(67 days)
Not Found
No
The device description focuses on mechanical action (rotating shaft, agitator, aspiration) and does not mention any computational or learning components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is designed for "breaking apart and removing thrombus," which is a medical intervention aimed at treating a pathological condition (clotted hemodialysis access grafts), thus classifying it as a therapeutic device.
No
The device is described as a thrombectomy catheter designed to fragment and remove thrombus, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical catheter with a rotating shaft, agitator, sheath, collection line, syringe, battery supply, and luer connection, indicating it is a hardware device.
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.
- Device Description: The description details a mechanical device designed to physically interact with and remove material from a blood vessel. This is consistent with a surgical or interventional device, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is to treat a condition (thrombus removal), not to diagnose one.
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)
QEW, DXE
Device Description
The XTD™ Thrombectomy Catheter is a sterile, single-use, disposable catheter designed to simultaneously fragment and remove thrombus from clotted hemodialysis access grafts. The catheter consists of a flexible, spiral-conveyor shaft rotating within a plastic sheath. The shaft has a small, flexible, curved agitator which extends out of the sheath. As the agitator rotates it breaks the thrombus to particles are aspirated into the sheath and are conveyed by the rotating spiral shaft through the sheath to a collection line connected to a disposable vacuum syringe. A pinch clamp on the collection line isolates the svringe and allows the operator to manually control the delivery of suction to the catheter tip. The battery supply and a luer connection for the syringe are incorporated directly onto the catheter.
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)
The XTD™ Thrombectomy Catheter components have been tested to assess compliance with their specifications and to support claims of substantial equivalence to the predicate device. This testing includes the following:
Mechanical Bench Testing
Battery Life Testing
Electrical Safety Testing
Electrical Emissions Testing
Ship Testing
Test results have demonstrated conformance of the XTD™ Thrombectomy Catheter to its specification requirements, and that the XTD™ Thrombectomy Catheter is as safe and effective as the legally marketed predicate device.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and name are written in blue, with the acronym in a blue square.
October 8, 2021
Xtrak Medical Inc. Debbie Iampietro President 7 Tiffany Trail Hopkinton, Massachusetts 01748
Re: K021641
Trade/Device Name: XTD Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
Dear Debbie Iampietro:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 26, 2002. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -5 O'connell -S Date: 2021.10.08 10:19:03 -04'00'
Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2002
XTRAK Medical, Inc. Ms. Debbie Iampietro c/o QRC Consulting Associates 7 Tiffany Trail Hopkinton, MA 01748
K021641 Re:
Device Name: XTDTM Thrombectomy Cathater Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: July 2, 2002 Received: July 2, 2002
Dear Ms. Iampietro:
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.
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
2
Page 2 - Ms. Debbie Iampietro
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Nole Tuch
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Verl 3 - 4/24/96
Applicant: XTRAK MEDICAL, INC.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: XTD™ Thrombectomy Catheter
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)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021641
Prescription Use
(Per 21 CFR 801.109)
4
JUL 2 6 2002
K021641 response
ﭘﻪ
K021641
Attachment 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XTD™ Thrombectomy Catheter July 1, 2002
General Information
Classification: Trade Name:
Trade Name
Sponsor:
Class II
XTD™ Thrombectomy Catheter
Xtrak Medical, Inc. 26H Keewaydin, Dr. Salem, NH 03079 Tel: (603) 896-6416 Fax: (603) 893-7708
Contact:
Gary Boseck, Ph.D. President
Identification of Predicate or Legally Marketed Devices
The XTD™ Thrombectomy System (K013473) manufactured by Xtrak Medical, Inc.
Intended Use
For breaking apart and removing thrombus from hemodialysis access grafts.
Device Description
The XTD™ Thrombectomy Catheter is a sterile, single-use, disposable catheter designed to simultaneously fragment and remove thrombus from clotted hemodialysis access grafts. The catheter consists of a flexible, spiral-conveyor shaft rotating within a plastic sheath. The shaft has a small, flexible, curved agitator which extends out of the sheath. As the agitator rotates it breaks the thrombus to particles are aspirated into the sheath and are conveyed by the rotating spiral shaft through the sheath to a collection line connected to a disposable vacuum syringe. A pinch clamp on the collection line isolates the svringe and allows the operator to manually control the delivery of suction to the catheter tip. The battery supply and a luer connection for the syringe are incorporated directly onto the catheter.
Materials
All materials used in the manufacture of the XTD™ Thrombectomy Catheter are suitable for their intended use and are used commonly in the manufacture of previously cleared products.
Performance Testing
The XTD™ Thrombectomy Catheter components have been tested to assess compliance with their specifications and to support claims of substantial equivalence to the predicate device. This testing includes the following:
Mechanical Bench Testing Battery Life Testing Electrical Safety Testing Electrical Emissions Testing Ship Testing
Test results have demonstrated conformance of the XTD™ Thrombectomy Catheter to its specification requirements, and that the XTD™ Thrombectomy Catheter is as safe and effective as the legally marketed predicate device.
5
K021641 response
Summary of Substantial Equivalence
Xtrak Medical believes that the XTD™ Thrombectomy Catheter is substantially equivalent to the legally marketed predicate device. This claim of equivalence is supported by the identical intended use of the devices and their common fundamental scientific characteristics.