(265 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 Compact 1MHz is a therapeutic ultrasound device with a frequency of 1 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide 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 Compact 3MHz is a therapeutic ultrasound device with a frequency of 3 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide 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 provided document is a 510(k) summary for the Sonopulse Compact 1MHz and Sonopulse Compact 3MHz therapeutic ultrasound devices. It describes the devices' characteristics and compares them to a predicate device (Sonicator Plus 930). The submission aims to demonstrate substantial equivalence, not to prove that the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not include information on acceptance criteria, reported device performance against those criteria, or a study design as typically associated with a clinical trial to prove device efficacy or safety.
Instead, the "testing results" mentioned in the document refer to non-clinical testing to ensure the device meets established safety and performance standards for medical electrical equipment.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
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A table of acceptance criteria and the reported device performance
- Not available. The document does not specify quantitative clinical acceptance criteria (e.g., a certain percentage reduction in pain, or specific range of motion improvement) or report device performance against such criteria. The "testing results" refer to compliance with IEC standards for safety and general performance.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document describes non-clinical testing (IEC standards compliance), not a clinical trial with a "test set" of patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This information pertains to studies where expert opinion is used to establish ground truth for clinical outcomes, which is not described in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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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 is a therapeutic ultrasound device, not an AI-assisted diagnostic imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI algorithms, which are not the subject of this submission.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. The "truth" in this context is whether the device physically performs according to established engineering and safety standards (e.g., electrical safety, electromagnetic compatibility, ultrasonic output parameters).
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The sample size for the training set
- Not applicable. No machine learning or AI "training set" is mentioned or relevant to this submission.
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How the ground truth for the training set was established
- Not applicable. No machine learning or AI "training set" is mentioned or relevant to this submission.
Summary of available information (Non-Clinical Testing):
The document provides information about non-clinical testing to demonstrate the safety and essential performance of the device in compliance with international standards.
- Study Type: Non-clinical testing for compliance with IEC standards.
- Standards Met:
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic compatibility for medical electrical equipment.
- IEC 60601-2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment.
- Testing Performed By: Implied to be by the manufacturer (IBRAMED) or a certified testing laboratory, as part of the submission for regulatory approval.
- Proof of Compliance: The submission states that "Both the subject and predicate devices comply with this standard" for each listed IEC standard.
- Goal: To demonstrate "substantial equivalence" to a legally marketed predicate device (Sonicator Plus 930) by showing similar technological characteristics and compliance with recognized safety and performance standards. The conclusion explicitly states: "The differences between the subject and predicate devices do not affect the safety or effectiveness of the proposed device."
§ 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.