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510(k) Data Aggregation
(410 days)
VERSAJET Hydrosurgery System (III)
The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement:
- wound debridement (acute and chronic wounds, burns),
- soft tissue debridement and cleansing of surgical sites.
The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.
The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.
The pressure can be adjusted using either the foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.
The provided text describes a 510(k) premarket notification for the VERSAJET III Hydrosurgery System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with quantitative performance metrics for AI applications. The device described (a hydrosurgery system) is a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically relies on algorithms and data for its function.
Therefore, many of the requested categories in your prompt related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this traditional medical device submission.
However, I can extract information related to the device's "performance" in the context of a 510(k) (which means demonstrating safety and effectiveness compared to a predicate) and non-clinical testing.
Here's a summary based on the provided text, addressing the applicable points and indicating when information is not present or relevant to this type of device:
Device: VERSAJET III Hydrosurgery System
Predicate Device: VERSAJET II Hydrosurgery System (K143115)
Regulation Number: 21 CFR 880.5475 (Jet lavage)
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the way one would for an AI diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, "performance" in this context refers to the device's functional integrity, safety, and equivalence to the predicate device through non-clinical testing.
| Test Conducted | Objective/Acceptance Criteria (Implied) | Reported Device Performance/Conclusion |
|---|---|---|
| Pressure, Flow Rate and Hand Piece Reliability | (Implied) To ensure the device delivers consistent and appropriate pressure and flow rates as designed and that the handpieces are reliable during intended use, matching or exceeding predicate performance for debridement. | Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent. |
| Hand Piece Aerosolization & Bacterial Transmission | (Implied) To assess and prevent unacceptable levels of aerosol generation or bacterial transmission during use, ensuring user and patient safety and infection control. | Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent. |
| Console Cut-Off Pressure | (Implied) To verify the console's safety mechanism for pressure control, ensuring it operates within safe parameters and cuts off pressure appropriately to prevent injury or device malfunction. | Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent. |
| Console Reliability | (Implied) To assure the console's durability and consistent performance over its expected lifespan under various operational conditions. | Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent. |
| Operating Environment | (Implied) To confirm the device functions correctly and safely within its specified environmental conditions (e.g., temperature, humidity) and is resistant to typical operational stresses. | Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent. |
| Human Factors Summative Testing | (Implied) To evaluate the user interface and device interaction to ensure it is safe and effective for use by intended users, identifying and mitigating potential use errors. Acceptance criteria would involve demonstrating usability and safety per applicable human factors guidance. | Testing was completed consistent with IEC 62366, IEC 60601-1-6, and FDA Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices. Results support that the VERSAJET III is substantially equivalent. |
| Electrical safety | (Implied) To demonstrate compliance with electrical safety standards, preventing electrical hazards to both patients and operators. Acceptance criteria would be adherence to specific clauses of IEC 60601-1. | Performed per IEC 60601-1. Results support that the VERSAJET III is substantially equivalent. |
| EMC (Electromagnetic Compatibility) | (Implied) To ensure the device operates without causing or being susceptible to electromagnetic interference, preventing functional disruption or safety issues. Acceptance criteria would be adherence to specific clauses of IEC 60601-1-2. | Performed per IEC 60601-1-2. Results support that the VERSAJET III is substantially equivalent. |
| Bench top performance testing including challenge conditions | (Implied) To evaluate the device's functional performance under various simulated conditions, including worst-case scenarios, to ensure it meets design specifications for cutting, ablating, and removing tissue and foreign matter. This likely includes mechanical and fluid dynamics performance. | Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent. |
The overall conclusion for all tests is that they were completed to prove safety and effectiveness and to demonstrate substantial equivalence in performance to the predicate device. The submission states, "Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the VERSAJET III Hydrosurgery System is substantially equivalent to the predicate device for the intended use."
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a physical device, and the testing described is non-clinical bench testing, electrical safety, EMC, and human factors. There is no "test set" of patient data in the context of an AI algorithm evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, no patient data test set requiring expert ground truth for an algorithm. Human factors testing would involve user interaction, but this is different from establishing ground truth for diagnostic imaging.
4. Adjudication method for the test set
- Not Applicable. No test set of patient data requiring adjudication.
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
- No. This is not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical, manually operated medical device tool; it does not have an algorithm that performs a standalone function for diagnosis or intervention without human control.
7. The type of ground truth used
- Not Applicable. Ground truth, in the context of AI, refers to the verified correct output for a given input. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance benchmarks (e.g., a handpiece reliably delivers X pressure, a safety cutoff activates at Y point, components withstand Z cycles). The document does not detail specific "ground truth" methods beyond adherence to standards and demonstrating equivalence to predicate performance.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI model.
In summary, the provided document details a 510(k) submission for a conventional medical device (hydrosurgery system). The "acceptance criteria" and "study" refer to non-clinical engineering and performance testing aimed at demonstrating the device's safety, effectiveness, and substantial equivalence to a predicate device, rather than the performance metrics and ground truth methodologies typically associated with AI/SaMD products.
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