(16 days)
Not Found
No
The device description focuses on mechanical components and fluid dynamics (infusion/extraction pump, catheter, helix) for thrombus removal. There is no mention of AI, ML, image processing, or data-driven algorithms for decision-making or analysis. The performance studies are bench testing, not related to AI/ML model validation.
Yes
The device is indicated for the mechanical removal of thrombus and restoration of blood flow, which are therapeutic actions.
No
The device description clearly states its purpose is for "mechanical removal of thrombus" and "restoration of blood flow," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly details hardware components such as a catheter, pump, extraction line and bag, and a stainless steel helix, indicating it is a physical medical device, not software-only.
Based on the provided information, the ThromCat™ Thrombectomy Catheter System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae. This is a therapeutic procedure performed in vivo (within the body) to restore blood flow.
- Device Description: The device is a catheter system designed for physical intervention (maceration and removal of thrombus) within the blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ThromCat does not perform any such analysis of specimens.
The ThromCat is a medical device used for a therapeutic intervention, not for diagnostic testing of samples outside the body.
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 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 150cm 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
Not Found
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
Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the ThromCat design meets all specifications and intended use.
Key Metrics
Not Found
Predicate Device(s)
Kensey Nash Corporation's ThromCat™ Thrombectomy Catheter System (K060016)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
510(k) Number: K07Z|95
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted By: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 USA |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy R. Varughese, RAC
Regulatory Affairs Associate
Tel: (484) 713-2100
Fax: (484) 713-2903
E-mail: Cindy.Varughese@kenseynash.com |
| Trade Name: | ThromCat™ Thrombectomy Catheter System |
| Common Name: | Thrombectomy Device |
| Classification Name: | Catheter, Peripheral, Atherectomy (21 CFR Section 870.4875) |
| Regulatory Class: | Class II |
| Device Product Code: | MCW |
| Predicate Device: | Kensey Nash Corporation's ThromCat™ Thrombectomy
Catheter System (K060016) |
| Date Prepared: | July 30, 2007 |
Description of Device:
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 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 150cm 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.
Substantial Equivalence:
ThromCat is substantially equivalent to the predicate device with regard to intended use, principles of operation, and technological characteristics.
Non-Clinical Summarv:
Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the ThromCat design meets all specifications and intended use.
1
Public Health Service
Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow together.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2007
Kensey Nash Corp. c/o Ms. Cindy Varughese Regulatory Affairs Associate 735 Pennsylvania Drive Exton, PA 19341
Re: K072195
Trade/Device Name: ThromCat Thrombectomy Catheter System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: August 6, 2007 Received: August 7, 2007
Dear Ms. Varughese:
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. Cindy Varughese
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 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 Biometric's (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.
ena R. bachner
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):
Device Name:
ThromCat™ Thrombectomy Catheter System
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 (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 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. belmer
(Division Sign-Off) (Division Sign-Oll)
Division of Cardiovas Jular Device
510(k) Number K072195