(88 days)
The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain products of conception.
The Reprocessed MyoSure Tissue Removal Devices are sterile, disposable, hand-held tissue removal devices that are used to hysteroscopically remove intrauterine tissue. The devices are connected via a 6-foot (1.8-meter) flexible drive shaft to a motorized control unit. A foot pedal allows the user to control the cutting action of the tissue removal device by turning the motor in the control unit on and off. The proximal end of the 10-foot (3-meter) vacuum tubing is connected to a collection canister. The devices use mechanical resection by drawing the tissue through the cutting window under suction, while the inner blade simultaneously rotates and reciprocates to cut the tissue.
The provided text describes the regulatory clearance for reprocessed MyoSure Tissue Removal Devices (K201756). The clearance is based on demonstrating substantial equivalence to predicate devices, supported by performance data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative, pass/fail format. Instead, it lists general categories of performance testing and states that the devices comply or demonstrate effectiveness without providing specific numerical thresholds or outcomes for each test.
However, based on the listed "Functional Performance" tests, we can infer general performance areas. The reported device performance is broadly stated as: "The results of the evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices effectively cut and resect tissue in accordance with the intended use." and "The results of bench testing and laboratory evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices are at least as safe and effective and perform as well as the identified legally marketed predicate devices as described herein."
Here's an inferred table based on the functional performance tests and general statements:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Shaft deflection | Performance demonstrated per testing. |
| Leak decay | Performance demonstrated per testing. |
| Drive cable plug insertion | Performance demonstrated per testing. |
| Shaft insertion force | Performance demonstrated per testing. |
| Torque | Performance demonstrated per testing. |
| Linearity | Performance demonstrated per testing. |
| Revolutions Per Minute | Performance demonstrated per testing. |
| Reciprocation | Performance demonstrated per testing. |
| Wear particulate | Performance demonstrated per testing. |
| Bend | Performance demonstrated per testing. |
| Tissue cutting and removal | Effectively cut and resect tissue. |
| Reliability | Performance demonstrated per testing. |
| Device functional attributes | Performance demonstrated per testing. |
| Equipment compatibility | Performance demonstrated per testing. |
| Biocompatibility | In accordance with FDA Guidance and ISO 10993-1. |
| Reprocessing Validation | Derived from recommendations of AAMI/TIR 30:2011, ASTM D7225-13:2013, AAMI/TIR 12:2010, AAMI/ANSI ST35:2003, ISO/TS 15883-5, ASTM F3208-18. |
| Sterilization | In accordance with ANSI/AAMI/ISO 11135-1:2014. |
| Shelf Life | Verification testing included package integrity and functional performance after aging. |
| Electrical Safety | Complies with IEC 60601-1 standard for safety. |
Important Note: The document does not provide specific numerical acceptance thresholds (e.g., "Shaft deflection must be
§ 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.