(165 days)
The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception
Smith & Nephew's TRUCLEAR Morcellator System and TRUCLEAR Morcellators use mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance.
Subject of this premarket notification is modifications to the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and its associated morcellators.
The provided text is a 510(k) summary for the Smith & Nephew TRUCLEAR Morcellator System and TRUCLEAR Morcellators. This submission aims to modify the indications for use of an already cleared device, primarily by adding "Retained products of conception" to the list of tissues that can be resected.
The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically expected for a novel diagnostic or AI-powered device. Instead, it is a notification for a modification to the intended use of an existing, already cleared medical device that operates via mechanical resection.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of submission and are not present in the provided text.
Here's a breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document is a 510(k) for a change in intended use for an already cleared mechanical device, not a performance study comparing the device against specific metrics. The "performance data" mentioned refers to clinical literature supporting the additional indications, not direct device performance against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This is not a study assessing diagnostic performance or AI algorithm accuracy. The submission relies on "Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators" to support the expanded indications. There is no mention of a specific test set, its size, or data provenance for algorithmic validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No specific test set with expert-established ground truth is described.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable/Not provided. This device is a mechanical morcellator, not an AI-powered diagnostic tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is a mechanical device.
7. The type of ground truth used
Not applicable/Not provided. For a mechanical device, performance is typically confirmed through engineering testing (e.g., tissue resection speed, morcellation efficiency, safety features like sharps exposure control), biocompatibility, and sterilization validation, not against a "ground truth" in the diagnostic sense. The clinical literature cited likely presents observational data or comparative studies of clinical outcomes for the procedure itself, not "ground truth" for an algorithm.
8. The sample size for the training set
Not applicable/Not provided. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of the document's approach:
The core of this 510(k) submission (K132015) is that Smith & Nephew is seeking to expand the "Indications for Use" for their already cleared TRUCLEAR Morcellator System and TRUCLEAR Morcellators.
- Predicate Devices: The submission identifies several previously cleared Smith & Nephew TRUCLEAR Morcellator Systems and blades (K110038, K103389, K041774, K031787) as predicates.
- Device Description and Technological Characteristics: The key point is explicitly stated: "There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance." This means the device itself, its mechanism of action (mechanical resection), and its safety profile are considered unchanged from the previously cleared versions.
- Proposed New Indications: The new proposed indications include "Retained products of conception" alongside the previously cleared "Submucous myomas" and "Endometrial Polyps."
- Performance Data (Justification for new indications): Rather than presenting new device performance data from a specific study against acceptance criteria, the submission states: "Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators support the use of TRUCLEAR for the proposed additional indications." This implies that existing published studies demonstrate the clinical utility and safety of using this type of device for resecting retained products of conception.
- Conclusion: The FDA grants clearance based on the determination that the device is "substantially equivalent" to its predicates, given that there are no major design changes and that the expanded indications are supported by existing clinical literature.
In essence, for this specific 510(k), the acceptance criteria for the modification are that (a) there are no significant changes to the device itself that would raise new questions of safety or efficacy, and (b) sufficient clinical evidence (from literature) exists to support the expanded use without introducing new risks or questions about effectiveness. The "study" proving this is the body of existing clinical literature, rather than a de novo performance study.
§ 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.