(314 days)
The Cleaner™ Rotational Thrombectorny System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The Cleaner™ Rotational Thrombectorny System is a 5.8Fr perculaneous mechanical thrombectorny catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000 rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspiration through an introducer sheath.
The provided text describes a medical device, the Cleaner™ Rotational Thrombectomy System, and its regulatory submission. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-driven device.
The document is a 510(k) summary for a thrombectomy catheter. The "Non-Clinical Performance Testing" section mentions: "The expanded indications for use to include native vessel dialysis fistulae are based on the bench testing and animal data presented in the performance section of the submission. A GLP animal study was conducted utilizing the Cleaner Rotational Thrombectomy System in a Lagomorph IVC model."
This indicates that an animal study and bench testing were performed to support the expanded indications, but these are not for an AI/algorithm-driven device, nor do they detail specific acceptance criteria for performance metrics that would be relevant to such a device (e.g., sensitivity, specificity, accuracy).
Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm-driven device meets those criteria cannot be extracted from this document, as the device is a mechanical thrombectomy system.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
| Submitter: | Rex Medical, L.P.1100 East Hector St., Suite 245Conshohocken, PA 19428 | FEB 18 2010 |
|---|---|---|
| Contact Person: | John LeedleSenior Design EngineerPhone: (610) 940-0665 x117Fax: (610) 940-1590Email: jleedle@rexmedical.com | |
| Date Prepared: | March 24th, 2009 | |
| Trade Name: | Cleaner™ Rotational Thrombectomy System | |
| Common Name: | Thrombectomy catheter | |
| Classification Name: | Peripheral Atherectomy Catheter (21 CFR 870.4875, Product Code MCW) | |
| Predicate Device(s):K011056 | Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) | |
| K011056 | Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) | |
| K060904 | Cleaner™ Rotational Thrombectomy System |
Device Description:
The Cleaner™ Rotational Thrombectorny System is a 5.8Fr perculaneous mechanical thrombectorny catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000 rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspiration through an introducer sheath.
Intended Use:
The Cleaner™ rotational thrombectorny system is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
Technological Characteristics:
The Cleaner™ Rotational Thrombectomy System is similar with regard to materials, intended use, principles of operation and technological characteristics to the predicate device. Any differences that may exist do not significantly affect the safety and efficacy of the device. Results of bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectorny System is as safe and effective as the legally marketed predicate device.
Non-Clinical Performance Testing:
The expanded indications for use to include native vessel dialysis fistulae are based on the bench testing and animal data presented in the performance section of the submission. A GLP animal study was conducted utilizing the Cleaner Rotational Thrombectomy System in a Lagomorph IVC model.
Conclusions:
Rex Medical considers the Cleaner™ Rotational Thrombectomy System to be substantially equivalent to the predicate device listed above. The conclusions are based on performance testing and similarities in indications for use, materials, technological characteristics, principle of operation and design features.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three wavy lines representing the body and head. The figure is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 8 2010
Rex Medical, L.P. c/o Susan D. Goldstein-Falk 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K091029
Trade/Device Name: Cleaner Rotational Thrombectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: February 1, 2010 Received: February 3, 2010
Dear Ms. Goldstein-Falk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Susan Goldstein Falk
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nmun R. V. hmer
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Cleaner™ Rotational Thrombectomy System
Indications For Use:
The Cleaner™ Rotational Thrombectorny System is indicated for mechanical declotting The Gleaner - Productional This Clicklysis access grafts.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LIME-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma P. La dues
2/3
(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices
510(k) Number_Kog102-9
Page 1 of __ 1_
§ 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).