(197 days)
Not Found
Not Found
No
The summary describes a mechanical device for declotting dialysis grafts and does not mention any AI or ML components or functionalities.
Yes
The device is described as permitting mechanical declotting of acute clot in thrombosed dialysis grafts, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is used for mechanical declotting of acute clot in thrombosed dialysis grafts, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly mentions a "Catheter" and a "Rotator Drive Unit," which are hardware components. The performance studies also refer to a clinical trial involving patients and procedures, further indicating a physical device.
Based on the provided information, the Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "mechanical declotting of acute clot in thrombosed dialysis grafts." This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The PTD Catheter does not perform such tests.
- Device Description (though not found): The description of the device as a "catheter" used for "mechanical declotting" further supports its role as a therapeutic device used within the body.
- Lack of IVD-related information: The provided text does not mention any analysis of biological samples, laboratory procedures, or diagnostic results, which are characteristic of IVDs.
Therefore, the Arrow-Trerotola™ PTD Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in coniunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.
Product codes
MCW
Device Description
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.
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
Clinical evaluation results from IDE G950225 are included in the submission, and are summarized below.
A 122 patient randomized study comparing mechanical thrombolysis (PTD) to pulse-spray thrombolysis was recently completed at six institutions. The results of this clinical trial support claims for (1) equivalency in acute technical patency rates, (2) equivalency in acute major complication rates, and (3) reduced mean procedure time. In addition, the results support secondary claims of (1) equivalency in the rates of any complication (major or minor) and (2) equivalency in 3 month clinical patency rates.
Key Metrics
Not Found
Predicate Device(s)
The Angiodynamics Pro™ Infusion Catheter thrombolytic procedure.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
JUL 2 5 1997
Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 2400 Bernville Road Reading, Pennsylvania 19605
Re: K970080 Arrow-Trerotola™ Percutaneous Thrombolytic Device Requlatory Class: II (two) Product Code: MCW Dated: July 22, 1997 Received: July 23, 1997
Dear Mr. Nickel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions,
1
or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
JUL 25 -
SECTION 2 - 510(k) SUMMARY
The device is substantially equivalent to the Angiodynamics Pro™ Infusion Catheter thrombolytic procedure.
Indications for Use: The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in coniunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.
The device has comparable technological characteristics to the predicate device.
The nonclinical test results included in the submission are as follows:
JUL 25 .
Animal Studies
-
- Evaluation of venous injury caused by a percutaneous mechanical thrombolytic device - rabbit study.
-
- Pulmonary emboli from pulse-spray and mechanical thrombolysis: Evaluation with an animal Dialysis Graft Model.
-
- Preclinical in-vivo testing of a rotational mechanical thrombolytic device.
Bench Testing
-
- Basket durability test
-
- Mechanical tests
- Destructive tensile and destructive torque testing for the following A. device joints, or bonds:
- . Torque cable
- Stiffness rod-to-torque cable .
- Splined Luer hub-to-torque cable .
- Nitinol basket wires-to-metal cap and sleeve .
- Nitinol basket-to-torque cable .
- Plastic tip-to-metal cap .
- Hemostasis hub-to-sheath extension sleeve ●
- Side arm-to-hemostasis hub ●
- Luer hub-to-hemostasis hub side arm ●
Biocompatibility Testing
All components tested per ISO 10993.
Clinical evaluation results from IDE G950225 are included in the submission, and are summarized below.
A 122 patient randomized study comparing mechanical thrombolysis (PTD) to pulse-spray thrombolysis was recently completed at six institutions. The results of this clinical trial support claims for (1) equivalency in acute technical patency rates, (2) equivalency in acute major complication rates, and (3) reduced mean procedure time. In addition, the results support secondary claims of (1) equivalency in the rates of any complication (major or minor) and (2) equivalency in 3 month clinical patency rates.
3
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Image /page/3/Picture/1 description: The image shows the word "ARROW" in large, bold, sans-serif font. Below the word "ARROW" is the word "INTERNATIONAL" in a smaller, thinner, sans-serif font. The text is black against a white background.
2400 Bernville Road Reading, PA 19605 ·
(610) 378-0131 FAX: (610) 374-5360
SECTION 10 - INDICATIONS
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.
Tau k-Ryn
(Division Sign Oil) (Division - Catchevascurar Respiratory, and passiblogical Devices K910080 510(k) Number -
9691