(889 days)
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Not Found
No
The device description details a simple electromechanical device with a fixed vibration cycle and manual intensity control. There is no mention of adaptive behavior, learning, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes.
The device's stated purpose is to "improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counter-stimulation," and clinical trials were conducted to assess its safety and effectiveness in treating patients with RLS.
No
The device's description and intended use clearly state its purpose is to improve sleep quality in RLS patients through vibratory counter-stimulation, not to diagnose RLS or any other condition.
No
The device description clearly outlines physical components including a cloth-covered foam pad, embedded electric motors, eccentric weights, and an electronic controller with a knob for intensity control. This indicates a hardware-based device, not software-only.
Based on the provided information, the Symphony Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Symphony Device Function: The Symphony Device is a physical device that applies vibratory counter-stimulation to the legs. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to improve sleep quality in patients with RLS through physical stimulation, not through the analysis of biological specimens.
Therefore, the Symphony Device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The purpose of the Symphony Device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counter-stimulation.
Product codes
OVP
Device Description
The Symphony Device is a non-sterile, reusable, cloth-covered foam pad that contains six embedded electric motors that swing eccentric weights to produce vibration throughout the pad. The device is designed to be placed under the user's legs while sleeping. When the device is activated, an electronic controller runs a 35 minute preset vibration cycle. The controller allows the patient to control the intensity level of the vibration for the first 30 minutes of the cycle. In the last five minutes, the controller slowly ramps down the vibration intensity of the device and then automatically shuts the device off at the end of the timed cycle. One repeat cycle can be initiated by the patient. The controller contains the on/off function and has variable mechanical counter-stimulation intensity settings (1 to 9). The motor amplitude and frequency (vibration) can be set to different levels of intensity by means of a knob. The polyurethane foam pad is covered by an inner lycra cover and an outer cover. The outer cover on the Symphony™ Device is made of cotton. The device will be offered in three sizes: Small, Medium, and Large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Two clinical trials were conducted to assess the safety and effectiveness of counter-stimulation with the Symphony Device in the treatment of patients with primary RLS. The primary difference between the two studies was the design of the sham device. The first study (SMI-001) used a sound-emitting (auditory) sham in the control group, while the second study (SMI-002) used a light-emitting sham control. Both studies had the same primary and secondary endpoints.
1. SMI-001
Design: This was a prospective, 1:1 randomized, multicenter (5 sites) trial which assessed the safety and effectiveness of the Symphony Device in the reduction of symptoms associated with RLS by comparison to an auditory sham control device. Subjects were adults with moderate to severe primary RLS involving only the legs, with a minimum baseline score of 15 points on the International Restless Legs Scale (IRLS) scale and symptoms occurring at least 15 nights per month. Patients with secondary RLS, other sleep disorders, disorders involving the legs (e.g., cellulitis, deep vein thrombosis) or taking unapproved medications to treat their RLS were excluded. If subjects were on an approved RLS medication, they were required to be on stable doses during the trial. Patients used the device for at least one 35 minute cycle each night. The primary endpoint was the mean change from baseline in the IRLS total score to week 1, 2, 3 and 4. The safety endpoint was a descriptive analysis of adverse events from both groups. Secondary endpoints included the mean change from baseline to 4 weeks in the Medical Outcomes Study (MOS) Sleep Scale scores and the Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire (RLSQOL). The MOS inventory is a patient-reported questionnaire that evaluates sleep disturbance. The MOS sleep problem index I (MOS-I) contains 6 of the 12 inventory questions, while the MOS sleep problem index II (MOS-II) contains an additional 3 questions (9 of the 12). The scale measures sleep difficulty based on recall about sleep quality during the four weeks prior to taking the test.
Results: A total of 77 subjects were enrolled in the study at a 1:1 ratio (39 used Symphony, 38 used the sham device). Although there were no statistically significant differences between active and sham groups for the primary endpoint (IRLS score), there were statistically significant improvements in the mean MOS-I scores (-16.76 for Symphony vs -5.09 for sham. p=0.0117) and MOS-II scores (-15.83 for Symphony vs -5.34 for sham, p=0.0230).
Adverse Events: There were 7 AEs in the Symphony group (17.9%) and 1 in the sham group (2.6%) that were at least possibly device-related. There were an additional 2 AEs in the Symphony group and 3 AEs in the sham group that were not device-related. All device-related AEs resolved after use of the device was stopped, without medical intervention or clinical sequelae. One AE (cramping sensation in both legs) was graded as moderate and all 7 remaining AEs were graded as mild. The most common AE was worsening of RLS symptoms, which occurred in 4 subjects with the Symphony device (10.3%) and 1 subject with the sham device (2.6%). Worsening of RLS symptoms resolved within 3 weeks of discontinuation of device use without additional intervention. Other device-related AEs reported in the Symphony group included non-RLS leg cramps (2 AEs, 5.1%) and leg soreness (1 AE, 2.6%).
2. SMI-002
Design: This was a prospective, 2:1 randomized, multicenter (4 sites) trial which assessed the safety and effectiveness of the Symphony Device in the reduction of symptoms associated with RLS by comparison to a light-emitting sham control device. The inclusion criteria, study design, and endpoints were very similar to SMI-001, with only minor differences.
Results: A total of 81 subjects were enrolled in the study at a 2:1 ratio (52 used Symphony, 29 used the sham device). Although there were no statistically significant differences between active and sham groups in any of the primary or secondary endpoints, there were mean improvements in the MOS-I scores (-10.13 for Symphony vs -5.48 for sham, p=0.2358) and MOS-II scores (-11.41 for Symphony vs -7.36 for sham, p=0.3040) that did not achieve statistical significance.
Adverse Events (AEs): There were 5 AEs in the Symphony group (9.6%) and 2 in the sham group (6.9%) that were at least possibly device-related. There were an additional 2 AEs that were not device-related, both in the Symphony group. All device-related AEs in the Symphony group were categorized as worsening of RLS symptoms and resolved within 3 weeks of discontinuation of device use without additional intervention. One of these AEs was graded as moderate and the remaining 4 were graded as mild. In the sham group, 1 AE was categorized as worsening of RLS symptoms (mild), which resolved after stopping use of the sham device. The other AE was pain below the knee (moderate), which resolved with use of a heating pad.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5895 Vibratory counter-stimulation device.
(a)
Identification. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special controls for this device are:(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety.
(2) If the device contains software or firmware, appropriate verification, validation, and hazard analysis must be performed.
(3) The elements of the device that contact the patient must be assessed to be biocompatible.
(4) Non-clinical testing data (including vibration frequency, amplitude, and acceleration) must demonstrate that the device performs as intended under anticipated conditions of use.
(5) Labeling must include:
(i) Specific information pertinent to use of the device by the intended patient population and the treatment regimen;
(ii) Warning to only use the device on normal, intact, clean, healthy skin;
(iii) Warning to not use the device if the user has leg skin disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;
(iv) Warning to discontinue use if Restless Leg Syndrome symptoms worsen; and
(v) Instructions for end users to contact the device manufacturer and MedWatch in case they experience any adverse events when using this device.
0
DE NOVO CLASSIFICATION REQUEST FOR SYMPHONY DEVICE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Vibratory counter-stimulation device. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.
NEW REGULATION NUMBER: 882.5895
CLASSIFICATION: CLASS II
PRODUCT CODE: OVP
BACKGROUND
DEVICE NAME: SYMPHONYTM DEVICE
SUBMISSION NUMBER: DEN110011
DATE OF DE NOVO: JULY 13, 2011
- CONTACT: SENSORY MEDICAL, INC. FRED BURBANK, MD, CEO 1235 Puerta del Sol, #500 SAN CLEMENTE, CA 92673
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II
INDICATIONS FOR USE
The purpose of the Symphony Device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counter-stimulation.
LIMITATIONS
For prescription use only.
Limitations on device use are also achieved through the following statements included in the Instructions for Use Manual:
1
Contraindication:
- . This device should not be used on patients who have been diagnosed with deep venous thrombosis (DVT) in either leg during the last 6 months because of the known potential to dislodge or break up the clot and cause a pulmonary embolism.
Warnings:
The Symphony Device is only intended for use on patients with primary Restless Legs Syndrome (RLS). It is not intended to be used by people who:
- have leg skin disorders such as eczema, psoriasis, cellulitis, non-healing wounds; or .
- . have secondary RLS.
Due to the potential for the device to cause worsening of symptoms in some patients, the patient labeling should include a warning to discontinue device use and contact a doctor if symptoms worsen.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Symphony Device is a non-sterile, reusable, cloth-covered foam pad that contains six embedded electric motors that swing eccentric weights to produce vibration throughout the pad. The device is designed to be placed under the user's legs while sleeping. When the device is activated, an electronic controller runs a 35 minute preset vibration cycle. The controller allows the patient to control the intensity level of the vibration for the first 30 minutes of the cycle. In the last five minutes, the controller slowly ramps down the vibration intensity of the device and then automatically shuts the device off at the end of the timed cycle. One repeat cycle can be initiated by the patient.
The controller contains the on/off function and has variable mechanical counter-stimulation intensity settings (1 to 9). The motor amplitude and frequency (vibration) can be set to different levels of intensity by means of a knob. The polyurethane foam pad is covered by an inner lycra cover and an outer cover. The outer cover on the Symphony™ Device is made of cotton. The device will be offered in three sizes: Small, Medium, and Large.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Symphony is intended to only contact intact skin for a limited duration (