POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851

K030082 · Richard Wolf Medical Instruments Corp. · HRX · Oct 30, 2003 · Orthopedic

Device Facts

• Record ID: K030082
• Device Name: POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary blades/ abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue. For use with endoscopic accessories: - In arthroscopy, e.q. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations) - In thorax surgery, e.g. for removing hematomas . - In sinus surgery, e.g. for removing of polyps . - In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue

Device Story

Power Control 2303 is an electromechanical motor control unit for surgical rotary blades, abraders, and morcellators. System inputs include user-selected speed/mode via interface and footswitch activation. Device transforms electrical power into controlled mechanical rotation for tissue ablation; provides integrated aspiration for tissue removal. Used in OR settings by surgeons. Features include clockwise, counter-clockwise, and oscillation modes (100-6000 rpm); programmable blade stop position; graphical LCD display with optical/acoustic status signals. Integrates into R.Wolf RIWO NET SYSTEM via CAN-BUS for remote/speech/touchscreen control. Output allows surgeons to perform precise tissue resection, benefiting patients through minimally invasive endoscopic access.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software-controlled motor drive; 100-6000 rpm speed range; clockwise/counter-clockwise/oscillation modes; CAN-BUS interface for network integration; graphical LCD display; optical/acoustic status indicators; footswitch control. Complies with IEC601-1, IEC601-1-2, and UL2601-1 standards.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring tissue removal, including arthroscopy (meniscus resection, soft tissue removal, osseous tissue abrasion), thorax surgery (hematoma removal), sinus surgery (polyp removal), and spinal surgery (arthroscopic microdiskectomy for degenerated tissue).

Regulatory Classification

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.

Predicate Devices

• Intra-articulated arthro power system 2161 (K871250)
• RIWO DRIVE 2302 Generator and accessories (K970088)
• RIWO DRIVE small handle (K984521)
• SIOS-Interface for various devices (K002328)

Submission Summary (Full Text)

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Page ①

OCT 3 0 2003

Instruments Corporation

353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: [phone] Customer Service: 800-323-WOLF www.richard-wolf.com

K 0300 82

# 13.0 510(k) Summary of Safety and Effectiveness

| Submitter: | | Date of Preparation: | January 8, 2003 |
|---------------------------------------------------------------------|----------------------------------------------|----------------------------------------|-----------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | 14 184 79 |
| 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: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa | | |
| Contact title: | Quality Assurance Manager | | |
| Product Information: | | | |
| Trade name: | Power Control 2303 with Power Stick M4 | Model number: | 2303.011/.901/.911, 8564.121/.851 |
| Common name: | Motor control, motor handle | Classification name: | Electric surgical rotary blade/ abrader |
| Information on devices to which substantial equivalence is claimed: | | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
| 1 K871250 | 1 Intra-articulated arthro power system 2161 | 1 Richard Wolf | |
| 2 K970088 | 2 RIWO DRIVE 2302 Generator and accessories | 2 Richard Wolf | |
| 3 K984521 | 3 RIWO DRIVE small handle | 3 Richard Wolf | |
| 4 K002328 | 4 SIOS-Interface for various devices | 4 Richard Wolf | |

#### 1.0 Description

The POWER CONTROL 2303 controls the motor in the POWER STICKS M3 and M4 that drives rotary blades and abraders, operated by a footswitch.

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Page (9)

#### 2.0 Intended Use

The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary blades/ abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue.

For use with endoscopic accessories:

- · In arthroscopy, e.q. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
- In thorax surgery, e.g. for removing hematomas .
- In sinus surgery, e.g. for removing of polyps .
- · In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue

#### 3.0 Technological Characteristics

The POWER CONTROL 2303 is controlled by software.

The modes clockwise, counter-clockwise or oscillation can be selected in four speed ranges from 100 rpm up to 6000 rpm. The stop position of the rotary blade can be set and stored, so that the blade will always stop in this position until it is removed.

Values, functions and components are monitored at the graphically LCD display in various languages, accompanied by optical and acoustic signals.

Via the integrated CAN-BUS interface, the POWER CONTROL 2303 can be integrated into the R.Wolf RIWO NET SYSTEM with remote control, speech control and touchscreen monitor.

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and 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.

#### 5.0 Performance Data

The POWER CONTROL System 2303 was designed to meet the standards IEC601-1, IEC601-1-2 and UL2601-1.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

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

By:

Robert Casasus

Date:

Robert L. Casarsa Quality Assurance Manager

13-2 revised 8/20/03

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 3 0 2003

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

Re: K030082

Trade/Device Name: Power Control 2303 with Power Stick M4 Regulation Number: 21 CFR 888.1100, 878.4820 Regulation Name: Arthroscope, Surgical instrument motors Regulatory Class: II Product Code: HRX, HWE, GEY Dated: August 21, 2003 Received: August 22, 2003

### Dear Mr. Casarsa:

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 - Mr. Robert L. Casarsa

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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# 5.0 INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Intended use:

_k030082

Power Control 2303 with Power Stick M4

The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary blades/ abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue.

Indication and Field of Use:

For use with endoscopic accessories:

- · In arthroscopy, e.g. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
- · In thorax surgery, e.g. for removing hematomas
- In sinus surgery, e.g. for removing of polyps
- In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030082

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

OR

Over-The Counter

(Optional Format 1'2-96)