(87 days)
The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic.
The SONOTOMETM System contains three subsystems: ultrasonic energy, irrigation and aspiration. The SONOTOME™ System uses a hollow titanium tip PROBE mounted to a reusable handpiece. The ultrasonic power generator provides energy to the handle which converts it into ultrasonic energy at the tip. The irrigation and the ultrasonic energy are activated by depressing the foot pedal. The vibrating probe mounted on the hand piece is then applied to the tissue desired to be removed. The application of ultrasonic energy through the tip breaks down the tissue through a cavitation action. The resultant debris is aspirated through the probe tip and into a disposable trap between the handpiece and the vacuum canister. The flow of saline is maintained to reduce the temperature of the probe and to provide for a means of irrigation to the surgical site.
The Sonokinetics SONOTOME™ System (K990572) is an ultrasonic aspiration device cleared through the 510(k) pathway.
Acceptance Criteria and Device Performance:
The 510(k) submission for the SONOTOME™ System is based on its substantial equivalence to previously cleared predicate devices: SonoKinetics' ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696).
The acceptance criteria for the SONOTOME™ System are implicitly defined by its technological characteristics being substantially equivalent to the predicate devices. The submission states that the device has not been modified from the ACRYL-X™ II System (K930629), and the current 510(k) is for expanded indications only. Therefore, the device performance is reported as identical to the ACRYL-X™ II System, and within the range of the CUSA® NS-200.
| Acceptance Criteria (Predicate Device K930629 / K910696) | Reported Device Performance (SONOTOME™ System) |
|---|---|
| Intended Use: Removal of thermoplastic cement from bones in revision procedures (K930629) OR Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic (K910696) | Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic |
| Basic operating principle: Metal tip driven by ultrasound, cooling and aspiration of plastic through tip (K930629) OR Metal tip driven by ultrasound causing tissue fragmentation and aspiration through tip (K910696) | Metal tip driven by ultrasound causing tissue fragmentation and aspiration through tip |
| System console: Self-contained with ultrasonic, irrigation, and aspiration subsystems | Self-contained with ultrasonic, irrigation and aspiration subsystems |
| Amplitude of vibration of tip: 240 microns, peak to peak (K930629) OR Adjustable up to 355 microns (K910696) | 240 microns, peak to peak |
| Vibration frequency: 20 kHz (K930629) OR 23 kHz (K910696) | 20 kHz |
| Irrigation flow rates: 10-400 ml/min (K930629) OR 1.5-50cc/min (K910696) | 10-400ml/min |
| Aspiration: 5-15 in. Hg. (K930629) OR 0-24 in. Hg (K910696) | 5-15 in. Hg. |
| Disposable components: Surgical Tips, suction trap, irrigation/suction tubing set | Surgical Tips, suction trap, irrigation/suction tubing set |
| Power requirements: 105-130 v a-c, 60 Hz, 500 watts (K930629) OR 100-120 VAC, 15amps, 50-60 Hz; 200-240 VAC, 10amps, 50-60 Hz (K910696) | 105-130 v a-c, 60 Hz, 500 watts |
Study Information:
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Sample size used for the test set and the data provenance:
- The document explicitly states: "Since this 510K is for expanded indications only, and the device has not been modified from that cleared under K930629, no further performance testing was performed."
- Therefore, there is no new test set or data provenance for the current 510(k) submission. The performance is based on the previously cleared device, ACRYL-X™ II System (K930629), and its historical data. The original studies for K930629 are not detailed in this submission.
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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, as no new performance testing was conducted for this 510(k) submission.
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Adjudication method for the test set:
- Not applicable, as no new performance testing was conducted for this 510(k) submission.
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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:
- No MRMC study was conducted. This device is a mechanical surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are typically performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study was done for an algorithm, as this is a mechanical surgical device.
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The type of ground truth used:
- For the original predicate devices, the ground truth would have been established through a combination of engineering specifications, preclinical testing (e.g., tissue ablation rates, aspiration efficiency, temperature control in various tissue types), and potentially clinical experience/observation for surgical outcomes. The current submission relies on the established performance of the predicate device.
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The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as this is not an AI/machine learning device.
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