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510(k) Data Aggregation
(135 days)
Discovery Irvine, California 92618
Re: K234021
Trade/Device Name: Masimo Stork Regulation Number: 21 CFR 870.2705
counter use |
| Classification Regulation/Product Code: | 21 CFR 870.2705
| |
| Regulation, ProductCode | 21 CFR 870.2705
| 21 CFR 870.2705
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters.
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) during no-motion, and low perfusion conditions of infants and neonates who are 0 to 18 months of age and between 6 to 30 lbs. The Masimo Stork™ is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months and between 6 to 30 lbs. Masimo Stork™ is indicated for use in home environments.
The Masimo Stork can be used to supplement a caregiver's decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2; rather, the Masimo Stork™ is intended to provide a notificient data are available for analysis.
The Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. The Masimo Stork is not intents and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.
The Masimo Stork is a wearable device that is applied to a baby's foot for the spot-checking and continuous monitoring of functional arterial oxygen saturation (SpO2), pulse rate (PR), and skin temperature. Masimo Stork is provided with wireless communication capabilities (e.g., Bluetooth) so that the parameter data can be communicated for monitoring (e.g., display, alarms).
The Masimo Stork can be used with the following components:
- Stork Boot: The Stork Boot is a silicone holder that helps in the placement and securement of the . Stork on to the baby's foot.
- Stork Hub: The Stork Hub is an alarm and connectivity device that helps in the communication of physiological data wirelessly from Stork to a software application. The Hub provides the charging of the Stork and can optionally be provided with a camera.
- . Stork App: The Stork App is a mobile device application installed on a smart device that provides the graphical user interface for the Stork for viewing and monitoring the physiological parameters.
- . Stork Cloud: The Stork Cloud is software that helps to store physiological data.
The Masimo Stork is a wearable device intended for monitoring physiological parameters in infants and neonates. The acceptance criteria and the studies performed to prove the device meets these criteria are detailed below, primarily focusing on its SpO2 (functional oxygen saturation of arterial hemoglobin) and Pulse Rate (PR) measurement performance, as well as skin temperature.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Masimo Stork's performance are derived from the specifications compared against the predicate device (Dream Sock DEN220091) and its previous clearance (K223721). The reported performance is based on the clinical studies conducted.
| Feature | Acceptance Criteria (from Masimo Stork Specifications / K223721) | Reported Device Performance (from Clinical Studies) |
|---|---|---|
| SpO2, No Motion (70-100%) | 1.5% Arms | 1.24% Arms (overall for equivalence study) |
| SpO2, Motion (70-100%) | 1.5% Arms | Not explicitly stated for motion, but overall 1.24% Arms (implied to meet or exceed) |
| SpO2, Low Perfusion (70-100%) | 2% Arms | Not explicitly stated for low perfusion, but overall 1.24% Arms (implied to meet or exceed) |
| Pulse Rate, No Motion (25-240 bpm) | 3 bpm Arms | (Derived from SpO2 accuracy, not directly stated in bpm for PR in clinical results summary) |
| Pulse Rate, Motion (25-240 bpm) | 5 bpm Arms | (Derived from SpO2 accuracy, not directly stated in bpm for PR in clinical results summary) |
| Pulse Rate, Low Perfusion (25-240 bpm) | 3 bpm Arms | (Derived from SpO2 accuracy, not directly stated in bpm for PR in clinical results summary) |
| Temperature 25°C to 43°C (77°F to 109.4°F) | ±0.3°C (±0.54°F) | Performance not explicitly detailed in the provided text, but generally inferred to meet. |
| Monitoring Availability (Low Motion) | Not explicitly stated as acceptance criteria, but reported | 99.7% |
Note: The document primarily presents accuracy in terms of ARMS (Accuracy Root Mean Square) for SpO2 and does not explicitly state separated ARMS values for PR in the clinical study summary tables, implying that PR performance aligns with SpO2 accuracy or is established through other internal testing meeting the stated specifications.
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes three clinical studies:
- Study 1 (Equivalence to RD SET Adhesive sensor):
- Sample Size: 30 subjects (14 light skin pigments, 16 dark skin pigments).
- Data Provenance: Not explicitly stated but inferred to be prospective clinical data collected during desaturation studies. The country of origin is not specified.
- Study 2 (Form, Fit, and Function - Convenience Sample):
- Sample Size: 42 infants and neonates (22 dark, 20 light skin pigmentations), across different ages and weights (0-18 months, 6-30 lbs).
- Data Provenance: Prospective clinical data collected during a doctor's visit. The country of origin is not specified.
- Study 3 (Overnight At-Home Study):
- Sample Size: 19 infants and neonates.
- Data Provenance: Prospective clinical data collected in a home environment (overnight use). The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
The provided document does not indicate the use of "experts" in the context of establishing ground truth for the physiological measurements (SpO2, PR, Temperature). Ground truth for these parameters in medical device testing, especially for pulse oximeters, is typically established using:
- Co-oximetry (blood gas analysis) for SpO2, and simultaneous ECG or invasive arterial pressure monitoring for PR, validated against reference standards.
- For temperature, a calibrated reference thermometer would typically be used.
The statement "The first study supported the equivalence of the performance of the Masimo Stork to the FDA cleared RD SET Adhesive sensor (K191059)" implies that the RD SET Adhesive sensor served as a comparative reference, which is a common method for ground truth in this context, alongside the direct physiological measurements. The experts involved would typically be medical professionals collecting and analyzing these reference measurements.
4. Adjudication Method for the Test Set
The document does not describe any "adjudication method" in the context of expert consensus or disagreement. This is generally not relevant for direct physiological measurements where ground truth is established objectively by reference devices or clinical gold standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a direct physiological monitor, not an AI software interpreting images or other complex data that typically benefits from MRMC studies to evaluate human-AI collaboration. The studies focus on the device's accuracy against established references, not on improving human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The performance data presented, particularly the ARMS values for SpO2, represents the standalone performance of the Masimo Stork device (algorithm only). The clinical studies directly assess how accurately the device measures SpO2 and PR compared to a reference standard, without human interpretation of the device's output being part of the core performance calculation. The device provides "notifications" and "display" to caregivers, but the core measurement accuracy is intrinsic to the device's algorithms.
7. Type of Ground Truth Used
The ground truth for the SpO2 measurements appears to be established through:
- Reference device comparison: "The first study supported the equivalence of the performance of the Masimo Stork to the FDA cleared RD SET Adhesive sensor (K191059)." This implies the RD SET sensor serves as a highly accurate reference.
- Desaturation studies: Subjects "undergoing desaturation in accordance with ISO 80601-2-61" typically involves controlled environments where arterial oxygen saturation is varied, and blood samples are drawn for co-oximetry, which is considered a gold standard for SpO2.
- For skin temperature, the ground truth would be from a calibrated reference thermometer, though details are not provided beyond the accuracy claim.
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For medical devices that directly measure physiological parameters like pulse oximeters, the development often involves extensive internal testing and calibration with various physiological models and human subjects, rather than distinct "training" and "test" sets in the machine learning sense. The provided clinical studies serve as validation (test) sets for the device's final performance. If there were machine learning components, that information is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Since a separate "training set" with ground truth establishment is not described in the context of this document, this information is not available. The performance specifications are stated as inherent to the device's design and are validated by the clinical studies.
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(329 days)
NEW REGULATION NUMBER: 21 CFR 870.2705
CLASSIFICATION: Class II
PRODUCT CODE: QYU
BACKGROUND
Infant pulse rate and oxygen saturation monitor for over-the counter use Regulation Number: 21 CFR 870.2705
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.
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