(20 days)
The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas and benign conditions requiring endometrial ablation via suction channel under continious flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control)
- Footswitch
- Veloxion Resectoscope
- Veloxion Fluid Control Set
- Veloxion Video Control Unit
- Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- Tissue Catch: For collection of gross resected tissue pieces for pathology.
- Waste Management Bags: To provide bags for final collection of outflow.
The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.
This document describes the FDA clearance for the Veloxion System, a device used in gynecological procedures. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and study design for performance.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
This document does not provide specific acceptance criteria or reported device performance metrics in a quantifiable way. It states: "Results of tests provided for the predicate were adequate to support the new indication." This implies that the device met certain performance standards, but those standards and the actual performance are not detailed here.
Missing Information: Specific numerical acceptance criteria (e.g., accuracy thresholds, failure rates, precision limits) and the measured performance of the device against these criteria.
2. Sample size used for the test set and the data provenance:
This document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). It refers to "tests provided for the predicate" but does not detail them.
Missing Information: The specific sample size of the test set, the country of origin of the data, and whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document does not mention the use of experts to establish a ground truth or their qualifications. Given the nature of the device (a hysteroscopic system for tissue resection/coagulation and fluid management), the "ground truth" would likely be related to the device's functional integrity, safety, and effectiveness in performing its intended tasks, rather than image interpretation.
Missing Information: Information on experts used for ground truth establishment and their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This document does not describe any adjudication method.
Missing Information: The adjudication method used for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This document does not refer to a multi-reader multi-case comparative effectiveness study or AI assistance. The Veloxion System appears to be a surgical device with fluid management and visualization capabilities, not an AI-powered diagnostic tool for human readers.
Missing Information: Information on MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This document does not describe a standalone algorithm performance study. The device is a system with human-in-the-loop operation (trained gynecologists).
Missing Information: Information on standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This document does not explicitly state the type of ground truth used. For a device like the Veloxion System, the "ground truth" for proving effectiveness and safety would likely involve a combination of:
- Pre-clinical testing: Bench testing for mechanical, electrical, fluid management, and energy delivery performance.
- Biocompatibility testing: To ensure materials are safe for human contact.
- Sterilization validation: To confirm the device can be properly sterilized.
- Clinical validation (if applicable and part of the predicate device's data): Observing the device's performance in surgical settings, potentially using outcomes data for the predicate.
The primary predicate (K190113) was cleared previously, and the current submission (K191335) largely relies on the predicate's testing. The specific new indication mentioned is "endometrial ablation," which suggests that the testing would focus on the device's ability to safely and effectively perform ablation, possibly verified through histopathology or visual confirmation of ablation efficacy.
Missing Information: Explicit statement of the type of ground truth used.
8. The sample size for the training set:
This document does not mention a training set sample size. This is because the Veloxion System is a physical medical device, not an algorithm that requires a "training set" in the machine learning sense.
Missing Information: A training set sample size.
9. How the ground truth for the training set was established:
This document does not mention a training set or how its ground truth was established, for the same reasons as point 8.
Missing Information: How ground truth for a training set was established.
Summary of what the document does provide:
- Device Name: Veloxion System
- Indications for Use: Intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, removal of intrauterine polyps and myomas, and benign conditions requiring endometrial ablation via suction channel under continuous flow conditions following resection using a bipolar resectoscope. It also distends the uterus with saline for viewing and monitors fluid volume differential.
- Predicate Device: Veloxion System (K190113) from Corinth MedTech, Inc.
- Basis for Clearance: Substantial equivalence to the predicate device, with an added indication for endometrial ablation. The submission states, "Results of tests provided for the predicate were adequate to support the new indication." This implies that the validation work done for the predicate device, plus any additional testing for the new indication, was sufficient.
§ 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.