(1056 days)
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Not Found
No
The device description and performance studies focus on mechanical pressure application and patient-reported outcomes, with no mention of AI/ML terms or data processing related to learning or prediction.
Yes.
The device is intended to reduce symptoms of moderate to severe primary Restless Leg Syndrome (RLS), which is a therapeutic purpose.
No
The device is described as a treatment for Restless Leg Syndrome, not as a tool to diagnose it. Its purpose is to reduce symptoms, and the performance studies measure symptom improvement, not diagnostic accuracy.
No
The device description clearly outlines physical components like a cloth wrap, VELCRO straps, plastic buckles, and pressure pads, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce symptoms of moderate to severe primary Restless Leg Syndrome (RLS) in adults and used during periods of rest or relaxation, when symptoms of RLS occur." This describes a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Device Description: The device is a physical foot wrap designed to apply pressure. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Performance Studies: The performance studies focus on the reduction of RLS symptoms as measured by patient-reported outcomes and clinical impressions. This aligns with evaluating the effectiveness of a therapeutic intervention, not the accuracy of a diagnostic test.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The RESTIFFICTM Restless Leg Relaxer Foot Wrap is a prescription device intended to reduce symptoms of moderate to severe primary Restless Leg Syndrome (RLS) in adults and used during periods of rest or relaxation, when symptoms of RLS occur.
Product codes
OTX
Device Description
The RESTIFFICTM Restless Leg Relaxer Foot Wrap device is a foot wrap designed to apply continuous, adjustable squeezing pressure on specific muscles in the feet. The device is to be applied before bedtime or while the person is seated or supine.
A more complete description of the device includes the following:
- An outer cloth wrap to support and hold the pressure pad in place. (The wrap has an . open end so the pad can be removed and replaced, if needed. Only the cloth comes in contact with the skin);
- . VELCRO straps and plastic buckles to hold the cloth wrap in place and allow for adjusting the pressure; and
- Pressure pads of high density foam to put pressure on the medial and bottom part of the foot. The RESTIFFICTM achieves its targeted pressure with a T- shaped pad that presses into the medial and bottom part of the foot.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lower extremity, such as the leg or foot, feet
Indicated Patient Age Range
adults
Intended User / Care Setting
For prescription use only.
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
The sponsor has provided evidence from a single arm, historically-controlled, open label study (n=30 adult subjects with symptoms of moderate to severe RLS) utilizing the RESTIFFICTM wrap lasting eight weeks (six weeks of treatment with the RESTIFFICTM wrap).
The primary outcome measure for assessment of effectiveness for the RESTIFFICTM wrap was the International Restless Legs Scale (IRLS) score, a patient-reported outcome measure. The IRLS score is the best validated and most widely used measure of effectiveness of a RLS treatment, though it is prone to significant placebo effects.
Secondary outcome measures included Clinical Global Impression-Improvement (CGI-I), Clinical Global Impression-Severity (CGI-S) and Clinical Global Impressions-Efficacy Index (CGI-EI), all of which are the investigators' assessed measures of the subject's illness.
Subjects in the study demonstrated a statistically significant decrease in symptoms from severe or moderate to mild RLS, overall as measured by the IRLS rating scale (mean 17.22 reduction in IRLS score overall). CGI-I results demonstrated that all subjects improved: none became worse after wearing the device. Ninety (90%) percent (27/30) of subjects were "much improved" or "very much improved" by study end. CGI-S results revealed that 97% (29/30) of subjects experienced a decrease in severity. 83% (25/30) of subjects decreased at least two levels in severity. CGI-EI revealed 86% (26/30) of subjects showed moderate to marked improvement with no side effects.
Safety was assessed by recording adverse events and analyzing them for severity and relation to the study device. There were 11 non-serious device-related adverse events (AEs) in 10 subjects due to use of the RESTIFFICTM wrap. These included transient numbness, pain, or burning that resolved when the device was loosened. No serious AEs were noted in the study population. It was also reported that no subjects stopped using the device due to AEs.
Key Metrics
- IRLS score: mean 17.22 reduction
- CGI-I: 90% (27/30) of subjects were "much improved" or "very much improved" by study end.
- CGI-S: 97% (29/30) of subjects experienced a decrease in severity. 83% (25/30) of subjects decreased at least two levels in severity.
- CGI-EI: 86% (26/30) of subjects showed moderate to marked improvement with no side effects.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5760 Nonpowered lower extremity pressure wrap.
(a)
Identification. A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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DE NOVO CLASSIFICATION REQUEST FOR RESTIFFICTM RESTLESS LEG RELAXER FOOT WRAP
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Nonpowered lower extremity pressure wrap. A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome (RLS).
NEW REGULATION NUMBER: 890.5760
CLASSIFICATION: CLASS I (EXEMPT, from premarket notification review, subject to limitations in 21 CFR 890.9)
PRODUCT CODE: OTX
BACKGROUND
DEVICE NAME: RESTIFFICTM RESTLESS LEG RELAXER FOOT WRAP
SUBMISSION NUMBER: K102707
DATE OF DE NOVO: JANUARY 23, 2011
- CONTACT: MARY M. SORG P.J. SLEEPER'S 2210 ELK ROAD WATERFORD, PA 16441
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS I
INDICATIONS FOR USE
The RESTIFFICTM Restless Leg Relaxer Foot Wrap is a prescription device intended to reduce symptoms of moderate to severe primary Restless Leg Syndrome (RLS) in adults and used during periods of rest or relaxation, when symptoms of RLS occur.
LIMITATIONS
For prescription use only.
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Limitations on device use are also achieved through the following statements included in the Instructions for Use Manual:
Warnings:
- If you have neuropathy (numbness or tingling in hands or feet), poor circulation, peripheral vascular disease, varicose veins, deep vein thrombosis or history of blood clots, foot and/or leg swelling, DO NOT use the RESTIFFIC™ device.
- · Do NOT wear if you have breaks, sprains, bruises and bruising problems, wounds, sores, fragile or thin skin, burns, cuts, rash or abrasions involving your feet and /or legs.
- Do NOT wear when engaged in activities that put pressure on your feet: examples: standing, walking, running, exercising, or operating a vehicle or bicycle.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
RATIONALE FOR EXEMPTION
The technology of a nonpowered lower extremity foot wrap is relatively simple in that it achieves its effect through mechanical pressure and there are low risks associated with use of the device. Therefore, a nonpowered lower extremity foot wrap, when indicated as prescription use devices, are appropriate for exemption from premarket notification, subject to the limitations of exemptions identified in 21 CFR 890.9. Given the simplicity of the design, including the lack of any electrical components, general controls provide reasonable assurance of safety and effectiveness if device manufacturers comply with such requirements, which includes current good manufacturing practice requirements (21 CFR part 820), and general labeling (21 CFR part 801).
Examples exceeding the limitations of exemption could include indications for over-the-counter use or a significant change in the technological characteristics.
DEVICE DESCRIPTION
The RESTIFFIC™ Restless Leg Relaxer Foot Wrap device is a foot wrap designed to apply continuous, adjustable squeezing pressure on specific muscles in the feet. The device is to be applied before bedtime or while the person is seated or supine.
A more complete description of the device includes the following:
- An outer cloth wrap to support and hold the pressure pad in place. (The wrap has an . open end so the pad can be removed and replaced, if needed. Only the cloth comes in contact with the skin);
- . VELCRO straps and plastic buckles to hold the cloth wrap in place and allow for adjusting the pressure; and
- Pressure pads of high density foam to put pressure on the medial and bottom part of ●
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the foot. The RESTIFFIC™ achieves its targeted pressure with a T- shaped pad that presses into the medial and bottom part of the foot.
SUMMARY OF NONCLINICAL/BENCH STUDIES
The device design is relatively simple as it does not contain any software, electronics, circuit boards, nor is it electrically powered; therefore EMC or electrical safety testing is not necessary. The only 'mechanical aspect' of the device is the use of Velcro straps to tighten the wrap about the foot to apply 'therapeutic pressure' to the foot to have an impact on relieving RLS symptoms in adults.
BIOCOMPATIBILITY/MATERIALS
The RESTIFFIC™ foot wrap is intended to only contact intact skin for a limited duration (