(28 days)
Used to permit direct viewing of the cervical canal and the uterine Cavity for the purpose of performing diagnostic and surgical procedures. As used with the Gynecare Versapoint System, the indications for use include: Excision on intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa When used for resection of endometrial tissue with the G-VAP Electrode, the device is indicated for Endometrial Ablation.
The Gyrus Hysteroscopic Resectoscope that we intend to market employs an electrode specific resectoscope-working element. All other sheaths, etc., are standard COMEG components. A "Quick Connection" feature is used to attach the working element to the sheath. Endoscopic electrosurgical instruments and accessories are described under "Endoscope and Accessories" in 21 CFR 876.1500, and Hysteroscopes and described in 21 CFR 884.1690. The Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The surgeon performs the examination through the cervical canal. The working elements are the devices that house and control various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The surgeon controls the back and forth movement of the electrode using finger controls. The working elements also house a telescope for visualization. Current is transmitted to the electrode through a high frequency cable. These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts. The Gyrus Hysteroscopic Resectoscope as cleared in K982771, is identical to the COMEG Resectoscope cleared via K971882, with the working element modified to fit the Gyrus Medical Ltd. electrode. Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories, 21 CFR 876.1500, and endoscope ESU units and accessories are described in 21 CFR 876.4300. Hysteroscopes are described in 21 CFR 884.1690. The Rotating Outer Sheath connection for the working element is of a "snap-on" construction, identical to the cleared device. The principal difference is in the rotating collar which allows 360 degree rotation of the fluid inlet. The Visual Obturator provides the same functionality as the standard obturator facilitating insertion to the uterus. In addition, the Visual Obturator allows use of the hysteroscope (telescope) during insertion, allowing visualization.
The provided text describes a 510(k) premarket notification for the Gyrus Hysteroscopic Resectoscope. It details the device's description, intended use, and indications for use, as well as a statement about performance data. However, the document does not contain specific acceptance criteria, a detailed study description, or quantitative performance metrics typically found in a study report.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitely defined in the document. The document states that "Preclinical as well as bench top testing has been performed to verify that The product meets the performance requirements described." However, these specific requirements are not detailed. | The preclinical and bench top testing "substantiates the efficacy of the resectoscope for the hysteroscopic usage." No quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity, success rate, etc.) are provided. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The testing is referred to as "Preclinical as well as bench top testing," implying laboratory or in-vitro settings rather than clinical trials with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Not specified. The document does not describe a study involving expert assessment or ground truth establishment in a diagnostic or interpretive context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document describes a medical device, specifically a surgical resectoscope, not an AI or imaging diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified. The "performance requirements" would likely be related to the mechanical, electrical, and functional aspects of the resectoscope (e.g., cutting efficacy, coagulation ability, visualization clarity, structural integrity), which are verified through various physical and functional tests rather than a ground truth in the diagnostic sense.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study (as described in the document):
The document mentions that "Preclinical as well as bench top testing has been performed to verify that The product meets the performance requirements described." This testing was conducted to substantiate the efficacy of the resectoscope for hysteroscopic usage. However, the document does not provide details on:
- The specific "performance requirements" or acceptance criteria.
- The methodology of the preclinical and bench top tests.
- The quantitative results of these tests.
- Any sample sizes (number of devices tested, number of simulated procedures, etc.).
Essentially, the document states that testing was done and the device performed as required, and this was sufficient for a 510(k) submission based on substantial equivalence to a predicate device. It is not a detailed scientific study report with explicit acceptance criteria and quantitative results.
§ 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.