(123 days)
The indications for use of the proposed device are the same as those for the predicate devices.
Ultrasound therapy:
- Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
- Relief of pain, muscle spasms and joint contractures resulting from:
- Capsular tightness
- Capsular scarring
Electrotherapy:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Symptomatic relief or management of chronic, intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.
The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).
The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.
At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:
Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated
The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.
The provided document is a 510(k) Summary for the Zimmer MedizinSysteme Soleoline device family. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through entirely novel clinical studies. Therefore, the information provided focuses on comparisons to existing devices and compliance with standards, rather than new studies with acceptance criteria and detailed performance metrics as one might find for a novel AI device.
Based on the provided text, here is an attempt to address the points, acknowledging the nature of a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in the typical sense of a novel device study (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing that the new device (Soleoline) has the same intended use and similar technological characteristics as the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially a comparison of technical specifications against the predicate devices.
Here's a table summarizing key comparisons from the document, which implicitly serve as demonstration of equivalent performance to the established predicate devices:
| Feature/Parameter | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Zimmer Soleoline) |
|---|---|---|
| General | ||
| Intended Use | Same as Predicate Devices (Ultrasonic diathermy, Powered muscle stimulator, etc.) | Same as Predicate Devices (Ultrasonic diathermy, Powered muscle stimulator, Ultrasound and muscle stimulator) |
| Indications (Electrotherapy) | Matched to Predicate Devices (Relaxation of muscle spasm, pain relief, etc.) | Matched to Predicate Devices (Relaxation of muscle spasm, pain relief, etc.) |
| Indications (Ultrasound) | Matched to Predicate Devices (Pain relief, muscle spasms, joint contractures, etc.) | Matched to Predicate Devices (Pain relief, muscle spasms, joint contractures, etc.) |
| Prescriptive Use | Yes | Yes |
| Maximum adjustable therapy time | 60 min (for electrotherapy), 30 min (for ultrasound) | 60 min (electrotherapy, general), 30 min (ultrasound) |
| Patient Leakage Current (Normal) |
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator 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. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator 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 applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles 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 ultrasound and muscle stimulator 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 ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.