RECRUIT MICROCATHETER

K091563 · Reverse Medical Corporation · MMX · Jul 30, 2009 · Cardiovascular

Device Facts

• Record ID: K091563
• Device Name: RECRUIT MICROCATHETER
• Applicant: Reverse Medical Corporation
• Product Code: MMX · Cardiovascular
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

Device Story

ReCruit™ Microcatheter is a flexible, tapered, reinforced composite catheter with a distal braided mesh retrieval element. Used in peripheral, neuro, and cardiovasculature to retrieve misplaced foreign objects (coils, balloons, catheter fragments, wires). Operated by physicians during interventional radiologic procedures. Input: manual advancement of a guidewire or ReAct™ stylet through the catheter lumen to radially expand the distal mesh element. Radiopaque markers facilitate fluoroscopic visualization for precise placement. Output: mechanical capture of foreign objects within the expanded mesh. Benefits: enables non-surgical removal of misplaced interventional devices, reducing patient risk. Includes luer fitting for liquid infusion and hydrophilic coating for navigation.

Clinical Evidence

Bench testing only. Preclinical studies included in vitro and in vivo laboratory studies to demonstrate performance under simulated use conditions. Biocompatibility testing confirmed compliance with ISO 10993-1 and FDA requirements.

Technological Characteristics

Flexible, tapered reinforced composite catheter with distal braided mesh retrieval element. Includes stainless steel ReAct™ stylet with platinum tip. Features radiopaque markers for fluoroscopic visualization. Hydrophilic coating. Compatible with guide catheters. Designed for vessel diameters 2mm to 4mm. Materials are medical grade and biocompatible.

Indications for Use

Indicated for retrieval of intravascular foreign objects (coils, balloons, catheter fragments, loop wires) misplaced during interventional radiologic procedures in peripheral, neuro, and cardiovasculature. For use with a guiding catheter.

Regulatory Classification

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.

Predicate Devices

• in-Time Retrieval Device (K014109)

Submission Summary (Full Text)

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K091563

# 4. 510(k) Summary

Date prepared

Name

Contact Person

Device name

Common name

Model No.

Classification name

Classification regulation

Predicate devices

Description

July 30, 2009

Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618

JUL 80 2009

Amy Eskina Director, Regulatory Quality & Clinical Affairs Reverse Medical Corporation Tel [phone] ext 234 Fax [phone]

ReCruit™ Microcatheter

Foreign Body Remover

TBD

Percutaneous Retrieval Device

870.5150 MMX

K014109; in-Time Retrieval Device; Clearance date: March 12, 2002

The Reverse Medical ReCruit™ Microcatheter consists of a flexible, tapered reinforced composite catheter with a braided mesh retrieval element attached to the distal region of the catheter. The inner lumen can accommodate a guidewire to aid in placement of the catheter. The catheter contains radiopaque markers to facilitate fluoroscopic visualization- a distal tip marker, markers at the proximal and distal end of the retrieval element, and circumferentially placed markers within the retrieval element. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. The selection of guidewire sizes in accordance with device compatibility allows for guidewires to be used either for navigation and placement or for deployment of the element.

The proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is coated with a hydrophilic coating. The catheter is designed to be used with a guide catheter.

The catheter is offered in various retrieval element sizes to accommodate physician preferences and patient anatomy.

Each ReCruit™ Microcatheter is packaged with a ReAct™ stylet and torque device. The ReAct™ stylet is a stainless steel wire with a platinum tip that may be used to activate the ReCruit™ Microcatheter's retrieval element. The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm.

Materials used in the Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.

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### Reverse Medical Corporation ReCruit™ Foreign Body Retrieval Microcatheter 510(k) Submission

Indications for Use

Summary of substantial equivalence

The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

Preclinical studies conducted included in vitro and in vivo laboratory studies to demonstrate that the Reverse Medical ReCruit™ Microcatheter performed as intended under simulated use conditions. Biocompatibility testing was performed to demonstrate that the device meets ISO 10993-1 requirements and FDA requirements.

The Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter has the following similarities to the previously cleared predicate device:

- . Same indications for use;
- . Same intended use;
- . Same intended treatment site;
- . Similar operating principle;
- Similar technological characteristics; .
- Same packaging methods .
- ♪ Same sterilization methods

In. summary, the Reverse Medical ReCruit™ Microcatheter as described in this submission is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1.00 2009

Reverse Medical Corporation c/o Mr. Mark Job Reviewer Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K091563

Trade Name: ReCruit Foreign Body Retrieval Microcatheter Regulation Number: 21 CFR 870.5150 Regulation Name: Percutaneous Retrieval Device Regulatory Class: Class II Product Code: MMX Dated: July 17, 2009 Received: July 21, 2009

Dear Mr. Job:

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 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 - Mr. Mark Job

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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincered yours,

W

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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Reverse Medical Corporation ReCruit™ Foreign Body Retrieval Microcatheter 510(k) Submission

3. Indications for Use

510(k) Number (if known):

Device Name: Reverse Medical ReCruit™ Microcatheter

Indications for Use:

The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(DivIsion Sign-Off) Division of Catalovascular Devices 510(k) Number