(696 days)
The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
The Biofusionary Bebe is used for diathermic heating of tissue. The Biofusionary Bebe hand piece tip is comprised of a coil shaped antenna which directs the flow of current parallel to the tissue surface, without contacting the tissue surface, thereby directing the magnetic component of the electromagnetic energy into tissue to result in the formation of eddy currents in tissue. These eddy currents encounter resistance, leading to localized heating.
This 510(k) premarket notification describes the Biofusionary Bebe System, a shortwave diathermy device intended for generating deep heat within body tissues to treat conditions like pain, muscle spasms, and joint contractures. The submission primarily focuses on establishing substantial equivalence to a predicate device (Chattanooga Group-Intelect SWD 100, K083433) rather than a standalone clinical study for therapeutic effectiveness.
Here's an analysis of the acceptance criteria and supporting studies, to the extent provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't present a formalized table of acceptance criteria with specific quantitative targets for clinical outcomes. Instead, it relies on demonstrating that the device meets product specifications and performs comparably to the predicate device in terms of heating capabilities and safety.
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Conformance to product specifications | "The results showed the system met specification." |
| Heating capabilities: Therapeutic temperature (40 °C) achievement | Achieved 40 °C at surface in approx. 5 min. |
| Achieved 40 °C at 1cm in 5-10 min. | |
| Achieved 40 °C at 2cm in 8-13 min. | |
| Heating capabilities: Surface temperature not exceeding 45 °C | Surface of phantom did not exceed 45 °C for the duration of the study. |
| Usability: Adequacy of User Manual and protocols | Instructions were adequate; users understood and could apply the device. |
| Safety: Safe levels of exposure to electromagnetic energy (IEEE 95.1-2005) | Passed occupational testing in accordance with IEEE 95.1-2005. |
| Similarity to predicate device in heating capabilities and safety precautions | "The results of heating studies also support the substantial equivalence of the Biofusionary Bebe with the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Heating Characterization Studies (Benchtop): Phantoms and ex vivo porcine skin tissue were used. No specific sample sizes for these tests are provided.
- In Vivo Studies: "in vivo studies on rats" were conducted. No specific sample size is provided.
- Clinical Studies: "two clinical studies completed to further determine feasibility and safety and effectiveness." No specific sample size is provided for these. The document states they were "feasibility and safety and effectiveness" studies, implying they might not be large-scale effectiveness trials.
- Usability Study: "naive users were first instructed to review the User Manual and protocols for use of the device, followed by actual use of the device in a mock setting." No specific sample size for users is provided.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the description of "clinical studies," they were likely prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and submission. The "ground truth" for heating capabilities was derived from instrument measurements (temperature probes in phantoms/tissue). For usability, direct observation and questioning of users served as the assessment method. For safety, compliance with engineering standards (IEEE 95.1-2005) was the basis.
4. Adjudication Method for the Test Set
Not applicable. The testing described involves objective measurements (temperature, electromagnetic field levels) or direct observation/feedback in the usability study, rather than expert adjudication of interpretations.
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 shortwave diathermy system, a therapeutic medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an AI algorithm. It's a hardware-based therapeutic device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Heating Capabilities: Measured temperature readings within phantoms and ex vivo porcine tissue. This is an objective, instrument-based "ground truth."
- Usability: User feedback and direct observation of user interaction with the device and manual.
- Safety: Compliance with established engineering and safety standards (e.g., IEEE 95.1-2005).
- Clinical Studies (Feasibility, Safety, Effectiveness): The document does not explicitly detail the ground truth or endpoints for the "two clinical studies." However, for diathermy devices, effectiveness would typically be gauged by physiological measurements (e.g., actual tissue temperature increases in vivo) and potentially patient-reported outcomes for pain relief or improved function, monitored for safety endpoints like adverse events. The document only states they were "to further determine feasibility and safety and effectiveness."
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
§ 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.