(556 days)
Not Found
Not Found
Unknown
The description mentions the device can "automatically increase[d] in response to a baby's cries," which suggests some level of automated response based on input (cries). However, it doesn't explicitly state that AI or ML is used for this analysis or response, and the "Mentions AI, DNN, or ML" field is marked "Not Found". It could be a simpler rule-based system.
No
The device is intended to facilitate a supine position during sleep and reduce the risk of SIDS/SUID, which is preventative rather than therapeutic.
No.
The device's intended use and description state it facilitates a supine position during sleep to reduce SIDS/SUID risk. It does not mention diagnosing any condition.
No
The device description clearly states that the SNOO is comprised of a bassinet and a sleep sack, which are physical hardware components. While there is a SNOO App mentioned, the core functionality and intended use are tied to the physical bassinet and sleep sack.
Based on the provided information, the SNOO Smart Sleeper bassinet and SNOO Sleep Sack are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SNOO's Function: The SNOO's intended use and device description clearly state that it is a physical device designed to facilitate a supine sleep position for infants. It does not involve the analysis of any biological specimens.
The SNOO is a medical device, but it falls under a different classification than IVD devices. It is a device intended to physically interact with the patient (the infant) to achieve a specific physiological outcome (maintaining a supine position).
N/A
Intended Use / Indications for Use
The SNOO Smart Sleeper is indicated as follows:
The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.
Product codes
OTG
Device Description
The SNOO Smart Sleeper (SNOO) is comprised of the SNOO bassinet and the SNOO Sleep Sack that iointly constitute an infant securement device intended to facilitate a supine position during sleep. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.
The SNOO Sleep Sack is a cotton swaddle with fixed wings made of woven cotton fabric that extend to the right and left of the infant's body. Three sizes of sleep sacks (small 5-12lbs, medium 12-18lbs. and large 18-25lbs) are provided with each bassinet to accommodate the growing baby. Small loops at the end of each SNOO Sleep Sack wing are slid over the safety clips of the SNOO bassinet to securely position the swaddled infant on the back. The SNOO Sleep Sack has corresponding wings that are designed to be physically attached to those clips after the baby is wrapped in the sleep sack - thereby keeping the infant securely positioned on the back during sleep and to prevent rolling.
The SNOO bassinet also provides sound and motion. White noise and rocking can be automatically increased in response to a baby's cries. There is a SNOO App which can be used to adjust the levels of motion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
from birth to 6 months of age
Intended User / Care Setting
Home use by caregivers
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
Not Found
Summary of Performance Studies
Real world evidence (RWE) showing a rate of supine sleep position of approximately 98.7% in 1012 users (confidence interval [97.8%,99.2%]).
Over 93 hours of video recordings showed all observed infants remaining in a supine position during their time in the SNOO.
Real-world evidence on 106,723 SNOO users compared the incidence of reported SIDS/SUID in SNOO users to historical data from the CDC Wide-ranging Online Data for Epidemiological Research (WONDER) database. The data did demonstrate that the device did not increase the risk of SIDS/SUID in the study population.
A Human Factors validation study was completed in accordance with the FDA 2016 guidance "Applying Human Factors and Usability Engineering to Medical Devices". Fifteen test participants were evaluated on tasks that included unpacking the SNOO, setting up the system, swaddling a baby (doll) in the SNOO Sleep Sack, securing the baby (doll) in the SNOO bassinet, and properly removing the baby (doll) from the device. The validation study met the acceptance criteria and was deemed acceptable.
Key Metrics
Rate of supine sleep position: approximately 98.7% (confidence interval [97.8%,99.2%]).
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR SNOO SMART SLEEPER
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Infant supine sleep system. An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).
NEW REGULATION NUMBER: 21 CFR 880.5690
CLASSIFICATION: Class II
PRODUCT CODE: OTG
BACKGROUND
DEVICE NAME: SNOO Smart Sleeper
SUBMISSION NUMBER: DEN210039
DATE DE NOVO RECEIVED: September 20, 2021
SPONSOR INFORMATION:
Happiest Baby, Inc. 3115 S. La Cienega Blvd. Los Angeles, California 90016
INDICATIONS FOR USE
The SNOO Smart Sleeper is indicated as follows:
The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.
LIMITATIONS
The SNOO is demonstrated to facilitate a supine position during sleep; however, the SNOO has not directly demonstrated a reduction in the incidence of SIDS/SUID.
1
This device is only indicated for use with infants who cannot consistently roll over.
The device is not a substitute for adult supervision.
Do not use this product if the infant can push up on hands and knees, can roll over consistently, or has reached 6 months of age, whichever comes first.
DEVICE DESCRIPTION
The SNOO Smart Sleeper (SNOO) is comprised of the SNOO bassinet and the SNOO Sleep Sack that iointly constitute an infant securement device intended to facilitate a supine position during sleep. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.
The SNOO Sleep Sack is a cotton swaddle with fixed wings made of woven cotton fabric that extend to the right and left of the infant's body. Three sizes of sleep sacks (small 5-12lbs, medium 12-18lbs. and large 18-25lbs) are provided with each bassinet to accommodate the growing baby. Small loops at the end of each SNOO Sleep Sack wing are slid over the safety clips of the SNOO bassinet to securely position the swaddled infant on the back. The SNOO Sleep Sack has corresponding wings that are designed to be physically attached to those clips after the baby is wrapped in the sleep sack - thereby keeping the infant securely positioned on the back during sleep and to prevent rolling.
Image /page/1/Picture/6 description: The image shows a baby swaddled in a white blanket, lying on a black and white patterned surface. The baby is lying on its back, with its head turned to the left. The swaddle is wrapped tightly around the baby's body, with only its head and face visible. The baby appears to be content and relaxed. The black and white patterned surface appears to be a baby lounger.
The SNOO bassinet also provides sound and motion. White noise and rocking can be automatically increased in response to a baby's cries. There is a SNOO App which can be used to adjust the levels of motion.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
2
The patient-contacting components of the SNOO Smart Sleeper (SNOO) include the SNOO bassinet fitted sheet and the SNOO Sleep Sack. The SNOO bassinet fitted sheet is made of 100% cotton. and the SNOO Sleep Sack is made of 95% cotton and 5% elastane. and features mesh panels made of 100% polyester. Biocompatibility testing was performed on the patient contacting components of the SNOO. Testing included Cytotoxicity testing per ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity, sensitization testing per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, and irritation testing per ISO 10993-23:2021 Biological Evaluation of Medical Devices, Part 23: Tests for Irritation on the final finished device.
SHELF LIFE
Durability of the SNOO Sleep Sack's zipper and safety loops were evaluated. The effect of washing over the expected lifecycle of the SNOO Sleep Sack and SNOO bassinet fitted sheet was assessed. Use life testing was completed to demonstrate a use life of 6 months.
ELECTROMAGNETIC CAPABILITY & ELECTRICAL SAFETY
Electrical safety testing was performed in accordance with the following standards:
- . BS EN 61558-1 Safety of transformers, reactors, power supply units and combinations thereof - General requirements and tests
- . BS EN 61558-2-16 Safety of transformers, reactors, power supply units and combinations thereof - Part 2-16: Particular requirements and tests for switch mode power supply units and transformers for switch mode power supply units for general applications.
- . UL 1310 - Class 2 Power Units CAN/CSA C22.2 No. 223 - Power Supplies with Extra-low Voltage Class 2 Outputs.
Electromagnetic compatibility (EMC) testing was conducted per the FDA Recommended Standard IEC 60601-1-2. The SNOO Smart Sleeper demonstrated that it complies with the emission limits conducted for CISPR 11. Additionally, conducted and radiated emissions testing was performed per CFR 47 FCC Part 15. Subpart B. which included EMC testing to the same frequencies (0.15 MHz- 30MHz) and acceptance limits as IEC 60601-1-2.
PERFORMANCE TESTING - BENCH
The SNOO Smart Sleeper bassinet was tested in accordance with ASTM F2194-16e1 (Standard Consumer Safety Specification for Bassinets and Cradles) and 16 CFR 1218 (Requirements for bassinets and cradles).
The SNOO Sleep Sack was tested as described in the table below.
3
| Test
Performed | Device
Description /
Sample Size | Test
Method | Acceptance
Criteria | Results
(PASS/ FAIL) |
|-------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------|
| Zipper
Durability
Test | 10 zippers /
batch | Open and close the zipper 500 times at
an approximate speed of 10cm/sec. | 500 cycles without
any jamming or
breaking issues. | PASS |
| Loop Hook
&
Unhooking | 3 SNOO
Sacks
(1 Small.
1 Medium,
1 Large) | Perform 500 hook and unhook cycles
on SNOO Sleep Sack elastic loops to
the safety clips, per the IFU
instructions. | Visual Inspection
for deterioration of
components after
500 hook and
unhook cycles. | PASS |
| Washing
Durability
Test | 10 pieces /
batch | Utilizing any commercial large
washing machine and household
clothes drying machine, wash and dry
the Sleep Sack for 100 cycles. After
every 10 cycles, measure the
dimensions. | Dimension
deviates less than
10%, except for
safety clip width
(