Carescape SpO2 - Masimo

K212876 · Masimo Corporation · DQA · Oct 8, 2021 · Cardiovascular

Device Facts

• Record ID: K212876
• Device Name: Carescape SpO2 - Masimo
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 8, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE SpO2 - Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

Device Story

CARESCAPE SpO2 - Masimo is a pulse oximetry module connecting to multi-parameter patient monitors (e.g., GE CARESCAPE ONE). It utilizes Masimo SET technology to process physiological signals from an optical sensor applied to the patient. The module transforms light absorption data (spectrophotometry and photoplethysmography) into SpO2 and pulse rate values. It is used in professional healthcare facilities for continuous monitoring during clinical care and intra-hospital transport. Output is communicated to the host monitor for display and alarm triggering. The device aids clinicians in assessing patient oxygenation and heart rate, facilitating timely clinical intervention.

Clinical Evidence

No clinical data. The device is substantially equivalent to the predicate based on identical technological characteristics and performance specifications.

Technological Characteristics

Pulse oximetry module using Masimo SET technology. Principle: spectrophotometry and photoplethysmography. Dimensions: 5.40" x 2.68" x 1.00". Power source: host monitor. Connectivity: wired interface to host monitor. Ingress protection: IP47 (module), IPX2 (with sensor). Operating temperature: 0°C to +35°C. Continuous operation mode.

Indications for Use

Indicated for monitoring Functional Oxygen Saturation (SpO2) and Pulse Rate (PR) in adult, pediatric, and neonatal patients within professional healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• CARESCAPE ONE (K200494)
• Masimo SET IntelliVue Pulse Oximeter Module (K040259)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2021

Masimo Corporation Kertana Shankar Regulatory Specialist II 52 Discovery Irvine, California 92618

Re: K212876

Trade/Device Name: CARESCAPE SpO2 - Masimo Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 7, 2021 Received: September 9, 2021

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 (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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

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

Enclosure

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## Indications for Use

510(k) Number (if known)

K212867

Device Name Carescape SpO2 - Masimo

Indications for Use (Describe)

The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 - Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

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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, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORP" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>FAX: [phone] |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | September 7, 2021 |
| Contact: | Kertana Shankar<br>Regulatory Specialist II<br>Masimo Corporation<br>Phone: [phone] |
| Trade Name: | CARESCAPE SpO2 - Masimo |
| Common Name: | Oximeter |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/ DQA |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | Labeling Update |
| Primary Predicate: | K200494 - CARESCAPE ONE |
| Secondary Predicate: | Masimo SET IntelliVue Pulse Oximeter Module (K040259) |
| Performance Standards | There are no performance standards pursuant to Section 514 of the<br>Food, Drug and Cosmetic Act for the above device. |

#### 1 Device Description

The CARESCAPE SpO2-Masimo (module) is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to monitor Masimo pulse oximeters (SpO2 and PR). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

The CARESCAPE SpO2 - Masimo is equipped with the same Masimo Technology Board as the predicate device (K200494), which provides the Masimo SET Technology for the measurement and monitoring of pulse oximetry data.

The module is labeled CARESCAPE SpO2 – Masimo or GE CARESCAPE SpO2 – Masimo. Both versions are identical except for the labeling to distinguish the version distributed by Masimo. The purpose of this submission is to receive clearance to market CARESCAPE SpO2 - Masimo under its own 510(k).

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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 word "Masimo" is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

The performance specifications for CARESCAPE SpO2 - Masimo remains the same as that previously 510(k) cleared for the predicate device, GE CARESCAPE SpO2 – Masimo (K200494).

See Table 1 below product specifications.

| Table 1 - CARESCAPE SpO2 - Masimo Specifications | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------|
| Feature | Specification |
| Performance Specification (Arms) | |
| SpO2, no motion (70-100%) | 2% (Adults, Pediatrics and Infants)<br>3% (Neonates) |
| SpO2, motion (70-100%) | 3% (Adults, Pediatrics, Infants, and Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults and Pediatrics, and Infants)<br>3% (Neonates) |
| Pulse Rate, no motion (25-240 bpm) | 3 bpm (Adults, Pediatrics, and Neonates) |
| Pulse Rate, motion (25-240 bpm) | 5 bpm (Adults, Pediatrics, and Neonates) |
| Pulse Rate, low perfusion (25-240 bpm) | 3 bpm (Adults, Pediatrics, and Neonates) |
| Environmental | |
| Operating Temperature | 0°C to +35°C, ambient humidity |
| Storage Temperature | -40°C to +70°C, ambient humidity |
| Operating Humidity | 5% to 95%, non-condensing |
| Storage Humidity | 5% to 95%, non-condensing |
| Operating Altitude | -500 m to 4000 m |
| Storage Altitude | -500 m to 5572 m |
| Ingress Protection from Solids/ Liquids | IP47 (per IEC 60529)<br>IPX2 (per IEC 60529 when used with sensor and sensor interface) |
| Mode of Operation per IEC 60601-1 | |
| Mode of Operation | Continuous |

#### 2 Intended Use/ Indications For Use

The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 - Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

#### Technological Characteristics 3

### Principle of Operation

There is no change in the principle of operation as part of this submission from the previous clearance under K200494. The module still utilizes the same principles of operation for pulse oximetry governed by the

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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-like shape inside, followed by the word "Masimo" in bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" in smaller, gray letters, followed by the address "52 Discovery, Irvine, CA 92618".

following principles:

- 1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
- 2. 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.

## Mechanism of Action for Achieving the Intended Effect

There is no change to the Mechanism of Action of the CARESCAPE SpO2 – Masimo from the previous clearance K200494.

The CARESCAPE SpO2 - Masimo still achieves its intended use through the connection of an optical sensor applied to the patient's measurement site to detect physiological signal data. This signal data is then sent to the module (subject device), which processes the data and provides physiological parameter data, which is then communicated to the patient monitor (e.g., GE CARESCAPE ONE) monitor through the power and communication connector interface. The communicated parameter data is in turn displayed on the connected patient monitor (e.g., GE CARESCAPE ONE) along with any visual and audible alarms that are triggered by the parameter data.

### ব Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device

The subject device, CARESCAPE SpO2 – Masimo, and the primary predicate device, GE CARESCAPE SpO2 - Masimo cleared as part of CARESCAPE ONE (K200494), have the following key similarities:

- Both devices have the same intended use
- . Both devices are indicated for the same patient population
- Both devices have the same principle of operation and mechanism of action

The subject device and the primary predicate device have the following differences:

- . The labeling for the CARESCAPE SpO2 - Masimo was modified to include the revised indications for use description specific to the subject device's cleared indications as part of the primary predicate clearance (K200494).
To support the addition of the Carescape SpO2 – Masimo module's indications for use statement as substantially equivalent, a secondary predicate, Masimo SET Intelli Vue Pulse Oximeter Module (K040259), which has the same intended use and technological characteristics as the subject device and primary predicate was referenced to align the indications for use description. There is no change in the intended use or technological characteristics from the primary predicate.

The subject and primary predicate are the same and therefore substantially equivalent. The subject device labeling changes do not modify the intended use from the primary predicate device.

See Table 2 - below for the comparison between the subject device and the predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

| Table 2 - Comparison Table | | | | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE | Masimo SET IntelliVue Module | Comparison to Predicate<br>Device |
| | | (K200494) - GE CARESCAPE<br>SpO2 - Masimo | (K040259) | |
| 510(k) Number<br>General<br>Information | Subject Device | Primary Predicate | Secondary Predicate | |
| Intended Use | The CARESCAPE SpO2 - Masimo is<br>intended to be used with multi-parameter<br>physiological patient monitors (e.g., GE<br>CARESCAPE ONE) for use in multiple<br>areas and intra-hospital transport within a<br>professional healthcare facility.<br><br>The CARESCAPE SpO2 – Masimo is<br>indicated for the monitoring of Functional<br>Oxygen Saturation (SpO2) and Pulse Rate<br>(PR). The CARESCAPE SpO2 – Masimo<br>is indicated for use on adult, pediatric, and<br>neonatal patients and on one patient at a<br>time. | The CARESCAPE ONE is both a<br>multi-parameter physiological patient<br>monitor and an accessory to a multi-<br>parameter patient monitor intended for<br>use in multiple areas and intra-hospital<br>transport within a professional<br>healthcare facility.<br><br>The CARESCAPE ONE is indicated<br>for the monitoring of hemodynamic<br>(including ECG, ST segment,<br>arrhythmia detection, invasive<br>pressure, non-invasive blood pressure,<br>SpO2, pulse rate, and temperature),<br>and respiratory (impedance respiration<br>and CO2 airway gas) physiological<br>parameters.<br><br>The CARESCAPE ONE can be used<br>as a standalone monitor. In this mode<br>of operation, the CARESCAPE ONE<br>provides ECG, ST segment,<br>arrhythmia detection, invasive<br>pressure, noninvasive blood pressure,<br>SpO2, pulse rate, temperature,<br>impedance respiration, and CO2<br>airway gas parameter acquisition and<br>monitoring. | The Masimo SET® IntelliVue Pulse<br>Oximeter Module is intended for the<br>continuous noninvasive monitoring<br>of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate (measured by an SpO2<br>sensor) for adult, pediatric, and<br>neonatal patients in hospitals and<br>hospital-type facilities.<br><br>The IntelliVue Pulse Oximeter<br>Module is indicated for the<br>continuous noninvasive monitoring<br>of functional oxygen saturation of<br>arterial hemoglobin and pulse rate.<br><br>The IntelliVue Pulse Oximeter<br>Module is indicated for use with<br>adult, pediatric and neonatal patients<br>during both motion and no motion<br>conditions, and for patients who are<br>well or poorly perfused in hospitals<br>and hospital-type facilities. | Same<br><br>Intended use of the subject<br>device is the same as the<br>predicates in providing<br>SpO2 and Pulse Rate.<br><br>However, as this<br>submission is specific to<br>the clearance of<br>CARESCAPE SpO2 –<br>Masimo, the description<br>of the indications for use<br>is revised to be specific to<br>the subject device's<br>cleared indications for use<br>as part of predicate<br>(K200494).<br><br>The description of the<br>indications for use for the<br>subject device is revised<br>to align with the<br>secondary predicate which<br>has the same intended use<br>and same technology as<br>the subject device and<br>primary predicate but<br>specific language around<br>the indications that is |
| Table 2 – Comparison Table | | | | |
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE<br>(K200494) - GE CARESCAPE<br>SpO2 - Masimo | Masimo SET IntelliVue Module<br>(K040259) | Comparison to Predicate<br>Device |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| | | The CARESCAPE ONE can be<br>connected as an accessory to a<br>compatible CARESCAPE monitor. In<br>this mode of operation, the<br>CARESCAPE ONE provides ECG,<br>ST segment, arrhythmia detection,<br>invasive pressure, non-invasive blood<br>pressure, SpO2, pulse rate,<br>temperature, impedance respiration,<br>and CO2 airway gas parameter<br>acquisition. Visual and audible alarms,<br>user controls, and user interface on the<br>CARESCAPE ONE are not active in<br>this mode. | | applicable to both the<br>subject device and<br>primary predicate. |
| | | The CARESCAPE ONE is indicated<br>for use on adult, pediatric, and<br>neonatal patients and on one patient at<br>a time. | | |
| | | The CARESCAPE ONE is indicated<br>for use under the direct supervision of<br>a licensed healthcare practitioner, or<br>by personnel trained in the proper use<br>of the equipment in a professional<br>healthcare facility. | | |
| | | Contraindications for using<br>CARESCAPE ONE:<br>The CARESCAPE ONE is not<br>intended for use within a controlled<br>MR environment. | | |
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE<br>(K200494) - GE CARESCAPE<br>SpO2 - Masimo | Masimo SET IntelliVue Module<br>(K040259) | Comparison to Predicate<br>Device |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| Classification<br>Regulation/ Product<br>Code | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | Same |
| Principle of<br>Operation | Pulse oximetry is governed by the<br>following principles:<br>1. Oxyhemoglobin (oxygenated blood)<br>and deoxyhemoglobin (non-<br>oxygenated blood) differ in their<br>absorption of red and infrared light<br>(spectrophotometry).<br>2. The amount of arterial blood in tissue<br>changes with your pulse<br>(photoplethysmography). Therefore,<br>the amount of light absorbed by the<br>varying quantities of arterial blood<br>changes as well. | Pulse oximetry is governed by the<br>following principles:<br>1. Oxyhemoglobin (oxygenated<br>blood) and deoxyhemoglobin<br>(non-oxygenated blood) differ in<br>their absorption of red and<br>infrared light (spectrophotometry).<br>2. The amount of arterial blood in<br>tissue changes with your pulse<br>(photoplethysmography).<br>Therefore, the amount of light<br>absorbed by the varying quantities of arterial blood changes as well. | Pulse oximetry is governed by the<br>following principles:<br>1. Oxyhemoglobin (oxygenated<br>blood) and deoxyhemoglobin<br>(non-oxygenated blood) differ in<br>their absorption of red and<br>infrared light<br>(spectrophotometry).<br>2. The amount of arterial blood in<br>tissue changes with your pulse<br>(photoplethysmography).<br>Therefore, the amount of light<br>absorbed by the varying<br>quantities of arterial blood<br>changes as well. | Same |
| Performance Specifications | | | | |
| SpO2, No Motion<br>(70-100%) | 2% (Adults, Pediatrics, Infants)<br>3% (Neonates) | 2% (Adults, Pediatric, Infant)<br>3% (Neonates) | 2% (Adults, Pediatric, Infant)<br>3% (Neonates) | Same. |
| SpO2, Motion (70-<br>100%) | 3% (All population) | 3% (All population) | 3% (All population) | Same |
| SpO2, Low<br>Perfusion (70-100%) | 2% (Adults, Pediatrics, Infants)<br>3% (Neonates) | 2% (Adults, Pediatric, Infant)<br>3% (Neonates) | 2% (Adults, Pediatric, Infant)<br>3% (Neonates) | Same |
| Pulse Rate, No<br>Motion (25 - 240<br>bpm) | 3 bpm (Adults, Pediatrics, and Neonates)…