(329 days)
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.
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.
Here's a breakdown of the acceptance criteria and the studies proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility/Materials | Cytotoxicity | Grade $\le$ 2 | PASS at 1:8 dilution |
| Sensitization | No evidence of tissue reaction | PASS | |
| Irritation | No evidence of tissue irritation | PASS | |
| Acute Systemic Toxicity | No unscheduled deaths; no weight loss >10% | PASS | |
| Material Mediated Pyrogenicity | Animals survive and are healthy via temperature monitoring | PASS | |
| Electromagnetic & Electrical | Essential Performance | Conforms to IEC 60601-1-2:2014, IEC 60601-1:2006 + A1:2013, ASNI C63.27:2017, AAMI TIR69:2017, IEC 60601-1-11:2015/AMD1:2020 | Conforms to all listed standards |
| Software | Validation (Major LOC) | Appropriate documentation provided to support validation in accordance with FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued May 11, 2005) | Documentation provided and accepted for Major LOC |
| Performance Testing - Bench | Pulse Amplitude (PA) Accuracy | $\le$(b)% ARMS AND As the simulator PA rises from (b)%, the $\Delta$PR $\le$ 1bpm & Simulator PA $\Delta$SpO2 (b)% $\le$ PA $\le$ (b)% (b)% $\le$ PA < (b)% $\le$ (b)% (Specific numerical values for (b) are redacted in the provided text.) | PASS (Specific numerical values for the reported performance are not provided, but it states "PASS") |
| Pulse Rate Accuracy | $A_{RMS} \le$ 1 bpm | PASS | |
| Alarm Testing | Functionality works as intended (per 60601-1-8:2006+ AMD1:2012+AMD2:2020) | PASS | |
| Clinical Performance | SpO2 Accuracy (Breathe-down) | RMS < 3% (for both non-motion and motion) | Non-motion RMS: 2.51% Motion RMS: 2.46% (Meets criteria) |
| Pulse Rate Accuracy (Breathe-down) | RMS < 5 bpm (for both non-motion and motion) | Non-motion RMS: 2.47 bpm Motion RMS: 2.54 bpm (Meets criteria) | |
| SpO2 Accuracy (At-Home Study) | (Implicit: Demonstrate acceptable accuracy for SpO2 in intended use population) | Average Root Mean Square (Ams) of 2.16% (This is a performance result, and while not an explicit "acceptance criteria" value, it shows the device's accuracy in the intended environment, implicitly meeting the expectation for clinical performance.) | |
| Pulse Rate Accuracy (At-Home Study) | (Implicit: Demonstrate acceptable accuracy for PR in intended use population) | Average Root Mean Square (Ams) of 3.53 bpm (Similar to SpO2, this is a performance result indicating acceptable accuracy.) | |
| Alarm Specificity (Bradycardia) | (Implicit: High specificity to minimize false positives) | 100% (High specificity indicates very low false positives, meeting an implied acceptance criterion for alarm reliability.) | |
| Alarm Specificity (Oxygen Desaturation) | (Implicit: High specificity to minimize false positives) | 99.86% (High specificity indicates very low false positives, meeting an implied acceptance criterion for alarm reliability.) | |
| Skin Irritation | Low rate and low severity of skin reactions (Implicit criterion based on biocompatibility and safety.) | Estimated rate of reactions per person per week of 0.16 (95% CI 0.01, 0.40). All skin reactions were severity 1 (Slight indentation or mild color change). (Meets implicit criterion for low rate and severity.) | |
| Human Factors/Usability | Caregiver Use & Interpretation | Caregiver can correctly use the device based solely on reading the labeling and correctly interpret outputs and understand next steps. | All subjects responded to critical tasks by responding to the infant upon annunciation of notification events. Correct response included assessing the infant's condition and correcting the root cause of the notification. (Meets criterion for correct use and response.) |
2. Sample Size for the Test Set and Data Provenance
- Breathe-down Study:
- Sample Size: 18 healthy adults
- Provenance: Prospective, conducted in a controlled environment (likely a lab/clinical setting) with induced lower SpO2. "invasive pulse oximetry and the Masimo pulse oximeter" used as reference.
- At-Home Study:
- Sample Size: 35 subjects (infants between post menstrual age $> $44 weeks and $\ge$ 18 months, weighing 6-30 lbs)
- Provenance: Prospective, conducted in a home environment. Independent from the algorithm training set.
- NICU Study:
- Sample Size: 66 patients (infants postmenstrual age $< $44 weeks)
- Provenance: Prospective, single-center clinical study conducted in a Neonatal Intensive Care Unit (NICU).
- Skin Observation Study:
- Sample Size: 43 participants (infants with an average age of 7.0 $\pm$ 4.7 months). 30 wore the device for $\ge$ 48 hours.
- Provenance: Prospective study.
- Usability Testing:
- Sample Size: 20 participants (lay caregivers)
- Provenance: Conducted in a simulated-use environment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number or specific qualifications of experts used to establish a "ground truth" for the test sets in the typical sense of expert annotation for machine learning.
- For the Breathe-down Study, an "invasive pulse oximetry and the Masimo pulse oximeter" served as reference devices for SpO2 and Pulse Rate measurements.
- For the NICU Study, "hospital grade pulse oximeters and electrocardiogram (ECG)" were used as continuous monitoring references.
- For the Skin Observation Study, the skin inspections were likely performed by trained medical personnel, though their specific qualifications or number are not detailed.
4. Adjudication Method for the Test Set
The provided text does not mention any formal adjudication methods (like 2+1 or 3+1) for establishing ground truth for the test sets. The ground truth seems to be established through:
- Comparison against established reference medical devices (invasive pulse oximetry, Masimo pulse oximeter, hospital-grade pulse oximeters, ECG).
- Direct observation for events like skin irritation.
- Observation of user actions in usability testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was mentioned or conducted, as this device is a direct monitoring device and not an AI-assisted diagnostic tool for human interpretation.
6. Standalone (Algorithm Only) Performance
Yes, standalone (algorithm only) performance was evaluated for the Dream Sock.
- Breathe-down Study: This study directly measured the SpO2 and Pulse Rate accuracy of the device (algorithm) against reference methods under simulated motion and non-motion conditions.
- At-Home Study: This study evaluated the SpO2 and Pulse Rate accuracy of the device in a home environment.
- NICU Study: This study evaluated the alarm functionality (specificity) of the device's algorithms against reference monitoring.
These studies assess the device's inherent ability to measure and alarm without direct human input beyond setting up the device and receiving notifications.
7. Type of Ground Truth Used
The ground truth used in the studies includes:
- Reference Medical Devices: Invasive pulse oximetry, Masimo pulse oximeter, hospital-grade pulse oximeters, and electrocardiogram (ECG) for SpO2 and Pulse Rate measurements and alarm validation.
- Direct Observation/Subjective Assessment:
- Skin irritation assessed through inspections (Skin Observation Study).
- Caregiver responses to notifications in usability testing.
8. Sample Size for the Training Set
The document explicitly states that the subjects in the At-Home Study (35 subjects) were "independent from the algorithm training set." However, it does not provide the sample size for the training set itself.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established. It only mentions that the At-Home study's subjects were independent from the training set, implying a separate training phase occurred, but offers no specifics on its data sources or annotation methods.
{0}------------------------------------------------
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 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.
{1}------------------------------------------------
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.
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
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
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
{2}------------------------------------------------
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.
Base Station
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.
Mobile Application
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.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
Biocompatibility testing was performed according to FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process." The sponsor tested cytotoxicity, skin sensitization and skin irritation of the sock. The sponsor tested according to the guidelines for long-term, intact skin contact. Due to the device failing cvtotoxicity testing until 1:8 dilution, the sponsor provided acute systemic toxicity, and material mediated pyrogenicity testing to support safety of the device in the fragile population.
| Test | Purpose | Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| Cytotoxicity | To identify anycytotoxic effects to thepatient | ISO 10993-1 | Grade $[\le]$ 2 | PASS at 1:8 dilution |
| Sensitization | To identify tissuereactions from the patch | ISO 10993-1 | No evidence oftissue reaction | PASS |
| Irritation | To identify tissueirritation | ISO 10993-1 | No evidence oftissue irritation | PASS |
| Acute SystemicToxicity | To identify healthhazards likely to arisedue to acute exposure | ISO 10993-11 | No unscheduleddeaths; no weightloss >10% | PASS |
| Material MediatedPyrogenicity | Detection of materialmediated pyrogenicity | ISO 10993-11 | Animals survive andare healthy viatemperaturemonitoring | PASS |
See clinical section for skin observation study that was used to support the safe use of the device in the intended use population.
{3}------------------------------------------------
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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PulseAmplitude(PA) | Verify theaccuracy of thePA comparedagainst thesimulator value& verify PR andSpO2 is accurateat different Pas | 3 devices weretested with asimulator and thePR, SpO2, andPA weremeasured by theDUT | $≤$ (b)% ARMSANDAs the simulator PA risesfrom (b)(4)%, the ΔPR≤1bpm&Simulator PA ΔSpO2 (b)%≤PA $≤$ (b)% (b)%≤PA<(b)% $≤$ (b)% (b)%≤PA<(b)% $≤$ (b)% | PASS |
{4}------------------------------------------------
| Pulse RateAccuracyTest | To evaluate thepulse rateperformance forthe full claimedrange | ISO 80601-2-61Clause201.12.1.104 | $A_{RMS} \leq 1$ bpm | PASS |
|---|---|---|---|---|
| AlarmTesting | Ensure alarmfunctionalityworks asintended | Testing was performed according to 60601-1-8:2006+ AMD1:2012+AMD2:2020 | PASS |
SUMMARY OF CLINICAL INFORMATION
USABILITY TESTING
Usability Testing was provided in accordance with the FDA Guidance Document, "Applying Human Factors and Usability Engineering to Medical Devices- Guidance for Industry and Food and Drug Administration Staff" (issued February 02, 2016).
Twenty (20) participants belonging to a user group of lay caregivers participated in the human factors validation study. The testing was performed in a simulated- use environment using a sequence of tasks. All subjects responded to critical tasks by responding to the infant upon annunciation of notification events. Correct response included assessing the infant's condition and correcting the root cause of the notification.
Skin Observation Study
A prospective study was performed to support the safety of the Dream Sock hardware, the Sock. The study included 43 participants with an average age was 7.0±4.7 months. Thirty participants wore the device for at least 48 hours. The skin was checked every 4 hours for any skin irritation. The skin reactions were evaluated for severity. Three skin reactions occurred in 2 of the 43 participants leading to an estimated rate of reactions per person per week of 0.16 (95% CI 0.01. 0.40). All skin reactions were determined to be a severity of 1 (Slight indentation or mild color change (pink/slightly darker)).
Breathe Down Study
A Breathe-down study was performed in 18 healthy adults over the age of 18 years using an invasive pulse oximetry and the Masimo pulse oximeter. The performance of the device across the 70-100% SpO2 range was assessed in adults because it is unethical to induce lower SpO2 in infants. The device was placed on the subject's hand and simulated motion and non-motion imitations. The pulse rate and SpO2 were collected. The accuracy was provided for motion and non-motion simulations. The results are shown in the table below. The results for the SpO2 met the acceptance criteria of RMS<3% for the nonmotion and motion simulations. The results for the acceptance criteria of the RMS<5bpm for the non-motion and motion simulations.
{5}------------------------------------------------
| Non-motion(RMS) | Motion(RMS) | |
|---|---|---|
| SpO2 | 2.51 | 2.46 |
| Pulse Rate | 2.47 | 2.54 |
At-Home Study
A clinical study was performed on subjects between post menstrual age>44 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<44 weeks in the NICU were monitored with. the device for 48 hours. The skin under the Sock was inspected every 4 hours and the device is switched between feet every 8 hours. Sixty-six patients were continuously monitored with the Dream Sock, hospital grade pulse oximeters and electrocardiogram (ECG). In addition to the skin irritation observations, this testing was used to provide information about the alarm functionality at the preset thresholds. The specificity for the bradycardia and oxygen desaturation thresholds were 100% and 99.86%, respectively. This analysis indicates that the risk of false positive alarms is low.
Signal Quality Scoring in Pediatrics
Signal Quality was evaluated with patients in the Skin Observational Study and the At-Home study for a total of 70 patients. A full range of Fitzpatrick scale was included. Data were collected during various levels of activities with different intensities. The results showed evidence of no deterioration based on skin tone, or foot/ankle circumference within the intended use population. There was minimal deterioration based on movement.
{6}------------------------------------------------
LABELING
The labeling of the device satisfies the special controls listed below:
- A description of what the device measures and outputs to the user; .
- Instructions for proper placement of the device; .
- Instructions on care and cleaning of the device; .
- . Recommended actions based on device outputs to the user;
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of the infant pulse rate and oxygen saturation monitor for over-the-counter use and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Poor quality incomingphotoplethysmography signalresulting in failure to detect pulserate (PR) and oxygen saturation(SpO2) | Clinical performance testing |
| Human factors testing | |
| Electrical safety testing | |
| Electromagnetic compatibility testing | |
| Labeling | |
| Misinterpretation and/or over-reliance on device output, leading tofailure to seek treatment despiteacute symptoms | Human factors testing |
| Labeling | |
| Adverse tissue reaction | Clinical performance testing |
| Biocompatibility evaluation | |
| Human factors testing | |
| Labeling | |
| False positive leading tounnecessary medical procedures | Clinical performance testing |
| Non-clinical performance testing | |
| Software verification, validation, and hazard analysis | |
| Human factors testing | |
| Labeling | |
| False negative resulting in failure todetect high or low pulse rate eventand/or low SpO2 level event | Clinical performance testing |
| Non-clinical performance testing | |
| Software verification, validation, and hazard analysis | |
| Human factors testing | |
| Labeling |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the infant pulse rate and oxygen saturation monitor for over-the-counter use is subject to the following special controls:
{7}------------------------------------------------
- (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include the following:
- Evaluation of the effect of confounding variables, like skin pigmentation, on (i) performance; and
- (ii) Demonstration of the consistency of the output and representativeness of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment; and
- (iii) Evaluation of all adverse events, including skin irritation.
- (2) Software verification, validation, and hazard analysis must be performed. Documentation must include:
- Technical specifications of the software, including software algorithm(s) and its (i) inputs and outputs; and
- Specification of acceptable incoming sensor data quality control measures. (ii)
- (3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmography signal quality and validate any alarms.
- (4) The skin-contacting components of the device must be demonstrated to be biocompatible.
- (5) Performance testing must support the electrical safety and electromagnetic compatibility (EMC) of the electrical components of the device.
- (6) Human factors and usability testing must demonstrate the following:
- The caregiver can correctly use the device based solely on reading the device (i) labeling; and
- (ii) The caregiver can correctly interpret the device outputs and understand next steps to take based on the outputs.
- (7) Labeling must include:
- Instructions for identifying the intended use population of the device, including (i) populations where the device should not be used, and conditions of monitoring;
- (ii) A description of what the device measures and outputs to the caregiver, including instructions for the interpretation of results and appropriate actions;
- (iii) Situations in which the device may not operate at an expected performance level; and
- Instructions for cleaning the device and cleaning frequency. (iv)
BENEFIT-RISK DETERMINATION
The risks of the device include unnecessary medical attention, over-reliance on the device outputs, and misinterpretation of the device output. Unnecessary medical attention ("false positive") may result in caregiver's reaching out to medical professionals when treatment is not necessary, which uses unnecessary medical resources leading to the clinician's workload being disrupted. Over-reliance on the device outputs ("false negative") may result in delay of treatment, missed interventions. Additionally, due to the fragile skin of the intended population, skin irritation may occur if the device is worn incorrectly or not cleaned properly.
{8}------------------------------------------------
The device monitors the infant's pulse rate and SpO2, so it provides continuous vital sign monitoring of the healthy infant without clinician oversight. Also, the device provides additional information to the caregiver in addition to adult supervision.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
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.
The probable benefits outweigh the probable risks for the Dream Sock. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the Dream Sock is granted and the device is classified as follows:
Product Code: OYU Device Type: Infant pulse rate and oxygen saturation monitor for over-the counter use Regulation Number: 21 CFR 870.2705 Class: II
N/A