(286 days)
Therapeutic Ultrasound:
- Pain relief
- Reduction of muscle spasms
- Localized increase in blood flow
- Increase range of motion of contracted joints using heat and stretch techniques
The Sonopulse III offers 1.1 and 3.3MHz ultrasound using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
The Sonopulse offers 1.1 and 3.3MHz ultrasound using a 7cm² or 3cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
A. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sonopulse and Sonopulse III therapeutic ultrasound devices are based on substantial equivalence to a legally marketed predicate device, the Sonicator Plus 930. The device performance is assessed through compliance with specific IEC standards, demonstrating basic safety and essential performance.
| Feature | Acceptance Criteria (Predicate Device: Sonicator Plus 930) | Reported Device Performance (Sonopulse / Sonopulse III) |
|---|---|---|
| Indications for Use | Therapeutic Ultrasound: | Therapeutic Ultrasound: |
| - Pain relief | - Pain relief | |
| - Reduction of muscle spasms | - Reduction of muscle spasms | |
| - Localized increase in blood flow | - Localized increase in blood flow | |
| - Increase range of motion of contracted joints using heat and stretch techniques | - Increase range of motion of contracted joints using heat and stretch techniques | |
| Maximum Treatment Time | 30 minutes | 30 minutes |
| Frequency | 1.1 MHz ±10% | 1.1 MHz ±10% |
| 3.2 MHz ±10% | 3.2 MHz ±10% | |
| Modes | Continuous | Continuous |
| Pulsed - 20% duty cycle | Pulsed - 20% and 50% duty cycle | |
| Pulse Repetition | 100Hz ±20% | 100Hz, 16Hz, 48Hz (Note: The subject devices offer more pulse repetition frequencies, but 100Hz is covered, which aligns with the predicate.) |
| Safety and Performance Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5 (compliance) | Both the subject (Sonopulse and Sonopulse III) and predicate devices comply with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic compatibility), and IEC 60601-2-5 (Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment). |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical testing program focused on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions where the new device is compared to a legally marketed device rather than undergoing extensive clinical trials for efficacy.
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or clinical samples for evaluating the device's therapeutic effect. Instead, the "test set" refers to the devices themselves (Sonopulse and Sonopulse III) undergoing engineering and performance testing.
- Data provenance: The testing was performed in accordance with IEC (International Electrotechnical Commission) standards. The country of origin for the data is implied to be where these engineering tests were conducted, likely Brazil, given the submitter's location (IBRAMED - Industria Brazileria de EQUIPAMENTOS MEDICOS). This is a retrospective application of standards to existing device designs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to compliance with established engineering and safety standards (IEC 60601 series). The "experts" involved would be the testing engineers and regulatory bodies (like those certifying compliance to IEC standards), not medical experts establishing ground truth for clinical outcomes or diagnoses.
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Adjudication method for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., image readings). Here, the "adjudication" is through verification against objective engineering test parameters outlined in the IEC standards.
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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 comparative effectiveness study was done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This submission is for a therapeutic ultrasound device, not a diagnostic or AI-enabled device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is a physical therapeutic device, not a software algorithm. Its operation relies on direct human application and interaction.
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The type of ground truth used:
- The "ground truth" for this submission is compliance with international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5) and demonstration of substantial equivalence to a legally marketed predicate device (Sonicator Plus 930) in terms of indications for use, technological characteristics, and performance parameters.
- It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather engineering and regulatory compliance.
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The sample size for the training set:
- This is not applicable. The device is a hardware therapeutic device, not a machine learning algorithm, so there is no "training set" in the computational sense. The "training" for the device design would be iterative engineering and adherence to established design principles for medical devices.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the device's design and manufacturing is established through adherence to quality management systems (e.g., ISO 13485) and medical device regulations during its development and production.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.