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510(k) Data Aggregation
(125 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 resecting device. It is also intended to distend the uterus by filling with saline to facilitate viewing with a hysteroscope and to monitor the volume differential between into and out of the uterus.
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control)
- Footswitch
- Veloxion Resecting Device Kit:
- Veloxion Resecting Device
- Sheath
- Continuous Flow Optical Obturator
- Veloxion Fluid Control Set
- Veloxion Saline Pole
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items apply no aspiration to the patient, they only handle waste after it is already outside the patient), which includes: - Waste Accessory Bag for collection of waste aspirated form the patient and from under patient's buttocks,
- Waste Accessory Tubing for collection of waste from under the patient's buttocks
- Waste Management Pump for moving the waste to the Waste Bag.
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 a hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.
The provided text describes a 510(k) premarket notification for the Veloxion System, a hysteroscopy device, and compares it to predicate devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the format requested, particularly for an AI/algorithm-based device.
The "Performance Data" section (Page 8 of the original document) lists various tests performed, but these are general engineering and functional validation tests for the hardware components of the hysteroscope system (e.g., software V&V, integrity, functional testing of aspiration/irrigation, dimensional inspection, simulated use, durability, electrical safety, usability). These tests are typical for a medical device's safety and effectiveness but do not detail specific acceptance criteria for device performance in a clinical context (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor do they describe a study comparing the device's diagnostic or assistive capabilities against a specific ground truth, as would be expected for an AI/algorithm.
Therefore, many of the requested data points cannot be extracted from this document as they are not present. The document focuses on establishing substantial equivalence based on technological characteristics and general performance testing of the physical system, not on the performance of a specific algorithm or AI component in a diagnostic or interpretive task.
If the "Veloxion System" refers to a device with an AI component for interpretation, that information is not detailed within this 510(k) summary. The summary describes fluid control, tissue resection, and coagulation functions.
Based on the information provided in the document:
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A table of acceptance criteria and the reported device performance: Not available in a format detailing clinical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or algorithm. The document lists general performance data for the physical device, such as "Software Verification and Validation Testing," "Integrity: System withstands operating pressures," "Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control," etc. These are not quantifiable metrics that can be presented in a table against acceptance criteria for an AI's diagnostic or interpretive performance.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The testing described is for the hardware system's functionality and safety, not for an algorithm's diagnostic performance on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or not provided, as there is no mention of a diagnostic performance study with ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.
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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 or not provided. The document describes a medical device for hysteroscopy, not an AI-assisted diagnostic tool for interpretation by human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable or not provided. The device described performs physical actions (resection, coagulation, fluid control) and monitoring, not standalone image analysis or diagnostic tasks.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided, as there is no diagnostic performance study described.
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The sample size for the training set: Not applicable or not provided. This would be relevant for an AI/machine learning model, which is not the focus of this 510(k) summary.
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How the ground truth for the training set was established: Not applicable or not provided.
Summary of available performance data (from section VII "Performance Data") related to the device's functional performance:
The document indicates that the following performance data were provided in support of substantial equivalence:
- Software Verification and Validation Testing performed per IEC 62304 and FDA guidance.
- Integrity testing (system withstands operating pressures).
- Functional Testing (Cut and coagulation, aspiration, irrigation, pressure control).
- Dimensional Inspection and Testing.
- Simulated Use (Tissue resection and spot coagulation, regulation of cavity pressure).
- Durability Testing (Electrode durability for tissue resection and coagulation).
- Fluid deficit testing.
- Comparative testing to predicate for electrode durability, pressure control, and fluid control.
- Electrical Safety & EMC per IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009, and IEC 60601-2-2:2009.
- Usability Testing (Use related risk evaluation).
Conclusion from the document:
Based on these performance tests, the Veloxion System is considered substantially equivalent, safe, and effective as the predicate systems. The document confirms that the differences between the Veloxion System and predicate devices (e.g., dual pump system, programmed flow rates, single-use patient-contacting components) were evaluated through performance testing to demonstrate safety and effectiveness.
In essence, the document confirms the device meets acceptance criteria related to its mechanical, electrical, software, and functional performance, but not for AI/algorithm-based diagnostic or interpretive capabilities, as those are not described as functions of this device.
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(120 days)
The Hysteroscopy Pump HM6 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
The Hysteroscopy Pump HM6 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a manmachine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.
This document describes a 510(k) premarket notification for the Hysteroscopy Pump HM6. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical studies with acceptance criteria. Therefore, the information provided is primarily focused on demonstrating the similarity of the new device to existing devices on the market, relying on bench testing for performance.
Here's an analysis of the provided information concerning acceptance criteria and studies:
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 data in the traditional sense of a clinical trial proving a specific efficacy or accuracy metric. Instead, the "performance testing" section refers to bench tests and compliance with standards. The key "acceptance criterion" for this 510(k) submission is showing that the device is substantially equivalent to predicate devices and that the modifications do not raise new questions of safety and effectiveness.
The document highlights the following performance aspects and their comparison to the predicate Aquilex System:
| Acceptance Criterion (Implied) | Reported Device Performance (Hysteroscopy Pump HM6) |
|---|---|
| Accuracy of fluid deficit measurement | Improved to = 0% compared to = 10% for the predicate device (Aquilex System) due to a separate scale for inflow volume. |
| Maximum selectable pressure | Identical to the Aquilex System (150 mmHg). |
| Safety features (e.g., active pressure reduction, overpressure warnings, fluid deficit warnings) | Same or similar to predicate devices. |
| Software validation | Performed in accordance with FDA Guidance document "General Principles of Software Validation", with the software considered "Major Level of Concern". |
| Electrical Safety and EMC | Performed in accordance with IEC 60601-1 by an accredited test institute. |
| Design modifications (mechanics, hardware, software) | Results from internal design control process, including risk analysis. Validation and verification testing of system specifications performed as bench tests. |
| Tubing design and material | Identical to the Aquilex System, with minor length changes and addition of a clamp for the outflow tube set. |
| Fluid bag detection feature | New safety feature informs user if fluid in bag is |
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(82 days)
The IUR Fluid Management System is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
The IUR Fluid Management System consists of a microprocessor controlled pump intended to distend the uterus and a monitoring unit designed to monitor the irrigation fluid losses during hysteroscopic procedures. The pump unit functions according to the peristaltic principle. It consists of a power supply, main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active pressure reduction ensures the conformity of the preset nominal pressure value with the actual measured pressure. The pump unit is designed with several alarms to inform the operator in case of an overpressure. The fluid monitoring unit operates with a volume differential measurement to determine the fluid losses remained in the patient. It consists of the following components: display unit, bag holder, bag deflector, carrier plate for the pump unit, scale pole, unit stands pole, weighting unit, container holder, roller base and load controller. The deficit threshold alarm level can be selected by the operator in the range of 0-2000 ml. The IUR Fluid Management System is only functional if the monitoring unit is connected to the pump unit and a specific resectoscope is attached.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The "Performance Data" section (VIII) only states that the device complies with International Standards IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). These are safety and compatibility standards, not specific performance acceptance criteria related to its intended use (liquid distension and fluid loss monitoring).
Therefore, I cannot populate the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
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