(150 days)
Application of therapeutic ultrasound for:
· Pain.
- · Pain relief, muscle spasms, and joint contractures.
- · Relief of pain, muscle spasms, and joint contractures that may be associated with:
- o Adhesive capsulitis.
- o Bursitis with slight calcification,
- o Myositis,
- o Soft tissue injuries, and
- o Shortened tendons due to past injuries and scar tissues.
- · Relief of pain, muscle spasms, and joint contractures resulting from:
- o Capsular tightness, and
- o Capsular scarring.
- · Localized increase in blood flow.
- · Increased range of motion of contracted joints using heat and stretch techniques.
The JAS Pulse is a physical medicine ultrasonic diathermy device. The JAS Pulse device consists of a handheld transducer that generates high frequency sound waves. These sound waves penetrate tissue and are used to treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow. The handheld device is intended to be single patient use and is used with ultrasonic gels to facilitate coupling to the patient's skin surface and to enhance ultrasonic penetration.
Components of the JAS Pulse device include the handheld electrical control unit with user interface to select treatment power levels and time intervals. The controller drives the handheld treatment applicator to provide continuous and pulsed 1MHz therapeutic ultrasound. Ultrasonic gels applied to the user's area of pain facilitate ultrasonic coupling and penetration to facilitate the therapeutic ultrasound.
This document is a 510(k) premarket notification for the "JAS Pulse™ Ultrasonic Therapy" device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this type of regulatory submission.
However, based on the provided text, we can extract the acceptance criteria in terms of technical performance and safety standards, and confirm that the device meets these criteria through various non-clinical performance data.
Here's a breakdown of the information that can be extracted, and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are defined by the technical specifications of the predicate devices and compliance with recognized standards. The "Comparison to Predicates" column effectively serves as the reported device performance relative to these criteria.
| Device Feature/Criterion | Acceptance Criteria (from Predicates / Standards) | Reported Device Performance (JAS Pulse) | Conclusion |
|---|---|---|---|
| Indications for Use | Consistent with predicate devices for therapeutic ultrasound applications (e.g., pain relief, muscle spasms, joint contractures, localized increase in blood flow, increased ROM). | Identical to various aspects of predicate devices. | Equivalent |
| System Components | Plastic enclosure, handheld transducer applicator. | ABS plastic with screw assembly, Ultem plastic transducer with molded silicone grip. | Identical in plastic construction to each predicate. |
| Power Source | AC Line 100-240V, 50/60 Hz. | AC Line 100-240V, 50/60 Hz. | Identical. |
| Crystal Material | PZT (Piezoelectric ceramic). | PZT. | Identical. |
| Technology of Ultrasound Generation | Piezoelectric. | Piezoelectric. | Identical (industry standard). |
| Acoustic Working Frequency | Within range of 1.0 MHz ± 10% (some predicates list 0.8 MHz to 2.4 MHz). | 1.0 MHz ± 10%. | Within range of ultrasound diathermy devices per CFR 890.5300 (a). |
| Treatment Waveform Modes | Pulsed & Continuous. | Pulsed & Continuous. | Identical. |
| Timer Settings & Accuracy | 0-30 minutes, with varying accuracies listed for predicates. | 0 - 15 minutes ± 0.2 minutes. | Equivalent (treatment time dependent on area, multiple sessions allowed for larger areas). |
| Beam Type | Collimated. | Collimated. | Identical. |
| Maximum Effective Intensity | Not to exceed 3 W/cm² (with ±20% accuracy specified for predicates). | Continuous (High): 1.4 W/cm² ± 20%; Pulsed (Low): 0.7 W/cm² ± 20%. | Different from some predicates but within standard and complies with IEC60601-2-5. |
| Maximum Output Power | Various values (e.g., 0-21W for predicates, with ±20% accuracy). | Continuous (High): 1.59W ± 20%; Pulsed (Low): 0.79W ± 20%. | Similar to Soleo Sono; different from others but complies with IEC60601-2-5. |
| Maximum Temporal-Maximum Output Power | Various values (e.g., 1-21W for predicates, with ±20% accuracy). | Continuous (High): 1.59W ± 20%; Pulsed (Low): 0.79W ± 20%. | Different from some predicates but complies with IEC60601-2-5. |
| Maximum Temporal-Maximum Intensity | Various values (e.g., 1-3 W/cm² for predicates, with ±20% accuracy). | Continuous (High): 1.4 W/cm² ± 20%; Pulsed (Low): 0.7 W/cm² ± 20%. | Different from some predicates but complies with IEC60601-2-5. |
| Pulse Duration | Various settings for continuous and pulsed modes across predicates. | Continuous (High): 10ms; Pulsed (Low): 5ms. | Identical to settings of 100Hz at 50% duty cycle, and 100%. |
| Pulse Repetition | Various settings for continuous and pulsed modes across predicates. | Continuous (High): 10ms (100Hz); Pulsed (Low): 10ms (100Hz). | No direct comparison provided in table for this specific parameter, but implied by duty cycle match. |
| Duty Factor | Continuous: 100%; Pulsed: various (e.g., 5-50%). | Continuous (High): 100%; Pulsed (Low): 50%. | Identical to SoleoSono, Sonopulse, US-101L 100% and 50% duty cycle settings. |
| Ratio of Temporal Maximum Output Power to Output Power | Continuous: 1:1; Pulsed: various (e.g., 2:1 to 20:1). | Continuous (High): 1:1; Pulsed (Low): 2:1. | Equivalent to predicate at equivalent settings. |
| Maximum Patient Contact Surface Temperature | Meets IEC 60601-2-5, section 201.11 protection against excessive temperature. | Transducer surface does not exceed 43 ℃ when measured under test conditions 201.11.1.3.101.1 as stated in IEC 60601-2-5. | Same. |
| Beam Nonuniformity Ratio (BNR) | Various values (e.g., 3.5 ± 30% to 4.3:1 or less for predicates). | 2.5 ± 30%. | Different from some predicates but complies with IEC60601-2-5. |
| Effective Radiating Area (ERA) | Various values (e.g., 1 cm² to 7 cm² with ±20% accuracy for predicates). | 1.133 cm² ± 20%. | Similar to Soleo Sono 1cm² treatment applicator; different from others but complies with IEC60601-2-5. |
| Electrical Safety Standards Compliance | IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2. | IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2. | Identical. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Edition 3: 2007-03. | JAS Pulse demonstrated compliance. | Met. |
| Electrical Safety (Specific Standards) | AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012. | JAS Pulse demonstrated compliance. | Met. |
| Usability (Specific Standards) | IEC 60601-1-6 Edition 3.0: 2010-01, AAMI 62366. | JAS Pulse demonstrated compliance. | Met. |
| Specific Ultrasonic Safety (Specific Standards) | IEC 60601-2-5: Edition 3.0 2009-07. | JAS Pulse demonstrated compliance. | Met. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable. This submission relies on performance testing against standards and comparison to predicate device specifications, not a clinical test set of patients.
- Data Provenance: Not applicable for clinical data. The performance data is based on laboratory testing of the device against recognized standards and technical comparisons to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth from experts (e.g., radiologists) is typically for diagnostic imaging devices, not therapeutic devices like this one that are evaluated based on physical performance and safety metrics.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable.
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:
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human interpretation of medical images is involved, often in the context of AI assistance. This device is a therapeutic ultrasound device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not directly applicable in the terms usually associated with AI/diagnostic algorithms. The "standalone" performance for this device refers to its physical output characteristics (acoustic intensity, power, frequency, temperature, etc.) when operated according to its design. This performance was evaluated through laboratory testing against the relevant IEC standards (e.g., IEC 60601-2-5 for ultrasonic physiotherapy equipment).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this device, in a regulatory context focused on substantial equivalence, is defined by the established safety and performance requirements set by international standards (e.g., IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2) and the known technical specifications of legally marketed predicate devices. Laboratory measurements demonstrating compliance with these standards and equivalence to predicate specifications serve as the evidence.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This device is not an AI/machine learning product that requires training data in the traditional sense.
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable.
§ 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.