(66 days)
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 judgement would require the use of an ultrasonic aspirator with sharp debridement.
The SonicOne Ultrasonic Wound Care System 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 handpiece sheaths.
The provided text describes the Misonix SonicOne Ultrasonic Wound Care System and Accessories, focusing on its substantial equivalence to predicate devices rather than independent clinical studies with specific acceptance criteria and performance metrics. Therefore, many of the requested sections regarding acceptance criteria, study data, and ground truth establishment cannot be fully populated from the given information.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Safety Standards | Compliance with: | The device has been designed and tested to pass the following voluntary standards: |
- IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
- IEC 60601-1-2:2001 (Medical Electrical Equipment General Requirements for EMC)
- FCC Part 18 (EMC Requirements)
- ISO 10993-1:2009 (Biological evaluation of medical devices —Part 1: Evaluation and testing)
- ISO 10993-7:2008 (Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals)
- 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) |
| Performance (Functional) | Not explicitly stated. | The SonicOne is stated to be "identical to the AUSS-6 Ultrasonic Surgical Aspirator cleared under 510K #K050776." It is also considered substantially equivalent in "Mode of Operation, Hardware Design and Output Parameters" to the predicate devices. This implies it meets the performance characteristics of those cleared devices. |
| Clinical Efficacy | Not explicitly stated. | "The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission." This refers to a determination of substantial equivalence based on predicate devices' clearance, not a new clinical study. |
Study Details (Based on Substantial Equivalence Claim)
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Sample size used for the test set and the data provenance:
- No direct test set for performance on patients was used for this 510(k) submission. The submission relies on the substantial equivalence to predicate devices (Arobella Medical LLC AR 1000 Ultrasonic Wound Therapy System K062544 and Misonix Inc. Alliger Ultrasonic Surgical System AUSS-6 K050776).
- Therefore, there is no specific data provenance (country of origin, retrospective/prospective) for a new clinical test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical test set with ground truth established by experts was used for this submission. The basis for clearance is substantial equivalence to already cleared devices and their established indications for use.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No new clinical test set requiring adjudication was performed as part of this 510(k).
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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. This device is a physical medical device (ultrasonic wound care system), not an AI/software-based diagnostic or assistive tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not contain software and is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of this 510(k), the "ground truth" for efficacy is implicitly the established safety and effectiveness of the predicate devices for their cleared indications. The submission argues that the SonicOne is substantially equivalent in design and function, therefore sharing the same safety and efficacy profile.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no training set in the context of AI.
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How the ground truth for the training set was established:
- Not applicable. See above.
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.