(207 days)
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
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:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Requirements (specifically "that the product meets the performance requirements described") | "it was determined that the device performs safely and effectively." |
Explanation: The provided text is a 510(k) summary for a medical device accessory. For such devices, a detailed list of specific, quantifiable acceptance criteria and performance metrics is generally not included in the summary itself. Instead, the summary refers to a broader assessment of "performance requirements described" that are met through pre-clinical and bench-top testing. The actual detailed criteria would be in the full submission, which is not provided here.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on the sample size or data provenance (such as country of origin or retrospective/prospective nature) for any test set. The performance data section only states, "Pre-clinical as well as bench top testing has been performed to verify that the product meets the performance requirements described." This implies laboratory-based testing rather than studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not include information on the number or qualifications of experts used to establish ground truth. As noted above, the testing described appears to be pre-clinical/bench-top, not clinical, rendering this type of ground truth establishment less relevant for this submission.
4. Adjudication Method for the Test Set
The provided text does not include any information on an adjudication method for a test set. This would typically be relevant for clinical studies or studies involving expert assessment of outputs, neither of which are described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in the provided 510(k) summary. The summary focuses on pre-clinical and bench-top testing to demonstrate substantial equivalence, not a comparison of human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is an "Electrosurgical Electrode" and an "Bipolar Electrosurgical Electrode" that is used "in conjunction with the Scuba Electrosurgical Generator." It is a physical accessory used by a surgeon. Therefore, no standalone (algorithm only) performance study was relevant or performed, as the device itself is not an algorithm or AI.
7. The Type of Ground Truth Used
Based on the description of "Pre-clinical as well as bench top testing," the ground truth would likely be established through engineering specifications, physical measurements, and possibly simulated tissue models to verify the device's functional integrity, power delivery, tissue effects (cutting, desiccation), and safety features (e.g., electrical insulation, temperature control). It would not involve expert consensus, pathology, or outcomes data in the typical sense for an AI/algorithm-based device.
8. The Sample Size for the Training Set
The provided text does not mention a training set or any machine learning/AI components. This device is a physical electrosurgical electrode, not an AI software.
9. How the Ground Truth for the Training Set Was Established
As the device is a physical electrosurgical electrode and not an AI software, there is no training set and therefore, no process for establishing ground truth for a training set.
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3/1/99
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, and septa. |
| Excision of intrauterine myomas | |
| Excision of intrauterine polyps | |
| Lysis of intrauterine adhesions | |
| Incision of uterine septa | |
| 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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510(k) Summary of Safety and Effectiveness, Continued
| 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 | Susan AloyanDirector of Regulatory Affairs and Quality AssuranceGynecare/Ethicon, Inc.235 Constitution Drive,Menlo Park, California 94025-1108 |
| Date | July 31, 1998 |
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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 a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.
MAR 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan M. Aloyan GYNECARE, INC. 235 Constitution Drive Menlo Park, CA 94025 Re: K982738 G-VAP Electrodes for Gynecare Scuba System Dated: December 2, 1998 Received: December 3, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85HIH 21 CFR 884.4160/Procode: 85 HFG
Dear Ms. Aloyan:
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, 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 (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 Recister. 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.
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/dsma/dsmamain.html".
Sincerely yours,
J.J.
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): ___K982738
Device Name:
Indications for Use:
G-VAP Electrode for use with the SCUBA Hysteroscopic Electrosurgery System
Tissue cutting, removal, and dessication as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the reatment of intrauterine myomas, polyps, adhesions, and septa.
Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 1 Prescription Use OR Over-The-Counter Use
(Optional Format 1-2-9G)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Optional Format 1-2-9G
§ 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.