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510(k) Data Aggregation
(329 days)
Dream Sock
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 220 bpm and the SpO2
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 $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 $
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