(427 days)
MUSCLE STIMULATOR
INDICATIONS FOR USE:
- Relaxation of muscle spasms
- 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
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
ULTRASOUND
INDICATIONS FOR USE:
Application of deep heat for:
- Temporary relief of minor pain
- Muscle spasm relief
- Joint contracture relief
Not for treatment of malignancies. Not for use on the face.
The Futura Pro (US Specification) is a 10 channel Electronic Muscle Stimulator system with a diathermic ultrasound attachment.
The main muscle stimulation part consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions. These pulses for muscle stimulation are applied via self adhesive electrodes applied on the skin.
The ultrasound attachment is also powered by the main control unit. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit.
Set programs, with predetermined parameters, are selectable by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LEDs identifying each output as the electrodes are positioned and the intensity adjusted.
The system is powered either internally from a 12V rechargeable sealed battery within the main control unit or via an external12VDC power supply.
Not part of this submission: Electrodes and Conductive gel. Dr. Wenker shall purchase and distribute the FDA-cleared electrodes and coupling gel, which have been specified by Ultratone Scientific Instruments to ensure proper operation of their equipment. Initially, Ultratone Scientific Instruments has specified electrodes and coupling gel from the respective manufacturers, Axelgaard and Parker. Dr. Wenker shall be purchasing and distributing these two items separately.
The stimulator contains safe-start electronic output interlock circuits to ensure stimulation is not suddenly applied to the patient at turn on. The stimulation outputs can subsequently be adjusted by a master output control.
The provided 510(k) summary for the Futura Pro (US Specification) does not contain specific acceptance criteria with corresponding performance metrics from a dedicated study. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and performance standards.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not present a formal table of acceptance criteria with measured device performance. Instead, it relies on a comparison with predicate devices and compliance with international standards. The "performance" is implicitly demonstrated by the device's technical specifications falling within acceptable ranges or being comparable to the predicates, as well as by meeting safety standards.
The document highlights some differences where the Futura Pro (US Specification) exceeds the predicate in certain aspects (e.g., current density, which is still "well within accepted levels," and power density), and improvements in user interface and control. These are presented as benefits rather than failures to meet specific quantified criteria.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) related to clinical efficacy is mentioned. The submission states, "No clinical tests were performed." Non-clinical tests were for compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical tests were performed, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study was done. The submission explicitly states, "No clinical tests were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Futura Pro is a physical medical device (muscle stimulator and ultrasound), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in this context. The operational performance of the device itself (e.g., electrical outputs, ultrasound parameters) was likely assessed during non-clinical testing to ensure it met design specifications and safety standards.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was compliance with established national and international safety and performance standards (e.g., BS EN 60601 series, BS EN 55022, BS EN 61000 series). The device's technical specifications and outputs were measured against the requirements of these standards.
8. The Sample Size for the Training Set
Not applicable, as this device does not involve an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets "acceptance criteria" (understood here as regulatory requirements for substantial equivalence and safety) is primarily a non-clinical testing and comparison study.
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Non-Clinical Tests:
- Purpose: To demonstrate that the Futura Pro (US Specification) performs as intended and conforms to the specified safety and performance standards.
- Methods: Comparison of outputs (electrical stimulation and ultrasound parameters) with predicate devices and independent testing against a comprehensive list of European (BS EN) and international standards for medical electrical equipment, including general safety, particular requirements for stimulators and ultrasonic physiotherapy equipment, and electromagnetic compatibility (EMC).
- Key Findings (as reported): "Comparisons of the outputs for the Futura Pro (US Specification) and the predicates show similar results that are suitable for transcutaneous electrical muscle stimulation and the application of deep heat using ultrasound." The device also successfully passed all listed BS EN standards.
- Data Provenance: Testing carried out by the manufacturer (Ultratone Scientific Instruments) and independent laboratories (implicitly, for certification to BS EN standards). Location of these labs is not specified.
- Design: This was a series of engineering and performance verification tests rather than a clinical study.
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Substantial Equivalence Argument:
- The submission argues that the Futura Pro is substantially equivalent to legally marketed predicate devices (Ultratone 20, K926410, and Ultrasonic Therapy Appliance, K050410).
- This is supported by detailed technological comparisons in tables for both the muscle stimulator and ultrasound parts, highlighting similarities in intended use, power source (with minor variations), number of output modes/channels, channel isolation, software control, design, frequency, mode, waveform type, applicator size, effective radiating area, temporal max power, temporal max effective intensity, and beam nonconformity ratio.
- Differences are acknowledged and explained as not raising new safety or effectiveness issues, often being presented as benefits (e.g., illuminated connectors, self-adhesive electrodes that result in higher but acceptable current density, graphical display, sophisticated control circuitry, integrated power for ultrasound).
In essence, the "study" for this device was a combination of engineering design validation, verification testing against recognized standards, and a comprehensive comparison of technical characteristics to already cleared predicate devices, all performed in a non-clinical setting. No human subjects were involved.
§ 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.