(112 days)
Not Found
No
The device description focuses on mechanical and fluid dynamics for thrombus removal, and there is no mention of AI or ML in the provided text, including the specific "Mentions AI, DNN, or ML" section.
Yes
The device is indicated for "mechanical removal of thrombus" and "restoration of blood flow," which are therapeutic actions to address a medical condition.
No
The device description indicates that the ThromCat system is used for "mechanical removal of thrombus" and "restoration of blood flow," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details hardware components such as a catheter, pump, tubing, and bag, and mentions non-clinical testing related to hardware (biocompatibility, EMC, electrical safety, mechanical testing).
Based on the provided information, the ThromCat™ Thrombectomy Catheter System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The ThromCat system is a mechanical device used within the body (percutaneously) to remove thrombus from blood vessels.
- The intended use clearly describes a therapeutic procedure. It's for "mechanical removal of thrombus" and "restoration of blood flow," which are actions performed directly on the patient's circulatory system.
- The device description details a mechanical system. It involves a catheter, pump, and tubing to physically interact with and remove material from the vessel.
Therefore, the ThromCat™ Thrombectomy Catheter System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.
Product codes
MCW
Device Description
ThromCat™ Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr x 4.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing and 150 cm length catheter provide an infusion flow to "wash' the vessel, while simultaneously providing an extraction flow to remove thrombus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
synthetic hemodialysis access grafts and native vessel dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Testing: ThromCat has undergone non-clinical testing, e.g., biocompatibility, EMC, electrical safety, mechanical testing and animal studies that provide reasonable assurance of safety and effectiveness for its intended use. In vitro and in vivo comparison testing was conducted on ThromCat and the predicate device, X-Sizer Catheter.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
Kensev Nash
APS 25 2003
510(k) Summary
Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist
735 Pennsylvania Drive
Exton, PA 19341
KENSEY NASH CORPORATION
Submitted by:
Contact Person:
Date Prepared:
510(k) #: Device Trade Name: Common/Usual Name: Proposed Classification:
March 6, 2006
K060016
ThromCat™ Thrombectomy Catheter System Thrombectomy Device Catheter, Peripheral, Atherectomy 21 CFR 870.4875, MCW, Class II
Ph: (484) 713-2100 Fax: (610) 524-5489
Device Description:
ThromCat Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr x 4.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing and 150 cm length catheter provide an infusion flow to "wash' the vessel, while simultaneously providing an extraction flow to remove thrombus.
Intended Use:
ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.
Predicate Devices:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| ev3 Inc. | X-Sizer® Catheter System | K021096 |
| Microvena Corporation | Amplatz Thrombectomy Device | K982657 |
Substantial Equivalence:
ThromCat is similar with regard to materials, intended use, principles of operation and technological characteristics to the predicate mechanical thrombectomy devices in terms of section 510(k) substantial equivalence; any differences that may exist do not significantly affect the safety and efficacy of the device. Results of bench testing and animal studies demonstrate ThromCat is as safe and effective as the legally marketed predicate devices.
Non-Clinical Testing:
ThromCat has undergone non-clinical testing, e.g., biocompatibility, EMC, electrical safety, mechanical testing and animal studies that provide reasonable assurance of safety and effectiveness for its intended use. In vitro and in vivo comparison testing was conducted on ThromCat and the predicate device, X-Sizer Catheter.
1-800 524 1984
ΚΕΝSEY ΝΑSΗ CORPORATION, 735 ΡΕΝΝSYLVANIA DRIVE, ΕΧΤΩΝ. ΡΑ 19341
1
Image /page/1/Picture/1 description: The image shows a logo with a circular border containing text, and an abstract symbol in the center. The symbol consists of three curved lines that resemble a stylized bird in flight. The text around the border is small and difficult to read, but it appears to be part of an official seal or emblem. The logo is black and white and has a simple, clean design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AFR 2 5 2006
Kensey Nash Corporation c/o Ms. Jennifer Bosley Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, PA 19341
Re: K060016
Trade Name: ThromCat™ Thrombectomy Catheter System Regulation Number: 21 CFR 870.4875 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MCW Dated: April 6. 2006 Received: April 7. 2006
Dear Ms. Bosley:
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, Drue. 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. Ilisting 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 max publish further announcements concerning vour device in the Federal Register.
2
Page 2 - Mr. Alex Kou
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Davia R. bochner
Image /page/2/Picture/5 description: The image shows a handwritten symbol or character on the left side, which appears to be a combination of curved and angular lines. To the right of this symbol, there are two lines of text. The first line contains the letter 'E', and the second line contains the letter 'D'. The text is in a simple, sans-serif font and is aligned vertically.
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
510(k) Number (if known): K 6660 م ا
.
ThromCat™ Thrombectomy Catheter System Device Name:
Indications For Use:
ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 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)
R. Bruce W. Hunnell
Division . S. . Off) (Division of Cardiovascular Devices
510(k) number