(135 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological monitoring technology.
No.
The device is intended for monitoring physiological parameters and providing data to supplement a caregiver's decision, not for diagnosis, treatment, or replacement of medical care.
Yes
The device is intended for "monitoring of multiple physiological parameters" including SpO2, Pulse Rate, and skin temperature, and the results from this monitoring can be used to "supplement a caregiver's decision to seek additional guidance for the care of an infant or neonate". While it explicitly states it is not for diagnosis, the act of monitoring physiological parameters to inform care decisions is a diagnostic function.
No
The device description explicitly lists hardware components like the "Stork Boot" and "Stork Hub" which are integral to the device's function of collecting physiological data. While there is a software component (Stork App and Stork Cloud), the device itself is a wearable hardware device with accompanying software.
Based on the provided information, the Masimo Stork is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Masimo Stork's Function: The Masimo Stork is a wearable device that directly monitors physiological parameters (SpO2, Pulse Rate, Skin Temperature) from the body surface (foot). It does not involve the collection or analysis of specimens taken from the body.
Therefore, the Masimo Stork falls under the category of a physiological monitoring device, not an IVD.
N/A
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 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.
Product codes
QYU, FLL
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.
- . 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot
Indicated Patient Age Range
0 to 18 months of age
Intended User / Care Setting
Caregiver in home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
-
Clinical Study 1: Supported the equivalence of Masimo Stork to the FDA cleared RD SET Adhesive sensor (K191059) for SpO2 performance.
- Sample Size: 30 subjects (14 light skin, 16 dark skin)
- Study Type: Desaturation study in accordance with ISO 80601-2-61.
- Key Results: Bias 0.47, MAB 0.94, Precision 1.15, ARMS 1.24, LOA [-1.78, 2.71]. Npairs 1848.
-
Clinical Study 2: Convenience sample study to support form, fit, and function.
- Sample Size: 42 infants and neonates
- Data Source: Doctor's visit. Subjects classified by Massey-Martin scores for skin pigmentation (6 Dark, 14 Medium, 22 Light).
- Key Results: Overall performance 0.94% Crms.
- Dark (Massey 7-10): Bias 0.11, Precision 0.77, CRMS 0.78, LOA [-1.40, 1.62], Nsubj 6, Npairs 2698.
- Medium (Massey 4-6): Bias -0.04, Precision 1.00, CRMS 1.00, LOA [-2.00, 1.92], Nsubj 14, Npairs 8395.
- Light (Massey 1-3): Bias -0.24, Precision 0.90, CRMS 0.93, LOA [-1.99, 1.52], Nsubj 22, Npairs 14879.
-
Clinical Study 3: Overnight at-home study for prolonged use in the home environment.
- Sample Size: 19 infants and neonates
- Study Type: At-home parent-led use.
- Key Results: Supported acceptability of Masimo Stork in providing good availability of monitoring throughout its use (99.7% under low motion conditions).
Key Metrics
- 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)
Predicate Device(s)
DEN220091 – Dream Sock
Reference Device(s)
K223721 – Masimo Stork
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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) |
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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 of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | April 26, 2024 |
| Contact: | Kertana Shankar
Regulatory Manager
Masimo Corporation
Phone: (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 Registration
Number: | 3011353843 |
| Reason for Premarket
Notification: | 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 |
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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).
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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.
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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.
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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 Stork | |||
| Subject Device | ||||
| (K234021) | Dream Sock | |||
| Predicate Device | ||||
| (DEN220091) | Comparison to Predicate | |||
| Classification | Class II, Infant pulse rate and oxygen saturation | |||
| monitor for over-the-counter use | Class II, Infant pulse rate and oxygen | |||
| saturation monitor for over-the-counter use | Same as the predicate device. | |||
| Regulation, Product | ||||
| Code | 21 CFR 870.2705, Class II/ QYU | 21 CFR 870.2705, Class II/ QYU | Same as the predicate device. | |
| Additional Product | ||||
| Code(s) | FLL | N/A | Different from the predicate | |
| device. | ||||
| The subject device additionally | ||||
| supports skin temperature | ||||
| feature, same as the feature | ||||
| cleared as part of K223721. | ||||
| 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, 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 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. | Same as the predicate device. | |||
| Both devices are intended to | ||||
| monitor babies using pulse | ||||
| oximetry features with alarms. | ||||
| Table 4-1 Comparison between Subject and Predicate Devices | ||||
| Feature | Masimo Stork | |||
| Subject Device | ||||
| (K234021) | Dream Sock | |||
| Predicate Device | ||||
| (DEN220091) | Comparison to Predicate | |||
| 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. | 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 | ||||
| Dream Sock 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. | ||||
| Dream Sock 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. | ||||
| Principles of Operation | The pulse oximeter technology relies on the | |||
| absorption differences of red and infrared light to | ||||
| determine SpO2 and Pulse Rate. | ||||
| Temperature measure relies on a thermistor that | The pulse oximetry sensor uses red and | |||
| infrared light which is transmitted through | ||||
| oxyhemoglobin and are sensed in the | ||||
| photoelectric cell. The red and infrared light | ||||
| is absorbed in different amounts depending on | Similar to the predicate device. | |||
| The subject device additionally | ||||
| supports skin temperature | ||||
| feature, 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 Stork | |||
| Subject Device | ||||
| (K234021) | Dream Sock | |||
| Predicate Device | ||||
| (DEN220091) | Comparison to Predicate | |||
| Supported Display | ||||
| Devices | Smart Device App | Smart Device App | The subject device additionally | |
| supports skin temperature | ||||
| feature, same as the feature | ||||
| cleared as part of K223721. | ||||
| Pulse Oximeter Sensor | ||||
| Type | Reusable | Reusable | Same as the predicate device. | |
| Temperature Sensor | ||||
| Type | Reusable | N/A | Different from the predicate | |
| device. | ||||
| Indicated population | Infants, Neonates ( |