(139 days)
The Regenesis Model 42 is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
The Regenesis Model 42 device is a pulsed short-wave diathermy device. The device has a solid state design that is very simple. It has no microprocessor and therefore no software.
The Regenesis Model 42 unit consists of a main control console connected by cable to a treatment pad. The pad and cable are a single unit which is connected or disconnected easily from the console. The pad surface is water proof, bacterial resistant and designed to be placed directly on the patient or on top of any standard dressings used over the area to be treated.
The provided text describes a 510(k) premarket notification for the Regenesis Model 42, a pulsed short-wave diathermy device. This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria and performance data for clinical outcomes.
Here's a breakdown based on your request, highlighting what information is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance (Pain & Edema Reduction) | Not specified. Substantial equivalence is based on the predicate device's established use. | No specific clinical performance metrics (e.g., pain score reduction, edema volume decrease) are reported in this document. The device is intended for "adjunctive use in the palliative treatment of postoperative pain and edema," implying it supports other treatments rather than being a primary standalone treatment for definitive cure or complete resolution. |
| Electrical Safety | Not explicitly stated, but implied adherence to relevant safety standards. | "Amethyst Technologies carried out testing on the Regenesis Model 42 to address...electrical safety." "The results of all these tests support the substantial equivalence of the device." |
| Electromagnetic Compatibility (EMC) | Not explicitly stated, but implied adherence to relevant EMC standards. | "Amethyst Technologies carried out testing on the Regenesis Model 42 to address...electromagnetic compatibility." "The results of all these tests support the substantial equivalence of the device." |
| Stray Radiation | Not explicitly stated, but implied adherence to relevant radiation safety limits. | "Amethyst Technologies carried out testing on the Regenesis Model 42 to address...stray radiation." "The results of all these tests support the substantial equivalence of the device." |
| Applicator Field Patterns | Not explicitly stated, but implied similarity to the predicate device for effective energy delivery. | "Amethyst Technologies carried out testing on the Regenesis Model 42 to address...applicator field patterns." "The results of all these tests support the substantial equivalence of the device." |
| Technological Characteristics | "The new device has the same indications statement as the predicate device and it has the same technological characteristics." | The Regenesis Model 42 is a pulsed short-wave diathermy device with a solid-state design, no microprocessor or software, and a main control console connected to a treatment pad. This is presented as being the same as the predicate device. |
Study Details:
The provided information focuses on a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove clinical efficacy through a new study with explicit acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a clinical test set from this document. The "tests" mentioned (electrical safety, EMC, stray radiation, applicator field patterns) were engineering/technical tests performed on the device itself, not clinical trials with human subjects.
- Data Provenance: The technical testing was performed by "Amethyst Technologies." The document does not specify the country of origin for this testing or whether it was retrospective or prospective. It was likely prospective testing of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The described testing involves engineering and technical evaluations of device performance (electrical, electromagnetic, radiation, field patterns), not clinical diagnoses or assessments requiring expert consensus on ground truth. The "ground truth" for these tests would be the established engineering standards and specifications.
4. Adjudication Method for the Test Set:
- Not applicable. As described, the testing involves objective measurement against pre-defined technical standards, not subjective assessments requiring adjudication among multiple experts.
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:
- Not applicable. This device is a physical therapy device (nonthermal shortwave therapy), not an imaging or diagnostic AI device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Partially applicable, but in a different context. The "tests" (electrical safety, EMC, etc.) were standalone performance evaluations of the device's technical characteristics without human intervention influencing the device's basic operation. However, there's no "algorithm" in the sense of AI or image processing being evaluated. The device itself is a standalone medical device.
7. The Type of Ground Truth Used:
- For the technical tests (electrical safety, EMC, etc.), the ground truth would be established engineering and safety standards (e.g., IEC standards, FCC regulations) and the expected physical properties/behavior of such a device. This is implied by the testing performed.
- For the clinical indications, the "ground truth" is that the predicate device (MRT® SofPulse™) was legally marketed for the palliative treatment of postoperative pain and edema. The Regenesis Model 42 is demonstrating substantial equivalence to this already cleared device.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established in this manner.
Summary of the K972093 Submission:
The Regenesis Model 42 aims to demonstrate substantial equivalence to the MRT® sofPulse™ shortwave diathermy device (K903675). This means it asserts that it has the same indications for use (palliative treatment of postoperative pain and edema in superficial soft tissue) and same technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The "testing" mentioned in the document (electrical safety, electromagnetic compatibility, stray radiation, and applicator field patterns) was conducted by Amethyst Technologies. The purpose was to show that the engineering and physical performance of the Regenesis Model 42 is comparable to that expected of a device for which substantial equivalence is claimed, and to ensure it meets basic safety and performance requirements for such devices. The document explicitly states: "The results of all these tests support the substantial equivalence of the device."
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz 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)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.