(258 days)
The Versalet II Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.
The VERSAJET™ II Hydrosurgery System consists of two basic system components: the reusable power console and the single-use, sterile (Ethylene Oxide) handpiece and tubing assembly. A footswitch is also available for operating the system. The VERSAJET™ II Hydrosurgery System uses a pressurized stream of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. The device provides cutting, irrigation and evacuation in the same tool. The high velocity stream of saline simultaneously washes the tissue surface and vacuums away foreign material from the wound. The 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 footswitch or a sealed membrane switch on the front panel of the power console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on user preference and the needs of a particular application. Associated accessories include: VERSAJET EXACT Handpieces, single-use, sterile, in three configurations . . VERSAJET PLUS Handpieces, single-use, sterile, in three configurations Footswitch
The document provided is a 510(k) premarket notification for the VERSAJET™ II Hydrosurgery System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria in the manner typically seen for novel AI/diagnostic devices.
Therefore, the information required to populate the fields of your request (acceptance criteria, specific study details for performance metrics, sample sizes, expert involvement, ground truth, etc.) is largely not present in this type of regulatory submission for this particular device.
Here's an explanation of why and what information is available:
- Type of Device: The VersaJet II Hydrosurgery System is a physical medical device (jet lavage system) used for wound debridement. It's not a diagnostic AI or imaging device where performance metrics like sensitivity, specificity, or accuracy are typically reported for clinical decision-making.
- Regulatory Pathway (510(k)): A 510(k) submission aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is often demonstrated through bench testing and comparisons to the predicate, rather than large-scale clinical trials establishing novel performance criteria.
Based on the provided document, here's what can be extracted or inferred, and what cannot be:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs its intended function (cutting, irrigation, evacuation) similar to the predicate. | - Environmental testing successfully completed. |
- Reliability testing demonstrated improved reliability of modified components.
- Performance testing demonstrated:
- Effective cutting pressure range per console power setting is substantially equivalent to the predicate.
- System priming is substantially equivalent to the predicate.
- Console cut off pressure function is substantially equivalent to the predicate.
- Handset insertion, removal, engagement and disengagement forces are substantially equivalent to the predicate. |
| Safety: Device is safe for its intended use, particularly after modifications. | - Biocompatibility testing on handpieces successfully completed per ISO 10993 (Cytotoxicity, Skin Irritation, Sensitization).
- Device complies with IEC 60601-1 (3rd edition) electrical safety standards.
- Modifications addressed "electrical issues of not turning on," "oil leakage," and "corrosion." |
| Biocompatibility: Materials in contact with the patient are biocompatible. | - Biocompatibility on the VersaJet Handpieces has been successfully completed in accordance with applicable parts of ISO 10993. |
| Sterilization: Device can be effectively sterilized. | - Method of Sterilization: Identical to predicate. Implied validation through standard compliance (ISO 11135). |
| Compliance with relevant standards. | - Device complies with ISO13485, ISO 14971, ISO 15223-1, ISO 15223-2, BS EN 980, BS EN 1041, IEC 60601-1-2, IEC 60601-1, ISO 11135, ISO 11607-1, ISO 10993-1, ISO 10993-10. |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not provided in detail. The document describes "bench testing" and "environmental testing," "reliability testing," and "performance testing" but does not specify the sample sizes (e.g., number of devices tested, number of simulated procedures) or data provenance (e.g., specific country of origin or whether data simulates real-world use) for these tests in a way that would be relevant for an AI/diagnostic device. The testing described focuses on engineering validation rather than clinical efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is not relevant for this device's regulatory submission. There is no concept of "ground truth" derived from expert consensus in the context of validating a jet lavage system's physical performance or safety.
4. Adjudication method for the test set:
- Not Applicable. No expert adjudication is described or required for this type of device validation.
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 a physical device, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for this device's validation is adherence to engineering specifications, safety standards, and performance equivalence to a predicate device, as demonstrated through various bench tests and material analyses.
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not involve a "training set."
In summary: The provided document is a 510(k) submission for a physical medical device. It focuses on demonstrating "substantial equivalence" through engineering and biocompatibility testing, rather than reporting on the performance metrics (like sensitivity, specificity, or reader studies) typically associated with AI or diagnostic devices that would require detailed acceptance criteria, sample sizes, and ground truth methodologies.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.