(389 days)
Not Found
No
The summary describes a standard electrosurgical device and its materials, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used for medical procedures like vaporization, ablation, coagulation, and resection of soft tissue to treat conditions such as fibroids, myomas, and endometriosis, indicating a therapeutic purpose.
No
The device description and intended use clearly state that it is used for surgical procedures (vaporization, ablation, coagulation, resection of soft tissue), not for diagnosing conditions.
No
The device description explicitly states it is an electrosurgical device made of physical materials (stainless steel, teflon, etc.) and includes physical components like electrodes and rollers. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an electrosurgical device used for procedures within the body (vaporization, ablation, coagulation, resection of soft tissue in the urology tract, fibroids, myomas, endometrial ablation, endometriosis). It is a surgical tool, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical components or processes associated with IVDs, such as reagents, assays, sample analysis, or diagnostic results based on biological markers.
Therefore, this device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These specific EVAP electrodes can be used for vaporization, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.
Product codes
85 KNF
Device Description
The EVAP electrode is an electrosurgical device made of medical grade stainless steel, teflon, new silver, and Hytrel tubing. Some EVAP versions have gold plated rollers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urology tract, fibroids or myomas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Clinical Tests: Using canine models, it has been shown that coagulation depth increases with higher wattage, but does not exceed 2-3mm. Irrigation reduces the risk of heat damage. Long term morbidity and healing were not known.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).
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.............................................................................................................................................................................. P.07 Phone: 847.943.1143 Fax: 847.913.4488
K970961
P192
RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
10 1998
টি
10 1998
APR
| Summary of Safety and Effectiveness | |||||
|---|---|---|---|---|---|
| Company / Institution Name: Richard Wolf Medical Instruments Corporation | 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: Robert L. Casarsa | |||||
| Contact Title: | Quality Assurance Manager | ||||
| Product Information: | |||||
| Trade name: | EVAP Electrodes | Model number: | |||
| Common name: | Roller Electrode | ||||
| Coagulation Electrode | |||||
| Electrosurgical Electrode | Classification name: | ||||
| Electrode, Electrosurgical | |||||
| Information on devices to which substantial equivalence is claimed: | |||||
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer | |||
| 1. | 1. See contents of submission | 1. | |||
| 2. | 2. | 2. | |||
| 3. | 3. | 3. | |||
| 4. | 4. | 4. | |||
| 5. | 5. | 5. |
1978 11:1
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970961
p292
Description 1.0
The EVAP electrode is an electrosurgical device made of medical grade stainless steel, teflon, new silver, and Hytrel tubing. Some EVAP versions have gold plated rollers.
Intended Use 2.0
These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.
Technological Characteristics 3.0
There are no significant technological characteristics of the new device compared to the existing device.
4.0 Substantial Equivalence
The EVAP electrodes are substantially equivalent to devices sold or previously sold by Richard Wolf Medical Instruments, Circon, and ProSurg. Specifically Richard Wolf models approved by 510(k) K953983, Circon model VE-B, and proSutg model SB-24W.
Performance Data 5.0
Devices were tested to meet the appropriate sections of the ANSI/AAMI standard on High 4 Frequency Devices.
6.0 Clinical Tests
Using canine models, it has been shown that coagulation depth increases with higher wattage, but does not exceed 2-3mm. Irrigation reduces the risk of heat damage. Long term morbidity and healing were not known.
7.0 Data Conclusions
The Richard Wolf EVAP Electrode is equivalent to existing electrodes, particularly those approved by the Richard Wolf 510(k) K953983, ProSurg, and ACMI/Circon.
By: Robert L. Casan
Robert L. Casarsa Quality Assurance Manager
Date: Apr 3 98
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures standing side by side. The text "DEPARTMENT OF HEALTH &" is written vertically along the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 1998
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K970961
.
EVAP Electrodes Dated: January 16, 1998 Received: January 20, 1998 Regulatory Class: II 21 CFR 884.4160/Procode: 85 KNF
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 (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 equivaliation 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 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/dsmallsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K970961
Device Name:__________________________________________________________________________________________________________________________________________________________________ Vaporization Electrodes
Indications for Use:
These specific EVAP electrodes can be used for vaporization, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODDF.)
Daler D. Sathing/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970696
Prescription Use
Per CFR 21 CFR 801.103
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Over-The Counter Use_
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