The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

Device Description

The Cleaner "1" Rotational Thrombectomy System is a 7F percutaneous mechanical thrombectomy 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 4000rpm. 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 aspirated through the introducer sheath.

AI/ML Overview

The provided text describes a 510(k) summary for the Cleaner Rotational Thrombectomy System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through detailed clinical studies with specific acceptance criteria and detailed performance metrics as one might find for a de novo or PMA submission.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in the provided document. The document states that "bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device." It also mentions "Non-Clinical Performance Testing" derived from risk assessment and ISO standards, but does not provide specific details on the acceptance criteria or results.

Based on the provided text, here’s a breakdown of what can be inferred or is directly stated, and what cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device," but it does not specify these criteria or the reported performance metrics against them. The conclusion simply states the device is "substantially equivalent" to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No test set for clinical performance is mentioned. The testing described is "bench testing and animal studies," which are non-clinical. No sample sizes for these are provided, nor is their provenance or study design (retrospective/prospective) detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. There's no mention of a clinical test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. There's no mention of a clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was mentioned. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's evaluation as described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not a standalone algorithm. Its performance is inherent to its mechanical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. For the non-clinical "bench testing and animal studies," the ground truth would be physical measurements and observations of the device's mechanical performance in relevant models, but the specific types are not detailed.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable. As above, no machine learning training set is mentioned.

Summary of what the document does state:

Device: Cleaner™ Rotational Thrombectomy System.
Intended Use: Mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
Predicate Devices: Cleaner™ Rotational Thrombectomy System (K091029 and K060904).
Testing Conducted: "Bench testing and animal studies" to demonstrate safety and effectiveness, and "Non-Clinical Performance Testing" derived from risk assessment and ISO standards.
Conclusion: The device is "substantially equivalent" to the predicate devices based on this testing and similarities in intended use, materials, technological characteristics, principle of operation, and design features.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for REX MEDICAL. The logo is in black and features a stylized, curved shape on the left side. The text "REX MEDICAL" is written in bold, sans-serif font, with each letter connected to the next.

19428

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:	K120346
Submitter:	Rex Medical, L.P.1100 E. Hector Street, Suite 245Conshohocken, PA 19428
Contact Person:	Nicholas CiccarelliDesign EngineerPhone: (610) 940-0665 x109Fax: (610) 940-1590Email: nciccarelli@rexmedical.com
Date Prepared:	February 1, 2012
Trade Name:	Cleaner TM Rotational Thrombectomy System
Common Name:	Peripheral Atherectomy Catheter (21 CFR 870.4875, Product Code MCW)
Predicate Device(s):	Cleaner TM Rotational Thrombectomy SystemK091029

K091029	Cleaner TM Rotational Thrombectomy System
K060904	Cleaner TM Rotational Thrombectomy System

Device Description

Intended Use:

The Cleaner™ Rotational Thrombectomy 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 regards to materials, intended use, principles of operation and technological characteristics to the predicate device. Results of

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bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device.

Non-Clinical Performance Testing:

All . Sing performed on the Cleaner "M Rotational Thrombectomy System was derived from the risk assessment which evaluated the safety and effectiveness of the design modifications to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.

Conclusion:

Rex Medical considers the Cleaner™ Rotational Thrombectomy System to be substantially equivalent to the predicate devices 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a stylized depiction of a caduceus, a traditional symbol of medicine, featuring a staff with a snake winding around it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 1 2012

Rex Medical c/o Ms. Susan Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K120346

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: May 1, 2012 Received: May 4, 2012

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.

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Page 2 - Ms. Susan Goldstein-Falk

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

W.G. Hilleham

C-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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REX MEDICAL

1100 East Hector Street, Conshohocken, PA 19428

Special 510(k): Device Modification Cleaner IM Rotational Thrombectomy System

Indications for Use

1205 510(k) Number (if known):

Device Name: Cleaner™ Rotational Thrombectomy System

Indications For Use:

The Cleaner 10 Rotational Thrombectorny System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The Counter Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.S. Hillham

ion Sian-l (Division of Cardiovascular Devices,

510(k) Number C120346

Regulation Number and Section

§ 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).