(29 days)
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.
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).
The provided text describes the CARESCAPE SpO2 - Masimo device, whose 510(k) submission (K212876) is for a labeling update and to market the device under its own 510(k). The device itself is identical to the primary predicate device, GE CARESCAPE SpO2 – Masimo (part of K200494), with no changes to hardware, software, or performance. Therefore, new performance data was not generated for this submission.
The acceptance criteria provided in the document are the performance specifications of the device as previously cleared with the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this submission is for a device that is identical to a previously cleared predicate, the "reported device performance" refers to the previously established performance specifications which are considered met, as there are no changes to the device itself.
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (as per predicate) |
|---|---|---|
| Performance Specification (Arms) | ||
| SpO2, no motion (70-100%) | 2% (Adults, Pediatrics, Infants) | 2% (Adults, Pediatrics, Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| SpO2, motion (70-100%) | 3% (Adults, Pediatrics, Infants, Neonates) | 3% (Adults, Pediatrics, Infants, Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults, Pediatrics, Infants) | 2% (Adults, Pediatrics, Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| Pulse Rate, no motion (25-240 bpm) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) |
| Pulse Rate, motion (25-240 bpm) | 5 bpm (Adults, Pediatrics, Neonates) | 5 bpm (Adults, Pediatrics, Neonates) |
| Pulse Rate, low perfusion (25-240 bpm) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the primary predicate device, additional testing was not considered necessary to support the substantial equivalence."
Therefore, no new test set was used for this particular submission. The performance data is derived from the testing conducted for the primary predicate device (K200494), but the details of that testing (sample size, data provenance) are not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this submission as no new testing was performed to establish ground truth.
4. Adjudication method for the test set
Not applicable for this submission as no new testing was performed to establish ground truth that would require adjudication.
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
Not applicable. This device is an oximeter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The performance specifications listed are standalone performance metrics of the oximeter device. Details of the studies establishing these specifications were conducted for the predicate device, but are not described in this document.
7. The type of ground truth used
For an oximeter measuring SpO2 and Pulse Rate, the ground truth typically involves invasive blood gas analysis (for SpO2) and ECG or simultaneous direct measurement (for Pulse Rate) against which the device's measurements are compared. These methods would have been used during the original testing of the predicate device.
8. The sample size for the training set
Not applicable. This document is for a medical device (oximeter), not an AI model requiring a training set. The device operates on physical principles, not machine learning.
9. How the ground truth for the training set was established
Not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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 ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618FAX: (949) 297-7592 |
|---|---|
| Date: | September 7, 2021 |
| Contact: | Kertana ShankarRegulatory Specialist IIMasimo CorporationPhone: (949) 297-7260 |
| 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: | 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 theFood, 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)3% (Neonates) |
| SpO2, motion (70-100%) | 3% (Adults, Pediatrics, Infants, and Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults and 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) |
| 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)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:
-
- Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
-
- The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
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 PredicateDevice |
| (K200494) - GE CARESCAPESpO2 - Masimo | (K040259) | |||
| 510(k) NumberGeneralInformation | Subject Device | Primary Predicate | Secondary Predicate | |
| Intended Use | The CARESCAPE SpO2 - Masimo isintended to be used with multi-parameterphysiological patient monitors (e.g., GECARESCAPE ONE) for use in multipleareas and intra-hospital transport within aprofessional healthcare facility.The CARESCAPE SpO2 – Masimo isindicated for the monitoring of FunctionalOxygen Saturation (SpO2) and Pulse Rate(PR). The CARESCAPE SpO2 – Masimois indicated for use on adult, pediatric, andneonatal patients and on one patient at atime. | The CARESCAPE ONE is both amulti-parameter physiological patientmonitor and an accessory to a multi-parameter patient monitor intended foruse in multiple areas and intra-hospitaltransport within a professionalhealthcare facility.The CARESCAPE ONE is indicatedfor the monitoring of hemodynamic(including ECG, ST segment,arrhythmia detection, invasivepressure, non-invasive blood pressure,SpO2, pulse rate, and temperature),and respiratory (impedance respirationand CO2 airway gas) physiologicalparameters.The CARESCAPE ONE can be usedas a standalone monitor. In this modeof operation, the CARESCAPE ONEprovides ECG, ST segment,arrhythmia detection, invasivepressure, noninvasive blood pressure,SpO2, pulse rate, temperature,impedance respiration, and CO2airway gas parameter acquisition andmonitoring. | The Masimo SET® IntelliVue PulseOximeter Module is intended for thecontinuous noninvasive monitoringof functional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate (measured by an SpO2sensor) for adult, pediatric, andneonatal patients in hospitals andhospital-type facilities.The IntelliVue Pulse OximeterModule is indicated for thecontinuous noninvasive monitoringof functional oxygen saturation ofarterial hemoglobin and pulse rate.The IntelliVue Pulse OximeterModule is indicated for use withadult, pediatric and neonatal patientsduring both motion and no motionconditions, and for patients who arewell or poorly perfused in hospitalsand hospital-type facilities. | SameIntended use of the subjectdevice is the same as thepredicates in providingSpO2 and Pulse Rate.However, as thissubmission is specific tothe clearance ofCARESCAPE SpO2 –Masimo, the descriptionof the indications for useis revised to be specific tothe subject device'scleared indications for useas part of predicate(K200494).The description of theindications for use for thesubject device is revisedto align with thesecondary predicate whichhas the same intended useand same technology asthe subject device andprimary predicate butspecific language aroundthe indications that is |
| Table 2 – Comparison Table | ||||
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE(K200494) - GE CARESCAPESpO2 - Masimo | Masimo SET IntelliVue Module(K040259) | Comparison to PredicateDevice |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| The CARESCAPE ONE can beconnected as an accessory to acompatible CARESCAPE monitor. Inthis mode of operation, theCARESCAPE ONE provides ECG,ST segment, arrhythmia detection,invasive pressure, non-invasive bloodpressure, SpO2, pulse rate,temperature, impedance respiration,and CO2 airway gas parameteracquisition. Visual and audible alarms,user controls, and user interface on theCARESCAPE ONE are not active inthis mode. | applicable to both thesubject device andprimary predicate. | |||
| The CARESCAPE ONE is indicatedfor use on adult, pediatric, andneonatal patients and on one patient ata time. | ||||
| The CARESCAPE ONE is indicatedfor use under the direct supervision ofa licensed healthcare practitioner, orby personnel trained in the proper useof the equipment in a professionalhealthcare facility. | ||||
| Contraindications for usingCARESCAPE ONE:The CARESCAPE ONE is notintended for use within a controlledMR environment. | ||||
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE(K200494) - GE CARESCAPESpO2 - Masimo | Masimo SET IntelliVue Module(K040259) | Comparison to PredicateDevice |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| ClassificationRegulation/ ProductCode | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | Same |
| Principle ofOperation | Pulse oximetry is governed by thefollowing principles:1. Oxyhemoglobin (oxygenated blood)and deoxyhemoglobin (non-oxygenated blood) differ in theirabsorption of red and infrared light(spectrophotometry).2. The amount of arterial blood in tissuechanges with your pulse(photoplethysmography). Therefore,the amount of light absorbed by thevarying quantities of arterial bloodchanges as well. | Pulse oximetry is governed by thefollowing principles:1. Oxyhemoglobin (oxygenatedblood) and deoxyhemoglobin(non-oxygenated blood) differ intheir absorption of red andinfrared light (spectrophotometry).2. The amount of arterial blood intissue changes with your pulse(photoplethysmography).Therefore, the amount of lightabsorbed by the varying quantities of arterial blood changes as well. | Pulse oximetry is governed by thefollowing principles:1. Oxyhemoglobin (oxygenatedblood) and deoxyhemoglobin(non-oxygenated blood) differ intheir absorption of red andinfrared light(spectrophotometry).2. The amount of arterial blood intissue changes with your pulse(photoplethysmography).Therefore, the amount of lightabsorbed by the varyingquantities of arterial bloodchanges as well. | Same |
| Performance Specifications | ||||
| SpO2, No Motion(70-100%) | 2% (Adults, Pediatrics, Infants)3% (Neonates) | 2% (Adults, Pediatric, Infant)3% (Neonates) | 2% (Adults, Pediatric, Infant)3% (Neonates) | Same. |
| SpO2, Motion (70-100%) | 3% (All population) | 3% (All population) | 3% (All population) | Same |
| SpO2, LowPerfusion (70-100%) | 2% (Adults, Pediatrics, Infants)3% (Neonates) | 2% (Adults, Pediatric, Infant)3% (Neonates) | 2% (Adults, Pediatric, Infant)3% (Neonates) | Same |
| Pulse Rate, NoMotion (25 - 240bpm) | 3 bpm (Adults, Pediatrics, and Neonates) | 3 bpm (Adults, Pediatrics, andNeonates) | 3 bpm (Adults, Pediatrics, andNeonates) | Same |
| Pulse Rate, Motion(25 – 240 bpm) | 5 bpm (Adults, Pediatrics, and Neonates) | 5 bpm (Adults, Pediatrics, andNeonates) | 5 bpm (Adults, Pediatrics, andNeonates) | Same |
| Table 2 - Comparison Table | ||||
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE(K200494) – GE CARESCAPESpO2 - Masimo | Masimo SET IntelliVue Module(K040259) | Comparison to PredicateDevice |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| Mechanical | ||||
| Overall Dimension | 5.40" by 2.68" by 1.00" | 5.40" by 2.68" by 1.00" | 3.9" by 3.8" by 1.4" | Same as primary predicate |
| Electrical | ||||
| Power Source | Host device | Host device | Host device | Same |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | Same |
| Electromagneticcompatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Same |
| Environmental | ||||
| OperatingTemperature | 0°C to 35°C | 0°C to 35°C | 0°C to 55°C | Same as primary predicate |
| Mode of Operation per IEC 60601-1 | ||||
| Mode of Operation | Continuous | Continuous | Continuous | Same |
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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in 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".
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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 checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/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 letters. To the right of the logo is the text "MASIMO CORPORATION" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
റ Performance Data
Performance Bench Testing
As there are no hardware or software changes as part of this submission from the previous clearance, no performance bench testing was included as part of this submission.
Biocompatibility Testing
As there are no changes to the patient contacting materials as part of this submission from the previous clearance, no biocompatibility testing was included as part of this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no changes to the hardware or software as part of this submission from the previous clearance, no Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning testing was included with this submission.
Software Verification and Validation Testing
As there are no software changes as part of this submission from the previous clearance, no software testing was included as part of this submission.
Wireless and Cybersecurity Testing
As the CARESCAPE SpO2 - Masimo module uses wired communication for the transfer of parameter data and alarm status, and does not have wireless features at this time, no wireless testing was included as part of this submission.
Human Factors and Usability Testing
As there are no changes made to user interfaces as part of this submission from the previous clearance, no human factors and usability testing was included as part of this submission.
Non-clinical Testing
As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence.
Clinical Testing
As the subject device utilizes the same monitoring technology as the primary predicate device, additional testing was not considered necessary to support the substantial equivalence.
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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 a bold, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
Conclusion 6
The subject device, CARESCAPE SpO2 - Masimo, and the primary predicate device, GE CARESCAPE SpO2 – Masimo (K200494) were found to be substantially equivalent as both have the same intended use and same technological characteristics.
§ 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).