(439 days)
Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
- Pain.
- Pain relief, muscle spasms, and joint contractures.
- Relief of pain, muscle spasms, and joint contractures that may be associated with:
- Adhesive capsulitis,
- Bursitis with slight calcification,
- Myositis,
- Soft tissue injuries, and
- Shortened tendons due to past injuries and scar tissues.
- Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and
- Capsular scarring.
- Localized increase in blood flow.
- Increased range of motion of contracted joint using heat and stretch techniques.
As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures.
It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound.
The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.
This looks like a fascinating case study. Based on the provided FDA 510(k) clearance letter and summary, here's an analysis of the acceptance criteria and the study that proves the device meets them.
It's important to note that this document is for an Ultrasound Stimulator (Ultrasonic Diathermy), which delivers therapeutic ultrasound, not an AI/Software as a Medical Device (SaMD) that typically involves image analysis or diagnostic support. Therefore, many of the typical acceptance criteria and study designs related to diagnostic accuracy, MRMC studies, and nuanced ground truth establishment for AI models (as implied by the original request's detailed points) are not applicable to this type of physical therapy device.
The "acceptance criteria" here are primarily based on demonstrating substantial equivalence to predicate devices through engineering specifications, performance testing, and safety profiles, rather than clinical efficacy studies in the way an AI diagnostic tool would require.
Acceptance Criteria and Study Proving Device Meets Criteria
Given that the device is an Ultrasound Stimulator aiming for 510(k) clearance based on substantial equivalence, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) but rather in terms of demonstrating that its technical characteristics, performance, and safety are equivalent to legally marketed predicate devices. The "study" proving it meets these criteria is a comprehensive set of non-clinical, bench performance tests and comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
For an Ultrasound Stimulator, the "acceptance criteria" are primarily a demonstration of equivalence to the predicate devices across various technical and functional parameters, and compliance with relevant safety standards. The "reported device performance" are the results of the non-clinical tests and direct comparisons to the predicate devices.
| Parameter/Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Identical or substantially equivalent indications to predicate device. | Apply stationary/continuous ultrasound for deep heat, pain relief, muscle spasms, joint contractures, increased circulation, range of motion (identical to primary predicate, similar to other predicate). |
| Product Code | Identical to predicate device. | IMI, PFW (Identical to predicate ManaSport+, and PFW to sam 2.0) |
| Prescription Status | Identical (Prescription Use). | Prescription Use (Identical). |
| Power Source | Similar, safe power delivery. | 100~240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery (Identical to primary predicate, similar to other predicate). |
| Number of Outputs | 1 or 2 outputs. | 1 or 2 (Identical to sam 2.0, similar to ManaSport+ which is 1). |
| Software/Microprocessor Control | Presence and safe operation. | Yes (Identical). |
| Safety Features | Automatic No-Load Trip, Automatic Shut Off, User Override Control, Indicator Display (On/Off, Low Battery). | All 'Yes' for these features (Identical where predicate information available). |
| Timer Range | Functionally acceptable and safe timer range. | 30 minutes (per cycle), max 4 cycles (Longer than primary predicate (20min), shorter than predicate (240min), deemed safe by temperature control). |
| Compliance with Voluntary Standards | Compliance with relevant IEC/ISO electrical safety, EM compatibility, and biocompatibility standards. | Yes (Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-5, ISO 10993-5, ISO 10993-10, IEC 60601-1-6, IEC 60601-1-11). |
| Biocompatibility | Non-toxic, non-irritating materials. | Yes (Identical). |
| Sterility | Non-sterile device. | Non-Sterile (Identical). |
| Housing Construction Material | Compatible material. | ABS (Identical). |
| Physical Dimensions/Weight | Similar physical characteristics not affecting safety/effectiveness. | Console/Generator: 138×62×22 mm, 0.18 kg (Similar to predicates). Treatment Head: 61 x 45 x 12 mm, 0.047 kg (Similar to predicates). |
| Functions and Design | Ultrasound generation. | Ultrasound (Identical). |
| Frequency | 1.5 MHz or similar. | 1.5 MHz ± 10% (Identical to primary predicate, similar to other predicate's 3MHz). |
| Leakage Current | Below maximum limit. |
§ 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.