HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE

K973341 · Richard Wolf Medical Instruments Corp. · GEI · Nov 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973341
• Device Name: HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.

Device Story

Monopolar HF electrodes designed for laparoscopic microsurgery; used for tissue dissection, coagulation, and destruction. Device inputs include unipolar high-frequency current from external HF generators; operates under endoscopic visualization. Used in clinical settings (outpatient/pediatric) by trained physicians. Output is thermal effect on tissue via electrode tip. Benefits include small diameter for minimally invasive access.

Clinical Evidence

No clinical tests performed.

Technological Characteristics

Monopolar HF electrodes; small diameter for minimally invasive laparoscopy. Materials and design identical to previous Richard Wolf devices. Energy source: external unipolar high-frequency generator. Used with trocar sleeves and operating endoscopes.

Indications for Use

Indicated for examination, diagnostics, and/or therapy in medical disciplines, particularly outpatient and pediatric laparoscopy. Used by qualified, trained personnel. No specific contraindications; physician determines suitability based on patient condition.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Coagulation electrodes 394, 376 (pre-enactment)
• Pediatric Operating Instruments (Karl Storz)
• Suction Coagulators (Jarit)

Submission Summary (Full Text)

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353 Corporate Work Parkway Vernen Hills. Whichs edde ! Phone: 847,943,1113 lax: 847,945,488

# NOV 1 3 199 K 9733 4 1

RICHARD WOL MEDICAL INSTRUMENTS COR

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| <b>510(k) Summary of Safety and Effectiveness</b> | | | | | | | |
|---------------------------------------------------|------------------------------------|---------------------------------------------------------------------|-----------------------------------|-----------------------------------------------------|--------------------|--|--|
| Submitter: | | | Date of Preparation: | | | | |
| | | | September 3, 1997 | | | | |
| Company / Institution name: | | | | FDA establishment registration number: | | | |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | 14 184 79 | | | | |
| Division name (if applicable): | | | Phone number (include area code): | | | | |
| N.A. | | | [phone] | | | | |
| Street address: | | | | FAX number (include area code): | | | |
| 353 Corporate Woods Parkway | | | | [phone] | | | |
| City: | | State/Province: | Country: | | ZIP / Postal Code: | | |
| Vernon Hills | | Illinois | USA | | 60061 | | |
| Contact name: | | Mr. Robert L. Casarsa | | | | | |
| Contact title: | | | | | | | |
| | | Quality Assurance Manager | | | | | |
| Product Information: | | | | | | | |
| Trade name: | | | Model number: | | | | |
| Monopolar Electrodes 3.5 | | | | 8379.452, 462, .482 | | | |
| Common name: | | | | Classification name: | | | |
| | Monopolar HF Electrodes | | | Endoscopic Electrical Surgical Unit and Accessories | | | |
| | | Information on devices to which substantial equivalence is claimed: | | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | | | | |
| 1 pre-enactment | 1 Coagulation electrodes 394, 376 | | 1 Richard Wolf | | | | |
| 2 | 2 Pediatric Operating Instruments | | 2 Karl Storz | | | | |
| 3 | 3 Suction Coagulators | | | 3 Jarit | | | |
| 4 | 4 | | | 4 | | | |

#### 1.0 Description

배

The electrodes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and out-patient and pediatric microsurgery.

#### 2.0 Intended Use

The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.

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353 Corporate Weeds Parkway Tronan Hills Himeis occe 1 Phone: 847 - 015, 1113 F.tx. 847, 245 1488

### RICHARD WOLF

MEDICAL INSTRUMENTS CORPORATION

Technological Characteristics 3.0 The electrodes have the same design and material as earlier R. Wolf devices. The I he closed on the submitted devices and its predecessors is the small diameter for

minimally invasive laparoscopy.

#### Substantial Equivalence 4.0

The devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf, Karl Storz, and Jarit.

#### Performance Data 5.0

No know FDA performance standards exist.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.

By: *Thet Hlasen*

Robert L. Casarsa Quality Assurance Manager

Date: Sept 3, 92

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized abstract design resembling an eagle or a bird in flight, composed of three curved lines. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K973341 Trade Name: Monopolar Electrodes 3.5mm Regulatory Class: II Product Code: GEI Dated: September 3, 1997 Received: September 5, 1997

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 requirements , as set forth in the Quality System Regulation (OS) 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.

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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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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## Indications for Use

17:

| 510(k) Number (if known): | 973341 |
|---------------------------|---------------------|
| Device Name: | Unipolar electrodes |

### Intended Use:

The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.

### Indication:

The electrodes are used for examination, diagnostics, and/or therapy by personnel who are qualified and suitably trained in connection with endoscopically used accessories in different medical disciplines, particularly suitable for outpatient and pediatric laproscopy.

### Contraindications:

Currently there are no known contraindications directly related to the product. The physician in charge must determine whether the intended application is possible based on the patient's general condition. For further instruction and notes, refer to the latest specialized literature.

### Combinations:

The electrodes are used in combination with unipolar HF devices, trocar sleeves, and operating endoscopes.

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| Concurrence of CDRH Office of Device Evaluation (ODE) | |
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| | <img alt="Signature" src="signature.png" width="200"/> |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K97334/ |

| Prescription Use<br>Per 21 CFR 801.109 | X |
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OR

| Over-The Counter | |
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