K Number
K973341
Device Name
HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE
Date Cleared
1997-11-13

(69 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. 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.
Device Description
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. The electrodes have the same design and material as earlier R. Wolf devices. The closed on the submitted devices and its predecessors is the small diameter for minimally invasive laparoscopy.
More Information

1 pre-enactment

Not Found

No
The summary describes standard surgical electrodes and does not mention any AI or ML capabilities.

No
The device is described as electrodes used for dissection, coagulation, and removing/destroying tissue, which are surgical procedures rather than therapeutic interventions designed to treat a disease or condition. While "therapy" is mentioned in the intended use, the specific actions described are surgical and diagnostic.

Yes

The "Intended Use / Indications for Use" and "Device Description" sections explicitly state the electrodes are used for "examination, diagnostics," and are "particularly suitable for diagnostics."

No

The device description explicitly states it is an electrode, which is a hardware component used for dissection and coagulation.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device's function as being used for dissection, coagulation, and tissue removal/destruction using high-frequency current under endoscopic view. These are therapeutic and surgical procedures performed directly on the patient's body.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
  • Device Description: The description reinforces its use as part of a surgical instrument set for laparoscopic microsurgery.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information based on sample analysis, or any of the typical characteristics of an IVD.

Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

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.

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Data 5.0
No know FDA performance standards exist.

6.0 Clinical Tests
No clinical tests performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

1 pre-enactment

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

0

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

510(k) Summary of Safety and Effectiveness
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.(847) 913-1113
Street address:FAX number (include area code):
353 Corporate Woods Parkway(847) 913-0924
City:State/Province:Country:ZIP / Postal Code:
Vernon HillsIllinoisUSA60061
Contact name:Mr. Robert L. Casarsa
Contact title:
Quality Assurance Manager
Product Information:
Trade name:Model number:
Monopolar Electrodes 3.58379.452, 462, .482
Common name:Classification name:
Monopolar HF ElectrodesEndoscopic Electrical Surgical Unit and Accessories
Information on devices to which substantial equivalence is claimed:
510(k) NumberTrade or proprietary or model nameManufacturer
1 pre-enactment1 Coagulation electrodes 394, 3761 Richard Wolf
22 Pediatric Operating Instruments2 Karl Storz
33 Suction Coagulators3 Jarit
444

1.0 Description

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.

1

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

Image /page/1/Picture/16 description: The image shows the mathematical expression "8 - 2". The number 8 is on the left side of the minus sign, and the number 2 is on the right side of the minus sign. This expression represents a subtraction operation.

2

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

Image /page/2/Picture/4 description: The image shows the date November 3, 1997. The month is abbreviated as NOV. The day is 3 and the year is 1997. The text is in a simple, sans-serif font.

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.

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,

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

4

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
----------------------------------------------------------------------------
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) NumberK97334/

| Prescription Use

Per 21 CFR 801.109X
-------------------------------------------

OR

Over-The Counter
--------------------

1 - 2