(139 days)
RSC61-9
Not Found
No
The device description focuses on mechanical action (rotating spiral conveyor shaft, negative pressure) and electrical control. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes.
The device is used for "breaking apart and removing thrombus from hemodialysis access grafts," which directly treats a medical condition.
No
The device is described as a thrombectomy system designed for breaking apart and removing thrombus from hemodialysis access grafts. Its function involves mechanical removal of thrombus, not diagnosis. The "Intended Use" section explicitly states its purpose as "For breaking apart and removing thrombus," which is a treatment action, not a diagnostic one.
No
The device description clearly outlines hardware components including a catheter, control console, and collection bottle, and the performance studies include testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For breaking apart and removing thrombus from hemodialysis access grafts." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical system for physically removing thrombus. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample analysis, or diagnostic output.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic device used for a physical intervention.
N/A
Intended Use / Indications for Use
For breaking apart and removing thrombus from hemodialysis access grafts.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The XTD™ Thrombectomy System consists of the XTD™ Thrombectomy Catheter has a flexible, rotating Control Console, and ATD - Oollection BF plastic sheatist end of the spiral shaft spiral conveyor shart contained within a chipitator. As the agitator rotates it macerated thrombus within the graft and the rotating spiral conveyor shaft conveys the macerated thrombus within the gran and the rolating spiral of researc, to a disposable Collection Bottle.
thrombus through the sheath, assisted by negative pressure, to a disposation thromous inrough the sheath, assisted by nogative process. It as a many of the catheter operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hemodialysis access grafts
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)
Performance Testing The ATD™ Thrombectonly Oystem oumponents nave been to the predicate devices.
their specifications and to support claims of substantial equivalence to the predicate devices. This testing includes the following:
- Mechanical Strength Testing .
- Fatigue Strength Testing .
- Electrical Safety Testing ●
- Biocompatibility Testing ●
- In-vitro Performance Testing ●
- In-vivo (animal) Testing ●
- Human Clinical Testing .
Test results have demonstrated conformance of the XTD™ components to their specification Test results have demonstrated confidmance of the ATD - compensent is the results and effective as the legally marketed predicated devices.
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.
Possis Anglosel Rapid Thrombecomy Oystem (RSC61-9), Arrow International, Inc.
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
§ 870.4875 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
6 2002 MAR
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
XTD™ Thrombectorny System Xtrak Medical, Inc. January 17, 2002
General Information
Classification:
Class II
XTD™ Thrombectomy System Trade Name: Xtrak Medical, Inc. Sponsor: 26H Keewaydin, Dr. Salem, NH 03079 (603) 896-6416 Tel: (603) 893-7708 Fax: Gary Boseck, Ph.D. Contact: President
Identification of Predicate or Legally Marketed Devices
ldentification of Predicate of Legally Manufactured by Possis Medical, Possis Anglosel Rapid Thrombecomy Oystem (RSC61-9), Manufactured by Arrow International, Inc.
Intended Use
mtended Use
Device Description
Device Description
The XTD™ Thrombectomy System consists of the XTD™ Thrombectomy Catheter has a flexible , rd The XTD™ Thrombectorly System Consists of the XTD™ catheter has a flexible, rotating Control Console, and ATD - Oollection BF plastic sheatist end of the spiral shaft spiral conveyor shart contained within a chipitator. As the agitator rotates it macerated thrombus within the graft and the rotating spiral conveyor shaft conveys the macerated thrombus within the gran and the rolating spiral of researc, to a disposable Collection Bottle.
thrombus through the sheath, assisted by negative pressure, to a disposation thromous inrough the sheath, assisted by nogative process. It as a many of the catheter operation.
Materials
Materials
All materials used in the manufacture of the XTD™ Catheter are suitable for their intended use All materials used in the manufacture of previously cleared products.
Performance Testing
Perrormance Testing The ATD™ Thrombectonly Oystem oumponents nave been to the predicate devices.
their specifications and to support claims of substantial equivalence to the predicate devices. This testing includes the following:
- Mechanical Strength Testing .
- Fatigue Strength Testing .
- Electrical Safety Testing ●
- Biocompatibility Testing ●
- In-vitro Performance Testing ●
- In-vivo (animal) Testing ●
- Human Clinical Testing .
1
Test results have demonstrated conformance of the XTD™ components to their specification Test results have demonstrated confidmance of the ATD - compensent is the results and effective as the legally marketed predicated devices.
Summary of Substantial Equivalence
Sammary of Gubountial Equiv Thrombectomy System is substantially equivalent to the legally marketed predicate devices. This claim of equivalence is supported by the identical intended use of the devices and their common technological characteristics.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002 MAR
Xtrak Medical, Inc. c/o Gary Boseck, Ph.D. 26H Keewaydin Dr Salem, NH 03079
Re: K013473
XTD™ Thrombectomy System Regulation Number: 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: II (two) Product Code: MCW Dated: January 17, 2002 Received: January 18, 2002
Dear Dr. Boseck:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave acterimentaly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manat date of the Medical Device Amendments, or to connine.co. phor to May 20, 1978, as can and and and the Federal Food, Drug, devices mat have occh reclassinod in assess approval of a premarket approval application (PMA). and Costicule Act (71ct) that to novice, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (500 a00 ro) as . Existing major regulations affecting your device can may oc subject to suen additions, 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 I least be advised that I Dri 3 lisualite of our device complies with other requirements of the Act that I Dri has made a acterimalistions administered by other Federal agencies. You must
3
Page 2 - Gary Boseck, Ph.D.
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 CFK Fart 807), fabeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxioning your maxicant of your device to a legally prematication. The PDA mixing of cassification 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 and If you desire specific advice to: your witto diagnostic devices), please contact the Office of additionally 21 CTTC Far 009.10 Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1500. Traditions) , 1977-194-4639. Also, please note the your devices, prease commonding by reference to premarket notification" (21CFR Part 807.97). I guilation chitited, "Misolanants of responsibilities under the Act may be obtained from the Other general miormation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dork Tills
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ver/ 3 - 4/24/96
Applicant: XTRAK MEDICAL, INC.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: XTD™ Thrombectomy System
Indications For Use:
For breaking apart and removing thrombus from hemodialysis access grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devige (Per 21 CFR 801.109)
510(k) Number K013473
(Optional Format 1-2-96)