(29 days)
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 and motion conditions and for patients who are well or poorly perfused.
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 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.
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.
This FDA premarket notification (K232389) describes the addition of the Radius PPG as a compatible accessory to two existing devices: the Carescape SpO2 - Masimo (K221953) and the Masimo rainbow SET IntelliVue (K162675). The notification states that "there were no hardware or software changes made to the subject devices as part of this submission from the previous clearances." Therefore, the performance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed for the primary devices themselves in this document, but rather for the accessory's clinical performance.
The provided document focuses on demonstrating that the addition of the Radius PPG accessory does not raise new questions of safety and effectiveness, and that the clinical performance of the Radius PPG on patients of different skin pigmentations is equivalent.
Here's an analysis of the provided information, focusing on the Radius PPG accessory's clinical performance criteria as outlined:
1. A table of acceptance criteria and the reported device performance
The document provides clinical performance data for SpO2 monitoring with the Radius PPG across different skin pigmentations. The acceptance criteria for SpO2 accuracy in oximeters are typically expressed as the "Arms" (Accuracy Root Mean Square) value. Although a specific acceptance criterion is not stated as a numerical target in the document for this submission, the reported "Arms" values are compared, implicitly seeking to demonstrate acceptable accuracy across patient populations. Standard SpO2 accuracy for oximeters without motion is usually around 2% Arms.
| Feature | Acceptance Criteria (Implied by context and typical SpO2 device performance) | Reported Device Performance (Radius PPG) |
|---|---|---|
| SpO2 Accuracy (Arms, Overall) | Around 2% or better (Typical for pulse oximeters) | 1.75 |
| SpO2 Accuracy (Arms, Light Skin) | Around 2% or better | 1.79 |
| SpO2 Accuracy (Arms, Dark Skin) | Around 2% or better | 1.75 |
The reported Arms values of 1.75, 1.79, and 1.75 suggest that the Radius PPG accessory meets or exceeds typical accuracy expectations for pulse oximetry.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (for Radius PPG clinical data):
- Subjects: 22
- Samples: 762 (Overall)
- Light Skin Samples: 449
- Dark Skin Samples: 313
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical data for such devices is typically collected prospectively in controlled settings to assess accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of device (pulse oximeter) does not rely on expert interpretation for ground truth. The ground truth for SpO2 measurement is typically established using a reference co-oximeter connected to arterial blood samples (invasi
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For pulse oximetry, the ground truth is derived from objective measurements (arterial blood gas analysis with a co-oximeter), so such adjudication methods are not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a measurement device (a pulse oximeter accessory), not an AI-assisted diagnostic tool that involves human reader interpretation. Therefore, this type of study and effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical data presented (Bias, Precision, Arms) represents the standalone performance of the Radius PPG accessory in measuring SpO2. Pulse oximeters inherently operate in a "standalone" fashion by directly measuring physiological parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for SpO2 measurements is typically established through arterial blood gas analysis using a laboratory co-oximeter. This provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2), against which the non-invasive SpO2 readings from the device are compared. While not explicitly stated in this summary, this is the standard method for validating pulse oximeter accuracy.
8. The sample size for the training set
The document does not explicitly mention a "training set" for the Radius PPG accessory. For traditional medical devices like pulse oximeters, the device's algorithms are developed and refined using empirical data during the R&D phase. The clinical data presented here is for validation, not training.
9. How the ground truth for the training set was established
As noted in point 8, a specific "training set" with ground truth establishment is not detailed in the context of this submission for a pulse oximeter accessory. The device's underlying technology (Masimo SET and rainbow SET Pulse Oximetry) would have been developed and validated with substantial data, and its core principles rely on the physics of light absorption by different hemoglobin species.
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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
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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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.
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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."
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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the 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 ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000 |
|---|---|
| Date: | September 1, 2023 |
| Contact: | Kertana ShankarSenior Regulatory SpecialistMasimo CorporationPhone: (949) 390-0140 |
| Trade Name: | CARESCAPE SpO2 – Masimo |
| Common Name: | Oximeter |
| Classification Regulation/Product Code: | 21 CFR 870.2700, Class II/ DQA |
| Establishment RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | 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 theFood, Drug and Cosmetic Act for the above device. |
Masimo rainbow SET IntelliVue Module:
| Submitter and Address ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000 |
|---|---|
| Date: | September 1, 2023 |
| Contact: | Kertana ShankarSenior Regulatory SpecialistMasimo CorporationPhone: (949) 390-0140 |
| Trade Name: | Masimo rainbow SET IntelliVue Module |
| Common Name: | Oximeter |
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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 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/Product Code: | 21 CFR 870.2700, Class II/ DQA |
|---|---|
| Establishment RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | Addition of Radius PPG as accessory |
| Predicate Device: | K162675 - Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
| Reference Device: | K183697 – Rad-97 with Centroid O2 |
| Performance Standards | There are no performance standards pursuant to Section 514 of theFood, 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.
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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-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)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) |
| 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 |
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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.
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Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the 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.
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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white 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. ●
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Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white 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.
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Image /page/12/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white 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 – MasimoSubject Device | CARESCAPE SpO2 – Masimo with SpHb,Predicate DeviceK221953 | Comparison to Predicate |
| Primary ClassificationRegulation/ Product Code | 21 CFR 870.2700, Class II/ DQA | 21 CFR 870.2700, Class II/ DQA | Same. |
| Intended Use/Indications for Use | The CARESCAPE SpO2 - Masimo isintended to be used with multiparameterphysiological patient monitors (e.g., GECARESCAPE ONE) for use in multiple areasand intrahospital transport within aprofessional healthcare facility.The CARESCAPE SpO2 – Masimo isindicated for the continuous noninvasivemonitoring of functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate(PR) of adult, pediatric, and neonatal patientsand on one patient at a time.The CARESCAPE SpO2 – Masimo isindicated for the continuous noninvasivemonitoring of total hemoglobin concentration(SpHb) for use on adult and pediatric patientsand on one patient at a time. | The CARESCAPE SpO2 - Masimo isintended to be used with multiparameterphysiological patient monitors (e.g., GECARESCAPE ONE) for use in multiple areasand intrahospital transport within aprofessional healthcare facility.The CARESCAPE SpO2 – Masimo isindicated for the continuous noninvasivemonitoring of functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate(PR) of adult, pediatric, and neonatal patientsand on one patient at a time.The CARESCAPE SpO2 – Masimo isindicated for the continuous noninvasivemonitoring of total hemoglobin concentration(SpHb) for use on adult and pediatric patientsand on one patient at a time. | Same. |
| Principle of Operation | CARESCAPE SpO2 – Masimo relieson the following principles:1. Oxyhemoglobin (oxygenated blood),deoxyhemoglobin (non-oxygenated blood) | CARESCAPE SpO2 – Masimo relieson the following principles:1. Oxyhemoglobin (oxygenated blood),deoxyhemoglobin (non-oxygenated blood) | Same. |
| Table 5-1 Comparison between Subject Device (CARESCAPE SpO2 – Masimo) and Predicate Device | |||
| Feature | CARESCAPE SpO2 – MasimoSubject Device | CARESCAPE SpO2 – Masimo with SpHb,Predicate DeviceK221953 | Comparison to Predicate |
| and blood plasma constituents differ in theirabsorption of visible and infrared light. | and blood plasma constituents differ in theirabsorption of visible and infrared light. | ||
| 2. The amount of light absorbed by arterialblood changes with your pulse(photoplethysmography). | 2. The amount of light absorbed by arterialblood changes with your pulse(photoplethysmography). | ||
| Based upon the above principles, Masimorainbow SET technology uses multiplewavelengths light (red to infrared) to identifythe differences in absorption at the different | Based upon the above principles, Masimorainbow SET technology uses multiplewavelengths light (red to infrared) to identifythe differences in absorption at the different | ||
| wavelengths to determine SpO2 and SpHb.The periodic variations in the absorption oflight are used to determine the pulse rate. | wavelengths to determine SpO2 and SpHb.The periodic variations in the absorption oflight are used to determine the pulse rate. | ||
| Performance Specifications (Arms) | |||
| SpO2, No Motion(70-100%) | 2% (Adults, Pediatrics, and Infants)3% (Neonates) | 2% (Adults, Pediatrics, and Infants)3% (Neonates) | Same. |
| SpO2, Motion(70-100%) | 3% (Adults, Pediatrics, Infants, andNeonates) | 3% (Adults, Pediatrics, Infants, andNeonates) | Same. |
| SpO2, Low perfusion(70-100%) | 2% (Adults, Pediatrics, and Infants)3% (Neonates) | 2% (Adults, Pediatrics, and Infants)3% (Neonates) | Same. |
| Pulse Rate, No motion(25-240 bpm) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) | Same. |
| Pulse Rate, Motion(25-240 bpm) | 5 bpm (Adults, Pediatrics, andNeonates) | 5 bpm (Adults, Pediatrics, andNeonates) | Same. |
| Pulse Rate, LowPerfusion | 3 bpm (Adults, Pediatrics, andNeonates) | 3 bpm (Adults, Pediatrics, andNeonates) | Same. |
| Table 5-1 Comparison between Subject Device (CARESCAPE SpO2 – Masimo) and Predicate Device | |||
| Feature | CARESCAPE SpO2 – MasimoSubject Device | CARESCAPE SpO2 – Masimo with SpHb,Predicate DeviceK221953 | Comparison to Predicate |
| (25-240 bpm) | |||
| Accessories | |||
| CompatibleAccessories | Masimo wired sensors and cables,Radius PPG | Masimo wired sensors and cables. | Different. Radius PPG isincluded as a compatibleaccessory to the subjectdevice.Bench testing wasperformed to support thesubstantial 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 | |||
| Temperature | 0°C to 35°C | 0°C to 35°C | Same. |
| Electrical | |||
| Power Source | Host device | Host device | Same. |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | Same. |
| Electromagneticcompatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Same. |
| Classification per IEC 60601-1 | |||
| Mode of operation perIEC 60601-1 | Continuous | Continuous | Same. |
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Image /page/13/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white waveform 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".
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Image /page/14/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in large, bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/15/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 5-2 Comparison between Subject Device (Masimo rainbow SET IntelliVue) and Predicate Device | |||
|---|---|---|---|
| Feature | Masimo rainbow SET IntelliVueSubject Device | Masimo rainbow SET IntelliVuePredicate DeviceK162675 | Comparison to Predicate |
| Primary ClassificationRegulation/ ProductCode | 21 CFR 870.2700, Class II/ DQA | 21 CFR 870.2700, Class II/ DQA | Same. |
| Intended Use/Indications for Use | The Masimo Rainbow SET IntelliVueModule Pulse CO-Oximeter is intended to beused with compatible Philips IntelliVuePatient Monitors. The indications for use asspecified for the IntelliVue Patient Monitorsapplies.The Masimo Rainbow SET IntelliVueModule Pulse CO-Oximeter is indicated forthe noninvasive monitoring of functionaloxygen saturation of arterial hemoglobin(SpO2), pulse rate, carboxyhemoglobinsaturation (SpCO),methemoglobin saturation (SpMet), totalhemoglobin concentration (SpHb), and/orrespiratory rate (RRa). The MasimoRainbow SET IntelliVue Module Pulse CO-Oximeter is indicated for use during both nomotion and motion conditions,and for patients who are well or poorlyperfused.The Masimo Rainbow SET IntelliVueModule Pulse CO-Oximeter is not intended | The Masimo Rainbow SET IntelliVueModule Pulse CO-Oximeter is intended to beused with compatible Philips IntelliVuePatient Monitors. The indications for use asspecified for the IntelliVue Patient Monitorsapplies.The Masimo Rainbow SET IntelliVueModule Pulse CO-Oximeter is indicated forthe noninvasive monitoring of functionaloxygen saturation of arterial hemoglobin(SpO2), pulse rate, carboxyhemoglobinsaturation (SpCO),methemoglobin saturation (SpMet), totalhemoglobin concentration (SpHb), and/orrespiratory rate (RRa). The MasimoRainbow SET IntelliVue Module Pulse CO-Oximeter is indicated for use during both nomotion and motion conditions,and for patients who are well or poorlyperfused.The Masimo Rainbow SET IntelliVueModule Pulse CO-Oximeter is not intended | Same. |
| Table 5-2 Comparison between Subject Device (Masimo rainbow SET IntelliVue) and Predicate Device | |||
| Feature | Masimo rainbow SET IntelliVueSubject Device | Masimo rainbow SET IntelliVuePredicate DeviceK162675 | Comparison to Predicate |
| to be used as the sole basis for makingdiagnosis or treatment decisions related tosuspected carbon monoxide poisoning; it isintended to be used in conjunction withadditional methods of assessing clinical signsand symptoms. | to be used as the sole basis for makingdiagnosis or treatment decisions related tosuspected carbon monoxide poisoning; it isintended to be used in conjunction withadditional methods of assessing clinical signsand symptoms. | ||
| Principle of Operation | Masimo rainbow SET IntelliVue relieson the following principles:1. Oxyhemoglobin (oxygenated blood),deoxyhemoglobin (non-oxygenated blood),and blood plasma constituents differ in theirabsorption of visible and infrared light.2. The amount of light absorbed by arterialblood changes with your pulse(photoplethysmography).Based upon the above principles, Masimorainbow SET technology uses multiplewavelengths light (red to infrared) to identifythe differences in absorption at the differentwavelengths to determine SpO2, SpCO,SpMet, and SpHb. The periodic variations inthe absorption of light are used to determinethe pulse rate. | Masimo rainbow SET IntelliVue relieson the following principles:1. Oxyhemoglobin (oxygenated blood),deoxyhemoglobin (non-oxygenated blood),and blood plasma constituents differ in theirabsorption of visible and infrared light.2. The amount of light absorbed by arterialblood changes with your pulse(photoplethysmography).Based upon the above principles, Masimorainbow SET technology uses multiplewavelengths light (red to infrared) to identifythe differences in absorption at the differentwavelengths to determine SpO2, SpCO,SpMet, and SpHb. The periodic variations inthe absorption of light are used to determinethe pulse rate. | Same. |
| Table 5-2 Comparison between Subject Device (Masimo rainbow SET IntelliVue) and Predicate Device | |||
| Feature | Masimo rainbow SET IntelliVueSubject Device | Masimo rainbow SET IntelliVuePredicate DeviceK162675 | Comparison to Predicate |
| The Masimo Rainbow Acoustic Monitoring(RAM) technology uses acoustic signals forrespiration rate (RRa) measurements. RRameasures a patient's respiration rate based onairflow sounds generated in the upper airway. | The Masimo Rainbow Acoustic Monitoring(RAM) technology uses acoustic signals forrespiration rate (RRa) measurements. RRameasures a patient's respiration rate based onairflow sounds generated in the upper airway. | ||
| Performance Specifications (Arms) | |||
| SpO2, No Motion(60-80%) | 3% (Adults, Pediatrics, and Infants) | 3% (Adults, Pediatrics, and Infants) | Same. |
| SpO2, No Motion(70-100%) | 2% (Adults, Pediatrics, and Infants)3% (Neonates) | 2% (Adults, Pediatrics, and Infants)3% (Neonates) | Same. |
| SpO2, Motion(70-100%) | 3% (Adults, Pediatrics, Infants, andNeonates) | 3% (Adults, Pediatrics, Infants, andNeonates) | Same. |
| SpO2, Low perfusion(70-100%) | 2% (Adults, Pediatrics, Infants, andNeonates) | 2% (Adults, Pediatrics, Infants, andNeonates) | Same. |
| Pulse Rate, No motion(25-240 bpm) | 3 bpm (Adults, Pediatrics, Infants, andNeonates) | 3 bpm (Adults, Pediatrics, Infants, andNeonates) | Same. |
| Pulse Rate, Motion(25-240 bpm) | 5 bpm (Adults, Pediatrics, Infants, andNeonates) | 5 bpm (Adults, Pediatrics, Infants, andNeonates) | Same. |
| Pulse Rate, LowPerfusion(25-240 bpm) | 3 bpm (Adults, Pediatrics, Infants, andNeonates) | 3 bpm (Adults, Pediatrics, Infants, andNeonates) | Same. |
| SpCO(1-40%) | 3% (Adults, Pediatrics, Infants) | 3% (Adults, Pediatrics, Infants) | Same. |
| SpMet(1-15%) | 1% (Adults, Pediatrics, Infants, andNeonates) | 1% (Adults, Pediatrics, Infants, andNeonates) | Same. |
| SpHb(8-17 g/dL) | 1 g/dL (Adults, and Pediatrics) | 1 g/dL (Adults, and Pediatrics) | Same. |
| Table 5-2 Comparison between Subject Device (Masimo rainbow SET IntelliVue) and Predicate Device | |||
| Feature | Masimo rainbow SET IntelliVue Subject Device | Masimo rainbow SET IntelliVue Predicate Device K162675 | Comparison to Predicate |
| RRa (4-70 bpm) | 1 bpm (Adults, and Pediatrics) | 1 bpm (Adults, and Pediatrics) | Same. |
| AccessoriesCompatible Accessories | Masimo wired sensors and cables,Radius PPG | Masimo wired sensors and cables. | Different. Radius PPG is included as a compatible accessory to the subject device.Bench testing was performed to support the substantial equivalence. |
| Mechanical | |||
| Overall Dimensions | 4.0" by 3.9" by 1.4" | 4.0" by 3.9" by 1.4" | Same. |
| Environmental Specifications | |||
| Operating ConditionsTemperature | 0°C to 55°C (32°F to 131°F) | 0°C to 55°C (32°F to 131°F) | Same. |
| Humidity | 95% RH max at 40°C | 95% RH max at 40°C | Same. |
| Storage conditions | |||
| Temperature | -40°C to 70°C (-40°F to 158°F) | -40°C to 70°C (-40°F to 158°F) | Same. |
| Humidity | 95% RH max at 65°C | 95% RH max at 65°C | Same. |
| Classification per IEC 60601-1 | |||
| Mode of operation per IEC 60601-1 | Continuous | Continuous | Same. |
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Image /page/16/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white waveform to the left. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/17/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white waveform 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".
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Image /page/18/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white waveform 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".
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Image /page/19/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.
6 Performance Data
Bench Testing
There were no hardware or software changes made to the subject devices as part of this submission from the previous clearances under K221953 and K162675.
Bench Testing is included in this submission to support compatibility between the subject devices and Radius PPG.
Biocompatibility Testing
As there were no changes made to the patient contacting materials of the subject devices from their previous clearances, no biocompatibility testing was included in this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no hardware changes made to the subject devices from the previous clearances, no electrical safety, environmental, mechanical, and cleaning testing was included as part of this submission.
Although there are no hardware changes that were made to subject devices, EMC emissions and immunity testing was conducted to support the acceptability of the electromagnetic compatibility of the subject devices with Radius PPG.
Software Verification and Validation Testing
As there are no software changes made to the subject devices from the previous clearances, no software testing was included as part of this submission.
Wireless Testing
Wireless testing is provided with this submission to support the compatibility between the subject devices with Radius PPG.
Cybersecurity Testing
As there were no changes made to the subject device that affects cybersecurity, no additional cybersecurity testing was considered required to support the substantial equivalence.
Human Factors and Usability Testing
As there are no user interface changes made to the subject device from the previous clearances, no human factors and usability testing is included as part of this submission.
Clinical Testing
As the subject devices use the same monitoring technology as the previous clearances (K221953 and
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Image /page/20/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" and the address "52 Discovery, Irvine, CA 92618" in a smaller, gray font.
K162675), no additional clinical testing was required to support the substantial equivalence.
However, to support the equivalence of the clinical performance of the Radius PPG on patients of different skin pigmentations, additional clinical data was provided. The results are provided below:
| Patient Population | Subjects | Samples | Bias | Precision | Arms |
|---|---|---|---|---|---|
| Overall | 22 | 762 | 0.04 | 1.75 | 1.75 |
| Light | 13 | 449 | 0.05 | 1.79 | 1.79 |
| Dark | 9 | 313 | 0.03 | 1.74 | 1.75 |
7 Conclusion
Based on the data provided as part of this submission, the subject devices, Carescape SpO2 – Masimo and Masimo rainbow SET IntelliVue, were found to be substantially equivalent to the predicate devices.
§ 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).