(29 days)
The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
The modified MyoSure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate MyoSure System:
- MyoSure Control Unit O
- MyoSure Tissue Removal Device o
- MyoSure Foot Pedal o
The MyoSure Control Unit contains an electric motor and software controller that drives the MyoSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSure Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter-blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.
- Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it indicates that the modified device's performance was evaluated against the predicate device. The conclusion states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Meets electrical safety standards. |
| EMC (Electromagnetic Compatibility) | Meets EMC standards. |
| Biocompatibility | New patient contact materials meet ISO 10993-1 requirements for Biological Evaluation of Medical Devices. |
| Performance (In-Vitro) | Demonstrated to be equivalent to the predicate MyoSure device. |
The study essentially aimed to prove equivalence to the predicate device (MyoSure Hysteroscopic Tissue Removal System, K091100) across these categories, rather than meeting specific numerical thresholds.
- Sample Size for Test Set and Data Provenance:
The document describes "in-vitro testing" for performance evaluation. It does not specify the sample size of the test set used for this in-vitro testing. Furthermore, there is no information regarding the data provenance (e.g., country of origin of the data, retrospective, or prospective), as this was an in-vitro study, not a clinical trial with human data.
- Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This was an in-vitro study comparing a modified device to a predicate device. Ground truth, in the sense of expert human assessment of medical images or conditions, was not established for this type of test. The performance was likely measured against objective physical or mechanical parameters relevant to tissue removal.
- Adjudication Method for the Test Set:
Not applicable, as there were no human readers or expert panels involved in establishing ground truth for a test set in the traditional sense. The evaluation was based on in-vitro measurements and comparisons.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document describes an in-vitro study focused on demonstrating equivalence to a predicate device, not a comparative study involving human readers with and without AI assistance.
- Standalone (Algorithm Only) Performance:
Not applicable. The device described, the MyoSure™ Hysteroscopic Tissue Removal System, is a mechanical medical device for tissue removal, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant to this submission. The performance assessment focused on the device's mechanical and material characteristics.
- Type of Ground Truth Used:
The "ground truth" for the in-vitro performance testing would have been objective measurements of physical parameters relevant to the device's function (e.g., cutting efficacy, tissue morcellation efficiency, fluid dynamics, material integrity under stress, etc.) compared against the performance of the predicate device under the same conditions. It was not based on expert consensus, pathology, or outcomes data in the context of human patients.
- Sample Size for the Training Set:
Not applicable. This device is a mechanical system, not an AI/machine learning model that requires a "training set."
- How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/machine learning model.
§ 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.