(90 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 via suction channel under continuous 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 Veloxion Controller (with Integrated Fluid Control), Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. It also includes Class I accessories for waste handling: Waste Management Tubing, Tissue Catch, and Waste Management Bags. The system provides bipolar resection and coagulation, distends the uterus with saline, controls intrauterine pressure, and monitors fluid deficit.
Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study conducted for the Veloxion System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in a pass/fail format for specific performance metrics. Instead, it describes performance characteristics that were tested and compared to the predicate device. For the purpose of this request, I will extract the performance characteristics that were "tested" and the reported "performance" from the "Technological Characteristics" table (Table 1) and the "Performance Data" section.
| Acceptance Criteria/Performance Characteristic | Reported Device Performance (Subject Veloxion System) | Notes / Comparison to Predicate |
|---|---|---|
| Fluid Deficit Monitoring | ||
| Set Fluid Deficit Range | From 250 to 2500ml | Same as Predicate |
| Fluid Deficit Rate ≥ 300ml/min notification | YES | Same as Predicate |
| Notification when Actual fluid deficit is 1000ml | YES (no pause, notification only) | Same as Predicate |
| Notification & pause when Actual fluid deficit is 2000ml | YES | Different (Predicate: NO) |
| Notification when Actual fluid deficit is within 250ml of Set Limit | YES | Same as Predicate |
| Device Stops when Set Limit or 2500ml is reached | YES | Same as Predicate |
| Pressure Control | ||
| Set Pressure Range | 35 to 120mmHg | Slightly different (Predicate: 35 to 125mmHg) |
| Positive Action to Increase Above 100mmHg | YES | Same as Predicate |
| Pressure Sensor | Dual, independent sensing of cavity pressure | Same as Predicate |
| Over-pressure condition detection | YES | Same as Predicate |
| Maximum Allowable Actual Cavity Pressure | 135mmHg for 5 seconds | Same as Predicate |
| Primary mitigation for risk of over-pressurization | Reverse rotation of irrigation wheel | Same as Predicate |
| Ultimate mitigation for risk of over-pressurization | Non-defeatable, continuous notification tone; Notification displayed: "Remove device from cavity. Check for Clog." | Same as Predicate |
| Fluid Flow and Management | ||
| Continuous Flow | YES | Same as Predicate |
| Irrigation fluid | Saline | Same as Predicate |
| Maximum # of saline bag(s) hung on saline load cell | Four (4) | Different (Predicate: One (1)) |
| Load cells | Separate load cells to weigh the saline bags and the waste bags | Different (Predicate: One load cell for combined saline and waste) |
| Pump Type | Dual Pump (Irrigation, Aspiration) | Same as Predicate |
| Irrigation Flow Rate (Programmed for each mode) | Steady State = 100ml/min, Cut = 380ml/min, Coag = 100ml/min, ASPIRATE = 650ml/min | Different (Predicate: ASPIRATE = 400ml/min) |
| Suction for aspiration of waste from patient drape | Facility Suction | Different (Predicate: Waste Accessory Pump) |
| Able to Monitor saline remaining? | YES | Same as Predicate |
| Imaging/Optics | ||
| Optics | Integrated, Sterile, 10° Endoscope | Different (Predicate: Compatible with reusable 30° marketed Endoscope) |
| Imaging | Integrated CMOS sensor | Different (Predicate: External CCD camera) |
| Total # Pixels | 160,000 | (Predicate: Unknown) |
| Pixels/mm2 | 160,000 | (Predicate: Unknown) |
| Light Source | LED light | Different (Predicate: Xenon, Halogen, LED) |
| Resectoscope/Electrode | ||
| Energy Type | Radiofrequency, Bipolar | Same as Predicate |
| Monopolar or Bipolar | Bipolar | Same as Predicate |
| Shaft OD (Sheath) | With Sheath Assembled: 25Fr (8.3mm) | Slightly different (Predicate: 26Fr (8.6mm)) |
| Electrode OD | 0.019" | Slightly different (Predicate: 0.015") |
| Electrode Material | Tungsten (99.95% purity) | Same as Predicate |
| Electrode Insulation | FEP | Same as Predicate |
| Electrode Actuation | Linear Oscillating Loop | Different (Predicate: Circumferential Oscillating Wire) |
| How Supplied (Sterility) | Sterile, Single Use (Resectoscope, Fluid Control Set) | Same as Predicate |
2. Sample Size for the Test Set and Data Provenance
The document lists various performance tests and comparative testing to the predicate, but it does not specify the sample sizes (n) used for each test set.
The data provenance is not explicitly stated regarding country of origin or whether the studies were retrospective or prospective. The studies appear to be benchtop performance and engineering tests conducted in-house by the manufacturer rather than clinical trials involving patient data. This is implied by tests such as "Comparative visualization testing in a simulated model" and "Simulated Use: Tissue resection and spot coagulation of cavity pressure, O imaging."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts or their qualifications for establishing ground truth for any of the performance tests described. The "performance data" section primarily describes engineering and benchtop tests, not clinical evaluations requiring expert interpretation.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
As the document does not describe studies involving human readers or interpretation of results that would require adjudication (e.g., image reading), no adjudication method is mentioned or implied.
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
There is no mention of an MRMC comparative effectiveness study, nor any evaluation of AI assistance or human reader improvement. The device described is a medical instrument (hysteroscope system), not an AI-powered diagnostic or interpretive tool that would typically involve such studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical instrument, not a standalone algorithm. Its performance is inherent to its mechanical, electrical, and optical functions.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the engineering and performance tests:
- Physical/Engineering Standards: Measurements against known physical properties or engineering specifications (e.g., pressure, flow rates, dimensions, temperature, electrical safety).
- Predicate Device Performance: Direct comparison to the performance of the legally marketed predicate device (K180752), establishing its performance as a de facto "ground truth" for equivalence.
- Simulated Models: For visualization and tissue interaction tests ("Comparative visualization testing in a simulated model," "Simulated Use: Tissue resection and spot coagulation").
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the technical performance data provided.
8. The Sample Size for the Training Set
This question is not applicable as the document describes a medical device, not a machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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.