EBI VUECATH ENDOSCOPIC SYSTEN

K990459 · Electro-Biology, Inc. · HRX · Apr 23, 1999 · Orthopedic

Device Facts

• Record ID: K990459
• Device Name: EBI VUECATH ENDOSCOPIC SYSTEN
• Applicant: Electro-Biology, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications. In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.

Device Story

EBI VueCath™ Spinal Endoscopic System is an arthroscopic device for lumbar and sacral spinal visualization; consists of fiberscope, disposable catheter, and accessories. Operates by connecting to compatible endoscopic video imaging systems via camera coupler and light cord adapters. Used by physicians in clinical settings to illuminate and visualize epidural space tissues; assists in diagnosis of spinal disease and delivery of epidural-approved drugs. Catheter inserted via caudal approach through sacral hiatus. Provides direct visual feedback to physician to guide diagnostic and therapeutic procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes fiberscope, disposable catheter, and accessories. Catheter material: medical grade polyurethane. Fiberscope outer jacket: polyimide. Connects to external endoscopic video imaging systems. Non-powered, fiberoptic visualization.

Indications for Use

Indicated for patients requiring observation of epidural anatomy, pathology, or drug delivery in the lumbar and sacral spine; used by physicians for visualization of epidural space tissues to assist in disease diagnosis via caudal approach through the sacral hiatus.

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

• EBI Spinal Endoscopic System
• Myelotec Myeloscope System

Submission Summary (Full Text)

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Kq90459

## 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(1)(3) of the Federal Food. Drug and Cosmetic Act.

| 1. Submitter: | Jon Caparotta |
|-----------------|-----------------------|
| | Electro-Biology, Inc. |
| | 100 Interpace Parkway |
| | Parsippany. NJ 07054 |
| Contact Person: | Jonas Wilf |
| Telephone: | [phone] X2208 |

Date prepared: February 11, 1999

| 2. Proprietary Name: | EBI VueCath™ Spinal Endoscopic System |
|----------------------|---------------------------------------------|
| Common Name: | Catheter |
| Classification Name: | Catheter, Conduction, Anesthesia (868.5120) |

- 3. Predicate or legally marketed* devices that are substantially equivalent:
- . EBI Spinal Endoscopic System - Electro-Biology, Inc.
- . Myelotec Myeloscope System - Myelotec Inc.
- Description of the device: The EBI VueCath™ Endoscopic Spinal System is an arthroscope ব 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 adapters.
- న. Intended Use: When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.

- Materials: The catheter is the patient contacting portion of the system. It is manufactured from 6. medical grade polyurethane. The outer jacket of the fiberscope is made out of polyimide.
- 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI VueCath™ Spinal Endoscopic System and another spinal arthroscopes and endoscopes currently on the market. It is substantially equivalent to the virtually identical Myelotec Myeloscope System device in design, materials and intended use. * Also, bench testing demonstrates that the device meets its functional requirements.

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Jon Caparotta Manager, Regulatory Affairs Electro Biology, Inc. 100 Interpace Parkway Parsippany, New Jersey 07054

K990459 Re: Trade Name: EBI VueCath™ Spinal Endoscopic System Regulatory Class: II Product Code: HRX Dated: February 11, 1999 Received: February 12, 1999

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 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.

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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,

fr 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:

When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.

Prescription Use
(Per 21 CFR 801.109)

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visior 510(k) Num