(27 days)
Not Found
No
The document describes a physical medical device (a dilatation catheter) and its modifications, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is intended for the dilatation of stenoses and obstructive lesions in arteries, which directly treats a medical condition.
No
The device is a dilatation catheter used for treating stenoses and obstructive lesions, not for diagnosing them. Its purpose is therapeutic intervention (dilatation), not diagnostic assessment.
No
The device description clearly identifies it as a physical catheter with a balloon, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a therapeutic procedure (dilatation of stenoses) performed directly on the patient's body (in peripheral arteries and dialysis fistulae).
- Device Description: The description details a physical catheter with a balloon, designed for mechanical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the illiac, femoral, poplited, illio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
PNO, LIT
Device Description
The 2 PTA Dilatation Catheter is a modification to the VascuTraK™ 2 PTA Dilatation Catheter cleared under K073025. The device is fabricated of the same materials as the unmodified device and has the same intended use.
The distal balloon sizes for the modified device include diameters from 5.0 - 7.0 mm and lengths up to 300mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries including the illiac, femoral, poplited, illio-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified device was tested using the same test procedures that were used for the unmodified device: these tests included tensile strength, balloon fatigue, compliance and burst. All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
YMed, Inc. c/o Mr. Thomas P. Schroeder 9951B Business Park Avenue San Diego, CA 92131
Re: K082343
Trade/Device Name: Vascutrak™ 2 PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: August 13, 2008 Received: August 15, 2008
Dear Mr. Schroeder:
This letter corrects our substantially equivalent letter of September 11, 2008.
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
Page 2 - Mr. Thomas P. Schroeder
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 August 12, 2008
・・ .
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VascuTraK™ 2 PTA Dilatation Catheter
Indications for use: The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the illiac, femoral, poplited, illio-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. Vahner
(Division Sim. Off) Division of Carolovascular Devices
510(k) Number_Ko8234 3
Page 17 of 55
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K082343 page 1 of 2
SEP 1 1 2008
YMed, Inc. Special 510(k) Device Modification August 12, 2008
510 (k) SUMMARY
Applicant and Manufacturer
YMed, Inc. 9951B Business Park Avenue San Diego. California 92131 Phone: (858) 549-1337 Fax: (858) 549-1717
| Contact Person: | Thomas Schroeder, Director, RA/QA |
|---|---|
| Prepared: | August 12, 2008 |
| Common Name: | PTA Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal; Product Code LIT |
| Proprietary name: | VascuTraK™ 2 PTA Dilatation Catheter |
Unmodified Device
The VascuTraK™ 2 Catheler 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 oroximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" or 0.018" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The unmodified device utilizes balloons with diameters up to 4.0 mm and lengths up to 120 mm.
Modified Device Description
The YMed VascuTraK™ 2 PTA Dilatation Catheter is a modification to the VascuTraK™ 2 PTA Dilatation Catheter cleared under K073025. The device is fabricated of the same materials as the unmodified device and has the same intended use.
The distal balloon sizes for the modified device include diameters from 5.0 - 7.0 mm and lengths up to 300mm.
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KC82343 page 302
YMed. Inc. Special 510(k) Device Modification August 12. 2008
Indications for Use
The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the illac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Technological Characteristics Comparison
The VascuTraK™ 2 PTA Dilatation Catheter is identical in design and construction to the currently marketed VascuTraK™ 2 PTA Dilatation Catheter. This version of the catheter features larger balloons for use in the larger peripheral arteries.
Performance and Safety
No new materials were used for this modification. 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°
The modified device will require a minimum sheath or guide catheter I.D of up to 0.120" depending upon balloon size. The revised labeling reflects the applicable sheath size for the larger balloon sizes.
The modified device was tested using the same test procedures that were used for the unmodified device: these tests included tensile strength, balloon fatigue, compliance and burst. All test results were satisfactory.
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. The modified device is considered safe for its intended use.