(368 days)
No
The summary describes standard physiological monitoring technology (pulse oximetry and temperature sensing) and does not mention AI, ML, or related concepts in the device description, performance studies, or key metrics. The signal processing mentioned is typical for pulse oximetry and not indicative of AI/ML.
No.
The device is strictly for monitoring physiological parameters (SpO2, Pulse Rate, and skin temperature) and does not provide any therapy or active treatment.
Yes
The device is intended for "monitoring of multiple physiological parameters" including "functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, motion, and low perfusion conditions," and "continuous skin temperature measurements." These physiological measurements are collected to provide information about the patient's health status, which is a characteristic of a diagnostic device.
No
The device description clearly outlines hardware components such as the wearable device itself (containing optical components), the Stork Boot, and the Stork Hub, in addition to the software components (App and Cloud). The performance studies also include testing of hardware aspects like biocompatibility, electrical safety, and mechanical testing.
Based on the provided information, the Masimo Stork is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Masimo Stork Function: The Masimo Stork is a wearable device that directly measures physiological parameters (SpO2, Pulse Rate, and skin temperature) from the baby's body (specifically, the foot) without requiring any specimens to be taken.
The device description and intended use clearly indicate that it is a non-invasive monitoring device.
N/A
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 no-motion, motion, and low perfusion conditions.
The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.
Product codes (comma separated list FDA assigned to the subject device)
DQA, FLL
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:
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
baby's foot
Indicated Patient Age Range
infants and neonates
Intended User / Care Setting
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
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 preventing non-actionable alarms and the good availability of the continuous monitoring throughout the use (99.7% under low motion conditions).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Clinical and 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.
- 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 (temperature measurement) in accordance with ISO 80601-2-56.
- Wireless Testing in accordance with FDA's Guidance for Industry and FDA Staff-Radio Frequency Wireless Technology in Medical Devices, dated August 2013.
- Software testing: IEC 62304 consistent with 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. Software considered as "moderate" level of concern.
- Cybersecurity Testing 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 in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016.
Clinical Testing:
- One study to support performance equivalence: 30 subjects (14 light, 16 dark skin pigmented) undergoing a desaturation protocol.
- Two studies to support form, fit, and function for indicated population:
- One study on 41 infants and neonates (22 dark, 20 light skin, 21 male, 21 female) comparing Masimo Stork SpO2 values to an FDA cleared pulse oximeter.
- One overnight study on 19 infants and neonates, parents used Masimo Stork overnight in a home environment. This supported safe prolonged use, acceptability, prevention of non-actionable alarms, and continuous monitoring availability (99.7% under low motion conditions).
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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)
Availability of continuous monitoring: 99.7% under low motion conditions.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K203208 – Guardian Angel Rx GA2000 Series Digital Vital Signs Monitoring System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K191059 - Masimo Rad-97 and Accessories including RD SET Adhesive sensors
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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).
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,
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
2
Enclosure
3
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 of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | December 15, 2023 |
| Contact: | Sindura Penubarthi
Associate Director, Regulatory Affairs
Masimo Corporation
Phone: (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 Registration
Number: | 3011353843 |
| Reason for Premarket
Notification: | New Device |
| Predicate Device: | K203208 – Guardian Angel Rx GA2000 Series Digital Vital
Signs Monitoring System |
| Reference Device: | K191059 - Masimo Rad-97 and Accessories including RD SET
Adhesive 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 Stork | ||
| Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs | ||
| Monitoring System | |||
| Predicate 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. |
| Additional | |||
| Product Code(s) | FLL | FLL | Same. |
| Intended 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 no-motion, motion, and low perfusion
conditions.
The Masimo Stork is also indicated for continuous skin
temperature measurements of infants and neonates. | The Guardian Angel Rx GA2000 Series Digital
Vital Sign Monitoring System (Model GA2101)
is indicated for use in measuring, recording, and
displaying functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate (PR) and body
temperature. The intended environments of use
are hospitals medical facilities, home care, and
subacute environments. This system is a reusable
device. The Oximeter Module(s) is indicated for
spot checking and/or continuous monitoring of
SpO2 and PR of pediatrics and infants during
non-motion and under well perfused conditions.
The Thermometer Module is indicated for
continuous armpit body temperature monitoring
of pediatrics, and infants. | Same. |
| Principles of
Operation | The pulse oximeter technology relies on the absorption
differences of red and infrared light to determine SpO2
and Pulse Rate. | The pulse oximeter technology relies on the
absorption differences of red and infrared light to
determine SpO2 and Pulse Rate. | Same. |
| Comparison between Subject and Predicate Device | | | |
| Feature | Masimo Stork
Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs
Monitoring System
Predicate Device
(K203208) | Comparison to Predicate Device |
| | Temperature measure relies on a thermistor that
correlates temperature to impedance changes. | Temperature measure relies on a thermistor that
correlates temperature to impedance changes. | |
| Parameters
Monitored | SpO2, PR, Temperature | SpO2, PR, Temperature | Same. |
| Supported
Display Devices | Smart Device App | Display Unit, Smart Device App | Similar. Both devices display
measurements on a smart device
app.
The predicate device also supports
the ability to display measurements
to a separate display unit.
Testing is provided to support the
display unit is not needed. |
| Pulse Oximeter
Sensor Type | Reusable | Reusable with Disposable Adhesives | Different. Subject device does not
use a disposable adhesive to secure
the sensor.
Testing is provided to support the
difference does not raise different
questions of safety and
effectiveness. |
| Temperature
Sensor Type | Reusable | Disposable | Different. Subject device is reusable.
Testing is provided to support the
difference does not raise different |
| Comparison between Subject and Predicate Device | | | |
| Feature | Masimo Stork
Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs
Monitoring System
Predicate Device
(K203208) | Comparison to Predicate Device |
| Indicated
population | Infants, Neonates (