(135 days)
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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2024
Masimo Corporation Kertana Shankar Regulatory Manager 52 Discovery Irvine, California 92618
Re: K234021
Trade/Device Name: Masimo Stork Regulation Number: 21 CFR 870.2705 Regulation Name: Infant pulse rate and oxygen saturation monitor for over-the-counter use Regulatory Class: Class II Product Code: QYU, FLL Dated: December 19, 2023 Received: December 20, 2023
Dear Kertana Shankar:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K234021
Device Name Masimo Stork
Indications for Use (Describe)
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.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete
time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPO", followed by the address "52 Discovery, Irvine, CA 92618".
| Submitter and Address ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592 |
|---|---|
| Date: | April 26, 2024 |
| Contact: | Kertana ShankarRegulatory ManagerMasimo CorporationPhone: (949) 390-0140 |
| Trade Name: | Masimo Stork |
| Common Name: | Infant pulse rate and oxygen saturation monitor for over-the-counter use |
| Classification Regulation/Product Code: | 21 CFR 870.2705, Class II/ QYU |
| Additional Product Code: | FLL |
| Establishment RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | Introduction of Masimo Stork for OTC use |
| Predicate Device: | DEN220091 – Dream Sock |
| Reference Device: | K223721 – Masimo Stork |
1 Device Description
This submission covers the introduction of the Masimo Stork for OTC use. The subject device was previously cleared with different indications under K223721 for prescription use. 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.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".
- . 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 specifications are provided in Tables 1-1 and 1-2:
| Table 1-1: Masimo Stork Specifications | |
|---|---|
| Feature | Specifications |
| Remote Access to Monitored Data | Yes |
| Support Communication Types | Wireless |
| Wireless Protocols Supported | Bluetooth, Wi-Fi |
| Communication Security | Encryption |
| Continuous Display of Parameter Data | Yes |
| Supported Display Devices | Smart Device |
| User Interface | Touchscreen (Smart Device) |
| Performance Specifications | |
| SpO2, No Motion (70-100%) | 1.5% |
| SpO2, Motion (70-100%) | 1.5% |
| SpO2, Low Perfusion (70-100%) | 2% |
| Pulse Rate, No Motion (25-240 bpm) | 3 bpm |
| Pulse Rate, Motion (25-240 bpm) | 5 bpm |
| Pulse Rate, Low Perfusion (25-240 bpm) | 3 bpm |
| Temperature 25°C to 43°C (77°F to 109.4°F) | ±0.3°C (±0.54°F) |
| Electrical Specifications | |
| Battery Type | Internal Rechargeable Lithium ion |
| Battery Life | 16 hours |
| Mechanical Specifications | |
| Overall Dimension | 2.48" x 1.90" x 1.17" |
| Environmental Specifications | |
| Operating Temperature | 41°F to 95°F (5°C to 35°C) |
| Operating Humidity | 10% to 95%, non-condensing |
| Storage/Transport Temperature | -4°F to 140°F (-20°C to 60°C) |
| Storage/Transport Humidity | 10% to 95%, non-condensing |
| Classification per IEC 60601-1 | |
| Electrical Safety | IEC 60601-1 |
| EMC | IEC 60601-1-2 |
| Electrical Isolation Type | Class II (Internally Powered) |
| Applied Part Type | BF Applied Part |
| Ingress Protection | IP22 |
| Mode of Operation | Continuous |
| Table 1-2: Masimo Hub Specifications | |
|---|---|
| Feature | Specifications |
| Electrical Specifications | |
| Types of Power Source | AC |
| AC Electrical Power Rating | 100 to 240 VAC, 50 to 60 Hz, 0.2A |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
| Table 1-2: Masimo Hub Specifications | |
|---|---|
| Feature | Specifications |
| Mechanical Specifications | |
| Overall Dimension | 2.39" x 2.39" x 2.0"(6.07 x 6.07 x 5.08 cm) |
| Environmental Specifications | |
| Operating Temperature | 41°F to 95°F (5°C to 35°C) |
| Operating Humidity | 10% to 95%, non-condensing |
| Storage/Transport Temperature | -4°F to 140°F (-20°C to 60°C) |
| Storage/Transport Humidity | 10% to 95%, non-condensing |
2 Intended Use/ Indications for Use
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 notification only when sufficient 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 intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.
3 Technological Characteristics
Principle of Operation
There were no changes made to the principles of operation of the subject device, Masimo Stork, as part of this submission from the previous clearance under K223721.
The subject device still relies on Masimo SET pulse oximetry, which relies on the Beer-Lambert law and the following principles of pulse oximetry to provide estimates of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate:
- Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. On the left is a red circle with a white checkmark-like symbol inside. To the right of the circle is the word "Masimo" in bold, black letters. Further to the right is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
- The amount of arterial blood in tissue changes with your pulse (photoplethysmography). . Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Masimo Stork also provides a skin temperature monitoring feature that relies on the principle of operations of a thermistor, which relies on the correlation of the detected junction temperature to difference in impedances. These impedances are then processed to calculate the temperature at the measurement site.
Mechanism of Action for Achieving the Intended Effect
There were no changes made to the mechanism of action of the subject device, Masimo Stork, as part of this submission from the previous clearance under K223721.
The Masimo Stork still achieves its intended effect by the application on to the baby's foot. To keep the Stork in place, a bootie shaped holder is provided that secures the sensor in place. The Stork provides wireless capabilities so that a cabled connection is not required for the continuous transmission of the parameter measurements. The wireless communication is established using Bluetooth to support alarms and display. To support the display of the parameter data monitored by the Stork, a smart device software application is used as the user interface. The software application displays the parameter data and provides notifications of alarm conditions. The software application (App) also allows for the viewing of parameter trend information. The Hub that is provided with the Stork is provided with an integrated speaker and visual indicators to also notify of alarm conditions independent of the App. The Hub provides redundancy in the event the smart device battery is depleted or the alarm notifications on the App are not detected.
4 Discussion of Similarities and Differences Between the Predicate and Subject Device
Similarities and Differences between the Predicate and Subject Device
The subject device, Masimo Stork, and the predicate device, Owlet Dream Sock (DEN220091), have the following key similarities:
- · Both devices have the same intended use.
- · Both devices are wearable.
- · Both devices support monitoring of SpO2 and PR.
- · Both devices support wireless communication for the transfer of physiological data for remote display and monitoring.
The subject device, Masimo Stork, and the predicate device, Owlet Dream Sock (DEN220091), have the following key differences:
- · The subject device is indicated for a wider patient population.
- · The subject device additionally monitors skin temperature.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
The purpose of this submission is the introduction of Masimo Stork for over-the-counter use. The subject device was previously cleared with different indications under K223721 for prescription use. To support the substantial equivalence of the subject device, the Dream Sock (DEN220091) is included as the predicate device. Between the subject and the predicate device, Dream Sock (DEN220091), there are no differences in the intended use of pulse oximetry monitoring. Both the subject device and predicate device have similar technological characteristics, but the subject device provides a different SpO2 performance specification of 1.5% Arms versus the predicate device that reports a 3% Arms specification.
To support the improvement in the SpO2 performance does not raise different questions of safety and effectiveness, the previous clearance for the Masimo Stork, K223721, is included as the reference device. The performance of the Masimo Stork parameters has not changed from its previous clearance under K223721.
Refer to Table 4-1 below for the detailed comparison between the subject and predicate devices.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. The address is "52 Discovery, Irvine, CA 92618" and is located to the right of the logo.
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
|---|---|---|---|---|
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| Classification | Class II, Infant pulse rate and oxygen saturationmonitor for over-the-counter use | Class II, Infant pulse rate and oxygensaturation monitor for over-the-counter use | Same as the predicate device. | |
| Regulation, ProductCode | 21 CFR 870.2705, Class II/ QYU | 21 CFR 870.2705, Class II/ QYU | Same as the predicate device. | |
| Additional ProductCode(s) | FLL | N/A | Different from the predicatedevice.The subject device additionallysupports skin temperaturefeature, same as the featurecleared as part of K223721. | |
| Indications for Use | The Masimo Stork is a wearable device intended forthe monitoring of multiple physiological parameters.The Masimo Stork is indicated for the spot-checkingand continuous monitoring of functional oxygensaturation of arterial hemoglobin (SpO2) and PulseRate (PR) during no-motion, motion, and lowperfusion conditions of infants and neonates who are0 to 18 months of age and between 6 to 30 lbs. TheMasimo Stork is also indicated for continuous skintemperature measurements of infants and neonateswho are 0 to 18 months and between 6 to 30 lbs.Masimo Stork is indicated for use in homeenvironments.The Masimo Stork can be used to supplement acaregiver's decision to seek additional guidance for | The Dream Sock analyzesphotoplethysmography data to identifyinstances when the infant's pulse rate (PR)and/or oxygen saturation (SpO2) movesoutside a preset range, and provides anotification to the caregiver, prompting themto assess the infant.The Dream Sock also displays the infant's PRand SpO2 values to the caregiver and displaystrends in these measured values, and theirrelationship to the preset ranges, over time.These PR and SpO2 notifications anddisplays on the Dream Sock are intended foruse in infants who are 1 to 18 months of ageand between 6 to 30 lbs. | Same as the predicate device.Both devices are intended tomonitor babies using pulseoximetry features with alarms. | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| the care of an infant or neonate. It is not intended toprovide notifications for every episode of theunexpected occurrences of elevated or depressed PRor a low SpO2; rather, the Masimo Stork is intendedto provide a notification only when sufficient data areavailable for analysis.The Masimo Stork is not intended to replace themonitoring, diagnosis, or treatment provided by aphysician or healthcare provider. The Masimo Storkis not intended for use with infants and neonatespreviously diagnosed with cardiovascular orrespiratory disease or conditions. | The Dream Sock is intended for over-the-counter (OTC) use only in a homeenvironment. It is not intended to providenotification for every episode of theunexpected occurrences of elevated ordepressed PR or a low SpO2 level; rather, theDream Sock is intended to provide anotification only when sufficient data areavailable for analysis. The notifications andassociated data can be used to supplement thedecision by caregivers to seek additionalguidance for medical care of the infant.Dream Sock is not intended to replacetraditional methods of monitoring, diagnosis,or treatment. | |||
| The Dream Sock is not intended for use withinfants previously diagnosed withcardiovascular or respiratory disease orconditions. | ||||
| Principles of Operation | The pulse oximeter technology relies on theabsorption differences of red and infrared light todetermine SpO2 and Pulse Rate.Temperature measure relies on a thermistor that | The pulse oximetry sensor uses red andinfrared light which is transmitted throughoxyhemoglobin and are sensed in thephotoelectric cell. The red and infrared lightis absorbed in different amounts depending on | Similar to the predicate device.The subject device additionallysupports skin temperaturefeature, same as the feature | |
| correlates temperature to impedance changes. | the oxygenation of the blood. | cleared as part of K223721. | ||
| Parameters Monitored | SpO2, PR, Temperature | SpO2, PR | Similar to the predicate device. | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| Supported DisplayDevices | Smart Device App | Smart Device App | The subject device additionallysupports skin temperaturefeature, same as the featurecleared as part of K223721. | |
| Pulse Oximeter SensorType | Reusable | Reusable | Same as the predicate device. | |
| Temperature SensorType | Reusable | N/A | Different from the predicatedevice. | |
| Indicated population | Infants, Neonates (<18 months) | Infants (1-18 months) | Similar to the predicate device. | |
| Remote Access toMonitored Data | Yes | Yes | Same as the predicate device. | |
| Supported Alarms | SpO2, PR, and Temperature | SpO2 and PR | Similar to the predicate device.The subject device additionallysupports skin temperature | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| Type of Alarm | Audible and visual | Audible and visual | feature, same as the featurecleared under K223721. | |
| Distributed AlarmSystem | Yes | Yes | Same as the predicate. | |
| SupportedCommunication | Bluetooth, Wi-Fi | Bluetooth | Similar to the predicate devicesame as the feature clearedunder K223721.Testing performed on thedevice supports the substantialequivalence. | |
| CommunicationSecurity | Encryption | Unknown | Different from the predicatedevice, same as the featurecleared under K223721.Testing performed on thedevice supports the substantialequivalence. | |
| Pulse Oximetry SensorApplication Site | Foot | Foot | Same as the predicate device. | |
| Performance Specification | ||||
| SpO2, No Motion (70-100%) | 1.5% | 3% | Different from the predicatedevice, same as the featurecleared under K223721. | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| SpO2, Motion (70-100%) | 1.5% | Not specified | Performance testing performedon the device supports thesubstantial equivalence.Different from the predicatedevice, same as the featurecleared under K223721. | |
| SpO2, Low Perfusion(70-100%) | 2% | Not specified | Performance testing performedon the device supports thesubstantial equivalence.Different from the predicatedevice, same as the featurecleared under K223721. | |
| Pulse Rate, No Motion | 3 bpm Arms, 25-240 bpm | 3 bpm Arms, 30-300 bpm | Performance testing performedon the device supports thesubstantial equivalence.Different from the predicatedevice, same as the featurecleared under K223721. | |
| Pulse Rate, Motion | 5 bpm Arms, 25-240 bpm | Not specified | Performance testing performedon the device supports thesubstantial equivalence.Different from the predicatedevice, same as the featurecleared under K223721. | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| Pulse Rate, LowPerfusion | 3 bpm Arms, 25-240 bpm | Not specified | Performance testing performedon the device supports thesubstantial equivalence.Different from the predicatedevice, same as the featurecleared under K223721. | |
| Temperature,MeasurementAccuracy | +/- 0.3°C | N/A | Performance testing performedon the device supports thesubstantial equivalence.Different from the predicatedevice, same as the featurecleared under K223721. | |
| TemperatureMeasurement Site | Foot | Foot | Same as the predicate device. | |
| Enclosure Material | Thermoplastic | Unknown | Different from the predicatedevice, same as the featurecleared under K223721.Testing performed on thedevice supports the substantialequivalence. | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| Overall Dimension | 2.48" x 1.90" x 1.17" | Unknown | Different from the predicatedevice, same as the featurecleared under K223721.Testing performed on thedevice supports the substantialequivalence. | |
| Operating Temperature | 5°C to 35°C (41°F to 95°F) | 5°C to 40°C (41°F to 104°F) | Different from the predicatedevice, same as the featurecleared under K223721.Testing performed on thedevice supports the substantialequivalence. | |
| Operating Humidity | 10% to 95%, non-condensing | 15% to 90%, non-condensing | Different from the predicatedevice, same as the featurecleared under K223721.Testing performed on thedevice supports the substantialequivalence. | |
| Storage/ TransportTemperature | -20°C to 60°C (-4°F to 140°F) | -25°C to 70°C (-13°F to 158°F) | Different from the predicatedevice, same as the featurecleared under K223721.Testing performed on thedevice supports the substantialequivalence. | |
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo StorkSubject Device(K234021) | Dream SockPredicate Device(DEN220091) | Comparison to Predicate | |
| Storage/ Transport Humidity | 10% to 95%, non-condensing | 0% to 90%, non-condensing | Different from the predicate device, same as the feature cleared under K223721.Testing performed on the device supports the substantial equivalence. | |
| Electrical Safety | IEC 60601-1 | Unknown | Different from the predicate device, same as the feature cleared under K223721.Testing performed on the device supports the substantial equivalence. | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same as the predicate device. | |
| Applied Part Type | BF Applied Part | Unknown | Same as the predicate device. | |
| Ingress Protection | IP22 | Unknown | Same as the predicate device. | |
| Mode of Operation | Continuous | Continuous | Same as the predicate device. |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. Below the logo is the address "52 Discovery, Irvine, CA 92618".
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo is a red circle with a white checkmark inside, followed by the word "Masimo" in black letters. The address is "52 Discovery, Irvine, CA 92618" and is located to the right of the logo.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the Masimo Corporation logo. The logo consists of a red circle with a white lightning bolt inside, followed by the word "Masimo" in black, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the Masimo Corporation logo. The logo consists of a red circle with a white lightning bolt inside, followed by the word "Masimo" in black, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo is a red circle with a white checkmark inside, followed by the word "Masimo" in black letters. The address is "52 Discovery, Irvine, CA 92618" and is located to the right of the logo.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo is a red circle with a white checkmark inside, followed by the word "Masimo" in black letters. The address is "52 Discovery, Irvine, CA 92618" and is located to the right of the logo.
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the Masimo Corporation logo. The logo consists of a red circle with a white lightning bolt inside, followed by the word "Masimo" in black, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black font. To the right of the logo is the text "MASIMO CORPORATION" in gray font, followed by the address "52 Discovery, Irvine, CA 92618" also in gray font.
5 Performance Data
There were no hardware or software changes made to the subject device from the previous clearance under K223721.
Performance Bench Testing
There were no hardware or software changes made to the subject device as part of this submission; therefore, the performance testing from the previous clearance (K223721) was leveraged to support the subject device met the special controls of product code QYU and its performance specifications.
Biocompatibility Testing
There were no changes made to the patient contacting materials of the subject device from the previous clearance under K223721; therefore, the biocompatibility testing from the previous clearance was leveraged to support the subject device met the special controls of product code QYU, and its biocompatibility risk acceptability.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
There were no hardware changes made to the subject device from the previous clearance (K223721); therefore, the testing from the previous clearance was leveraged to support the subject device met the special controls of product code QYU, and acceptability of the electrical safety, environmental, mechanical, and cleaning properties of the subject device.
Software Verification and Validation Testing
As there were no software changes made to the subject device from the previous clearance (K223721), the software testing from the previous clearance was leveraged to support the software verification and validation.
Wireless Testing
As there were no changes made to the subject device from the previous clearance (K223721), no new wireless testing was included as part of this submission.
Cybersecurity Testing
As there were no changes made to the subject device that affects cybersecurity, no new additional cybersecurity testing was included as part of this submission.
Human Factors and Usability Testing
The human factors and usability validation testing was performed in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016, and FDA
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
Guidance, Self-Selection Studies for Nonprescription Drug Products, April 2013, to support the acceptability of the human factors and usability risks of the Masimo Stork when used by OTC caregivers without clinician intervention.
The HF validation testing followed a two-part process, where the identification of the intended user participants using a self-selection process and the second part used the intended user participants in the validation of the device. The HF validation of the device comprised of simulated use testing and knowledge task evaluations, which were conducted using self-selected participants. A supplemental knowledge task testing was performed that evaluated the understanding of the information provided as part of the Masimo Stork operator's manual.
The results of the human factors and usability evaluation supported the acceptable human factors and usability risks by intended users in the home environment for over-the-counter use.
Clinical Testing
To support the performance of the Masimo Stork, three clinical studies were performed. The first study supported the equivalence of the performance of the Masimo Stork to the FDA cleared RD SET Adhesive sensor (K191059). This testing included data from 30 subjects of light (14) and dark (16) skin pigments undergoing desaturation in accordance with ISO 80601-2-61. The results of the testing supported the equivalence of the Masimo Stork to the cleared reference RD SET Adhesive sensor (K191059). The results are summarized below:
| Bias | MAB | Precision | ARMS | LOA | Nsubj | Npairs |
|---|---|---|---|---|---|---|
| 0.47 | 0.94 | 1.15 | 1.24 | [-1.78, 2.71] | 30 | 1848 |
The second study was a convenience sample study that was performed to support the form, fit, and function of the Masimo Stork in its indicated population. The study included 42 infants and neonates across different skin pigmentations (22 dark, 20 light), ages, and weights under a doctor's visit. Subjects were classified as light, medium, and dark based upon their Massey-Martin scores. Subjects with a Massey score of 1-3 were classified as "Light", 4-6 classified as "Medium" and 7-10 as "Dark". The overall performance of the Masimo Stork was 0.94 % Crms. The breakdown of the performance for light, medium, and dark subjects is provided below:
| Pigmentation | Bias | Precision | CRMS | LOA | Nsubj | Npairs |
|---|---|---|---|---|---|---|
| Dark(Massey 7-10) | 0.11 | 0.77 | 0.78 | [-1.40, 1.62] | 6 | 2698 |
| Medium(Massey 4-6) | -0.04 | 1.00 | 1.00 | [-2.00, 1.92] | 14 | 8395 |
| Light(Massey 1-3) | -0.24 | 0.90 | 0.93 | [-1.99, 1.52] | 22 | 14879 |
The third study was an overnight at-home study that was performed on 19 infants and neonates in which parents used the Masimo Stork overnight on their babies in a home environment. The study was performed to support the prolonged use of the intended home environment. The data also supported the
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in a smaller, sans-serif font. Below the company name is the address "52 Discovery, Irvine, CA 92618".
acceptability of Masimo Stork in providing good availability of the monitoring throughout its use (99.7% under low motion conditions).
The performance testing results support the substantial equivalence of the subject device.
6 Conclusion
Based on the data provided as part of this submission, the subject device, Masimo Stork, was found to be substantially equivalent to the predicate device.
N/A