(244 days)
Therapeutic Ultrasound is indicated for:
• Pain Relief
• Reduction of muscle spasms
• Localized increase in blood flow
• Increase range of motion of contracted joints using heat and stretch techniques
This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water.
Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu.
This device is a prescription equipment. Use by any persons other than physicians is prohibited.
This document is a 510(k) Summary for the Sonopuls 190 medical device, which is an ultrasound therapy equipment. It aims to demonstrate substantial equivalence to a predicate device (Sonomed IV/V).
Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets acceptance criteria:
The context of the provided document is a 510(k) submission for a non-AI-powered therapeutic ultrasound device. Therefore, many of the requested elements specifically pertaining to AI/ML device performance and testing (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or explicitly mentioned in this type of submission. The "acceptance criteria" here primarily refer to meeting regulatory standards and demonstrating substantial equivalence to a predicate device, rather than a specific performance metric for a diagnostic AI model.
However, I will extract what is available and note where the information is not present due to the nature of the device and submission.
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific quantitative "acceptance criteria" for the device's therapeutic performance in a table format with corresponding "reported device performance" in the way one might expect for a diagnostic AI device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with various electrical safety, performance, biocompatibility, and software standards, and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.
The closest equivalent to "performance" for this type of device relates to its physical output parameters (e.g., intensity, frequency, temperature rise, penetration depth) and compliance with safety standards. The "acceptance criteria" are implied by adherence to the listed standards and the conclusion of substantial equivalence.
Here's a table based on the "7. Technological Characteristics" and "8. Discussion of Differences", which details the device's specifications and compares them to the predicate, and serves as an indirect form of "performance" demonstration in this context. The "acceptance criteria" are implied to be "comparable to or not raising new questions of safety/effectiveness compared to the predicate device, and compliant with relevant standards."
| Characteristic / Acceptance Metric | Subject Device Performance (Sonopuls 190) | Predicate Device (Sonomed IV/V) Performance | Discussion/Substantial Equivalence Commentary (Implicit "Acceptance") |
|---|---|---|---|
| Indications for Use | Pain Relief, Reduction of muscle spasms, Localized increase in blood flow, Increase range of motion of contracted joints using heat and stretch techniques | Same as Subject Device | Similar. Formally accepted for substantial equivalence. |
| Product Code & Regulation | IMI, 890.5300 | IMI, 890.5300 | Identical. Formally accepted for substantial equivalence. |
| Crystal Material | PZT-8 (lead zirconate titanate) piezoceramic material | PZT | Similar. Accepted. |
| Technology of ultrasound generation | piezoelectric | piezoelectric | Identical. Accepted. |
| Power source | 100 - 240 VAC +/- 10% | 100 - 240 VAC | Similar. Accepted. |
| Output Mode | Continuous, Pulsed | Continuous, Pulsed | Identical. Accepted. |
| Intensity | 0 - 3.0 W/cm² | 0.1 - 2.0 W/cm² (cont), 0.1 - 3.0 W/cm² (pulsed) | Similar. Accepted. |
| Frequency | 1 MHz, 3 MHz | 1 MHz +/-5%, 3 MHz +/-5% | Similar. Accepted. |
| Acoustic Working Frequency and Accuracy (MHz) | 5 cm², 0.8 cm² and 1 MHz: 0.98 MHz ± 5%; 3 MHz: 3.1 MHz ± 5% | 1 MHz ± 5%, 3.3 MHz ± 5% | Similar. Accepted. |
| Effective Radiating Area (ERA) and Accuracy | 5 cm² applicator: 5 cm² ± 20%; 0.8 cm² applicator: 0.8 cm² ± 20% | 3.2cm² +/- 10% | Different. The ERA for the subject device's 5cm² applicator is larger and less accurate than the predicate's. However, it's deemed acceptable because it's identical to a cleared reference device (Omniversa) which uses the same parameters, thus raising no new safety questions. |
| Beam Nonuniformity Ratio (BNR) and Accuracy | 6:1 maximum | 2.8:1 maximum | Different. Subject device has a higher BNR. Accepted because BNR values in other cleared devices range between 2 and 6:1, and reliance on the thermal tissue testing using the reference device. No new safety/performance questions. |
| Maximum Value of the Output Power (Rated Output Power) and Accuracy (W) | 5 cm² applicator: 10 W ± 20%; 0.8 cm² applicator: 2 W ± 20% | 6.4 W ± 20% | Different. Subject device has higher maximum output power. Accepted because the reference device (Omniversa) was used safely in thermal tissue testing to support the submission, implying safety at these power levels. |
| Peak Temperature Rise vs. Time and Tissue Depth | 1.0MHz, 2.0W: 4.8°C for 10 min, depth 2.5cm; 3.0MHz, 2.0W: 5.8°C for 3 min, depth 0.8cm | 1MHz, 6.4W: 18°C for 20 min, depth 3cm; 3.3MHz, 6.4W: 19°C for 20 min, depth 1cm | Different. Subject device has less temperature rise over shorter time/shallower depth. Accepted as lower/slower temperature rise is "safer for the patient." |
| Maximum Patient Contact Surface Temperature of Treatment Head | 5 cm² applicator: |
§ 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.