Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Masimo Corporation Kertana Shankar Senior Regulatory Affairs 52 Discovery Irvine, California 92618 September 7, 2023 Re: K232389 Trade/Device Name: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 8, 2023 Received: August 9, 2023 Dear Kertana Shankar: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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. 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 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 (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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232389 Device Name Carescape SpO2 - Masimo #### Indications for Use (Describe) The CARESCAPE SpO2 - Masimo is intended to be used with multiparameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE SpO2 - Masimo is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time. The CARESCAPE SpO2 – Masimo with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232389 Device Name Masimo rainbow SET IntelliVue #### Indications for Use (Describe) The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended to be used with compatible Philips Intellivue Patient Monitors. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, infant, and neonatal patients during no motion conditions. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of respiratory rate (RRa) for adult and pediatric patients during no motion conditions. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray. # CARESCAPE SpO2 – Masimo: | Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: (949) 297-7000 | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Date: | September 1, 2023 | | Contact: | Kertana Shankar<br>Senior Regulatory Specialist<br>Masimo Corporation<br>Phone: (949) 390-0140 | | 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: | Addition of Radius PPG as accessory | | Predicate Device: | K221953 - Masimo Carescape SpO2 - Masimo with SpHb | | Reference Device: | K183697 – Rad-97 with Centroid O2 | | Performance Standards | There are no performance standards pursuant to Section 514 of the<br>Food, Drug and Cosmetic Act for the above device. | # Masimo rainbow SET IntelliVue Module: | Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: (949) 297-7000 | |-----------------------------------------------------|------------------------------------------------------------------------------------------------| | Date: | September 1, 2023 | | Contact: | Kertana Shankar<br>Senior Regulatory Specialist<br>Masimo Corporation<br>Phone: (949) 390-0140 | | Trade Name: | Masimo rainbow SET IntelliVue Module | | Common Name: | Oximeter | {6}------------------------------------------------ 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 black, bold font. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618". | Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/ DQA | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Establishment Registration<br>Number: | 3011353843 | | Reason for Premarket<br>Notification: | Addition of Radius PPG as accessory | | Predicate Device: | K162675 - Masimo Rainbow SET Intellivue Module Pulse CO-<br>Oximeter | | Reference Device: | K183697 – Rad-97 with Centroid O2 | | 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 purpose of this submission is to add Radius PPG as a compatible accessory to the Carescape SpO2 -Masimo (K221953) and Masimo rainbow SET IntelliVue (K162675). The description of the subject devices is provided below: # Carescape SpO2 - Masimo The Carescape SpO2 – Masimo is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE, K213234) to provide the ability to continuously monitor Masimo pulse oximetry parameters (SpO2, PR, and SpHb). 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. ## Masimo rainbow SET IntelliVue The Masimo rainbow SET IntelliVue is a module intended to compatible patient monitors (e.g., Philips IntelliVue, K221348) to provide continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). 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. #### 2 System Specifications The specifications for the Carescape SpO2 – Masimo (K221953) and the Masimo rainbow SET IntelliVue (K162675) are the same as the previous clearances. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark-like shape inside, followed by the word "Masimo" in bold, black letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" and the address "52 Discovery, Irvine, CA 92618" in a smaller, gray font. # See Tables 2-1 and Table 2-2 below for the subject device specifications: | Table 2-1 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, 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) | | SpHb (8-17 g/dL) | 1 g/dL (Adults and Pediatrics) | | Environmental | | | Operating Temperature | 0°C to +35°C | | Storage Temperature | -30°C to +70°C | | Operating Humidity | 5% to 95% RH, non-condensing | | Storage Humidity | 5% to 95% RH, non-condensing | | Mode of Operation per IEC 60601-1 | | | Mode of Operation | Continuous | | Table 2-2 Masimo rainbow SET IntelliVue Specifications | | |--------------------------------------------------------|------------------------------------------------| | Feature | Specification | | Performance Specification (Arms) | | | SpO2, No Motion (60-80%) | 3% (Adults, Pediatrics, Infants) | | SpO2, No Motion (70-100%) | 2% (Adults, Pediatrics, and Infants) | | | 3% (Neonates) | | SpO2, Motion (70-100%) | 3% (Adults, Pediatrics, Infants and Neonates) | | SpO2, Low Perfusion (70-100%) | 2% (Adults, Pediatrics, and Infants) | | | 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) | | SpCO (1-40%) | 3% (Adults, Pediatrics, and Infants) | | SpMet (1-15%) | 1% (Adults, Pediatrics, Infants, and Neonates) | | SpHb (8-17 g/dL) | 1 g/dL (Adults and Pediatrics) | | RRa (4-70 bpm) | 1 bpm (Adults and Pediatrics) | | Environmental | | | Operating Temperature | 0°C to +55°C | | Storage Temperature | -40°C to +70°C | | Operating Humidity | 95% RH max at 40°C | {8}------------------------------------------------ Image /page/8/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 letters. To the right of the logo is the text "MASIMO CORPORATION" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618". | Table 2-2 Masimo rainbow SET IntelliVue Specifications | | |--------------------------------------------------------|--------------------| | Feature | Specification | | Storage Humidity | 95% RH max at 65°C | | Mode of Operation per IEC 60601-1 | | | Mode of Operation | Continuous | #### 3 Intended Use/ Indications For Use The intended use statements for the subject devices are provided below: # CARESCAPE SpO2 - Masimo The CARESCAPE SpO2 - Masimo is intended to be used with multiparameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time. The CARESCAPE SpO2 – Masimo with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. ## Masimo rainbow SET IntelliVue The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is intended to be used with compatible Philips IntelliVue Patient Monitors. The indications for use as specified for the IntelliVue Patient Monitors applies. The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is intended for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is indicated for the non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. {9}------------------------------------------------ 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 word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, infant, and neonatal patients during no motion conditions. The Masimo rainbow SET® Intelli Vue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions. The Masimo rainbow SET® Intelli Vue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of respiratory rate (RRa) for adult and pediatric patients during no motion conditions. The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused. The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. #### 4 Technological Characteristics #### 4.1 Principles of Operation There have been no changes to the principles of operation of the subject devices from their previous clearances under K221953 and K162675. See below for the principles of operation of the subject devices: ## Carescape SpO2 – Masimo The Carescape SpO2 - Masimo uses the same Masimo SET and rainbow SET Pulse Oximetry technology as the predicate device (K221953) to noninvasively monitor SpO2, pulse rate, and SpHb. Carescape SpO2 - Masimo relies on the following principles: - . Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), and blood plasma constituents differ in their absorption of visible and infrared light. - . The amount of light absorbed by arterial blood changes with your pulse (photoplethysmography). Based upon the above principles, the periodic variations in the absorption of light are used to determine the pulse rate. {10}------------------------------------------------ Image /page/10/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, there is the text "MASIMO CORPORATION" and the address "52 Discovery, Irvine, CA 92618" in a smaller, gray font. #### Masimo rainbow SET IntelliVue The Masimo rainbow SET IntelliVue uses the same Masimo rainbow SET Pulse Oximetry technology as the predicate device (K162675) to provide the noninvasive optical measurements of Sp02, pulse rate, SpCO, SpMet and SpHb. The Masimo rainbow SET IntelliVue relies on the following principles: - . Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry). - The amount of arterial blood in tissue changes with pulse (photoplethysmography). The Masimo Rainbow Acoustic Monitoring (RAM) technology uses acoustic signals for respiration rate (RRa) measurements. RRa measures a patient's respiration rate based on airflow sounds generated in the upper airway. #### Mechanism of Action for Achieving the Intended Effect 4.2 The subject devices still achieve their intended purpose through the application of an optical sensor to the patient's measurement site to detect physiological signal data, same as the predicate devices (K221953 and K162675). This signal data is then sent to the subject devices, either through a wired sensor and cable connection, or through the Radius PPG. When used with the Radius PPG, the Radius PPG reusable is pared with the wireless receiver connected to the subject devices through the subject device's sensor cable port similar to a wired sensor connection. Once paired, the Radius PPG reusable module is connected to the Radius PPG sensor part to begin monitoring and communication of the measured data to the subject devices. The subject devices have Masimo technology boards installed that process the data to provide physiological parameter data, which is then communicated to the patient monitor (e.g., GE CARESCAPE ONE, Philips IntelliVue) through the power and communication connector interface. The communicated parameter data is in turn displayed on the connected patient monitor, along with any visual and audible alarms that are triggered by the parameter data. #### 5 Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device ## Similarities and Differences between Predicate and Subject Devices The subject devices (i.e., CARESCAPE SpO2 - Masimo, Masimo rainbow SET IntelliVue) and the respective predicate devices have the following kev similarities: - Both devices have the same intended use and technological characteristics. ● {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray. - Both devices have the same principle of operation and mechanism of action. - Both devices are indicated for the same patient population. - Both devices support the continuous monitoring of physiological parameters. Differences between the subject and predicate device: - Updated list of compatible accessories to include Radius PPG. ● Between the subject and predicate device, there are no differences in the intended use and technological characteristics. The subject devices have been previously cleared under K221953 and K162675, respectively, for use with Masimo sensor cable and sensor accessories. The purpose of this submission is to include the Radius PPG (cleared as "Centroid O2" under K183697) as a compatible accessory for the subject devices. Bench testing was conducted to support the addition of the Radius PPG accessory did not raise different questions of safety and effectiveness. The subject and predicate devices are the same and are therefore substantially equivalent. See Tables 5-1 and 5-2 for the comparison between the subject and predicate devices. {12}------------------------------------------------ Image /page/12/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 font. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618". | Table 5-1 Comparison between Subject Device (CARESCAPE SpO2 – Masimo) and Predicate Device | | | | |--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | CARESCAPE SpO2 – Masimo<br>Subject Device | CARESCAPE SpO2 – Masimo with SpHb,<br>Predicate Device<br>K221953 | Comparison to Predicate | | Primary Classification<br>Regulation/ Product Code | 21 CFR 870.2700, Class II/ DQA | 21 CFR 870.2700, Class II/ DQA | Same. | | Intended Use/<br>Indications for Use | The CARESCAPE SpO2 - Masimo is<br>intended to be used with multiparameter<br>physiological patient monitors (e.g., GE<br>CARESCAPE ONE) for use in multiple areas<br>and intrahospital transport within a<br>professional healthcare facility.<br><br>The CARESCAPE SpO2 – Masimo is<br>indicated for the continuous noninvasive<br>monitoring of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate<br>(PR) of adult, pediatric, and neonatal patients<br>and on one patient at a time.<br><br>The CARESCAPE SpO2 – Masimo is<br>indicated for the continuous noninvasive<br>monitoring of total hemoglobin concentration<br>(SpHb) for use on adult and pediatric patients<br>and on one patient at a time. | The CARESCAPE SpO2 - Masimo is<br>intended to be used with multiparameter<br>physiological patient monitors (e.g., GE<br>CARESCAPE ONE) for use in multiple areas<br>and intrahospital transport within a<br>professional healthcare facility.<br><br>The CARESCAPE SpO2 – Masimo is<br>indicated for the continuous noninvasive<br>monitoring of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate<br>(PR) of adult, pediatric, and neonatal patients<br>and on one patient at a time.<br><br>The CARESCAPE SpO2 – Masimo is<br>indicated for the continuous noninvasive<br>monitoring of total hemoglobin concentration<br>(SpHb) for use on adult and pediatric patients<br>and on one patient at a time. | Same. | | Principle of Operation | CARESCAPE SpO2 – Masimo relies<br>on the following principles:<br>1. Oxyhemoglobin (oxygenated blood),<br>deoxyhemoglobin (non-oxygenated blood) | CARESCAPE SpO2 – Masimo relies<br>on the following principles:<br>1. Oxyhemoglobin (oxygenated blood),<br>deoxyhemoglobin (non-oxygenated blood) | Same. | | Table 5-1 Comparison between Subject Device (CARESCAPE SpO2 – Masimo) and Predicate Device | | | | | Feature | CARESCAPE SpO2 – Masimo<br>Subject Device | CARESCAPE SpO2 – Masimo with SpHb,<br>Predicate Device<br>K221953 | Comparison to Predicate | | | and blood plasma constituents differ in their<br>absorption of visible and infrared light. | and blood plasma constituents differ in their<br>absorption of visible and infrared light. | | | | 2. The amount of light absorbed by arterial<br>blood changes with your pulse<br>(photoplethysmography). | 2. The amount of light absorbed by arterial<br>blood changes with your pulse<br>(photoplethysmography). | | | | Based upon the above principles, Masimo<br>rainbow SET technology uses multiple<br>wavelengths light (red to infrared) to identify<br>the differences in absorption at the different | Based upon the above principles, Masimo<br>rainbow SET technology uses multiple<br>wavelengths light (red to infrared) to identify<br>the differences in absorption at the different | | | | wavelengths to determine SpO2 and SpHb.<br>The periodic variations in the absorption of<br>light are used to determine the pulse rate. | wavelengths to determine SpO2 and SpHb.<br>The periodic variations in the absorption of<br>light are used to determine the pulse rate. | | | Performance Specifications (Arms) | | | | | SpO2, No Motion<br>(70-100%) | 2% (Adults, Pediatrics, and Infants)<br>3% (Neonates) | 2% (Adults, Pediatrics, and Infants)<br>3% (Neonates) | Same. | | SpO2, Motion<br>(70-100%) | 3% (Adults, Pediatrics, Infants, and<br>Neonates) | 3% (Adults, Pediatrics, Infants, and<br>Neonates) | Same. | | SpO2, Low perfusion<br>(70-100%) | 2% (Adults, Pediatrics, and Infants)<br>3% (Neonates) | 2% (Adults, Pediatrics, and Infants)<br>3% (Neonates) | Same. | | Pulse Rate, No motion<br>(25-240 bpm) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) | Same. | | Pulse Rate, Motion<br>(25-240 bpm) | 5 bpm (Adults, Pediatrics, and<br>Neonates) | 5 bpm (Adults, Pediatrics, and<br>Neonates) | Same. | | Pulse Rate, Low<br>Perfusion | 3 bpm (Adults, Pediatrics, and<br>Neonates) | 3 bpm (Adults, Pediatrics, and<br>Neonates) | Same. | | Table 5-1 Comparison between Subject Device (CARESCAPE SpO2 – Masimo) and Predicate Device | | | | | Feature | CARESCAPE SpO2 – Masimo<br>Subject Device | CARESCAPE SpO2 – Masimo with SpHb,<br>Predicate Device<br>K221953 | Comparison to Predicate | | (25-240 bpm) | | | | | Accessories | | | | | Compatible<br>Accessories | Masimo wired sensors and cables,<br>Radius PPG | Masimo wired sensors and cables. | Different. Radius PPG is<br>included as a compatible<br>accessory to the subject<br>device.<br>Bench testing was<br>performed to support the<br>substantial equivalence. | | Mechanical | | | | | Overall Dimensions | 5.40" by 2.68" by 1.00" | 5.40" by 2.68" by 1.00" | Same. | | Environmental Specifications | | | | | Operating Conditions | |…