MSS-28CS-301/701 NEEDLESCOPE

K013759 · Olympus Optical Co., Ltd. · GWG · Aug 20, 2002 · Neurology

Device Facts

• Record ID: K013759
• Device Name: MSS-28CS-301/701 NEEDLESCOPE
• Applicant: Olympus Optical Co., Ltd.
• Product Code: GWG · Neurology
• Decision Date: Aug 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

This instrument has been designed to be combined with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventricles and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for diagnostic procedures, such as observation of carebral aneurysms, observation of cerebral tissues including brain turnors, observation of cerebral vascular systems and cranial nerves, and observation of hypophysis turnors.

Device Story

Needlescope (MSS-28CS-301/701) is a rigid neurological endoscope designed for use with the OME-8000 operation microscope via a connecting adapter (MAJ-943). Device provides optical visualization of intracranial structures, including ventricles, parenchyma, aneurysms, and tumors. Operated by neurosurgeons in an operating room setting. Provides direct visual feedback to the surgeon through the microscope optics to assist in diagnostic procedures and confirmation of aneurysm clips. Benefits include enhanced visualization of deep or obscured cerebral structures during neurosurgery.

Clinical Evidence

No clinical data provided. Bench testing performed to evaluate thermal influence of illumination light on cow brain tissue; results showed no visible changes to surface or internal brain structures.

Technological Characteristics

Rigid neurological endoscope; includes connecting adapter for operation microscope. Illumination provided via distal end. Materials and design consistent with predicate neuro-endoscopes. No software or electronic processing components.

Indications for Use

Indicated for use in neurosurgical procedures requiring visualization of brain ventricles, brain parenchyma, cerebral aneurysms, cerebral tissues (including tumors), cerebral vascular systems, cranial nerves, and hypophysis tumors. Used in conjunction with the OME-8000 operation microscope.

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

• Neuro Endoscope (K973140)
• MaCHIDA FLEXIBLE NEURO-ENDSCOPE NEU-4/4L (K993568)

Reference Devices

• OLYMPUS NEURO ENDOSCOPE A7595

Submission Summary (Full Text)

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# 510(k) SUMMARY

# NEEDLESCOPE (MSS-28CS-301/701) and SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.

## A. Submitter's Name, Address, Phone and Fax Number

#### 1. Manufacturer of the subject device

Name & Address of Manufacturer;

Registration No : Address, Phone and Fax Number of R&D Department Endoscope Division

2. Name of Contact Person Name :

2-3-1 Shinjuku Monolis Nishi-shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 8010047 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan TEL [phone] FAX [phone]

Olympus Optical Co., Ltd.

Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL [phone] FAX [phone]

Address, Phone and Fax :

## B. Device Name, Common Name

1. Device Name :

2. Common/Usual Name :

3. Classification Name :

MSS-28CS-301/701 NEEDLESCOPE

#### NEEDLESCOPE

Neurological endoscope 21CFR882.1480

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## C. Predicate Devices:

| Model | Device Description &<br>510(k)#/ Date Cleared | Manufacturer |
|------------------------------------------------|-----------------------------------------------|--------------------------------|
| Neuro Endoscope | #K973140<br>07/29/1998 | Olympus Optical Co., |
| MaCHIDA FLEXIBLE<br>NEURO-ENDSCOPE<br>NEU-4/4L | #K993568<br>03/13/2000 | MACHIDA ENDOSCOPE<br>CO., LTD. |

#### D. Description of the Device

This instrument has been designed to be used with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventricles and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for diagnostic procedures, such as observation of cerebral aneurysms, observation of cerebral tissues including brain turnors, observation of cerebral vascular systems and cranial nerves, and observation of hypophysis tumors.

This Instruments are two types (MSS-28CS-301/701) of NEEDLESCOPE used with OPERATION MICROSCOPE OME-8000 which is 510(k) exemption device, and SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943) which Intervenes between the NEEDLESCPE and the OME-8000.

- 1. NEEDLESCOPE (MSS-28CS-301/701)
This device is used with the OPERATION MICROSCOPE OME-8000 for observing the brain ventricles and the brain parenchyma and for performing diagnostic procedures.

- 2. SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943) This device is for connecting the NEEDLESCOPE and OPERATION MICROSCOPE OME-8000.
#### E. Intended Use of the device

This instrument has been designed to be combined with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventricles and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for diagnostic procedures, such as observation of carebral aneurysms, observation of cerebral tissues including brain turnors, observation of cerebral vascular systems and cranial nerves, and observation of hypophysis turnors.

## F. Reason for not requiring clinical data

The application to the brain ventricles is the same as the predicate device OLTMPUS NEURO ENDOSCOPE A7595.

And also it is apparent by literatures that the application of this kind of device to the brain parenchyma is usual.

As the result of evaluating the thermal influence by Cow's brain to the brain ventricles and parenchyma by illumination light coming from the distal end of NEEDLESCOPE, there was no visible change on the surface and inside of the brain.

Olympus has determined that clinical data is not required, since the Needlescope MSS-28CS-301/701 does not contain any significant changes in the intended use, method of operation, materials or design that could affect the safety or effectiveness of this device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 0 2002

Olympus Optical Company, LTD. c/o Laura Storms-Tyler Olympus America, Incorporated Two Corporate Center Drive Melville, New York 11747 - 3157

Re: K013759

Trade/Device Name: MSS-28CS-301/701 Needlescope Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: Class II Product Code: GWG Dated: May 21, 2002 Received: May 22, 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, 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.

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Page 2 – Ms. Laura 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" (21 CFR 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,

Mark A. Milkerum

Celia M. Witten, Ph.D., M.D.

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

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510(k) Number (if known): Device Name:

0137 NEEDLESCOPE MSS-28CS-301/701

Indications for Use:

OLYMPUS NEEDLESCOPE MSS-28CS-301/701 has been designed to be combined with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventricles , and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for performing diagnostic procedures, such as observation of cerebral aneurysms, observation of cerebral tissues including brain tumors, observation of cerebral vascular systems and cranial nerves, and observation of hypophysis tumors.

Mark M-Milkerss

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

510(k) Number_

Concurrence of CDRH, Office of Device Evaluation ODE

Prescription Use_ (Per 21 CFR 876.4400)

OR

Over-The-Counter Use

(Optional Format 1-2-96)