FLEX ARM RETRACTOR SYSTEM

K071338 · Koros USA, Inc. · GZT · May 29, 2007 · Neurology

Device Facts

• Record ID: K071338
• Device Name: FLEX ARM RETRACTOR SYSTEM
• Applicant: Koros USA, Inc.
• Product Code: GZT · Neurology
• Decision Date: May 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room environment.

Device Story

Flex Arm Retractor System; mechanical surgical instrument assembly. Provides support for retractors, dilators, probes, and protecting shields during neurological procedures. Designed for use in MR-guided surgical environments. Operated by surgeons/trained medical professionals in operating rooms. Facilitates tissue dissection and retraction; enhances surgical access and visualization. Benefits patient by enabling precise tissue management during complex neurosurgical interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical self-retaining retractor system. Components include retractors, dilators, probes, and protecting shields. Designed for MR compatibility. No electronic or software components.

Indications for Use

Indicated for use by trained medical professionals in operating room environments for neurological surgical procedures requiring tissue dissection and retraction, including those utilizing MR visualization.

Regulatory Classification

Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2007

Koros USA, Inc. % CITECH Mr. Robert Mosenkis President 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K071338

Trade/Device Name: Flex Arm Retractor System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: May 11, 2007 Received: May 14, 2007

Dear Mr. Mosenkis:

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 such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Robert Mosenkis

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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

ncerely vours. ark N. Melkerso Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K071338

MAY - 1 2007

not known 510(k) Number:

Flex Arm Retractor System Device Name:

Indications For Use: Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room

environment.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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011-Division of General, Restorative, and Neurological Devices

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510(k) Number.