The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.

Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

Indications and Fields of Application:

For therapy with endoscopic accessories:

· in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
thoracic surgery, e.g. for removing hematomas .
sinus surgery (ENT), e.g. for removing polyps or cysts.In cases, bone structures are . removed or trimmed.
spine surgery (arthroscopic micro disectomy (AMD), spinal endoscopsy) e.g. removal of . pathological tissue.

Device Description

The RIWO Drive Generator is designed to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.

The motor handle is a tubular system. The modular system consists of:

motor unit
· motor housing
· suction adapter (8563.111) And/Or suction /irrigation adapter (8563.311)

The suction and irrigation stream are controlled by slide valves. The motor handle is connected to the RIWO Drive 2302 by a removable cable.

AI/ML Overview

The provided text describes the RIWO Drive System 2302 with small motor handles, an ENT electric surgical drill. However, the document does not contain any performance data from a specific study that would allow for an evaluation of acceptance criteria and reported device performance in the manner requested.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The document mentions that the devices "are designed and tested to assure their safety and effectiveness when used according to the instructions manual," but it does not specify quantitative performance metrics or thresholds for acceptance.
Reported Device Performance: Not reported. The document states "Performance Data: The RIWO Drive Generator with the motor handles were tested according to the standards IEC601-1 and UL2601-1." However, the results of these tests (e.g., speed accuracy, torque, safety parameter measurements) are not provided.

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

Sample Size: Not applicable/not provided for performance testing results.
Data Provenance: Not applicable/not provided for performance testing results.

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

Number of Experts: Not applicable. No clinical or diagnostic performance study is described that would require expert-established ground truth.
Qualifications: Not applicable.

4. Adjudication Method:

Adjudication Method: Not applicable.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical tests performed were not performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Standalone Study: Not applicable. This device is a surgical tool, not an AI algorithm. Its performance is intrinsic to its mechanical and electrical function, not an algorithm's output.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable. No clinical or diagnostic performance study is described. The "ground truth" for this type of device would typically be its adherence to engineering specifications and safety standards.

8. Sample Size for the Training Set:

Sample Size: Not applicable. There is no AI component or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable.

Summary of Device Information Provided:

Device Name: RIWO Drive System 2302 with small motor handles.
Intended Use: Driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions, with simultaneous suction and optional irrigation.
Technological Characteristics: Four speed settings, continuous digital display, automatic adaptation of speed/torque, acoustic and optical alarms, footswitch control, 360° motor handle rotation, modular construction, variable irrigation control, watertight, lightweight, detachable cable, BF insulation.
Safety/Performance Testing: Tested according to IEC601-1 and UL2601-1, which are general electrical medical equipment safety standards. The results of these tests are not provided.
Clinical Tests: "Clinical tests performed were not performed."
Substantial Equivalence: Claimed to be substantially equivalent to existing devices from Richard Wolf, Stryker, Xomed, and Karl Storz, based on posing the "same type of questions about safety or effectiveness" and new technological characteristics not diminishing safety or effectiveness.

In conclusion, while the document adequately describes the device and its intended use, it does not provide any specific performance data or studies that detail acceptance criteria and how the device performed against those criteria. The focus of this 510(k) summary is on substantial equivalence to predicate devices and adherence to general safety standards, rather than proving efficacy or detailed performance metrics through specific studies.

Summary

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3/17/99

1984521

510(k) Summary of Safety and Effectiveness		RICHARD WOLFMEDICAL INSTRUMENTS CORPORATION
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.	Date of Preparation:December 18, 1998
Division name (if applicable):	N.A.	FDA establishment registration number:14 184 79
Street address:	353 Corporate Woods Parkway	Phone number (include area code):(847) 913-1113
City:	Vernon Hills	FAX number (include area code):(847) 913-0924
State/Province:	Illinois	ZIP / Postal Code:60061
Country:	USA
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Product Information:
Trade name:	RIWO Drive System 2302 with small motor handles	Model number:2302, 8563.111, 8563.351, 8563.351 / .451 / .551
Common name:	Drive Generator, Motor Handles	Classification name:ENT electric surgical drill
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 K970088	1 RIWO Drive Generator with Footswitch, Motor handles and single use rotary blades and abraders	1 Richard Wolf
2 K972584	2 Hummer ENT micro debrdier	2 Stryker
3 K973499	3 XPS Straightshot Microresector	3 Xomed
4 K953370	4 Karl Storz Paranasal Sinus Shaver	4 Karl Storz

1.0 Description

The RIWO Drive Generator is designed to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.

The motor handle is a tubular system. The modular system consists of:

motor unit
· motor housing
· suction adapter (8563.111) And/Or suction /irrigation adapter (8563.311)

The suction and irrigation stream are controlled by slide valves. The motor handle is connected to the RIWO Drive 2302 by a removable cable.

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2.0 Intended Use

The RIWO Drive with motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.

Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

Technological Characteristics 3.0

RIWO Drive Generator

four speed settings, user selected .
continuous digital display of selected and true speed .
automatic adaptation of speed range and maximum torque (current) for three different . motor handles, display of speed range with LED
. acoustic and optical alarm for, 1) motor overload, 2) incorrect cable connection or interrupted cable
footswitch, operated by surgeon, to control motion forward, reverse, oscillation (3 changes . per second), speed and speed range automatically stored.

Motor Handle

360° rotation of clamping chuck for various cutting positions (8561.121 and 8562.111) .
modular construction (8563.111/.311) .
variable irrigation control with one-hand operation (8563.331) .
watertight housing and motor unit, for steam sterilization .
. lightweight design
. detachable cable
. BF insulation according to IEC601-1

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 510(k) devices sold by Richard Wolf and sold by Stryker, Xomed, or Karl Storz.

5.0 Performance Data

The RIWO Drive Generator with the motor handles were tested according to the standards IEC601-1 and UL2601-1.

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6.0 Clinical Tests

Clinical tests performed were not performed.

7.0 Conclusions Drawn

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

By: Robert L. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Dec 17, 98

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

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

Re:

K984521 RIWO Drive Small Motor Handle Dated: December 18, 1999 Received: December 21, 1999 Regulatory class: II 21 CFR 874.4250/Procode: 77 EQL 21 CFR 878.4820/Procode: 79 GEY

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 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). 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 vour device is classified (see above) into either class III (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 requirements, 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.

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) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

ag 4521 510(k) Number (if known):

Device Name: ___Small Motor Handles for RIWO Drive System 2302

Intended Use:

The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.

Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

Indications and Fields of Application:

For therapy with endoscopic accessories:

· in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
thoracic surgery, e.g. for removing hematomas .
sinus surgery (ENT), e.g. for removing polyps or cysts.In cases, bone structures are . removed or trimmed.
spine surgery (arthroscopic micro disectomy (AMD), spinal endoscopsy) e.g. removal of . pathological tissue.

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

David C. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number

Prescription Use
Per 21 CFR 801.109

ર - I

Over-The Counter_

Regulation Number and Section

§ 874.4750 Laryngostroboscope.

(a)
Identification. A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.