in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intra-articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
in sinus surgery, e.g. for removal of polyps
in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)

Device Description

The power Cutters and Burrs consist of a hollow, fenestrated tube, containing a rotating twoedged cylindrical blade (cutter) or an abrader (burr) that spins within the hollow tube. They are driven by a motor handle.

AI/ML Overview

This document is a 510(k) summary for the "Power Cutters and Burrs for RIWO Drive System" and outlines the device's substantial equivalence to previously marketed devices rather than detailing specific acceptance criteria and a study to prove they are met.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as presented in this document. The document explicitly states:

"No known performance standard exists."
"No clinical tests were performed."

However, I can extract information related to the general claims of safety and effectiveness and the basis for substantial equivalence.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics in the format of a clinical study or performance testing with defined thresholds.

The document claims:

"The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness."
"These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not applicable (N/A) – No clinical tests were performed, and no performance data from a test set is presented.
Data provenance: N/A – No clinical or performance data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A – No test set or ground truth establishment by experts is mentioned as part of device performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A – No test set or adjudication method is mentioned.

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

N/A – No MRMC study or AI component is mentioned. This device is a mechanical instrument (cutters and burrs), not an AI-assisted diagnostic tool.

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

N/A – This device is a mechanical surgical instrument, not an algorithm. Standalone performance as an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A – There is no mention of ground truth in the context of device performance evaluation tests. The primary basis for approval is substantial equivalence to predicate devices, which implies the predicate devices' established safety and effectiveness serve as an indirect "ground truth."

8. The sample size for the training set

N/A – There is no mention of a training set as this is not an AI/machine learning device.

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

N/A – Not applicable.

Summary of what the document DOES state regarding "performance":

The approval is based on "substantial equivalence" to existing devices, meaning:

"The submitted devices pose the same type of questions about safety or effectiveness as the compared devices."
"The new technological characteristics have not diminished safety or effectiveness."
The devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (However, the specific "tests" are not detailed or quantified in this summary, and it's stated "No clinical tests were performed.")

The predicate device for substantial equivalence is:

510(k) Number: K970088
Trade or proprietary or model name: RIWO Drive Generator w/ Footswitch, Motor Handles & Single Use Rotary Blades & Abraders
Manufacturer: Richard Wolf GmbH

In conclusion, this 510(k) summary focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a detailed study with acceptance criteria and measured performance outcomes for the device itself.

Summary

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

1 2 1999

P.04 1 847 913 0924 .> >> < < < proruce woods l'arkway Vernon Hills, Illinois 60061 Phone: 847,913.1413 Fax: 847.913.1488

K9 84304

RICHARD V MEDICAL INSTRUMENTS CORP

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510(k) Summary of Safety and Effectiveness

Submitter:		Date of Preparation:	August 10, 1999
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.	FDA establishment registration number:	1418479
Division name (if applicable):	N.A.	Phone number (include area code):	(847) 913-1113
Street address:	353 Corporate Woods Parkway	FAX number (include area code):	(847) 913-0924
City:	Vernon Hills	State/Province:	Illinois	Country:	USA	ZIP / Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Product Information:
Trade name:	Power Cutters and Burrs for RIWO Drive System	Model number:	Reusable: 8564, 8566, 8567, 8568, 8569, 8571Single Use: 4567, 4568, 4569, 4571
Common name:	Cutters and Burrs	Classification name:	Cutters and Burrs
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 K970088	RIWO Drive Generator w/ Footswitch, Motor Handles & Single Use Rotary Blades & Abraders	1 Richard Wolf GmbH
2	2	2

1.0 Description

2.0 Intended Use

The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.

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

Indication and field of application:

For therapy with endoscopic accessories:

in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intral articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
. in sinus surgery, e.g. for removal of polyps
. in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)

3.0 Technological Characteristics

· atraumatic design
color coding .
sterile, for single use models .
. multiple diameters and tip designs

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf.

5.0 Performance Data

No known performance standard exists.

6.0 Clinical Tests

No clinical tests were performed.

7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.

By: Ret. Casasa

Robert L. Casarsa Quality Assurance Manager

Date: Aug 10, 1999

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1.2 1999

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

Re: K984304 Trade Name: RIWO Drive Generator Regulatory Class: II Product Code: HRX Dated: May 14, 1999 Received: May 17, 1999

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 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 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.

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

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 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,

f
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Dastanatine Davise

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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fors

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K984304

Device Name:__________________________________________________________________________________________________________________________________________________________________ Single Use or Reusable Power Cutters and Burrs

Intended Use:

The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.

Indication and field of application:

For therapy with endoscopic accessories:

. in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intra-articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
. in sinus surgery, e.g. for removal of polyps
. in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)

Contraindications:

Contraindications are given in cases where the clinical condition of the patient or the specific case increases significantly the risk to the patient if motorized instrumentation is applied. This might result in an absolute or a relative contraindication.

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

seeeeto

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984304

Prescription Use
Per 21 CFR 801.109

Over-The Counter_

Revised 8/10/99

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.