(457 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 SONOMED apparatus is ultrasound equipment for therapy, which has been developed in accordance with the safety standards IEC 60601-2 and IEC 60601-2 and IEC 60601-2-5, class II, type BF, which makes it a safe apparatus of high reliability for the therapist and the patient.
SONOMED is medical electric equipment which provides therapeutic ultrasound treatment. Ultrasound is a mechanic stimulus directed to the body through ultrasonic beam emitted by a transducer/applicator, better known as head. This ultrasound is produced in the head through a piezoelectric crystal and is transmitted to the body through the aluminum surface of the head and a contact agent (gel). Depending on how the ultrasound beam passes through the tissues, its energy is gradually and selectively absorbed being transformed into heat, among other effects. This increase in temperature causes biological changes in the tissues as for instance increase in micro circulation, a reduced perception of pain, a reduction in inflammatory activity and an increase in the reestablishing rate of delicate tissues. The higher the ultrasound frequency, the more superficial will be its absorption.
The provided text is a 510(k) Summary for a medical device (Sonomed IV / Sonomed V), which establishes substantial equivalence to a predicate device. It does not describe an acceptance criteria study in the typical sense of evaluating the performance of an AI/ML device against specific metrics. Instead, it focuses on comparing the new device's characteristics to a legally marketed predicate device to demonstrate that it is equally safe and effective.
Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission. This document describes a comparison of product specifications and adherence to general safety standards.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly stated as not applicable:
1. A table of acceptance criteria and the reported device performance
The document doesn't define explicit "acceptance criteria" for a study in the context of AI/ML performance. Instead, it compares the technical specifications and indications for use of the subject device (Sonomed IV / Sonomed V) with a predicate device (Sonopulse, K130888). The acceptance, in this regulatory context, is that the subject device is substantially equivalent to the predicate device.
| Characteristic | Acceptance Criteria (Predicate's value/range) | Reported Device Performance (Subject Device) | Equivalent Discussion (Regulatory Conclusion) |
|---|---|---|---|
| Regulation Number | 890.5300 | 890.5300 | Same |
| Indications For Use | See list below | See list below | Same |
| Product Code | IMI | IMI | The subject device and the predicate has the same classification of the ultrasound, but the predicate has mode functions. |
| Console/Generator Dimensions | Not available (for predicate) | 31 x 18 x 6 cm | Equivalent |
| Treatment Head Dimensions | Not available (for predicate) | 15 x 5 x 4 cm | Equivalent |
| Console/Generator Weight | Not available (for predicate) | 1.2 Kg | Equivalent |
| Treatment Head Weight | Not available (for predicate) | 252 Grams | Equivalent |
| Power Supply | (AC Line) 100-240V ~50/60Hz | 100 - 240V 50/60Hz | Same |
| Leakage Current | Not available (for predicate) | 49 μA (Normal), 86 µA (single fault) | Equivalent |
| Crystal Material | Not available (for predicate) | PZT | Equivalent |
| Technology of ultrasound generation | Piezoelectric | Piezoelectric | Same |
| Treatment Mode(s) | Pulsed, continuous | Pulsed, continuous | Same |
| Beam Type | Pulsed, continuous (Likely a typo, should be collimated or divergent for predicate judging by context) | Collimated | Same (Assuming predicate is also collimated) |
| Transducer Diameter | 7cm² = 2,98 cm | 5cm² = 2,52cm | Equivalent |
| Acoustic Working Frequency | 1MHZ± 5%, 3.3MHz± 5% | 1MHZ± 5%, 3.3MHz± 5% | Frequencies of the devices are similar within the error margin. All the frequencies are covered by the regulation number 890.5300. |
| Effective Radiating Area and Accuracy | Not available (for predicate) | 3,2 cm² ±10% | The effective area of all products are similar. |
| Beam Nonuniformity Ratio | Not available (for predicate) | 2.8:1 | Similar. |
| Output Mode | Continuous, Pulsed | Continuous, Pulsed | Same |
| Maximum Timer Setting | 30 minutes | 20 minutes | The subject device has a lower treatment time. |
| Beam Maximum Intensity | Not available (for predicate) | 0,1 to 2,0 W/cm² (continuous), 0,1 to 3,0 W/cm² (Pulsed) | Similar. |
| Maximum Value of the Output Power | Not available (for predicate) | 6,4W ± 20% | The maximum power of the predicate is higher but the Beam maximum intensity is the same 2.0w/cm² for the continuous mode. |
| Maximum Value of the Effective Intensity | Not available (for predicate) | 0,1 to 2,0 W/cm² (continuous), 0,1 to 3,0 W/cm² (Pulsed) | Similar. |
| Temperature Rise (Head in air) | Not available (for predicate) | 18-19 ºC for 20 min, 1/3.3 MHz, 6.4W | Not available for comparison |
| Max Patient Contact Surface Temp | Not available (for predicate) | 32 ºC (1MHz), 36 ºC (3.3MHz) | Not available for comparison |
| Penetration Depth | 1Mhz 5cm, 3.3MHz 2cm | 1Mhz 5cm, 3.3MHz 2cm | Same |
Indications for Use:
- 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
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the submission is for a physical medical device (ultrasound equipment), not an algorithm that processes data. The "test set" in this context refers to non-clinical performance data and adherence to international standards, not a dataset of patient cases.
3. 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)
This information is not applicable. Ground truth in the context of an AI/ML algorithm evaluation is not relevant for this type of device submission. The device's performance is established by meeting technical specifications and safety standards, as detailed in the non-clinical performance data section.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for consensus-based ground truth establishment, which is not part of this device's evaluation.
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
This information is not applicable. An MRMC study is used to evaluate the diagnostic performance of software, often AI, in conjunction with human interpretation. This device is an ultrasonic diathermy machine, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical therapeutic ultrasound machine, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" for this device's safety and effectiveness is its adherence to established technical specifications and international safety standards (e.g., IEC 60601 series, ISO 10993-1).
8. The sample size for the training set
This information is not applicable. There is no training set for this type of physical therapeutic device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this type of physical therapeutic device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):
The study described in this 510(k) summary is a non-clinical performance evaluation and comparison to a predicate device.
- Objective: To demonstrate that the Sonomed IV and Sonomed V devices are substantially equivalent to the legally marketed predicate device, Sonopulse (K130888), in terms of intended use, principles of operation, and output characteristics, and that they meet general safety and essential performance requirements.
- Methodology:
- Indications for Use Comparison: The indications for use of the subject devices were directly compared to those of the predicate device and found to be identical.
- Technological Characteristics Comparison (Table 5.2 SE comparison): Key technical specifications of the Sonomed IV/V (e.g., regulation number, product code, power supply, treatment modes, acoustic frequency, penetration depth, output power, etc.) were compared against the predicate device (where available). The discussion highlights similarities and minor differences, concluding they are equivalent or that differences do not raise new questions of safety or effectiveness.
- Non-Clinical Performance Data: The Sonomed devices were tested in accordance with several international standards to ensure basic safety and essential performance. These standards include:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic disturbances)
- IEC 60601-2-5 (Particular requirements for ultrasonic physiotherapy equipment)
- IEC 62304 (Medical device software – Software life cycle processes)
- ISO 10993-1 (Biological evaluation of medical devices)
- Clinical Data: No clinical data were included in this submission. The determination of substantial equivalence was based solely on non-clinical performance and technological comparison.
- Conclusion: The documentation submitted concluded that the subject devices have comparable features and performance and are therefore substantially equivalent to the identified predicate 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.