FLEXPOSURE RETRACTOR

K983144 · Endius, Inc. · HRX · Feb 24, 1999 · Orthopedic

Device Facts

• Record ID: K983144
• Device Name: FLEXPOSURE RETRACTOR
• Applicant: Endius, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flexposure Retractor is a disposable manual surgical instrument intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

Device Story

Flexposure Retractor is a manual surgical instrument for posterior endoscopic microdiscectomy. Device consists of a tube-like retractor with an expandable distal tip; constructed from medical-grade stainless steel and heat-shrink polyester. Operation: device inserted through a cannula lateral to the spine midline; positioned on the lamina; user pulls a tip release line to split the polyester material; distal tip expands; a separate mechanical hand-held retractor is inserted and opened to expand the flexible stainless steel skirt to approximately 25 mm. Used in surgical settings by physicians to retract tissues, providing improved endoscopic access to the operative site. Benefits include enhanced visualization and access during minimally invasive spinal procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual surgical instrument; medical grade stainless steel construction; heat-shrink polyester tip release mechanism; expandable distal tip design; 25 mm expanded dimension; disposable; non-powered.

Indications for Use

Indicated for patients undergoing endoscopic discectomy procedures requiring access to the posterior lumbar spine.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Retractor included in the Sofamor Danek MED Microendoscopic Discectomy (K955471, K950501, K950130)

Submission Summary (Full Text)

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2/24/99

-983144

510(k) Summary for Endius Incorporated Flexposure Retractor

- 1. SPONSOR
Endius Incorporated 23 West Bacon Street Plainville, MA 02762 Telephone: [phone] Facsimile: 508-695-2501

Contact Person: Mark Bliss

September 4, 1998 Date Prepared:

- 2. DEVICE NAME

| Proprietary Name: | Flexposure Retractor |
|----------------------|----------------------------|
| Common/Usual Name: | Retractor |
| Classification Name: | Manual Surgical Instrument |

#### PREDICATE DEVICES 3.

Retractor included in the Sofamor Danek MED Microendoscopic Discectomy, K955471, K950501 and K950130.

#### 4. DEVICE DESCRIPTION

The Flexposure Retractor is a manual surgical instrument intended for use in posterior endoscopic microdiscectomy procedures. It is essentially a standard retractor designed to improve exposure of the surgical site. The Flexposure Retractor looks like a standard retractor/tube like device with the exception of the distal end. The distal end of the device can expand to better retract tissues from the operative site. The device includes a tip release line which is attached to an outer heat shrink polyester material. The purpose of the heat shrink polyester

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material is to maintain the retractor in the closed position. The remainder of the device is made from medical grade stainless steel.

The Flexposure Retractor is placed several centimeters lateral to the midline of the back through a cannula. The tip of the Retractor is positioned on the lamina. After positioning, the user pulls the tip release line which causes the heat shrink polyester material to split. The splitting of the heat shrink material allows for the expansion of the tip of the cannula. A mechanical hand held retractor is inserted through the cannula and opened causing the flexible stainless steel skirt of the retractor to be expanded to approximately a 25 mm dimension.

### ട്. INTENDED USE

The Flexposure Retractor is a disposable manual surgical instrument intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Endius Incorporated Flexposure Retractor is substantially equivalent to several legally marketed retractors including the retractor included in the Sofamor Danek MED Microendoscopic Discectomy, K955471, K950501 and K950130.

Both the Endius Retractor and the predicate Sofamor Danek retractor are intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

Both the Endius Retractor and the predicate Sofamor Danek retractor are similar in that they are inserted over step dilators to push the tissues away from the operative site. The Endius Retractor is different in that the distal tip of the retractor expands to provide improved endoscopic access to the posterior lumbar spine. This difference does not compromise safety or effectiveness of the device since the device functions essentially identical to the predicate device in retracting tissues. The only difference is the method of retraction. The materials of manufacture of both the proposed and predicate devices are medical grade stainless steel.

Based on the above discussion and the comparison chart below, Endius Incorporated believes that the Flexposure Retractor is substantially equivalent to the Sofamor Danek Retractor of the MED System.

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Endius. Inc. c/o Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K983144 Trade Name: Flexposure Retractor Regulatory Class: II Product Code: HRX Dated: December 7, 1998 Received: December 8, 1998

## Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 - Ms. Mary McNamara-Cullinane

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Flexposure Retractor

Indications For Use:

The Flexposure Retractor is a manual surgical instrument intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aseeees

ivision Sign-Off ivision of General Restorative Devices K983K

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)