(141 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical electrode and generator, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation, which are therapeutic medical procedures.
No
This device is described as an electrosurgical electrode used for tissue cutting, removal, desiccation, and excision in gynecologic procedures, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "Bipolar Electrosurgical Electrode" and is used with an "Electrosurgical Generator," indicating 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:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's tissue (tissue cutting, removal, desiccation) within the uterus. This is a therapeutic intervention, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is an electrosurgical electrode used with a generator. This is a surgical tool, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct surgical intervention on the patient.
N/A
Intended Use / Indications for Use
The G-VAP Electrode is intended for use in gynecologic hysteroscopic electrosurgical procedures. Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation
Product codes
85 HIH, 85 KNF
Device Description
The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical as well as bench top testing has been performed to verify that the product meets the performance requirements described. It was determined that the device performs safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Scuba Electrosurgical System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
K992901 page 1/2
SECTION 7 - 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
MODIFIED DEVICE NAME: Versapoint Electrosurgery G-VAP Electrode Accessory
PREDICATE DEVICE NAME: Scuba Electrosurgical System |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator. |
| Intended Use | The G-VAP Electrode is intended for use in gynecologic hysteroscopic electrosurgical procedures. |
| Indications Statement | Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation |
| Technological characteristics | The modified device has the same technological characteristics as the predicate devices. The form, fit, function and method of operation are similar. |
| | Continued on next page |
1
| Performance
Data | Pre-clinical as well as bench top testing has been performed to verify that the
product meets the performance requirements described. It was determined
that the device performs safely and effectively. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and
the information provided herein, we conclude that the new device is
substantially equivalent to the predicate devices under the Federal Food, Drug
and Cosmetic Act. |
| Contact | Gregory Jones
Director, Regulatory Affairs
Gynecare/Ethicon, Inc.
Rt. 22 West
Somerville, New Jersey 08876 |
| Date | August 27, 1999 |
age 2/2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Gynecare, Inc. c/o Mr. William Goeller Sr. Proiect Manager ETHICON. Inc. P.O. Box 151 Somerville, NJ 08876-0151 Re: K992901 VersaPoint G-VAP Electrode - (SCUBA) Electrosurgery System New Indication: Endometrial Ablation Dated: December 9, 1999 Received: December 10, 1999 Regulatory Class: II 21 CFR §884.1690/Procode: 85 HIH 21 CFR §884.4160/Procode: 85 KNF
Dear Mr. Goeller:
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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 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 requlation 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
3
INDICATIONS FOR USE
| 510(k) Number (if known): | Same as K962482 K992901 |
|---|---|
| Device Name: | Scuba Hysteroscopic Electrosurgery System |
| Indications for Use: | Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. |
| Excision of intrauterine myomas | |
| Excision of intrauterine polyps | |
| Lysis of intrauterine adhesions | |
| Incision of uterine septa | |
| Endometrial ablation |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/3/Figure/3 description: The image shows a form with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". Below the title, there are two options: "Prescription Use" and "Over-The-Counter Use", separated by "OR". The "Prescription Use" option has been selected with a check mark.
(Optional Format 1-2-96)