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.

Device Description

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.

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.
SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943) This device is for connecting the NEEDLESCOPE and OPERATION MICROSCOPE OME-8000.

AI/ML Overview

Because this is an older 510(k) summary, it does not contain the detailed study information typically found in more recent submissions. The submission explicitly states that clinical data is not required due to the device having no significant changes in intended use, method of operation, materials, or design that could affect safety or effectiveness compared to predicate devices. Therefore, the information requested regarding acceptance criteria and performance study details is not present in the provided text.

Specifically:

No acceptance criteria or reported device performance are listed. The submission relies on substantial equivalence to predicate devices rather than demonstrating performance against specific criteria.
No specific study is described that proves the device meets acceptance criteria, as none was deemed necessary.

Given the information available, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

Not applicable. The submission does not define specific acceptance criteria or report performance data. It relies on demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable. No test set is described, as clinical data was not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set and no ground truth establishment for a test set are described.

4. Adjudication method for the test set

Not applicable. No test set and no adjudication method are described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an endoscope, not an AI-powered diagnostic device, so an MRMC study with AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an endoscope, not an algorithm, so a standalone performance study as described is not relevant.

7. The type of ground truth used

Not applicable. No specific ground truth establishment method for device performance is mentioned as clinical data was not required. The submission implicitly relies on the proven safety and effectiveness of predicate devices and general medical literature for the application of this type of device.

8. The sample size for the training set

Not applicable. This is a hardware device (endoscope), not a machine learning algorithm, so a training set as typically understood for AI/ML is not applicable.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of Device Substantiation (based on the provided text):

The manufacturer (Olympus Optical Co., Ltd.) determined that clinical data was not required for the NEEDLESCOPE (MSS-28CS-301/701) and SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943). This determination was based on the following reasons:

The application to the brain ventricles is the same as the predicate device (Olympus Neuro Endoscope A7595).
Literature supports that the application of this type of device to brain parenchyma is "usual."
An evaluation of thermal influence (using a Cow's brain) to the brain ventricles and parenchyma by illumination light showed "no visible change on the surface and inside of the brain."
No "significant changes in the intended use, method of operation, materials or design" were identified that could affect the safety or effectiveness of this device compared to predicate devices.

Therefore, the submission relies on the concept of substantial equivalence to already legally marketed predicate devices rather than presenting de novo clinical study data against defined acceptance criteria.

Summary

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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

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 81-426-42-5177 FAX 81-426-46-5613

Olympus Optical Co., Ltd.

Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416

Address, Phone and Fax :

B. Device Name, Common Name

Device Name :
Common/Usual Name :
Classification Name :

MSS-28CS-301/701 NEEDLESCOPE

NEEDLESCOPE

Neurological endoscope 21CFR882.1480

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C. Predicate Devices:

Model	Device Description &510(k)#/ Date Cleared	Manufacturer
Neuro Endoscope	#K97314007/29/1998	Olympus Optical Co.,
MaCHIDA FLEXIBLENEURO-ENDSCOPENEU-4/4L	#K99356803/13/2000	MACHIDA ENDOSCOPECO., LTD.

D. Description of the Device

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.
1. 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).