(118 days)
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffiess, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
- Pain Relief .
- Reduce Muscle Spasm .
- . Decrease Joint Stiffness
- . Contractures
- Increase Blood Flow
- Chronic Inflammatory Conditions .
- . Bursitis
- Tenosynovitis
- Synovitis .
- Chronic Inflammatory Pelvic Disease
The Intelect® SWD 100/ Senior Shortwave Diathermy devices consists of a power supply that provides power to a radio frequency oscillator. This radio frequency oscillator provides stable, drift-free oscillations at the required frequency. The power amplifier generates the power required to drive the different types of electrodes. The output resonant tank tunes in the patient as part of the circuit and allows maximum power to be transferred to the patient.
The output intensity controls the percentage of maximum power transferred to the patient circuit. The tuning control adjusts the output circuit for maximum energy transfer from the radio frequency oscillator. The power output meter monitors only the current that is drawn from the power supply and not the energy being delivered to the patient.
The power output produces sufficient energy to raise the tissue temperature into a therapeutic range. The specific absorption rate (SAR) represents the rate of energy absorbed per unit area of tissue mass.
Patient sensation provides the basis for recommendations of continuous shortwave diathermy dosage and thus varies considerably with different patients. The following are recommended dosage guidelines: Dose I (lowest): No sensation of heat
Dose II (low): Mild heating sensation
Dose III (medium): Moderate (pleasant) heating sensation
Dose IV (heavy): Vigorous heating that is tolerable below the pain threshold
Therapy may be delivered to the patient via either capacitance or induction techniques. The Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy devices use the following accessories:
- Capacitive Electrodes
- Pair of 80mm round
- Pair of 120mm round
- Pair of 165mm round
- 180mm x 120mm flexible rubber electrodes
- 250mm x 145mm flexible rubber electrodes
- Inductive Electrodes
- Monode 14cm
- Diplode 18cm x 39cm
Each of these techniques can affect different biological tissues, therefore selection of the appropriate electrodes is essential for effective treatment.
This 510(k) premarket notification for the Intelect® SWD 100/Senior Solutions® Shortwave Diathermy device does not contain the kind of study design and results that are typical for devices that rely on AI or complex algorithms requiring performance metrics like sensitivity, specificity, or AUC.
This submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through adherence to recognized consensus standards for safety and electrical compatibility, and by proving similar indications for use. It is a traditional medical device submission, not one for an AI/ML-driven diagnostic or therapeutic support system.
Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance with AI, etc.) are not applicable to this specific submission.
Here's a breakdown based on the provided text, indicating where information is present and where it is not:
Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for AI/ML)
The "acceptance criteria" for this type of device submission are generally met by demonstrating:
- Compliance with recognized safety and performance standards: The device fulfills the requirements of relevant IEC and UL standards.
- Substantial equivalence to predicate devices: The device operates with the same fundamental technology and has similar indications for use as previously cleared devices.
- Ability to produce therapeutic deep heat: Implied by the device description and its function as a shortwave diathermy unit.
Since this is a physical therapy device that generates heat, its "performance" is more related to its electrical output and energy transfer capabilities, rather than diagnostic accuracy metrics. The document describes how it works (radio frequency oscillator, power amplifier, output resonant tank, intensity controls, tuning control, power output meter) and mentions the specific absorption rate (SAR) as a measure of energy absorbed. Therapeutic dosage is described in terms of patient sensation (Dose I-IV).
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard (as implied by submission) | Reported Device Performance/Evidence from Study | Notes |
|---|---|---|---|
| Safety | UL 60601-1: 2003 (Safety, 1st Ed) | Declared Conformity | The device complies with this standard. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2001 (EMC, 2nd Ed) | Declared Conformity | The device complies with this standard. |
| Specific Safety/Therapy Equipment | IEC 60601-2-3: 1991 (Safety of Short-Wave Therapy Equipment); Amd 1 – 1998, 2nd Ed | Declared Conformity | The device complies with this standard, though the FDA notes it doesn't recognize this specific standard. This is likely due to the FDA having its own guidelines or recognizing superseded versions, but the manufacturer still adhered to it. |
| Programmable Medical Electrical Systems | IEC 60601-1-4: 2000 (Programmable Medical Electrical Systems); Amd 1 – 1999 | Declared Conformity | The device complies with this standard. |
| Intended Use Equivalence | Similar indications of use as legally marketed predicate devices | K042554, K030382, K022458, K973732 | The FDA's substantial equivalence determination implies these were met. The indications listed are identical to those of common shortwave diathermy. |
| Therapeutic Heat Generation | Ability to produce sufficient energy to raise tissue temperature into a therapeutic range | Described in device function | The device description states: "The power output produces sufficient energy to raise the tissue temperature into a therapeutic range." Dosages I-IV are based on patient sensation of heat. No specific numerical performance (e.g., target temperature achieved) is provided, as it's typically user-dependent and sensation-based for this type of device. |
| Operating Frequency | Electromagnetic energy in the radio frequency band of 27.12 megahertz | Device operates at 27.12 MHz | Stated in the "Intended Use" section. |
Study Details (Not Applicable for AI/ML performance studies)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This submission is for a physical therapy device based on established technology, not an AI/ML diagnostic or predictive device with a "test set" in the computational sense. The "study" here is primarily one of engineering design verification and validation against pre-defined standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth as understood in AI/ML performance evaluation (e.g., expert labels on images) is not relevant for this device. The "ground truth" here is the established scientific and engineering principles of shortwave diathermy and regulatory compliance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there is no "test set" requiring expert adjudication in this context.
-
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:
- N/A. This is a standalone therapy device, not an AI-assisted diagnostic or decision support tool. Therefore, MRMC studies comparing human readers with and without AI are not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. While the device operates standalone in the sense that it delivers therapy without continuous intervention from an algorithm, the concept of "standalone performance" in the AI context (e.g., sensitivity/specificity of an algorithm making a diagnosis) is not relevant here. Its performance is about safely generating radiofrequency energy and heat.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The "ground truth" for this device's acceptance is based on:
- Compliance with recognized industry standards (UL, IEC).
- Scientific principles of shortwave diathermy.
- Regulatory precedent established by substantially equivalent predicate devices.
- Engineering verification and validation to ensure the device performs as designed.
- N/A. The "ground truth" for this device's acceptance is based on:
-
The sample size for the training set:
- N/A. This device does not use a "training set" in the AI/ML sense. Its operational parameters are based on physics and engineering, not learned from data.
-
How the ground truth for the training set was established:
- N/A. Since there's no training set, this is not applicable.
§ 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.