(207 days)
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Not Found
No
The summary describes a bipolar electrosurgical electrode and generator for tissue cutting and removal. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes.
The device is indicated for the treatment of intrauterine myomas, polyps, adhesions, and septa, which are medical conditions, making it a therapeutic device.
No
The device is described as an electrosurgical electrode used for tissue cutting, removal, and desiccation, which are therapeutic procedures, not diagnostic ones. The intended use focuses on treatment (excision, lysis, incision of intrauterine conditions).
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.
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, excision, lysis, incision). This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is an electrosurgical electrode used with a generator. This is a surgical tool, not a diagnostic reagent or instrument used to analyze samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's condition. The device is used for treatment, not diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely therapeutic/surgical.
N/A
Intended Use / Indications for Use
The G-VAP Electrode is intended for use in gynecologic hysteroscopic electrosurgical procedures.
Indications for Use: 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
Product codes (comma separated list FDA assigned to the subject device)
85HIH, 85 HFG
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
Not Found
Indicated Patient Age Range
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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
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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): 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.
Scuba Electrosurgical System
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.
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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
§ 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
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.
1
510(k) Summary of Safety and Effectiveness, Continued
| 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 | Susan Aloyan
Director of Regulatory Affairs and Quality Assurance
Gynecare/Ethicon, Inc.
235 Constitution Drive,
Menlo Park, California 94025-1108 |
| Date | July 31, 1998 |
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 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
3
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