(26 days)
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Not Found
No
The summary describes a standard electrosurgical electrode and generator system for hysteroscopic procedures. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is used for the treatment of various gynecologic conditions such as myomas, polyps, and adhesions, indicating its therapeutic intent.
No
The device is described as an electrosurgical electrode used for tissue cutting, removal, desiccation, and excision in gynecologic procedures, not for diagnosing conditions. It is a treatment device.
No
The device description explicitly states it is a "Loop Electrode" and is used in conjunction with an "Electrosurgical Generator," indicating it is a hardware device and 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 samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
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 treatment.
N/A
Intended Use / Indications for Use
The Loop 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 (comma separated list FDA assigned to the subject device)
85 HIH, 85 KNF
Device Description
The Loop Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intrauterine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Attachment 4 – 510(k) Summary
page 1 of 2
K 994418.
| 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 Loop Electrode
Accessory
PREDICATE DEVICE NAME: Scuba Electrosurgical System and
Versapoint Electrosurgery G-VAP Electrode Accessory |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The Loop Electrode is an Bipolar Electrosurgical Electrode. It is used in
conjunction with the Scuba Electrosurgical Generator. |
| Intended Use | The Loop 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 device. The form, fit, function and method of operation are similar. |
| | Continued on next page |
1
Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively. Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and Conclusion 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 - Domestic Gynecare/Ethicon, Inc. Route 22 Somerville New Jersey Date November 4, 1999
510(k) Summary of Safety and Effectiveness, Continued
2
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
JAN 2 4 2000
Gynecare, Inc. c/o Mr. William Goeller Sr. Proiect Manger ETHICON, Inc. P.O. Box 151 Somerville, NJ 08876-0151 Re: K994418
SCUBA System Hysteroscopic Electrosurgery System VRS Angled Loop Electrode Dated: December 28, 1999 Received: December 29, 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 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 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 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.
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): | K994418 |
|---|
Device Name:
Indications for Use:
Scuba Hysteroscopic Electrosurgery System
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and 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)
| Prescription Use | ✓ |
|---|---|
| OR Over The-Counter Use | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K994418 |
| (Optional Format 1-2-96) |