ARTHROSCOPE

K971083 · Electro-Biology, Inc. · HRX · Jun 23, 1997 · Orthopedic

Device Facts

• Record ID: K971083
• Device Name: ARTHROSCOPE
• Applicant: Electro-Biology, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The EBI Spinal Endoscopic System™ is intended as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine when assessing disease pathology using a percutaneous posterior approach.

Device Story

EBI Spinal Endoscopic System is an arthroscope for visualization of lumbar and sacral spinal anatomy. System components include a fiberscope, disposable catheter, and accessories. Fiberscope connects to standard endoscopic video imaging systems via camera coupler and light cord adaptors. Used by clinicians in a clinical setting to illuminate and visualize the epidural space during percutaneous posterior procedures. Provides direct visual feedback to assist in assessing spinal disease pathology.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes fiberscope, disposable catheter, and accessories. Catheter material: medical grade polyurethane. Fiberscope outer jacket: polyimide. Connectivity: compatible with standard endoscopic video imaging systems via camera coupler and light cord adaptors. Non-powered, mechanical visualization tool.

Indications for Use

Indicated for use as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine for assessment of disease pathology via percutaneous posterior approach.

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

• Myelotec Myeloscope System (not specified)
• Danek Spinal Endoscopic System (not specified)
• Nucleotome EndoFlex (not specified)
• Steerable Working Channel Scope (not specified)

Submission Summary (Full Text)

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EBI Electro Biology

Enhancing Bone Healing through Applied Science

K971083

JUN 23 1997

# 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI Spinal Endoscopic System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Electro-Biology, Inc.
6 Upper Pond Road
Parsippany, NJ 07054

Contact Person: Jon Caparotta
Telephone: [phone]

Date prepared: March 24, 1997

2. Proprietary Name: EBI Spinal Endoscopic System
Common Name: Arthroscope
Classification Name: Arthroscope and Accessories (888.1100)

3. Predicate or legally marketed devices that are substantially equivalent:
- Myelotec Myeloscope System - Myelotec Inc.
- Danek Spinal Endoscopic System - Sofamor Danek USA
- Nucleotome EndoFlex - Surgical Dynamics Inc.
- Steerable Working Channel Scope - Surgical Dynamics Inc.

4. Description of the device: The EBI Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adaptors.

Intended Use: The EBI Spinal Endoscopic System™ is intended as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine when assessing disease pathology using a percutaneous posterior approach.

5. Materials: The catheter is the patient contacting portion of the system. It is manufactured from medical grade polyurethane. The outer jacket of the fiberscope is made out of polyimide.

6. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI Spinal Endoscopic System and other spinal arthroscopes currently on the market. It is substantially equivalent* to the predicate devices in design, materials and intended use. Also, bench testing demonstrates that the device meets its functional requirements.

*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

Electro-Biology, Inc. - A Subsidiary of Biomet, Inc.

6 Upper Pond Road, Parsippany, NJ 07054-1079 • Telephone [phone] • Toll Free 800-526-2579 • Fax [phone]

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

Mr. Jon Caparotta
Manager, Regulatory Affairs
Electro-Biology, Inc.
6 Upper Pond Road
Parsippany, New Jersey 07054-1079

Re: K971083
Trade Name: Spinal Endoscopic System
Regulatory Class: II
Product Code: HRX
Dated: March 24, 1997
Received: March 25, 1997

JUN 23 1997

Dear Mr. Caparotta:

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 requirements, 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.

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Page 2 - Mr. Jon Caparotta

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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# Statement of Indications for Use

K971083

The EBI Spinal Endoscopic System is intended as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine when assessing disease pathology using a percutaneous posterior approach.


Prescription Use ☑
(Per 21 CFR 801.109)