(141 days)
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
The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Versapoint Electrosurgery G-VAP Electrode Accessory:
Summary of Device Performance and Acceptance Criteria
Based on the provided documents, limited specific details are given regarding explicit acceptance criteria and corresponding reported device performance values in a quantitative manner. The submission primarily relies on a qualitative statement of performance verification.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Device performs safely and effectively. | "It was determined that the device performs safely and effectively." |
| Performance Requirements | Meets all described performance requirements. | "product meets the performance requirements described." |
| Substantial Equivalence | Similar technological characteristics to predicate device (form, fit, function, method of operation). | "The modified device has the same technological characteristics as the predicate devices. The form, fit, function and method of operation are similar." |
| Intended Use | Suitable for tissue cutting, removal, and desiccation in gynecologic hysteroscopic electrosurgical procedures (myomas, polyps, adhesions, septa, endometrial ablation). | Device is intended for these uses and its performance supports them. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Pre-clinical as well as bench top testing" but does not provide details on the number of samples or tests conducted.
- Data Provenance: The nature of the testing (pre-clinical, bench top) suggests controlled laboratory environments. There is no information regarding country of origin of data or whether it was retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The provided summary describes testing of an electrosurgical electrode and generator, which typically involves engineering and functional performance testing, not diagnostic accuracy requiring expert panel review for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. As the testing is described as pre-clinical and bench top for an electrosurgical device, expert adjudication methods (like 2+1, 3+1) are not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. There is no mention of a multi-reader multi-case comparative effectiveness study. This type of study is typically relevant for interpretative diagnostic devices, not for an electrosurgical accessory.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is an electrosurgical electrode accessory, not a software algorithm or AI-based diagnostic tool. Therefore, a "standalone algorithm only" study is not relevant.
7. Type of Ground Truth Used
- Functional/Performance Standards: The ground truth would be established by engineering specifications, safety standards, and performance test protocols for electrosurgical devices (e.g., power output, safety cut-offs, tissue effect characteristics). The document generally states "performance requirements described," implying adherence to such standards.
8. Sample Size for the Training Set
- Not applicable. This device is a hardware accessory (electrosurgical electrode). The concept of a "training set" is typically associated with machine learning or AI models, which are not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned above, the concept of a training set and its ground truth does not apply to this type of medical device.
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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 AccessoryPREDICATE 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 myomasExcision of intrauterine polypsLysis of intrauterine adhesionsIncision of uterine septaEndometrial 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 |
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| PerformanceData | Pre-clinical as well as bench top testing has been performed to verify that theproduct meets the performance requirements described. It was determinedthat the device performs safely and effectively. |
|---|---|
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) andthe information provided herein, we conclude that the new device issubstantially equivalent to the predicate devices under the Federal Food, Drugand Cosmetic Act. |
| Contact | Gregory JonesDirector, Regulatory AffairsGynecare/Ethicon, Inc.Rt. 22 WestSomerville, 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
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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 myomasExcision of intrauterine polypsLysis of intrauterine adhesionsIncision of uterine septaEndometrial 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)
§ 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.