR 20 2009 | |
| Telephone: | 951-914-3311 | |
| Fax: | 951-914-0339 | |
| Contact Person: | Nadine Smith | |
| Date Prepared: | February 12, 2009 | |
| Device Trade Name: | FoxCross PTA Catheter (with 14mm balloon diameter) | |
| Device Common Name: | Percutaneous Catheter | |
| Device Classification Name: | Catheter | |
| Device Classification No.: | 21 CFR 870.1250 | |
| Device Classification: | Class II | |
| Device Product Code: | DOY |
Summary of Substantial Equivalence
The FoxCross PTA Catheter Line Extension (14mm balloon diameter) is substantially equivalent to the prodicate devices, the FoxCross PTA Catheter and the Agiltrac .035 PT A Catheter. The results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension.
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 Line Extension (with 14mm balloon diameter) is identical in technological characteristics, to the FoxCross PTA Catheter, with respect to product code, classification section, classification name, intended use, catheter lengths, introducer sheath size, and guide wire compatibility.
1
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs 26531 Ynez Road Temecula, CA 92591
MAR 2 0 2009
Re: K090509
FoxCross PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 25, 2009 Received: February 26, 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 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 Biometrics' (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.
Z
Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Abbott Vascular
Indications For Use Statement
510(k) Number (if known)
KO90509
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)
AND/OR
Over-The-Counter Use (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)
1-Off
Division of Cardiovascular Devices
for K090509
Page
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