(210 days)
The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
The PainShield MD PLUS is an electrically powered ultrasonic diathermy device intended to relieve pain, muscle spasms, and joint contractures. It is used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a bandage-like patch that adheres to the skin.
The PainShield MD PLUS is used to generate continuous wave (CW) ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicators allow treatment of less accessible body parts such as, for example, the heel, the Achilles tendon and the wrist. The device includes the above-mentioned transducers with a cable which connects to a small, rechargeable, battery-powered driver unit and self-adhering patch to apply the transducer on to the skin. The unit is also supplied with a charger used for recharging the battery. Ultrasonic gel is typically not required to be used with the PainShield MD PLUS device. However, for treatment over hairy sites where there might not be adequate sonic coupling between the applicator and the skin, users are instructed to apply standard, FDA-cleared ultrasound gel to the site to improve coupling.
The provided text describes the PainShield MD PLUS device and its substantial equivalence to a predicate device, PainShield MD, but it does not contain information about studies proving the device meets acceptance criteria related to clinical performance or effectiveness.
The document focuses on regulatory compliance through non-clinical testing (electrical safety, EMC, biocompatibility, and software validation) and a comparison of technological characteristics with its predicate device. This type of information is typical for a 510(k) submission where the goal is to demonstrate substantial equivalence, rather than provide new clinical effectiveness data.
Therefore, many of the requested details about acceptance criteria for clinical performance, sample size, ground truth, expert qualifications, and MRMC studies are not available in the provided text.
Here's a breakdown of the information that is available:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Category) | Reported Device Performance |
|---|---|
| Electrical Safety (compliance with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + A1:2012 (3rd Edition) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) | All applicable tests passed. |
| Electromagnetic Compatibility (EMC) (compliance with IEC 60601-1-2: 2014 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard, Electromagnetic Compatibility) | All applicable tests passed. |
| Home Healthcare Environment Safety (compliance with IEC 60601-1-11: 2015 (2nd Edition) - General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | All applicable tests passed. |
| Biocompatibility (compliance with ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | All applicable tests passed. |
| Software Verification and Validation (ensuring software functions as intended and meets design specifications) | All applicable tests passed. |
| Substantial Equivalence (technological characteristics, features, specifications, materials, mode of operation, and intended use are equivalent to the predicate device, and differences do not raise new issues of safety or effectiveness) | Concluded to be substantially equivalent to the predicate device, PainShield MD (K081075). Differences (two actuators, separate actuator/patch) do not raise new safety or effectiveness concerns. |
Missing Information (Not found in the provided text)
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth data is provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set data is provided.
- 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 device is an ultrasonic diathermy device, not an AI-powered diagnostic tool. No human-in-the-loop performance or AI assistance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, but a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical effectiveness, as no such studies are described. For the non-clinical tests (electrical safety, EMC, etc.), the "ground truth" is adherence to the specified international standards.
- The sample size for the training set: Not applicable as no machine learning/AI model training is described.
- How the ground truth for the training set was established: Not applicable as no machine learning/AI model training is described.
§ 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.