K Number

Device Name

Dream Sock

Manufacturer

Owlet Baby Care, Inc.

Date Cleared

2023-11-08

(329 days)

Product Code

QYU OYU

Regulation Number

870.2705

Intended Use

The Dream Sock analyzes photoplethysmography data to identify instances when the infant's pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant's PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level: rather, the feature is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The feature is not intended to replace traditional methods of monitoring, diagnosis or treatment. The Dream Sock is not intended for use with infants previously diagnosed with cardiovascular or respiratory disease or conditions.

Device Description

The Dream Sock uses photoplethysmography (PPG) on the infant's foot to measure the continuous pulse rate (PR) and oxygen saturation (SpO2) in the home environment. The device is intended to monitor healthy infants 1 to 18 months of age and between 6 to 30 lbs. The device includes alarms to alert the caregiver that the pulse rate or SpO2 has gone outside a preset range. The alarm thresholds are pulse rate <50 or >220 bpm and the SpO2<80%. The device calculates the outputs during times of motion and non-motion. The device includes 3 components: the sock hardware, the base station and mobile application. The wearable connects to the base station via Bluetooth (BLE). The Sock is the skin-contacting component that contains the PPG sensor and accelerometer. The accelerometer is used in signal quality algorithm. If too much motion is detected, then no measurement will be output. The PR and SpO2 algorithms are housed on the Sock. The algorithm uses a 10 second rolling window of the PPG data to calculate a measurement every second. The Sock communicates with the Base station using Bluetooth. The Base Station receives the readings and status from the sensor. When the PR and/or SpO2 measurement goes outside the preset threshold(s), a visual and auditory alarm will sound alerting the caregiver. When the caregiver acknowledges the alarm, the top of the base station is clicked to silence the alarm. The base station communicates with the Cloud which communicates with the phone application through WIFI. Additionally, this is used to charge the sensor. The mobile application displays the measurements and trend graphs of previous data. A new measurement is displayed every 5 seconds on the mobile application. If the base station alarms. the mobile application will display a notification.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard signal processing algorithms for calculating PR and SpO2 from PPG data and an accelerometer for motion detection. There is no mention of AI, ML, or deep learning in the device description, intended use, or performance studies. The algorithms are described as using a "10 second rolling window," which is a traditional signal processing technique.

Therapeutic

No.
The "Intended Use / Indications for Use" states that the device is "not intended to replace traditional methods of monitoring, diagnosis or treatment." It is primarily a monitoring device that provides notifications to prompt assessment, not to actively treat or mitigate a disease or condition.

Diagnostic

The text explicitly states: "The feature is not intended to replace traditional methods of monitoring, diagnosis or treatment." It is intended to provide notifications and supplement caregivers' decisions, not to diagnose.

SaMD (Software as a Medical Device)

The device description explicitly states that the device includes three components: the sock hardware, the base station, and the mobile application. The sock hardware contains the PPG sensor and accelerometer, which are physical components essential for data acquisition.

IVD (In Vitro Diagnostic)

Based on the provided information, the Dream Sock is not an In Vitro Diagnostic (IVD) 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.
Dream Sock's Function: The Dream Sock measures physiological parameters (pulse rate and oxygen saturation) directly from the infant's body using photoplethysmography. It does not analyze samples taken from the body.
Intended Use: The intended use is for monitoring and providing notifications to caregivers based on these direct measurements, not for analyzing biological specimens for diagnostic purposes.

Therefore, the Dream Sock falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Dream Sock analyzes photoplethysmography data to identify instances when the infant's pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range. and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant's PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.

The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level: rather, the feature is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The feature is not intended to replace traditional methods of monitoring, diagnosis or treatment.

The Dream Sock is not intended for use with infants previously diagnosed with cardiovascular or respiratory disease or conditions.

Product codes

QYU

Device Description

Regulation Number and Section

N/A

Summary

DE NOVO CLASSIFICATION REQUEST FOR OWLET DREAM SOCK

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Infant pulse rate and oxygen saturation monitor for over-the-counter use. An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).

NEW REGULATION NUMBER: 21 CFR 870.2705

CLASSIFICATION: Class II

PRODUCT CODE: QYU

BACKGROUND

DEVICE NAME: Dream Sock

SUBMISSION NUMBER: DEN220091

DATE DE NOVO RECEIVED: December 14, 2022

SPONSOR INFORMATION:

Owlet 3300 N. Ashton Blvd Suite 300 Lehi, UT 84043

INDICATIONS FOR USE

The Dream Sock is indicated as follows:

The Dream Sock is not intended for use with infants previously diagnosed with cardiovascular or respiratory disease or conditions.

LIMITATIONS

The Dream Sock does not detect, diagnose or reduce Sudden Infant Death Syndrome (SIDS) or Sudden Unexpected Infant Death (SUID).

The Owlet Dream Sock is not a substitute for adult supervision or safe sleep practices.

The Dream Sock is not intended to diagnose, cure, treat, alleviate, or prevent any disease or condition.

Alternate between feet every 8 hours and also after recharging the Sensor. Check the child's foot often for any signs of irritated skin.

The Dream Sock is not for babies and children with ongoing health conditions.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

See clinical section for skin observation study that was used to support the safe use of the device in the intended use population.

ELECTROMAGNETIC COMPATIBILITY & ELECTRICAL SAFETY

The Dream Sock conforms to the FDA-recognized standards for basic safety and essential performance of Medical Electrical Equipment. These standards include:

IEC 60601-1-2:2014- Medical Electrical Equipment, Part 1-2: General . requirements for safety- Collateral Standard: Electromagnetic compatibility-Requirements and tests
IEC 60601-1:2006 + A1:2013- Medical Electrical Equipment, Part 1: General . requirements for basic safety and essential performance
ASNI C63.27:2017- American National Standard for Evaluation of Wireless . Coexistence
. AAMI TIR69:2017- Technical Information Report Risk management of radiofrequency wireless coexistence for medical devices and systems.
IEC 60601-1-11:2015/AMD1:2020- 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

SOFTWARE

The Dream Sock has a Major Level of Concern (LOC). Appropriate documentation was provided to support the validation of the software for Major LOC in accordance with the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued May 11, 2005).

PERFORMANCE TESTING - BENCH

Test	Purpose	Method	Acceptance Criteria	Results
Pulse
Amplitude
(PA)	Verify the
accuracy of the
PA compared
against the
simulator value
& verify PR and
SpO2 is accurate
at different Pas	3 devices were
tested with a
simulator and the
PR, SpO2, and
PA were
measured by the
DUT	$≤$ (b)% ARMS
AND
As the simulator PA rises
from (b)(4)%, the ΔPR≤1bpm
&
Simulator PA ΔSpO2 (b)%≤PA $≤$ (b)% (b)%≤PA44 weeks and ≥18 months who weigh 6-30 lbs. The device was tested in 35 subjects who are independent from the algorithm training set. The results show that the SpO2 and pulse rate had an average root mean square (Ams) of 2.16% and 3.53 bpm, respectively.

Image /page/5/Figure/3 description: The image contains two scatter plots comparing measurements from two different devices. The left plot, titled "Figure 11.2 Masimo Radical 97 and Owlet OSS 3.0 PR Agreement", compares pulse rate measurements, with the Owlet OSS 3.0 on the y-axis and the Masimo Radical 97 on the x-axis. A regression line is plotted with the equation y = 1.02 + 0.998x and an R-squared value of 0.95. The right plot, titled "Figure 11.3 Masimo Radical 97 and Owlet OSS 3.0% Oxygen Agreement", compares SpO2 measurements, with the Owlet SpO2 on the y-axis and the Masimo SpO2 on the x-axis, and has a regression line with the equation y = 10.2 + 0.902x and an R-squared value of 0.72.

NICU Study

A prospective, single center, clinical study was conducted to support the alarm functionality. Subjects postmenstrual age