CLEANER ROTATIONAL THROMBECTOMY SYSTEM

K120346 · Rex Medical · MCW · Jun 1, 2012 · Cardiovascular

Device Facts

• Record ID: K120346
• Device Name: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
• Applicant: Rex Medical
• Product Code: MCW · Cardiovascular
• Decision Date: Jun 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Cleaner Rotational Thrombectomy System is a 7F percutaneous mechanical thrombectomy catheter used for declotting native vessel dialysis fistulae and synthetic dialysis access grafts. The device features a handle with a battery-operated motor that rotates a flexible, S-shaped guidewire at approximately 4000 rpm. The rotating wire, equipped with an integrated soft distal tip, creates a fluid vortex that macerates clots, allowing for aspiration through an introducer sheath. It is a sterile, single-use disposable device operated by a clinician in a clinical setting. The device provides atraumatic mechanical declotting, restoring patency to dialysis access sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and animal studies evaluating design modifications to the guidewire, with methodology and acceptance criteria derived from internal Rex Medical standards and relevant ISO standards.

Technological Characteristics

7F percutaneous catheter; battery-operated motor (approx. 4000 rpm); flexible S-shaped guidewire with soft distal tip; sterile, single-use disposable. Operates via mechanical rotation to create a fluid vortex for clot maceration. No software or electronic processing.

Indications for Use

Indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts in patients requiring dialysis access maintenance.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Cleaner™ Rotational Thrombectomy System (K091029)
• Cleaner™ Rotational Thrombectomy System (K060904)

Submission Summary (Full Text)

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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.<br>1100 E. Hector Street, Suite 245<br>Conshohocken, PA 19428 |
| Contact Person: | Nicholas Ciccarelli<br>Design Engineer<br>Phone: [phone] x109<br>Fax: [phone]<br>Email: [e-mail] |
| 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 System<br>K091029 |

| K091029 | Cleaner ^TM Rotational Thrombectomy System |
|---------|------------------------------------------------------|
| K060904 | Cleaner ^TM Rotational Thrombectomy System |

## 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.

### 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 [phone] or [phone] 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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.S. Hillham

ion Sian-l (Division of Cardiovascular Devices,

510(k) Number C120346