(14 days)
Not Found
No
The description focuses on the mechanical components and function of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is described as a "PTA Dilatation Catheter" intended for "dilatation of stenoses" and "treatment of obstructive lesions," which are therapeutic actions.
No
Explanation: The device is a dilatation catheter used for treatment (dilatation of stenoses), not for diagnosis.
No
The device description clearly outlines a physical catheter with a balloon, flexible shaft, 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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The VascuTraK™ II PTA Dilatation Catheter is a physical device used to mechanically dilate (widen) narrowed blood vessels within the body. It is an interventional device used in vivo (within a living organism), not in vitro (in glass or outside the body).
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's arteries and fistulae.
- Device Description: The description details a catheter with a balloon for inflation within the body, not equipment for analyzing biological samples.
Therefore, based on the provided information, the VascuTraK™ II PTA Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
PNO
Device Description
The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries; 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
Testing of the modified catheter was performed and included balloon performance and tip tensile testing. Results for the modified device were consistent with those of the original device.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of a bird with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
ThermopeutiX, Inc. c/o Mr. Thomas P. Schroeder Director, RA/QA 9925B Business Park Avenue San Diego, CA 92131
Re: K073025
Trade/Device Name: Vascutrak™ II PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Transluminal Peripheral Angioplasty Catheter Regulatory Class: Class II (Two) Product Code: PNO Dated: October 23, 2007 Received: October 26, 2007
Dear Mr. Schroeder:
This letter corrects our substantially equivalent letter of November 9, 2007.
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
Page 2 - Mr. Thomas Schroeder
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Misti L. Malone -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
YMed, Inc. Special 510(k) Device Modification October 19, 2007
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K073025
Device Name: VascuTraK™ II PTA Dilatation Catheter
Indications for use: The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, illo-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use: X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
prima R. Wilsonel (Division Sign-Off) Division of Cardiovascular Devices
510(k) Number 长۵23025
Page 17 of 50
3
073025 Med Inc. Special 510(k) Device Modification October 19, 2007
510 (k) SUMMARY
Applicant
NOV 0 9 2007
YMed, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717
Manufacturer
ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 542-1760 Fax: (858) 542-1717
Contact Person
Thomas Schroeder, Director, RA/QA
| Common Name: | PTA Catheter |
|---|---|
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal |
| Proprietary name: | VascuTraK ™ II PTA Dilatation Catheter |
Unmodified Device
The YMed VascuTraK™ II PTA Dilalation Catheter is modification to the VascuTraK™ PTA Dilatation Catheter cleared under K063657.
The distal tip configuration is being modified from a short lumen tip to permit use of an external guidewire to facilitate catheter exchange.
Indications for Use
The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, poplifeal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
4
K073025 p.20f2 YMed, Inc. Special 510(k) Device Modification October 19, 2007
Device Description
The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,
Technological Characteristics Comparison
The VascuTraK II PTA Dilatation Catheter is identical in design and construction to the currently marketed VascuTraK™ PTA Dilatation Catheter. This version of the catheter utilizes a short guidewire lumen rather than a short guidewire at the distal tip.
Performance and Safety
No new materials were used and the biological safety of the device was previously demonstrated through biocompatibility studies of patient contact materials in accordance with the requirements outlined in ISO 10993-1.
The modification does not affect the ability to sterilize the device; thus, the prior sterilization testing is valid. The device conforms to a Sterility Assurance Level (SAL) of 10°.
Testing of the modified catheter was performed and included balloon performance and tip tensile testing. Results for the modified device were consistent with those of the original device.
The supplied instructions for use provide the user with the applicable warnings and cautions during use. The device is contraindicated for the coronary arteries. There are no new safety or effectiveness issues related to this device.