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510(k) Data Aggregation
The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers. bedsores and vaginal ulcers. soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
The SonicOne Plus Ultrasonic Wound Care System and Accessories is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include Probe tips, Wrenches, Sterile and non sterile Tube sets and sterile Surgical Procedure bags and sterile Handpiece Sheaths.
This document describes the Misonix SonicOne Plus Ultrasonic Wound Care System and Accessories, which is an ultrasonic surgical system used for wound debridement. The submission aims to demonstrate substantial equivalence to predicate devices, namely the SonicOne Ultrasonic Wound Care System (K112782) and the AUSS-7 Ultrasonic Surgical System (K070313).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on compliance with a set of voluntary standards and successful completion of non-clinical tests. The "reported device performance" is essentially the statement that the device has "passed" these standards and tests. There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy provided, as this is a medical device for physical intervention, not diagnostic imaging or AI.
| Acceptance Criteria (Voluntary Standards & Non-Clinical Tests) | Reported Device Performance |
|---|---|
| UL 60601-1 2nd Edition (Medical Electrical Equipment, Part 1: General Requirements for Safety) | Passed |
| IEC 60601-1* 2nd Edition (Medical Electrical Equipment, Part 1: General Requirements for Safety) | Passed |
| ISO 10993-1:2009 (Biological evaluation of medical devices —Part 1: Evaluation and testing) | Passed |
| ISO 10993-7:2008 (Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals) | Passed |
| ISO 14971:2007 (Medical devices -- Application of risk management to medical devices) | Passed |
| ISO 15223-1:2007/A1:2008 (Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements) | Passed |
| ISO 11607:2006 (Packaging for Terminally Sterilized Medical Devices) | Passed |
| ISO 11135:2007 (Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) | Passed |
| IEC 62304: 2006 (Medical Device Software-Software Life Cycle Processes) | Passed |
| IEC 60601-1-4 (General Requirements for safety-Programmable electrical medical systems) | Passed |
| FCC Part 18 (EMC Requirements) | Passed |
| Output Frequency Measurements | Performed |
| Output Power Measurements (No Load to Maximum Load) | Performed |
| Tip Displacement Measurements | Performed |
| Irrigation Flowrate Measurements | Performed |
| Life Tests | Performed |
| Input Power Measurements | Performed |
| EMI Tests | Performed |
| Dielectric Tests on Mains Circuits | Performed |
| Patient Current Leakage and Patient Sink Current Measurements | Performed |
| Power Line Ground Leakage Measurements | Performed |
| Dielectric Tests on Patient Circuits | Performed |
| Sterilization Validations (ANSI/AAMI/ISO 11135:1994 or latest and ISO 11135:2007) | Validated |
| Reprocessing (cleaning/disinfecting/sterilization) instructions validation | Validated |
| Software Validation (cleared under FDA 510k #K070313, meets FDA guideline "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and ISO 60601-1-4) | Cleared and Meets Requirements |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "As such, no additional clinical data was obtained in anticipation of this submission." This indicates that there was no dedicated test set involving human subjects or clinical data for this specific 510(k) submission. The safety and performance assessment relies on non-clinical tests, engineering validations, and substantial equivalence to previously cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There was no clinical test set requiring ground truth establishment by experts for this submission. The device's safety and effectiveness are established through engineering and biological testing against established standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. There was no clinical test set 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
Not applicable. This device is an ultrasonic surgical system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI" is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by engineering standards and biological safety standards (e.g., ISO, IEC, UL, FCC for electrical safety, biocompatibility, sterilization, and electromagnetic compatibility). For the software component, the ground truth is its compliance with FDA guidelines and ISO 60601-1-4, as validated by previous clearance (K070313).
8. The Sample Size for the Training Set
Not applicable. The device is not an AI algorithm that requires a training set in the typical sense. Its design and operational parameters are based on established engineering principles and its predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI algorithm was used.
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