Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.

Device Description

The Olympus Endoscopic System for Lumbar Hernia Discectorny and Accessories consist of the following components:

Initial Placement Instruments (Guide Needle, Dilators, Mandolin, Flexible Sheath, Pusher, Side Sheath)
Olympus XELSPAS Series Manual Surgical Hand Instruments
Telescope to view operative site
Light Guide Adaptor an adaptor to be used with commercially available light systems to provide illumination
Surgical Holder Adaptor an adaptor to be used to attach the endoscope to Olympus surgical holder device (510(k) K960068)

AI/ML Overview

This 510(k) premarket notification describes the Olympus Endoscopic System for Lumbar Hernia Discectomy. It is important to note that this document is a 510(k) summary for substantial equivalence to existing devices, not a study describing the acceptance criteria and a study proving the device meets those criteria from an AI/performance perspective.

Therefore, I cannot directly provide information on acceptance criteria for device performance as typically understood in a clinical study validating a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy). This document focuses on demonstrating physical and intended use equivalence to predicate devices already on the market.

However, I can extract information related to the device description and its intended use, which would form the basis for any performance evaluation, if one were conducted.

Here's an analysis based on the provided text, but it will largely indicate what isn't present in terms of AI/performance acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria for device performance (e.g., diagnostic accuracy, sensitivity, specificity, or performance metrics for identifying herniations) because it's a 510(k) for substantial equivalence, not a performance study of a novel diagnostic or AI device. The "performance" being evaluated here is primarily functional equivalence to predicate devices.

The device's intended performance is:

Visualizing: Lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue.
Aiding in: Search and removal of vertebral bone and nucleus material.

The document implicitly "reports" that the device meets these intended uses by claiming substantial equivalence in technological characteristics, design, and materials to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study evaluating diagnostic performance on a test set of data (e.g., images for AI). It's a regulatory submission for a surgical endoscopic system based on equivalence to existing technology. If clinical testing was done to demonstrate functional equivalence (e.g., visualization quality during surgery), this document does not detail it.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a study evaluating diagnostic performance using ground truth established by experts.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission concerns a physical surgical endoscopic system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an endoscopic system, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic performance or AI. The "ground truth" for this submission is that the predicate devices are legally marketed and perform their intended function. The Olympus system is deemed "substantially equivalent" to this established "truth."

8. Sample Size for the Training Set

Not applicable. There is no AI model being trained discussed in this document.

9. How Ground Truth for the Training Set Was Established

Not applicable.

Summary regarding the device and the submission:

The Olympus Endoscopic System for Lumbar Hernia Discectomy is described as:

Intended Use: Visualizing lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.
Components: Guide Needle, Dilators, Mandolin, Flexible Sheath, Pusher, Side Sheath, Olympus XELSPAS Series Manual Surgical Hand Instruments, Telescope, Light Guide Adaptor, Surgical Holder Adaptor.
Substantial Equivalence Claim: The device is claimed to be substantially equivalent to Sofamor Danek's MED MicroEndoscopic Discectomy System, Sofamor Danek's INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO-ENDO Instruments (K950130), as well as another Olympus Endoscope (K951354) in optical characteristics and design. The materials of manufacture are standard medical products and identical to those cleared in legally marketed Olympus devices.

In conclusion, based on the provided 510(k) summary, there is no discussion of acceptance criteria for diagnostic/AI performance or a study demonstrating the device meets such criteria. The document focuses on demonstrating that the physical device is functionally and technologically equivalent to other legally marketed predicate devices for its intended surgical visualization and assistance purposes.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are simple and abstract, with flowing lines suggesting hair or head coverings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Olympus Optical Company, Ltd. Mr. James R. Veale Vice President, Regulatory Services c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K982133 Trade Name: Olympus Endoscopic Systems for Lumbar Hernia Discectomy Regulatory Class: II Product Code: HRX and KOG Dated: August 27, 1998 Received: August 28, 1998

Dear Mr. Veale:

This letter corrects our substantially equivalent letter of October 22, 1998 regarding the regulatory classification of your device, which is changed from HRZ to HRX. This device is regulated under 21 CFR 888.1100, Arthroscope and 21 CFR 876.1500, endoscope.

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

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Page 2 - Mr. James R. Veale

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 (301) 594-4595. 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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982133 510(k) Number (if known): J

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

boell

Division Sion-Off of General Re 1982133 510(k) Numbe

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

Optional Format (1-2-96)

CONFIDENTIAL

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OCT 2 2 1998

K982133

510(k) Summary for Olympus Endoscopic System for Lumbar Hernia Discectomy

SPONSOR/APPLICANT NAME, ADDRESS 1.

Olympus Optical Co. Ltd. Endoscope Division 2951 Ishikawa-Cho Hachioji, Tokyo 192-8507 Japan

Contact Person: Shigeyoshi Terawaki 0426-42-5101 Telephone: Facsimile: 0426-42-9979

DATE OF SUMMARY PREPARATION: June 16, 1998

Endoscopic System for Lumbar Hernia 2. TRADE/PROPRIETARY NAME: Discectomy and its Ancillary Equipment Endoscopic System for Lumbar Hernia COMMON/USUAL NAME: Discectomy Arthroscope and Accessories CLASSIFICATION NAME:
IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE TO WHICH 3. EQUIVALENCE IS BEING CLAIMED:

Sofamor Danek's MED MicroEndoscopic Discectomy System, Sofamor Danek's INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO-ENDO Instruments (K950130).

4. DEVICE DESCRIPTION

The Olympus Endoscopic System for Lumbar Hernia Discectorny and Accessories consist of the following components:

. Initial Placement Instruments

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Instrument	Function
Guide Needle	Guide to target site
Dilators	Dilation of tissues
Mandolin	Guide of Flexible Sheath, and Dissection of tissue on lamina
Flexible Sheath	Delivery of Endoscope
Pusher	Delivery of Flexible Sheath
Side Sheath	Delivery of Endoscope

Olympus XELSPAS Series Manual Surgical Hand Instruments .
Telescope to view operative site .
Light Guide Adaptor an adaptor to be used with commercially . available light systems to provide illumination
Surgical Holder Adaptor an adaptor to be used to attach the endoscope . to Olympus surgical holder device (510(k) K960068)

5. INTENDED USE

The Olympus Endoscopic System for Lumbar Hernia Discectomy is intended for visualizing lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue and for aiding in search and removal of vertebral bone and nucleus material.

ર. STATEMENT OF HOW TECHNOLOGICAL CHARACTERISTICS COMPARE TO PREDICATE

The Olympus Endoscopic System for Lumbar Hernia Discectomy is substantially equivalent to Sofamor Danek's MED MicroEndoscopic Discectomy System in technological characteristics. Both include an endoscope (arthroscope) for visualizing lumbar discs, lumbar herniated disc material, and lumbar paravertebral tissue. The proposed Olympus Endoscope is also substantially equivalent to the Olympus Endoscope described in 510(k) K951354, in optical characteristics and

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design. Both systems offer several surgical instruments for aiding in search and removal of vertebral bone and nucleus materials of manufacture of the Olympus system are all standard material used in medical products. Additionally, the materials in the proposed Olympus Endoscopic System for Lumbar Hernia Discectomy are identical to those cleared in legally marketed Olympus devices.

Additionally, the components of the Olympus Endoscopic System for Lumbar Hernia Discectomy are substantially equivalent in design and dimensions to other Olympus devices.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.