(4 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any AI/ML components or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
Yes
The device is intended for "dilatation of stenoses" and "treatment of obstructive lesions," which are therapeutic actions to alleviate medical conditions.
No
The device description clearly states it is a "dilatation catheter" intended for "dilatation of stenoses," which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a catheter with a balloon, which are physical hardware components, not software.
Based on the provided information, the VascuTraK™ PTA Dilatation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health.
- The VascuTraK™ Catheter is a physical device used for a therapeutic procedure (dilatation of stenoses) directly within the patient's body. It is an interventional device, not a diagnostic one that analyzes samples.
The description clearly outlines a device used for a medical procedure within the circulatory system, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The VascuTraK™ 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™ Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen and a 24 cm distal lumen that accepts a 0.014" guidewire. The distal end of the catheter contains a semi-compliant balloon that is inflated via the central lumen. 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
iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries, 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 biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the requirements outlined in ISO 10993-1. Physical testing was performed to assure catheter integrity including verification of balloon burst pressure.
Key Metrics
Not Found
Predicate Device(s)
K042624, K971010, K000101, K001134
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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
TUV America, Inc. c/o Ms. Laura Danielson 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K063657
Trade/Device Name: Vascutrak™ PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, angioplasty, peripheral, transluminal Regulatory Class: Class II Product Code: PNO Dated: December 7, 2006 Received: December 8, 2006
Dear Ms. Danielson:
This letter corrects our substantially equivalent letter of December 12, 2006.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
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
ThermopeutiX, Inc. (YMed) 510(k) Premarket Notification September 29. 2005
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K-063657 _________________________________________________________________________________________________________________________________________
Device Name: VascuTraK™ PTA Dilatation Catheter
Indications for use: The VascuTraK™ 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.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R-salines
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number 3063657
Page 8 of 94
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ThermopeutiX, Inc. (YMed) 510(k) Premarket Notification November 16, 2006
510 (k) SUMMARY
KO63657 ್
Applicant
YMed, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 542-1760 Fax: (858) 542-1717
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™ PTA Dilatation Catheter |
Predicate Devices
The YMed VascuTraK™ Catheter is substantially equivalent in general design and use fealures to many currently marketed balloon dilatation catheters used for peripheral angioplasty procedures; these predicate catheters are:
- Invatec Amphirion™ Deep PTA Catheter (K042624) 1)
- Cordis SAVVY® PTA Dilatalion Catheter (K971010) 2)
-
- Guidant VIATRAC® 14 Peripheral Dilatation Catheter (K000101)
-
- Boston Scientific Gazelle™ Balloon Dilatation Catheter (K001134)
DEC 1 2 2008
4
ThermopeutiX, Inc. (YMed) 510(k) Premarket Notification November 16, 2006
Indications for Use
K063657 2. 20t2
The VascuTraK™ 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 synthelic arteriovenous dialysis fistulae.
Device Description
The VascuTraK™ Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen and a 24 cm distal lumen that accepts a 0.014" guidewire. The distal end of the catheter contains a semi-compliant balloon that is inflated via the central lumen. The balloon is available in various diameters and lengths,
Technological Characteristics Comparison
The catheter is equivalent in design and construction to currently marketed PTA catheters. The construction materials used have an established history of safe use in similar medical devices.
Performance and Safety
The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the requirements outlined in ISO 10993-1. Physical testing was performed to assure catheter integrity including verification of balloon burst pressure.
The device is supplied sterily will conform to a Sterility Assurance Level (SAL) of 108. 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.