NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES

K031858 · Richard Wolf Medical Instruments Corp. · GWG · Jul 29, 2004 · Neurology

Device Facts

• Record ID: K031858
• Device Name: NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GWG · Neurology
• Decision Date: Jul 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Minature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures. The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.

Device Story

Neuro-endoscope system comprising sheaths, working inserts, obturators, endoscopes, forceps, electrodes, and articulated arm. Used in neurosurgery for intracranial procedures; provides visual observation of operating site and irrigation fluid management. EANS system facilitates visualization of cerebral structures obscured from standard microscope view. Operated by neurosurgeons in clinical settings. Articulated arm replaces stereotactic frame for positioning. Device enables minimally invasive access for diagnosis and therapy; benefits include improved visualization of deep or obscured cerebral structures and reduced invasiveness compared to traditional open surgery.

Clinical Evidence

No clinical tests performed.

Technological Characteristics

System includes endoscopes, sheaths, working inserts, obturators, forceps, electrodes, and articulated arm. Conforms to IEC 601-1, IEC 601-2-2, and IEC 601-2-18. Light source requirements: halogen up to 250W or gas discharge/Xenon up to 180W; fluid light cables prohibited. Mechanical design optimized for intraventricular access in pediatric and adult patients.

Indications for Use

Indicated for neurosurgical diagnosis and therapy during intracranial procedures, including intraventricular endoscopic procedures in newborns, children, and adults. EANS system indicated for visualization of cerebral structures and irrigation during microsurgical brain operations.

Regulatory Classification

Identification

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

Predicate Devices

• Neurological Endoscope Set (K970162)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains a handwritten string of alphanumeric characters. The string appears to read 'k031858'. The characters are written in a cursive style, with some connections between the letters and numbers. The handwriting is somewhat uneven, but the characters are generally legible.

# 13 510(k) Summary of Safety and Effectiveness

| Submitter: | Date of Preparation:<br>19. September 2003 | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------|
| Company / Institution name:<br>RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration<br>number:<br>14 184 79 | |
| Division name (if applicable):<br>N.A. | Phone number (include area code):<br>( 847 ) 913 1113 | |
| Street address: | FAX number (include area code):<br>( 847 ) 913 0924 | |
| City:<br>Vernon Hills | State/Province:<br>Illinois | Country:<br>USA ZIP / Postal Code:<br>IL 60061 |
| Contact name:<br>Mr. Robert L. Casarsa | | |
| Contact title:<br>Quality Assurance Manager | | |
| Product Information: | | |
| Trade name: | Model number: | |
| Miniature Neuro-Endoscope System by Hopf<br>and<br>Endoscopic Assisted Neuro Surgery-System | 8672.xxx,<br>8768.xxx,<br>and others | |
| Common name:<br>Neurological Endoscopy Set | Classification name:<br>Neurological endoscope | |
| Information on devices to which substantial equivalence is claimed: | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K970162 | 1 Neurological Endoscope Set | 1 Richard Wolf |

#### 1.0 Description

The submitted neuroendoscope sets are adaptable and therefore suitable for a variety of surgical manipulations. The set consists of sheaths with working channels respectively working inserts, obturators, endoscopes, forceps, electrodes and an articulated arm.

#### 2.0 Intended Use

The Miniature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures.

The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.

Rev 12/03

13-1

{1}------------------------------------------------

# Technological Characteristics 3.0

The new sets are used with an articulated arm instead of the stereotactic frame, so that they become shorter. The smaller outer diameter and the convenient working length make the endoscope system especially valuable for intraventricular endoscopic procedures in newborn and children, as well as in adults if anatomical situation allows it.

### Substantial Equivalence 4.0

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf and competitors.

#### 5.0 Performance Data

The neuroscopy sets are conforming to the international standards IEC 601-1, IEC 601-2-2, and IEC 601-2-18.

To avoid accumulation of heat due to high light energy, only halogen light sources of up to 250 W or other light sources, such as gas discharge lamps, Xenon, of up to max. 180 W must be used, fluid light cables are not allowed to be used.

# 6.0 Clinical Tests

No clinical tests performed.

# 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.

By: Robert J. Casarsa

Robert L. Casarsa Quality Assurance Manager

Date: Dec 15, 2003

{2}------------------------------------------------

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" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling an abstract representation of the American flag or a flowing ribbon.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2004

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061-3110

Re: K031858

Trade/Device Name: Neuro-Endoscope System by Hopf EANS-System (Endoscopic Assisted Neuro Surgery) Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: May 28, 2004 Received: June 1, 2004

Dear Mr. Casarsa:

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 10 mos based or 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 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.

{3}------------------------------------------------

Page 2 - Mr. Robert L. Casarsa

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/dsma/dsmamain.html

Sincerely yours,
R. Mark A. Melkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

| 510(k) Number (if known): | K031858 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Neuro-Endoscope System by Hopf<br>EANS-System (Endoscope Assisted Neuro Surgery) |
| Indications For Use: | The Minature Neuro-Endoscope System by Hopf allows<br>visual observation of the operating site while using working<br>channels, supply and drain channels. They are used for<br>diagnosis and therapy in neurosurgery, in connection with<br>endoscopic accessories, during intracranial procedures.<br>The EANS System (Endoscopic Assisted Neuro Surgery)<br>allows a visualization of cerebral structures not visible<br>through the microscope and at the same time offers the<br>option of supplying and draining irrigation fluid, for<br>examination and diagnosis of microsurgical brain operation. |

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of _1 _ _

**510(k) Number** K031858