(167 days)
Used to permit direct viewing and access to 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 of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa
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 are 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.
Here's an analysis of the provided text regarding the Gyrus Hysteroscopic Resectoscope's acceptance criteria and the study that proves it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, specific numerical acceptance criteria and detailed performance metrics are not explicitly stated in a quantifiable way. The document focuses on demonstrating substantial equivalence to predicate devices rather than quantitative performance against a predefined set of criteria.
| Acceptance Criteria (Inferred from "Performance Data" and "Technological Characteristics") | Reported Device Performance |
|---|---|
| Safety and Efficacy (General): Device is safe and effective for its intended use. | Pre-clinical and benchtop testing was performed to "verify that the product meets the performance requirements described" and "substantiates the efficacy of the resectoscope for the hysteroscopic usage." |
| Technological Equivalence: Same technological characteristics as predicate devices. | "The modified device has the same technological characteristics as the predicate devices. The form, fit and function is similar." |
| Intended Use Fulfillment: Enables viewing of cervical canal and uterine cavity for diagnostic/surgical procedures, including tissue cutting, removal, and dissection. | The device's "Intended Use" and "Indications Statement" align with these functions. |
| Substantial Equivalence: To legally marketed predicate devices. | "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, Cosmetic Act." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for any test set.
- Data Provenance: The document states "Pre-clinical as well as bench top testing has been performed." This implies controlled laboratory settings. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned, as the type of "test set" and the nature of the "ground truth" (see point 7) are not detailed.
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. This type of study is more common for diagnostic imaging AI systems and not typically for a resectoscope device.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
- No, a standalone (algorithm only) performance study was not done. This device is an instrument used by a human surgeon, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance relies on engineering verification and validation. This includes:
- Confirmation that the device functions as designed (e.g., proper control of electrodes, effective cutting/coagulation).
- Compliance with material specifications and safety standards.
- Functional equivalence to predicate devices.
There is no mention of ground truth established by expert consensus, pathology, or outcomes data from patient studies.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical instrument, not an AI algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this device.
§ 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.