(571 days)
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Not Found
No
The device description and performance studies focus on a cooling mechanism and its effects on sleep latency, with no mention of AI or ML algorithms for data analysis, decision-making, or personalized treatment.
Yes
The device is indicated to reduce sleep latency in patients with primary insomnia, which addresses a medical condition, qualifying it as a therapeutic device.
No
Explanation: The device is indicated to reduce sleep latency, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "cooling device comprised of three components: the bedside unit, the forehead pad, and headgear," and that it "pumps chilled fluid through the forehead pad." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Cerêve Sleep System is a cooling device that applies chilled fluid to the forehead. It does not involve testing any samples taken from the body.
- Intended Use: The intended use is to reduce sleep latency in patients with primary insomnia by applying cooling to the forehead. This is a physical intervention, not a diagnostic test.
Therefore, the Cerêve Sleep System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cerêve Sleep System is indicated to reduce sleep latency to Stage 1 and Stage 2 sleep in patients with primary insomnia.
Product codes
PLU
Device Description
The Cereve Sleep System is a cooling device comprised of three components: the bedside unit, the forehead pad, and headgear. The device pumps chilled fluid through the forehead pad, at patient selectable temperatures in a narrow range between 14 and 16 °C. The Cereve Sleep System bedside unit provides the means to cool the fluid and transport the fluid from the unit to the forehead pad. The bedside unit utilizes solid state thermoelectric devices to cool a thermal transfer fluid consisting of purified water and isopropyl alcohol. The unit has a user interface that allows the user to turn the unit on and off, and adjust the temperature within the range of 14 to 16 ℃. The unit contains a pump for circulating the thermal transfer fluid through the tubing and forehead pad. The bedside unit is powered by a DC electrical power supply and is controlled by an integral control unit (CU) and its firmware. The Cerêve Sleep System Headgear and Forehead pad contain the wearable portion of the sleep system. It is comprised of a multi-use urethane forehead pad that is in contact with the patient's head, the Lycra® headgear that holds the forehead pad in place, and a 6 foot section of insulated tubing that connects to the Cerêve Bedside Unit.
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
forehead
Indicated Patient Age Range
Age > 22 years
Intended User / Care Setting
prescription device for use in patients with insomnia. Home Healthcare Environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
CIP-006:
- Study Type: Randomized, multi-center (7 U.S. sites), sham-controlled study.
- Sample Size: 116 primary insomnia adult subjects.
- Key Results: "There were no statistically significant differences between the Cerêve and sham groups for the primary endpoints (latency to persistent sleep and sleep efficiency), nor for the secondary endpoints (Stage 3 NREM sleep and sleep quality). However, additional data analysis of the study showed there was a 12 minute reduction in the sleep latency to Stage 1 sleep (p=0.004) and Stage 2 sleep (p=0.008) in the Cereve group compared to the sham. The measures of sleep latency to Stage 1 and Stage 2 sleep did not require sustained sleep. There was no statistically significant difference between the Cerêve and sham groups for reduction in sleep latency to Stage 3 sleep."
-
CIP-003:
- Study Type: Multi-center (9 U.S. sites), controlled, within-subjects cross-over study comparing the effects of 2 different temperature modes.
- Sample Size: 145 subjects.
- Key Results: "Similar to CIP-006, there were numerical improvements in latency to persistent sleep and sleep efficiency in both groups, but there were no statistically significant differences between the two modes. The rate of adverse events was low and further supported the overall safety of the Cerêve Sleep System."
-
CIP-004:
- Study Type: Non-randomized home-use study to evaluate long-term use effects.
- Sample Size: 32 subjects from CIP-003.
- Key Results: "Subjects used the Cereve Sleep System in their home for 30 days and up to 5 months for safety assessments. The subjects had similar numerical improvements in latency to persistent sleep and sleep efficiency measures at 30 days as those observed in prior measurements obtained in CIP-003. The subjects reported improved self-reported sleep quality scores after 30 days use. These results demonstrate that the Cereve Sleep System effect is durable over 30 days of use in the home in these subjects."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5700 Thermal system for insomnia.
(a)
Identification. A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate electromagnetic compatibility and electrical safety.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Thermal performance of the device, including maintenance of the target temperature, must be evaluated under simulated use conditions.
(ii) Mechanical testing to demonstrate the device can withstand forces under anticipated use conditions.
(iii) Mechanical testing to demonstrate the device is resistant to leakage under anticipated use conditions.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Patient labeling must be provided to convey information regarding safe use of the device, including instructions for assembly.
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DE NOVO CLASSIFICATION REQUEST FOR CERÊVE SLEEP SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Thermal System for Insomnia. A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.
NEW REGULATION NUMBER: 882.5700
CLASSIFICATION: CLASS II
PRODUCT CODE: PLU
BACKGROUND
DEVICE NAME: CERÊVE SLEEP SYSTEM
SUBMISSION NUMBER: DEN140032
DATE OF DE NOVO: OCTOBER 20, 2014
CONTACT: CERÊVE, INC. 333 ALLEGHENY AVE, SUITE 201 OAKMONT, PA 15139
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II
INDICATIONS FOR USE
The Cerêve Sleep System is indicated to reduce sleep latency to Stage 1 and Stage 2 sleep in patients with primary insomnia.
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
Other than reduction of sleep latency to Stage 1 and Stage 2 sleep, the efficacy of other sleep measures associated with insomnia has not been established by the Cerêve Sleep System in controlled clinical trials.
Limitations on device use are also achieved through the following statements included in
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the Directions for Use manual:
Warning:
- · If the patient has a skin condition on his/her forehead that may make wearing the Cereve Sleep System uncomfortable, the physician will need to evaluate the skin condition prior to use of the Sleep System.
- · Patients with cold sensitivity reactions such as Raynaud's Disease should not use cooling therapies in order to avoid cold sensitivity reactions that may include cold sensations, color changes in their skin in response to cold, and a numb, prickly feeling or stinging pain upon warming.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
The Cereve Sleep System is a cooling device comprised of three components: the bedside unit, the forehead pad, and headgear. The device pumps chilled fluid through the forehead pad, at patient selectable temperatures in a narrow range between 14 and 16 °C. An illustration of the device is provided in Figure 1 below.
Image /page/1/Picture/7 description: The image shows a medical device and a cartoon depiction of the device in use. On the left, the device is shown on a mannequin head next to a white box with a digital display. The device is a blue head covering with black accents. On the right, a cartoon shows a person in bed wearing the head covering, which is connected to a device on the nightstand.
Figure 1. Cerêve Sleep System (left) and schematic of device in home use environment (right).
The Cereve Sleep System bedside unit provides the means to cool the fluid and transport the fluid from the unit to the forehead pad. The bedside unit utilizes solid state thermoelectric devices to cool a thermal transfer fluid consisting of purified water and isopropyl alcohol. The unit has a user interface that allows the user to turn the unit on and off, and adjust the temperature within the range of 14 to 16 ℃. The unit contains a pump for circulating the thermal transfer fluid through the tubing and forehead pad. The bedside unit is powered by a DC electrical power supply and is controlled by an integral control unit (CU) and its firmware. The Cerêve Sleep System Headgear and Forehead pad contain the wearable portion of the sleep
2
system. It is comprised of a multi-use urethane forehead pad that is in contact with the patient's head, the Lycra® headgear that holds the forehead pad in place, and a 6 foot section of insulated tubing that connects to the Cerêve Bedside Unit.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The forehead pad is constructed of urethane and is in direct contact with the patient's skin. Each use of the device results in a limited contact duration of less than 24 hours. Therefore, per ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing), cytotoxicity, sensitization, and irritation testing were performed on the forehead pad and the results were found to be acceptable.
The thermal fluid is not intended to contact the patient; however, if the forehead pad is damaged, there could be potential for the fluid to come in contact with the patient during use. Therefore, the thermal fluid also was tested per ISO 10993-1 for cytotoxicity, oral toxicity, and ocular irritation and the results were found to be acceptable.
The headgear is constructed of clothing grade Lycra®, which is commonly used to fabricate clothing in contact with intact skin. In lieu of biocompatibility testing, justification was provided that the same material has a demonstrated history of safe use.
STERILITY
The Cerêve Sleep System is a non-sterile, reusable device. It is intended only for external use. Cleaning instructions for the bedside unit and forehead pad are provided in the labeling.
ELECTROMAGNETIC COMPATIBILITY (EMC) AND ELECTRICAL SAFETY
The Cereve Sleep System was tested for and found to be in compliance with the following standards for electromagnetic compatibility and electrical safety:
| Standard | Title |
|---|---|
| AAMI ANSI ES60601- | |
| 1:2005/(R)2012 and | |
| A1:2012, C1:2009/(R)2012 | |
| and a2:2010/(r)2012 | (Consolidated Text) Medical Electrical Equipment - |
| Part 1: General Requirements For Basic Safety And | |
| Essential Performance | |
| AAMI ANSI IEC 60601-1- | |
| 2:2014 | Medical Electrical Equipment -- Part 1-2: General |
| Requirements For Basic Safety And Essential | |
| Performance -- Collateral Standard: Electromagnetic | |
| Disturbances -- Requirements And Tests | |
| IEC 60601-1-11 Edition 1.0 | |
| 2010-04 | Medical Electrical Equipment - Part 1-11: General |
| Requirements For Basic Safety And Essential | |
| Performance - Collateral Standard: Requirements For | |
| Medical Electrical Equipment And Medical Electrical | |
| Systems Used In The Home Healthcare Environment |
Table 1 - Summary of EMC and Electrical Safety Testing
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SOFTWARE
The Cerêve Sleep System bedside unit is powered by a DC electrical power supply and is controlled by an integral control unit (CU) and its firmware.
The Level of Concern of the software for the Cerêye Sleep System was assessed using the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and resulted in a determination of a Moderate level of concern.
- The software regulates the temperature of thermal fluid at the output of the bedside . unit to the temperature set point selected by the patient, and maintains the temperature set point without requiring additional patient adjustment by pulse-width modulation (PWM).
- The software will allow for variation of the fluid temperature set point at the output of . the bedside unit in preset increments based on patient adjustment.
- The software also includes additional safety features that provide for automatic shutdown for fault conditions. All of the fault conditions are backed up by hardware controls in the case of software loss of control.
Software validation was performed on all key performance characteristics for temperature control. Additionally, software validation was performed on all safety critical performance features for the following requirements: unit temperature (thermistor control), unit temperature (thermal cut-out), fluid temperature (thermistor control), and fluid temperature (thermal cut-out).
PERFORMANCE TESTING - BENCH
The Cerêve Sleep System was tested to characterize the device outputs at each temperature setting on the controller of the bedside unit. The non-clinical bench tests performed to support the performance and safety of the Cerêve Sleep System are summarized in the table below:
| Test | Test Summary | ||
|---|---|---|---|
| Fluid flow rate | The fluid flow rate through the forehead pad was evaluated and | ||
| verified to be within specification. | |||
| Time to reach target | The time for the device to reach the target temperature was | ||
| temperature | verified to be within specification. | ||
| Maintenance of target | The ability of the device to maintain the target temperature | ||
| temperature | setting for 8 hours was verified while operating at an ambient | ||
| temperature of (4) and applying heat to the forehead pad. | |||
| Sound level | The sound level generated from the device during use was | ||
| verified to be in an acceptable range. | |||
| Temperature drop | The temperature difference between the outlet of the forehead | ||
| across forehead pad | pad and inlet of the forehead pad was verified to be less than or | ||
| equal to b(4 while applying heat to the forehead pad. |
Table 2 - Summary of Non-clinical Testing
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| Test | Test Summary |
|---|---|
| Temperature drop | The temperature difference between the forehead pad and |
| from bedside unit and | bedside unit was verified to be less than or equal to b(4) |
| forehead pad | |
| Tubing and connector | The tubing connection strength was verified to withstand a |
| strength | minimum tensile force. |
| Puncture load on | The forehead pad integrity was verified to withstand a minimum |
| forehead pad | puncture load force without rupture. |
| Kinked/occluded | The device was verified not to leak when the tubing was |
| tubing and leakage | simulated in a kinked or occluded condition. The forehead pad |
| testing | assembly was also verified not to leak when exposed to tensile |
| forces beyond those anticipated during use conditions. | |
| Simulated distribution | The packaged device was confirmed to be undamaged and in |
| and conditioning | operable condition following simulated distribution conditions in |
| accordance with ASTM D4169-14 (Standard Practice for | |
| Performance Testing of Shipping Containers and Systems) and | |
| conditioning in accordance with ASTM D4332-14 (Standard | |
| Practice for Conditioning Containers, Packages, or Packaging | |
| Components for Testing). |
SUMMARY OF CLINICAL INFORMATION
Three clinical studies were conducted with the Cereve Sleep System in patients with primary insomnia. The studies are further summarized below.
1. CIP-006:
Design: This was the pivotal study in support of the Cerêve Sleep System. This was a randomized, multi-center (7 U.S. sites), sham-controlled study of 116 primary insomnia adult subjects.
Eligible subjects were provided with information about the study design and risks and signed the informed consent document. Criteria for inclusion included:
- Age > 22 years
- Diagnosis of insomnia that meets criteria for Diagnostic and Statistical Manual of . Mental Disorders, 4th Edition (DSM IV) diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD) general insomnia and Research Diagnostic Criteria (RDC) insomnia disorder criteria
- Agreement to remain alcohol free and avoid drugs that could affect sleep during the ● studv
-
14 on the Insomnia Severity Index ●
- Sleep-Wake diary that demonstrated sleep efficiency 85% on either the sleep disorder screening night or baseline PSG ●
- An AHI (apnea hypopnea index) >10 and/or a periodic limb movement arousal index . (PLMAI)>15 from screening night
- Body mass index >34
- Use of medications known to affect sleep or wake function
- Consumption of more than one alcoholic drink per day
- Consumption of caffeinated beverages >4 per day ●
Following completion of 2 nights baseline PSG recordings in a sleep lab setting, subjects were randomized to receive 2 additional nights PSG sleep studies using either the Cerêve Sleep System or the sham device. There were 2 co-primary endpoints for the study, including (1) latency to persistent sleep (time to the first epoch of sleep sustained for 10 minutes) based on PSG and (2) sleep efficiency (total sleep time / time in bed) based on PSG. The two secondary endpoints for the study were Stage 3 non-rapid eve movement (NREM) sleep based on PSG and subjective sleep quality based on response to a self-reported questionnaire (Pittsburgh Sleep Diary) following each night of sleep.
Results: There were no statistically significant differences between the Cerêve and sham groups for the primary endpoints (latency to persistent sleep and sleep efficiency), nor for the secondary endpoints (Stage 3 NREM sleep and sleep quality). However, additional data analysis of the study showed there was a 12 minute reduction in the sleep latency to Stage 1 sleep (p=0.004) and Stage 2 sleep (p=0.008) in the Cereve group compared to the sham. The measures of sleep latency to Stage 1 and Stage 2 sleep did not require sustained sleep. There was no statistically significant difference between the Cerêve and sham groups for reduction in sleep latency to Stage 3 sleep.
Adverse Events: There were a total of 3 adverse events (AEs) in the Cerêve group and 1 in the sham group that were deemed possibly or probably related to the device. The 3 AEs in the Cerêve group included headache. There were an additional 2 AEs in the Cerêve group and 1 AE in the sham group that were not device related. No serious AEs were observed in either group.
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2. CIP-003:
Prior to conducting CIP-006, the sponsor conducted a multi-center, controlled, within subjects cross-over study comparing the effects of 2 different temperature modes of the Cerêve Sleep System on subjects with primary insomnia. This was a multi-center (9 U.S. sites) study of 145 subjects with inclusion and exclusion criteria that were similar to those in CIP-006. Following screening and baseline PSG measurements, subjects had two sequential nights in each condition with the Cereve Sleep System separated by 3-5 nights at home. There were 2 co-primary endpoints for the study, including (1) latency to persistent sleep based on PSG and (2) sleep efficiency based on PSG.
Similar to CIP-006, there were numerical improvements in latency to persistent sleep and sleep efficiency in both groups, but there were no statistically significant differences between the two modes. The rate of adverse events was low and further supported the overall safety of the Cerêve Sleep System. The most common AE was headache, with a total of 11 headache AEs in 10 subjects that were deemed possibly, probably or definitely related to the device. Other AEs were deemed not to be device-related. No serious AEs were observed.
3. CIP-004:
Following CIP-003, the sponsor conducted a non-randomized home-use study to evaluate long-term use effects of the Cerêve Sleep System in 32 subjects from CIP-003. Subjects used the Cereve Sleep System in their home for 30 days and up to 5 months for safety assessments. The subjects had similar numerical improvements in latency to persistent sleep and sleep efficiency measures at 30 days as those observed in prior measurements obtained in CIP-003. The subjects reported improved self-reported sleep quality scores after 30 days use. These results demonstrate that the Cereve Sleep System effect is durable over 30 days of use in the home in these subjects. No serious device-related AEs were reported and further supported the safety of the Cerêve Sleep System for extended use.
LABELING
The Cerêve Sleep System User Manual is consistent with the clinical data and covers all of the hazards and other clinically relevant information that may impact use of the device. Patient labeling is also provided, which includes a warning for patients to consult with their physician if they have a skin condition that may make use of the device uncomfortable. The labeling includes the following caution statement noting the limitation of the established device effectiveness:
Other than reduction of sleep latency to Stage 1 and Stage 2 sleep, the efficacy of other sleep measures associated with insomnia has not been established by the Cerêve Sleep System in controlled clinical trials.
The labeling satisfies the requirements of 21 CFR & 801.109 Prescription devices.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of the Thermal System for Insomnia and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Method |
|---|---|
| Adverse Skin Reaction | Biocompatibility Assessment |
| Labeling | |
| Electromagnetic Interference with Other | Electromagnetic Compatibility Testing |
| Devices | Labeling |
| Electrical Safety (e.g., shock) | Electrical Safety Testing |
| Labeling | |
| Thermal Injury | Non-clinical Performance Testing |
| Software Verification, Validation, and | |
| Hazard Analysis | |
| Labeling |
| Table 3 - Identified Risks to Health and Mitigation Measures | |
|---|---|
| -------------------------------------------------------------- | -- |
SPECIAL CONTROLS:
In combination with the general controls of the FD&C Act, the Thermal System for Insomnia is subject to the following special controls:
-
- The patient-contacting components of the device must be demonstrated to be biocompatible.
-
- Performance testing must demonstrate electromagnetic compatibility and electrical safety.
-
- Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
- a. Thermal performance of the device, including maintenance of the target temperature, must be evaluated under simulated use conditions.
- Mechanical testing to demonstrate the device can withstand forces under b. anticipated use conditions.
- c. Mechanical testing to demonstrate the device is resistant to leakage under anticipated use conditions.
-
- Software verification, validation, and hazard analysis must be performed.
-
- Patient labeling must be provided to convey information regarding safe use of the device, including instructions for assembly.
BENEFIT/RISK DETERMINATION
The risks of the device are based on data collected in the clinical studies described above. There were no serious adverse events associated with the use of the device.
The probable benefits of the device are also based on data collected in the clinical studies described above. Although the clinical studies do not support that the device is effective for improvement of primary insomnia symptoms in general (including latency to persistent sleep,
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sleep efficiency, and sleep quality), the probable benefit is a reduction in the time to reach stage 1 and stage 2 sleep.
Additional factors to be considered in determining probable risks and benefits for the Cerêve Sleep System include: risks, such as headache, will be apparent to the individual user of the device with use. Similarly, if there is benefit to the individual user it should be apparent. One alternative low-risk treatment includes cognitive behavioral therapy. A second alternative therapy includes pharmacologic therapy which may carry greater risk. There are no similar medical devices on the market for this proposed indication for a reduction in the time to reach Stage 1 and Stage 2 sleep.
In conclusion, given the available information above, the data support that for reducing latency to Stage 1 and Stage 2 sleep in patients with primary insomnia, the probable benefit outweighs the probable risks for the Cerêve Sleep System. The device provides probable benefit for reducing time to Stage 1 and Stage 2 sleep and the risks can be mitigated by the use of general and the identified special controls.
CONCLUSION
The de novo request for the Cerêve Sleep System is granted and the device is classified under the following:
Product Code: PLU Device Type: Thermal System for Insomnia Class: II Regulation: 21 CFR 882.5700