OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4

K020507 · Olympus Winter & Ibe GmbH · GWG · Oct 8, 2002 · Neurology

Device Facts

• Record ID: K020507
• Device Name: OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: GWG · Neurology
• Decision Date: Oct 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.

Device Story

Olympus Neuroendoscopes are rigid endoscopes used for intracranial visualization. Device inputs consist of optical images captured within the ventricles, subarachnoid space, or brain parenchyma. The device functions as a visual conduit, transmitting images to the surgeon for real-time observation during neurosurgical procedures, including shunt placement, aneurysm microsurgery, and tumor/cyst visualization. Used in clinical/OR settings by neurosurgeons. Output is direct visualization of the surgical site, enabling the surgeon to navigate intracranial structures and perform interventions. Benefits include minimally invasive access to intracranial cavities and improved visualization for complex neurosurgical tasks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope; stainless steel construction; optical lens system; diameters ranging from 2.7 mm to 4.0 mm; field of view 68.4°–95.8°; direction of view 0°, 30°, or 70°; magnification 2.1–2.22; working distance 10 mm. Standalone device; non-powered optical instrument.

Indications for Use

Indicated for patients requiring visualization of brain ventricles, endoscopic-assisted microsurgery for cerebral aneurysms, shunt placement, and visualization of tumors, cysts, and neurovascular compression syndromes.

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

• Olympus Neuroendoscopes (K971340)

Submission Summary (Full Text)

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

OCT 0 8 2002

020507

# OLYMPUS

## WINTER & IB

Business address: Kuehnstr. 61 D-2204 Mailing address: Postfach 70 17 09 D-2201' Tel: [phone] Telefax +49-40-6 68

Olympus Neuroendoscopes

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDS 1990 and 21 CFR Part 807.92

Submitter's Name, Address, Phone, Coutact Person and Summary Date A.

Olympus Winter & Ibe Manufacturer of subject device: Keuhnstr. 61 D-22045 Hamburg Germany 8010313 Registration number: Contact Person:

Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville NY 11747-3157

Telephone: [phone]

#### B. Device Name

Device Name: Olympus Neurocndoscopes

Common/Usual Name: Neurological endoscopes

Neurological endoscope Classification Name:

Classification: 21 CFR 882.1480 Class II

- C. Predicate Devices:
Olympus Neuroendoscopes (K971340)

Device Description D.

The Olympus Neuroendoscope is a rigid endoscope indicated for intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal environments.

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

#### Intended Use of Device £.

The Olympus Neuroendoscopes are intendod for viewing the ventricles of the brain and for use in The Orympus Neurochaosopes are meeters and shunt placement and shunt placement and for ondoooopto absteted instruction of the rovascular compression syndromes.

| Item | Predicate<br>device, model<br>A7594A | Subject<br>device, S-<br>1349/1 | Subject<br>device, S-<br>1349/2 | Subject<br>device, S-<br>1349/3 | Subject<br>device, S-<br>1349/4 |
|-----------------------------|--------------------------------------|---------------------------------|---------------------------------|---------------------------------|---------------------------------|
| Telescope Diameter | Ø 4 mm | Ø 4 mm | Ø 2.7 mm | Ø 2.7 mm | Ø 2.7 mm |
| Telescope Total<br>Length | 218.5 mm | 218.5 mm | 225.3 mm | 225.0 mm | 233 mm |
| Telescope Working<br>Length | 158.1 mm | 158.1 mm | 158.1 mm | 157.7 mm | 156.7 mm |
| Lens Diameter | Ø 2.8 mm | Ø 2.8 mm | Ø 1.7 mm | Ø 1.7 mm | Ø 1.9 mm |
| Field of view | 95.8° | 95.8° | 70.8° | 68.4° | 85° |
| Direction of view | 0° | 0° | 0° | 30° | 70° |
| Best working distance | 10 mm | 10 mm | 10 mm | 10 mm | 10 mm |
| Magnification | 2.1 | 2.1 | 2.15 | 2.22 | 2.19 |

### Comparison to Predicate Devices F.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Storms-Tyler Director Regulatory Affairs and . Quality Assurance Olympus America, Inc. 2 Corporate Center Drive Melville, New York 11747

Re: K020507

Trade/Device Name: Olympus Neuroendoscope Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: July 3, 2002 Received: July 10, 2002

Dear Ms. Storms-Tyler:

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 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) 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. Iisting 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.

Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. The bottom half of the circle is blank. Inside the circle is a stylized design that resembles an abstract representation of a human form.

OCT 08 2002

OCT 0 8 2002

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

Page 2 - Ms. Storms-Tyler

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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}------------------------------------------------

510(k) Number (if known): K020507

Device Name: Olympus Neuroendoscope

Indications for Use:

The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.

(Please do not write below this line. Continue on another page is needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE) X Prescription Use _ the-Counter Use (Per 21 CFR 801.109) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -