(368 days)
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments.
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, motion, and low perfusion conditions.
The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.
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 Stork combines the signal processing and optical components (i.e., signal detecting parts) into a single pulse oximetry module. The module is flat to allow for the flush contact with a baby (e.g., neonate, infant) foot.
Masimo Stork can be used with following components:
-
- Stork Boot ("Boot") is a silicone holder that helps in the placement and securement of the Stork on to the baby's foot.
-
- Stork Hub ("Hub") is an alarm/ connectivity device that helps in the communication of the 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 ("App") is mobile device application that is connected through the Hub and/or directly to the Stork to provide the user interface for viewing and monitoring the physiological parameters.
-
- Stork Cloud ("Cloud") is the software that helps to store the physiological data. It also helps to monitor the wireless connections between the Hub, App, and Stork.
Here's a breakdown of the acceptance criteria and the studies conducted for the Masimo Stork device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (from Masimo Stork Specifications) | Reported Device Performance (from Clinical and Bench Testing Summaries) |
|---|---|---|
| SpO2, No Motion (70-100%) | 1.5% | Supported |
| SpO2, Motion (70-100%) | 1.5% | Supported |
| SpO2, Low Perfusion (70-100%) | 2% | Supported |
| Pulse Rate, No Motion (25-240 bpm) | 3 bpm | Supported |
| Pulse Rate, Motion (25-240 bpm) | 5 bpm | Supported |
| Pulse Rate, Low Perfusion (25-240 bpm) | 3 bpm | Supported |
| Temperature [25°C to 43°C (77°F to 109.4°F)] | ± 0.3°C (± 0.54°F) | Supported |
| Overall Dimensions | 2.48" x 1.90" x 1.17" | Supported (no significant differences from predicate) |
| Operating Temperature | 0°C to 40°C (32°F to 104°F) | Supported |
| Operating Humidity | 10% to 95%, non-condensing | Supported |
| Storage/Transport Temperature | -20°C to 60°C (-4°F to 140°F) | Supported |
| Storage/Transport Humidity | 10% to 95%, non-condensing | Supported |
| Electrical Safety | IEC 60601-1 | Compliant |
| EMC | IEC 60601-1-2 | Compliant |
| Ingress Protection | IP22 | Supported |
| Biocompatibility | ISO 10993-1 | Compliant |
| Software | IEC 62304 & FDA Guidance | Compliant with verification & validation |
| Cybersecurity | FDA Guidance | Compliant with mitigations against risks |
| Human Factors | FDA Guidance | Compliant with testing |
| Alarm Performance | Acceptable non-actionable alarms, good availability | 99.7% availability under low motion conditions |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2 Accuracy Clinical Study: 30 subjects (14 light skin pigmented, 16 dark skin pigmented).
- Data Provenance: Not explicitly stated regarding country of origin, but it describes a "desaturation protocol," which implies a controlled clinical setting, likely in a medical facility. The study appears to be prospective as subjects underwent the desaturation protocol.
- Form, Fit, and Function Clinical Study: 41 infants and neonates (22 dark skin pigmented, 20 light skin pigmented; 21 male, 21 female), across different ages and weights.
- Data Provenance: Not explicitly stated, but the description of "infants and neonates across different skin pigmentations, ages, weights, and genders" suggests this was a directly collected prospective study.
- Overnight Study (Prolonged Use and Alarm Performance): 19 infants and neonates.
- Data Provenance: "parents used the Masimo Stork overnight on their babies in a home environment." This indicates a prospective study conducted in a real-world home setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical studies. For the SpO2 accuracy study, it mentions comparison to an "FDA cleared pulse oximeter" (reference device K191059 - Masimo Rad-97 and Accessories including RD SET Adhesive sensors). It is implied that the reference device's measurements constitute the ground truth, which would typically be validated by medical professionals in such a clinical setting.
4. Adjudication Method for the Test Set
The document does not provide details on specific adjudication methods for the test sets. For SpO2 comparison, it states the Masimo Stork SpO2 values were compared to an FDA cleared pulse oximeter, implying the reference device's readings served as the comparative standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is a direct physiological monitor, not an AI-assisted diagnostic tool that relies on human interpretation of images or other complex data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance specifications provided for SpO2, Pulse Rate, and Temperature describe the standalone performance of the device's algorithms. The clinical studies (e.g., desaturation study, form/fit/function study, overnight study) assess the device's accuracy in measuring these parameters, inherently evaluating the algorithm's standalone performance in a real-world physiological context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- SpO2 and Pulse Rate: The ground truth for SpO2 and Pulse Rate accuracy was established by comparing the Masimo Stork's measurements against an FDA cleared pulse oximeter (specifically, the Masimo RD SET Adhesive Sensor, K191059) during a desaturation protocol. This typically involves arterial blood gas analysis (functional oxygen saturation) in a controlled environment to validate the reference oximeter, but the text explicitly states comparison to the cleared pulse oximeter as the direct ground truth for the Stork.
- Temperature: The ground truth for temperature measurement accuracy was established using a reference temperature source during laboratory accuracy testing (in accordance with ISO 80601-2-56).
- Alarm Performance: "Good availability of the continuous monitoring" and "preventing non-actionable alarms" were qualitative or quantitative assessments from the overnight home study, likely based on user feedback and technical data logging, without a specific 'ground truth' in the same sense as physiological measurements.
8. The sample size for the training set
The document does not provide details on the training set size for any algorithms within the Masimo Stork. It states that the device "utilizes the same principles of operation as other FDA cleared Masimo SET pulse oximetry devices" and uses "advanced signal processing algorithms as part of the FDA cleared Masimo SET pulse oximetry technology." This suggests that the core algorithms are pre-existing and validated from previous devices, not newly trained for the Stork with a specific, new training set.
9. How the ground truth for the training set was established
As the document does not specify a new training set for the Masimo Stork, it does not describe how ground truth for such a set was established. It implies reliance on the established and FDA-cleared Masimo SET pulse oximetry technology, which would have had its own validation and ground truth establishment during its initial development and clearance.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
December 15, 2023
Masimo Corporation Sindura Penubarthi Associate Director, Regulatory Affairs 52 Discovery Irvine, California 92618
Re: K223721
Trade/Device Name: Masimo Stork Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL Dated: October 2, 2023 Received: October 4, 2023
Dear Sindura Penubarthi:
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).
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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,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known) K223721
Device Name
Masimo Stork
Indications for Use (Describe)
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments.
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, and low perfusion conditions.
The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/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 company name is the company address, which is "52 Discovery, Irvine, CA 92618".
| Submitter and Address ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592 |
|---|---|
| Date: | December 15, 2023 |
| Contact: | Sindura PenubarthiAssociate Director, Regulatory AffairsMasimo CorporationPhone: (949) 396-4041 |
| Trade Name: | Masimo Stork |
| Common Name: | Oximeter |
| Classification Regulation/Product Code: | 21 CFR 870.2700, Class II/DQA |
| Additional Product Code: | FLL |
| Establishment RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | New Device |
| Predicate Device: | K203208 – Guardian Angel Rx GA2000 Series Digital VitalSigns Monitoring System |
| Reference Device: | K191059 - Masimo Rad-97 and Accessories including RD SETAdhesive sensors |
1. Device Description
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 Stork combines the signal processing and optical components (i.e., signal detecting parts) into a single pulse oximetry module. The module is flat to allow for the flush contact with a baby (e.g., neonate, infant) foot.
Masimo Stork can be used with following components:
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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 bold, black 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.
-
- Stork Boot ("Boot") is a silicone holder that helps in the placement and securement of the Stork on to the baby's foot.
-
- Stork Hub ("Hub") is an alarm/ connectivity device that helps in the communication of the 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 ("App") is mobile device application that is connected through the Hub and/or directly to the Stork to provide the user interface for viewing and monitoring the physiological parameters.
-
- Stork Cloud ("Cloud") is the software that helps to store the physiological data. It also helps to monitor the wireless connections between the Hub, App, and Stork.
The Masimo Stork specifications are as follows:
| Masimo Stork | |
|---|---|
| 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)] | $\pm 0.3°C (\pm 0.54°F)$ |
| Electrical Specifications | |
| Battery Type | Internal Rechargeable Lithium ion |
| Environmental Specifications | |
| Operating Temperature | 32°F to 104°F (0°C to 40°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 |
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Image /page/6/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 logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
| Masimo Hub | |
|---|---|
| Feature | Specifications |
| Electrical Specifications | |
| Types of Power Source | AC |
| AC Electrical Power Rating | 100 to 240 VAC, 50 to 60 Hz, 0.2A |
| 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. Masimo Stork is intended to be used in home environments.
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during nomotion, motion, and low perfusion conditions.
The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.
3. Technological Characteristics
Principle of Operations
The subject device. Masimo Stork, utilizes the same principles of operation as other FDA cleared Masimo SET pulse oximetry devices. Masimo SET pulse oximetry 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).
- 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.
These principles of operation are combined with the use of advanced signal processing algorithms as part of the FDA cleared Masimo SET pulse oximetry technology to help to minimize the impact of confounding factors, such as static absorbers (e.g., skin pigmentation, site thickness differences). The advanced signal processing features allow for better detection of the arterial signal.
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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 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".
The Masimo Stork also provides a skin temperature monitoring feature that relies on the principle of operations of a thermistor.
Mechanism of Action for Achieving the Intended Effect
The Masimo Stork 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 sensors in place. The Stork provides wireless capabilities so that a cabled connection is not required to transmit the parameters measurements continuously. The wireless communication is established by a paired Bluetooth connection to support alarms and display. To support the parameter data monitored by the Stork, a smart device software application is used as a 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 used 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. Summary of Technological Characteristics of Subject Device Compared to Predicate Device
Similarities and Differences between Predicate and Subject Device
The subject device, Masimo Stork, and the predicate device, Guardian Angel (K203208), have the following key similarities:
- · Both devices have the same intended use;
- · Both devices are wearable;
- · Both devices support similar monitoring technologies (SpO2, PR, and Temperature);
- · Both devices utilize wireless capabilities to allow for data to be transmitted for remote display and monitoring using a software application;
- · Both devices provide audible and visual alarms.
The subject device, Masimo Stork, and the predicate device, Guardian Angel (K203208), have the following key differences:
- · The subject device monitors skin temperature on the baby's foot.
As part of the submission, data was provided to support both devices have the same intended use. Testing was also provided to support the substantial equivalence of the subject device.
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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in bold, black letters, with a red circle containing a white line to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
| Comparison between Subject and Predicate Device | |||
|---|---|---|---|
| Feature | Masimo StorkSubject Device | Guardian Angel Rx GA2101 Digital Vital SignsMonitoring SystemPredicate Device(K203208) | Comparison to Predicate Device |
| Classification | Class II, Oximeter | Class II, Oximeter | Same. |
| Regulation,Product Code | 21 CFR 870.2700, Class II/DQA | 21 CFR 870.2700, Class II/DQA | Same. |
| AdditionalProduct Code(s) | FLL | FLL | Same. |
| Intended Use | The Masimo Stork is a wearable device intended for themonitoring of multiple physiological parameters. MasimoStork is intended to be used in home environments.The Masimo Stork is indicated for the spot-checking andcontinuous monitoring of functional oxygen saturation ofarterial hemoglobin (SpO2) and Pulse Rate (PR) in infantsand neonates during no-motion, motion, and low perfusionconditions.The Masimo Stork is also indicated for continuous skintemperature measurements of infants and neonates. | The Guardian Angel Rx GA2000 Series DigitalVital Sign Monitoring System (Model GA2101)is indicated for use in measuring, recording, anddisplaying functional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate (PR) and bodytemperature. The intended environments of useare hospitals medical facilities, home care, andsubacute environments. This system is a reusabledevice. The Oximeter Module(s) is indicated forspot checking and/or continuous monitoring ofSpO2 and PR of pediatrics and infants duringnon-motion and under well perfused conditions.The Thermometer Module is indicated forcontinuous armpit body temperature monitoringof pediatrics, and infants. | Same. |
| Principles ofOperation | The pulse oximeter technology relies on the absorptiondifferences of red and infrared light to determine SpO2and Pulse Rate. | The pulse oximeter technology relies on theabsorption differences of red and infrared light todetermine SpO2 and Pulse Rate. | Same. |
| Comparison between Subject and Predicate Device | |||
| Feature | Masimo StorkSubject Device | Guardian Angel Rx GA2101 Digital Vital SignsMonitoring SystemPredicate Device(K203208) | Comparison to Predicate Device |
| Temperature measure relies on a thermistor thatcorrelates temperature to impedance changes. | Temperature measure relies on a thermistor thatcorrelates temperature to impedance changes. | ||
| ParametersMonitored | SpO2, PR, Temperature | SpO2, PR, Temperature | Same. |
| SupportedDisplay Devices | Smart Device App | Display Unit, Smart Device App | Similar. Both devices displaymeasurements on a smart deviceapp.The predicate device also supportsthe ability to display measurementsto a separate display unit.Testing is provided to support thedisplay unit is not needed. |
| Pulse OximeterSensor Type | Reusable | Reusable with Disposable Adhesives | Different. Subject device does notuse a disposable adhesive to securethe sensor.Testing is provided to support thedifference does not raise differentquestions of safety andeffectiveness. |
| TemperatureSensor Type | Reusable | Disposable | Different. Subject device is reusable.Testing is provided to support thedifference does not raise different |
| Comparison between Subject and Predicate Device | |||
| Feature | Masimo StorkSubject Device | Guardian Angel Rx GA2101 Digital Vital SignsMonitoring SystemPredicate Device(K203208) | Comparison to Predicate Device |
| Indicatedpopulation | Infants, Neonates (<18 months) | Infants | questions of safety andeffectiveness.Similar. Subject device covers widepatient category aligned withreference device.Testing is provided to support theperformance on the widerpopulation. |
| Remote Accessto MonitoredData | Yes | Yes | Same. |
| SupportedAlarms | SpO2, PR, and Temperature | SpO2, PR and Temperature | Same. |
| Type of Alarm | Audible and visual | Audible and visual | Same. |
| DistributedAlarm System | Yes | Yes | Same. |
| SupportedCommunication | Bluetooth, Wi-Fi | Bluetooth, Wi-Fi | Same. |
| CommunicationSecurity | Encryption | Unknown | Subject device provides encryptedcommunication. |
| Pulse OximetrySensorApplication Site | Foot | Foot | Same. |
| Comparison between Subject and Predicate Device | |||
| Feature | Masimo StorkSubject Device | Guardian Angel Rx GA2101 Digital Vital SignsMonitoring SystemPredicate Device(K203208) | Comparison to Predicate Device |
| SpO2, NoMotion (70-100%) | 1.5% | 3% | Different. Subject device includesimproved performance specificationsimilar to reference device RD SETAdhesive Sensor (K191059). |
| SpO2, Motion(70-100%) | 1.5% | No motion only | Different. Subject device includesimproved performance specificationsimilar to reference device RD SETAdhesive Sensor (K191059). |
| SpO2, LowPerfusion (70-100%) | 2% | Well perfused only | Different. Subject device includesimproved performance specificationsimilar to reference device RD SETAdhesive Sensor (K191059). |
| Pulse Rate, NoMotion | Range: 25-240 bpm, 3 bpm Arms | Range: 30-290 bpm, 3 bpm Arms | Different. Subject device supports adifferent specification range.Testing provided to support theperformance across the specificationrange. |
| Pulse Rate,Motion | Range: 25-240 bpm, 3 bpm Arms | No motion only | Different. Subject device supports adifferent specification range.Testing provided to support theperformance across the specificationrange. |
| Pulse Rate, LowPerfusion | Range: 25-240 bpm, 3 bpm Arms | Well perfused only | Different. Subject device supports adifferent specification range. |
| Comparison between Subject and Predicate Device | |||
| Feature | Masimo StorkSubject Device | Guardian Angel Rx GA2101 Digital Vital SignsMonitoring SystemPredicate Device(K203208) | Comparison to Predicate Device |
| Temperature,MeasurementAccuracy | +/- 0.3°F | +/- 0.2°F | Testing provided to support theperformance across the specificationrange.Different. The subject device has adifferent claimed accuracy. |
| TemperatureMeasurementSite | Foot | Axillary | Testing is provided to support theperformance specificationDifferent. Subject device hasdifferent application site. |
| EnclosureMaterial | Thermoplastic | Thermoplastic | Testing is provided to support theperformance specification.Same. |
| OverallDimension | 2.48" x 1.90" x 1.17" | Unknown | Different. Subject device has adifferent form factor form thepredicate.Testing is provided to support thereis no significant differences. |
| OperatingTemperature | 5°C to 35°C (41°F to 95°F) | 5°C to 40°C (41°F to 104°F) | Different. Subject device hasdifferent claimed operating range.Testing is provided to support thespecified range. |
| Comparison between Subject and Predicate Device | |||
| Feature | Masimo StorkSubject Device | Guardian Angel Rx GA2101 Digital Vital SignsMonitoring SystemPredicate Device(K203208) | Comparison to Predicate Device |
| OperatingHumidity | 10% to 95%, non-condensing | 15% to 95%, non-condensing | Different. Subject device hasdifferent claimed operating range.Testing is provided to support thespecified range. |
| Storage/TransportTemperature | -20°C to 60°C (-4°F to 140°F) | -25°C to 70°C (-13°F to 158°F) | Different. Subject device hasdifferent claimed storage andtransport range.Testing is provided to support thespecified range. |
| Storage/TransportHumidity | 10% to 95%, non-condensing | 10% to 93%, non-condensing | Different. Subject device hasdifferent claimed storage andtransport range.Testing is provided to support thespecified range. |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same. |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same. |
| Applied PartType | BF Applied Part | BF Applied Part | Same. |
| IngressProtection | IP22 | Unknown | Subject device provides testing tosupport the claimed ingressprotection rating. |
| Mode ofOperation | Continuous | Continuous | Same. |
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Image /page/9/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 CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line going through it, followed by the word "Masimo" in black bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line going through it, followed by the word "Masimo" in black bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/12/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 CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/13/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 CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/14/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.
5. Performance Data
To support the substantial equivalence, performance clinical and bench testing was conducted and is included as part of this submission.
Performance Bench Testing
Bench testing was performed on the Masimo Stork to support the device met its applicable safety and performance specifications. The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met. The following nonclinical testing was performed:
- Biocompatibility testing per ISO 10993-1
- Electrical safety testing per IEC 60601-1
- . EMC testing per IEC 60601-1-2
- . Usability testing per FDA Human Factors and Usability Guidance
- . Software verification and validation testing per FDA Software Guidance
- Mechanical testing per IEC 60601-1 ●
- Performance testing per ISO 80601-2-61 ●
Laboratory Accuracy Testing
To support the temperature measurement feature of the Stork, performance bench testing was conducted in accordance with ISO 80601-2-56 that compared the accuracy of the surface temperature measurements against a reference temperature source to establish the laboratory accuracy.
Biocompatibility Testing
The patient contacting materials of Masimo Stork and Boot were tested to be biocompatible in accordance with ISO 10993.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
Electromagnetic compatibility testing was conducted in accordance with IEC 60601-1-2 and electrical safety in accordance with IEC 60601-1 standard. The environmental, and chemical, and chemical resistance testing has also been provided to support the safety of Masimo Stork.
Wireless Testing
As the Stork relies on the use of wireless technologies in the display and alarming capabilities, the design of the Stork includes mitigations for potential disruptions in communication. The wireless information was provided in accordance with FDA's Guidance for Industry and FDA Staff-Radio
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Image /page/15/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark-like shape inside, followed by the word "Masimo" in black, bold font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
Frequency Wireless Technology in Medical Devices, dated August 2013.
Software Testing
The Stork relies on the software to achieve its intended purpose, as a result a process consistent with IEC 62304 is followed in the development of the software for this device is classified as a moderate level of concern consistent with the FDA Guidance for Pulse Oximeters.
Software verification and validation testing was conducted and documented in accordance with FDA's Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. The software for this device was considered as a "moderate" level of concern because a failure or latent flaw in the software could directly result in minor to moderate injury to the patient.
Cybersecurity Testing
As the Masimo Stork relies on external communication and software to provide its intended purpose, the design accounts of the mitigations against cybersecurity risks. The cybersecurity information was provided in accordance with FDA Guidance for Industry and Food and Drug Administration Staff-Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, dated October 2, 2014.
Human Factors Usability Testing
To support the design features that are unique to the Stork, human factors testing is conducted in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016.
Clinical Testing
To support the performance of the Masimo Stork, three clinical studies are provided as part of this submission. A study was conducted to support the equivalence of the performance of the Masimo Stork to the FDA clearance RD SET Adhesive sensor (K191059). This testing included data from 30 subjects of light (14) and dark (16) skin pigmented subjects undergoing a desaturation protocol in accordance with ISO 80601-2-61.
To support the form, fit, and function of the Masimo Stork for its indicated population, two clinical studies were conducted. One study was conducted on 41 infants and neonates across different skin pigmentations (22 dark, 20 light), ages (21 male, 21 female), weights, and genders comparing the Masimo Stork SpO2 values to an FDA cleared pulse oximeter.
The other study was an overnight 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 done to support the safe prolonged use. The data also supported the acceptability of Masimo Stork in
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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-like shape 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".
preventing non-actionable alarms and the good availability of the continuous monitoring throughout the use (99.7% under low motion conditions).
The performance testing was found to support the subject device does not raise different questions of safety and effectiveness from that of the predicate device.
6. Conclusion
The submission supported the Masimo Stork is substantially equivalent to the predicate device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).