(345 days)
The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.
The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds. The streams of saline simultaneously wash the tissue surface and vacuum away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.
The HydroCision, Inc. Debridement System, a pulse lavage device with sharp debridement, was reviewed for K991383. The study relied on bench testing and a comparative animal study against a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality (Bench Testing) | Bench testing was conducted to determine device functionality. The summary implies the device met its functional requirements, although specific metrics or thresholds for "functionality" are not provided in this document. |
| Equivalence in wound cleaning (Porcine Study) | The HydroCision device and the predicate device (Zimmer Puls-A-Vac II) were found to be "equally effective in clearing bacterial and particulate contamination from the wounds as examined by quantitative bacteriology and radiographic analysis." This indicates the device met the criteria for comparable wound debridement effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Porcine Study (Test Set): While a specific number for the porcine subjects is not explicitly stated in the provided text, the study involved a comparison between the HydroCision device and the Zimmer Puls-A-Vac II device.
- Data Provenance: The porcine study was conducted as a prospective, in-vivo animal study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For the porcine study, it's possible that veterinary pathologists or microbiologists were involved in assessing bacterial and particulate contamination, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the given text. For the porcine study, it's unknown if multiple assessors were used and how discrepancies were resolved.
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 section is not applicable as the device is not an AI-powered diagnostic tool, but rather a surgical debridement system. The study was a comparison of device effectiveness, not human reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the device is not an algorithm. The "standalone" performance refers to the device's functional and cleaning capabilities demonstrated through bench and animal testing.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for functionality would have been engineering specifications and predetermined performance parameters for flow rates, power, etc.
- Porcine Study: The ground truth for wound cleaning effectiveness was established through:
- Quantitative Bacteriology: Direct measurement of bacterial load.
- Radiographic Analysis: Assessment of particulate contamination removal using imaging.
8. The Sample Size for the Training Set
This section is not applicable as there is no "training set" in the context of this device. The device is not a machine learning algorithm that requires training data. The development and validation relied on engineering design and performance testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set.
§ 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.