(212 days)
The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain.
Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary).
An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: Temporary increases in local blood flow and circulation. Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles. Temporary relief (or relaxation) of muscle spasms. Temporary relief of minor pain and stiffness associated with arthritis
The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is a device that provides ultrasonic diathermy, interferential current therapy, and infrared lamp therapy. It can be used with one or two ultrasound applicators, and the ultrasound therapy can be applied in a scanned or hands-free manner. An optional infrared light probe is also available.
The provided 510(k) summary for the Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation (K072256) does not describe a study involving a test set, expert adjudication, MRMC comparative effectiveness, or stand-alone algorithm performance in the typical sense of a clinical trial or algorithm validation study for diagnostic devices.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K062256) by affirming compliance with mandatory and consensus standards, and by performing risk analysis for the expanded indication of "hands-free" operation for ultrasound. The "acceptance criteria" here refer to safety thresholds and compliance with established performance standards for similar medical devices.
Here's an breakdown based on the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety/Performance Standard) | Reported Device Performance (as demonstrated by study/analysis) |
|---|---|
| Temperatures in tissues above 45 °C | With an intensity of ≤ 10W, the temperature of Tissue or Bone would not rise above 45 °C when used as directed. (See Attachment C-1, not provided in this excerpt) |
| Temperature rise in bone | With an intensity of ≤ 10W, the temperature of Tissue or Bone would not rise above 45 °C when used as directed. (See Attachment C-1, not provided in this excerpt) |
| Presence of Standing Waves | The ultrasound output is pulsed and will not support standing waves. |
| Self-heating of the ultrasound applicator | Measurements during the original submission (K062256) demonstrated that the applicator surface temperature did not exceed 45 °C when stationary, over the whole treatment time. Measurements were made at equal distances across the surface of the treatment surface. |
| Compliance with 21 CFR 1050.10 (Therapeutic Ultrasound) | The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation complies with this mandatory standard. |
| Compliance with IEC 60601-1 +A1, +A2 (General Safety) | The device is designed to comply with this consensus standard. |
| Compliance with UL 60601-1 (General Safety) | The device is designed to comply with this consensus standard. |
| Compliance with IEC 60601-1-2 (EMC) | The device is designed to comply with this consensus standard. |
| Compliance with IEC 60601-2-5 (Safety of Ultrasonic Physiotherapy Equipment) | The device is designed to comply with this consensus standard. |
| Compliance with IEC 60601-2-10 (Safety of Nerve and Muscle Stimulators) | The device is designed to comply with this consensus standard. |
| Operator monitoring during hands-free use (patient falling asleep) | The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep. (This is a procedural control, not a device performance metric). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data or images. The "tests" mentioned are primarily engineering and electrical safety measurements (e.g., thermal measurements, pulsed output analysis) for the device itself.
- Sample Size: Not applicable in the context of a clinical test set. The measurements were likely performed on a single or a small number of device units.
- Data Provenance: The measurements related to thermal output and standing waves were conducted internally by Hill Laboratories, likely in a laboratory setting. This is a technical validation, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not described as part of this submission. The "ground truth" for the engineering performance aspects would be the physical laws and measurement standards.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This submission is for an expanded indication for a physical therapy device, focusing on safety and technical equivalence rather than a diagnostic or screening efficacy study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical therapy equipment, not an AI algorithm for diagnosis or image analysis. Its operation inherently involves a human operator (therapist). The "hands-free" aspect refers to the applicator staying stationary on the patient, but the therapist still monitors the patient.
7. The Type of Ground Truth Used
The "ground truth" here is based on:
- Engineering and physical measurements: For thermal output, acoustic properties (standing waves), and electrical safety.
- Compliance with established standards: Mandatory (21 CFR 1050.10) and consensus standards (IEC 60601 series, UL 60601-1).
- Risk analysis: Identifying potential hazards and mitigation strategies (e.g., operator manual instructions).
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of machine learning or AI algorithms described in this submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there's no ground truth established for one.
§ 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.