The set consists of a telescope, forceps, sheath, obturator, adapter, tephine, punch, scissors, dilator, cannula, and caps. It is designed to be compatible with other available systems, but with increased emphasis on superior quality imaging. The scope system is designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Discoscope Set" (later referred to as the "Yeung Endoscopic Spine System") by Richard Wolf Medical Instruments Corp. This type of filing is for medical devices and generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance or efficacy against acceptance criteria through a clinical study with statistical endpoints.

Based on the content of the provided text, there is no information about acceptance criteria or a study designed to prove the device meets specific performance criteria. The submission explicitly states "Performance Data: None" and "Clinical Tests: None."

The document concludes that the device is substantially equivalent to predicate devices based on its intended use and technological characteristics.

Therefore, I cannot provide the requested information as it is not present in the given text.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: This information is not provided. The document states "Performance Data: None."
Sample size used for the test set and the data provenance: Not applicable, as no performance or clinical study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment relevant to performance criteria is mentioned.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical Tests: None."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this device is a physical endoscopic spine system, not an algorithm.
The type of ground truth used: Not applicable, as no performance or clinical study was conducted.
The sample size for the training set: Not applicable, as no training set for an algorithm is relevant to this device.
How the ground truth for the training set was established: Not applicable.

Summary

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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: $47.913.1143 Fax: 847.913.1488

K9734QS

MAR 1 3 1008

RICHARD MEDICAL INSTRUMENTS CORP

510(k) Summary of Safety and Effectiveness

Submitter:
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Division name (if applicable):	N.A.
Street address:	353 Corporate Woods Parkway
City:	Vernon Hills
State/Province:	Illinois
Country:	USA
ZIP / Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Date of Preparation:	January 12, 1998
FDA establishment registration number:	14 184 79
Phone number (include area code):	(847) 913-1113
FAX number (include area code):	(847) 913-0924

Product Information:
Trade name:	Discoscope Set
Model number:
Common name:	Spinal Arthroscopic Set
Classification name:	Arthroscope and Accessories

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or proprietary or model name	Manufacturer
K930191	MED Microendoscopy Disectomy System	Sofamor Danek
K922519	Kambin Arthroscopic Microdiscetomy System	Dyonics
3	3	3
4	4	4
5	5	5
6	6	6
7	7	7
8	8	8

1.0 Description

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Intended Use 2.0

Intended Use
The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.

Technological Characteristics 3.0

T echnological Characteristics
Designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.

Substantial Equivalence 4.0

Substantial Equivalence

Richard Wolf 8986.401 Operative Scope .
Sofamor Danek MED Endoscope .
Smith & Nephew Richards AMD VideoDiscoscope .

All devices have the same intended use.

5.0 Performance Data

None

Clinical Tests 6.0 None

7.0 Conclusions Drawn

Concellations branni the instruction manual.

By: Ret. Casana

Robert L. Casarsa Quality Assurance Manager

Date: Jan 9, 1998

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

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

Re : K973405 Yeung Endoscopic Spine System Trade Name: Regulatory Class: II Product Code: HRX Dated: January 9, 1998 Received: January 13, 1998

Dear Mr. Casarsa:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert L. Casarsa

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 requlation (21 CFR Part 801 and additionally 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 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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510(k) Number (if known):_ - 10(K) Nambo

Indications for Use:

Indications for USC.
The Yeung Endoscopic Spine System is indicated for the visualization and removal of hemiated discs in the lumbar region.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

luation (ODF)

(Division $ign-Off)
Division of General Botas D

Division of General Restorative Devices
510(k) Number K67340

Prescription Use
Per CFR 21 CFR 801.109

()ver-The-Counter Use_________________________________________________________________________________________________________________________________________________________

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.