INCL II ENDOSCOPE

K963642 · Sofamor Danek USA,Inc. · GWG · Mar 18, 1998 · Neurology

Device Facts

• Record ID: K963642
• Device Name: INCL II ENDOSCOPE
• Applicant: Sofamor Danek USA,Inc.
• Product Code: GWG · Neurology
• Decision Date: Mar 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material and for viewing herniated disc material in the lumbar spine via a percutaneous surgical approach. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).

Device Story

INCLUSIVE Endoscopic System is a surgical visualization device. It utilizes light-transmitting optical fibers and an image-transmitting fiber bundle to provide internal visualization. Operated by surgeons in clinical or surgical settings, the device aids in the search and removal of nucleus material during lumbar spine procedures and facilitates visualization of tissues in the brain, knee, shoulder, wrist, and TMJ. The system provides direct optical feedback to the clinician, assisting in surgical navigation and decision-making during minimally invasive percutaneous procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiber-optic endoscopic system consisting of light-transmitting optical fibers and an image-transmitting fiber bundle. Mechanical/optical design for visualization. No electronic or software components described.

Indications for Use

Indicated for patients requiring visualization or nucleus material removal in the lumbar spine (herniated discs), brain tissue visualization, or arthroscopic visualization of the knee, shoulder, wrist, and temporomandibular joint (TMJ).

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Submission Summary (Full Text)

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MAR 18 1998

510(k) Summary
INCLUSIVE® Endoscopic System
K963642
January 16, 1998

I. Company: Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
[phone]

II. Product Name: INCLUSIVE® Endoscopic System

III. This submission describes an endoscopic system and ancillary equipment. The endoscope consists of light transmitting optical fibers and an image transmitting fiber bundle contained within the scope.

IV. The INCLUSIVE Endoscope is indicated for aiding in the search and removal of nucleus material and for visualization of lumbar herniated discs. It is intended to be used percutaneously in the lumbar spine. The endoscope is also intended for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).

V. The INCLUSIVE Endoscope Device was claimed to be substantially equivalent to various commercially available arthroscopic and endoscopic systems. Information pertaining to these systems was provided in the submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Richard W. Treharne
Vice President, Research and Regulatory Affairs
Sofamor Danek
1800 Pyramid Place
Memphis, Tennessee 38132

Re: K963642
Trade Name: Inclusive Endoscopic System
Regulatory Class: II
Product Code: GWG
Dated: January 16, 1998
Received: January 16, 1998

Dear Mr. Treharne:

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 (QS) 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.

MAR 18 1998

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Page 2 - Mr. Treharne

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,


Enclosure

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Page 1 of 1
January 16, 1998

510(k) Number (if known): K963642

Device Name: INCLUSIVE® Endoscope

Indications for Use:

The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material and for viewing herniated disc material in the lumbar spine via a percutaneous surgical approach. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephen Rhodes
(Division Sign-Off)
Division of General Restorative Devices K963642
510(k) Number
OR
Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)