(30 days)
No
The summary describes a pulse oximetry module that utilizes existing Masimo SET and rainbow SET Technology for parameter measurement. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the activation of the SpHb feature and the distribution labeling difference compared to the predicate devices.
No
The device is described as a monitor performing non-invasive monitoring of physiological parameters (SpO2, PR, SpHb), not providing therapy.
Yes
The device continuously monitors physiological parameters like oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and total hemoglobin concentration (SpHb), which are used to assess a patient's health status, thus serving a diagnostic function.
No
The device is described as a "module" that connects to a patient monitor and patient cables/sensors. This indicates it is a hardware component, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)" and "continuous non-invasive monitoring of total hemoglobin concentration (SpHb)". These are measurements taken directly from the patient's body using a sensor, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description reinforces this by stating it "connects to Masimo patient cable and sensor accessories" and "provides the ability to continuously monitor Masimo pulse oximetry parameters". This describes a device that interacts directly with the patient to obtain physiological data.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the CARESCAPE SpO2 - Masimo is a patient monitoring device, not an In Vitro Diagnostic device.
N/A
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 continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patient at a time.
The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.
Product codes
DQA
Device Description
The Masimo CARESCAPE SpO2 – Masimo with SpHb ("CARESCAPE SpO2 – Masimo") is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) 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.
The CARESCAPE SpO2 – Masimo is the same module cleared as the GE CARESCAPE SpO2 – Masimo as part of the secondary predicate device (K213234), which provides the Masimo SET and rainbow SET Technology for the measurement and monitoring of pulse oximetry data. The only difference between the two modules is that the subject device is labeled for distribution by Masimo, and the secondary predicate is labeled for distribution by GE Healthcare. The difference between the subject device and primary predicate is the activation of the SpHb feature, the same as what was cleared as part of the secondary predicate (K213234).
As part of the development of the CARESCAPE SpO2 – Masimo, the module was also referenced as the following: "USB rainbow SET module", "CARESCAPE SpO2", and GE CARESCAPE SpO2 – Masimo".
As the CARESCAPE SpO2 - Masimo and GE CARESCAPE SpO2 - Masimo are the same, the performance specifications for the subject device and the secondary predicate device are also the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, and neonatal patients for SpO2 and PR monitoring.
Adult and pediatric patients for SpHb monitoring.
Intended User / Care Setting
Used with multi-parameter physiological patient monitors for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
As there were no performance changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no performance bench testing was included in this submission.
As no changes were made to patient-contacting materials in the subject device, compared to the previously cleared CARESCAPE SpO2 - Masimo (K212876), no biocompatibility testing was included in this submission.
As there were no software or hardware changes made to the subject device, compared to the previously cleared CARESCAPE SpO2 - Masimo (K212876), no Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning testing was included in this submission.
As there were no software changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no software testing was included in this submission.
As the CARESCAPE SpO2 – Masimo uses wired communication for the transfer of parameter data and alarms status and does not have wireless features at this time, no wireless testing was included in this submission.
As there were no user interface changes made to the subject device compared to the previously cleared CARESCAPE SpO2 - Masimo (K212876), no human factors and usability testing was included in this submission.
As the subject device uses the same monitoring technology as the predicate device, additional testing was not considered necessary to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 4, 2022
Masimo Corporation Unji Lee Regulatory Affairs Specialist I 52 Discovery Irvine, California 92618
Re: K221953
Trade/Device Name: Masimo CARESCAPE SpO2 - Masimo with SpHb Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 30, 2022 Received: July 5, 2022
Dear Unji Lee:
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
1
Page
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Todd Courtney 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)
Device Name Masimo CARESCAPE SpO2 - Masimo with SpHb
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 continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patient at a time.
The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric 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, bold letters. 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.
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7260
FAX: (949) 297-7592 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | August 3, 2022 |
| Contact: | Unji Lee
Regulatory Affairs Specialist II
Masimo Corporation
Phone: (949) 563-7426 |
| Trade Name: | Masimo CARESCAPE SpO2 - Masimo with SpHb |
| Common Name: | Oximeter |
| Classification Regulation/
Product Code: | 21 CFR 870.2700, Class II/ DQA |
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
Notification: | Labeling update |
| Primary Predicate: | Masimo CARESCAPE SpO2 - Masimo (K212876) |
| Secondary Predicate: | CARESCAPE ONE (K213234) |
| Performance Standards: | There are no performance standards pursuant to Section 514 of the
Food, Drug and Cosmetic Act for the above device. |
1. Device Description
The Masimo CARESCAPE SpO2 – Masimo with SpHb ("CARESCAPE SpO2 – Masimo") is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) 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.
The CARESCAPE SpO2 – Masimo is the same module cleared as the GE CARESCAPE SpO2 – Masimo as part of the secondary predicate device (K213234), which provides the Masimo SET and rainbow SET Technology for the measurement and monitoring of pulse oximetry data. The only difference between the two modules is that the subject device is labeled for distribution by Masimo, and the secondary predicate is labeled for distribution by GE Healthcare. The difference between the subject device and primary predicate
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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" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
is the activation of the SpHb feature, the same as what was cleared as part of the secondary predicate (K213234).
As part of the development of the CARESCAPE SpO2 – Masimo, the module was also referenced as the following: "USB rainbow SET module", "CARESCAPE SpO2", and GE CARESCAPE SpO2 – Masimo".
As the CARESCAPE SpO2 - Masimo and GE CARESCAPE SpO2 - Masimo are the same, the performance specifications for the subject device and the secondary predicate device are also the same.
Image /page/4/Picture/5 description: The image shows a white, rectangular-shaped medical device, possibly a pulse oximeter, with rounded edges. A label on the device reads "Masimo SET Rainbow" and "CARESCAPE SpO2". The device has a small opening on one end, likely for inserting a finger or toe to measure oxygen saturation. There are also a couple of buttons on the top of the device.
Figure 1 – CARESCAPE SpO2 – Masimo
Refer to Table 1 for 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, 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 |
| Operating Altitude | -500 m to 4000 m |
| Storage Altitude | -500 m to 5573 m |
| Ingress Protection from Solids/ Liquids | IP47 (per IEC 60529) |
| Mode of Operation per IEC 60601-1 | |
| Mode of Operation | Continuous |
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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, stylized 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.
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 continuous non-invasive 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 non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.
3. Technological Characteristics
Principle of Operation
The subject device uses the same Masimo SET and rainbow SET Pulse Oximetry technology as the primary predicate device (K212876) and secondary predicate device (K213234) 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 1. 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, Masimo rainbow SET technology uses multiple wavelengths of light (red to infrared) to identify the differences in absorption at the different wavelengths to determine SpO2 and SpHb. The periodic variations in the absorption of light are used to determine the pulse rate.
Mechanism of Action for Achieving the Intended Effect
The subject device and predicate devices have the same mechanism of action.
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) 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.
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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, stylized 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.
4. Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device
The subject and primary predicate device (K212876) have the following similarities:
- Both devices have the same intended use. ●
- Both devices have the same principle of operation and mechanism of action.
- Both devices have the same performance specifications for oxygen saturation (SpO2) and pulse rate ● (PR).
- Both devices are indicated for the same patient populations for oxygen saturation (SpO2) and pulse rate (PR).
The subject and primary predicate device (K212876) have the following difference:
- The subject device supports the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) as it was cleared as part of the secondary predicate (K213234).
The subject and predicate devices were found to be substantially equivalent, as both have the same intended use. The technological difference between the subject and primary predicate device is that total hemoglobin concentration (SpHb) monitoring is enabled on the subject device, the same as it was cleared on the secondary predicate (K213234).
To support that the technological difference between the subject device and the predicate device does not raise different questions of safety and effectiveness, the secondary predicate device (K213234) is included in this submission. The secondary predicate is the same device as the subject device, with exception to the labeling that is specific to the distribution under Masimo. The subject device and secondary predicate have the same intended use and same technological characteristics, as they are the same device.
Accordingly, the subject device was determined to be substantially equivalent.
Refer to Table 4-1 below for the comparison between the subject and predicate devices.
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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 line going through it, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
| Feature | CARESCAPE SpO2 – Masimo with
SpHb | CARESCAPE SpO2 – Masimo | CARESCAPE ONE – GE
CARESCAPE SpO2 - Masimo | Comparison to
Predicate Device |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject Device | Primary Predicate (K212876) | Secondary Predicate (K213234) | |
| General Information | | | | |
| Intended Use | The CARESCAPE SpO2 - Masimo is
intended to be used with multi-
parameter physiological patient
monitors (e.g., GE CARESCAPE ONE)
for use in multiple areas and intra-
hospital transport within a professional
healthcare facility.
The CARESCAPE SpO2 – Masimo is
indicated for the continuous non-
invasive 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 non-
invasive monitoring of total
hemoglobin concentration (SpHb) for
use on adult and pediatric patients and
on one patient at a time. | 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. | CARESCAPE ONE is both a multi-
parameter physiological patient monitor
and an accessory to a multi-parameter
patient monitor intended for use in
multiple areas and intra-hospital transport
within a professional healthcare facility.
CARESCAPE ONE is indicated for the
monitoring of hemodynamic and
respiratory physiological parameters.
When the CARESCAPE ONE is operated
as a standalone multi-parameter
physiological patient monitor, it provides
the following physiological parameters:
• ECG (heart rate, ST segment, and
arrhythmia detection)
• Pulse oximetry (pulse rate,
functional oxygen saturation
[SpO2])
• Non-invasive blood pressure
(systolic, diastolic, and mean arterial
pressures)
• Invasive pressure (pulse rate and
systolic, diastolic, and mean
pressures)
• Temperature | Same. Subject device
and predicates have the
same intended use. The
subject device includes
the SpHb feature, the
same as the secondary
predicate. |
| Table 4-1 | | | | |
| Feature | CARESCAPE SpO2 – Masimo with
SpHb | CARESCAPE SpO2 – Masimo | CARESCAPE ONE – GE
CARESCAPE SpO2 - Masimo | Comparison to
Predicate Device |
| | Subject Device | Primary Predicate (K212876) | Secondary Predicate (K213234) | |
| 510(k) Number | | | • Impedance respiration
When The CARESCAPE ONE is
connected as an accessory to a compatible
host monitor, it provides the following
physiological parameters to the host
monitor:
• ECG (heart rate, ST segment, and
arrhythmia detection)
• Pulse oximetry (pulse rate,
functional oxygen saturation
[SpO2], and total hemoglobin
concentration [SpHb])
• Non-invasive blood pressure
(systolic, diastolic, and mean arterial
pressures)
• Invasive pressure (pulse rate and
systolic, diastolic, and mean
pressures)
• Regional oxygen saturation (rSO2)
• Temperature
• Respiratory carbon dioxide (EtCO2,
FiCO2, and respiration rate)
• Impedance respiration
When the CARESCAPE ONE is
connected as an accessory to a compatible
host monitor, visual and audible alarms,
user controls, and user interface are | |
| Table 4-1 | | | | |
| Feature | CARESCAPE SpO2 – Masimo with SpHb | CARESCAPE SpO2 – Masimo | CARESCAPE ONE – GE
CARESCAPE SpO2 - Masimo | Comparison to
Predicate Device |
| 510(k) Number | Subject Device | Primary Predicate (K212876) | Secondary Predicate (K213234)
provided on the compatible host monitor
and not on CARESCAPE ONE.
CARESCAPE ONE is intended for use on
adult, pediatric, and neonatal patients and
on one patient at a time.
Regional oxygen saturation (rSO2) is an
adjunct parameter for noninvasive
monitoring of cerebral/somatic regional
oximetry of blood in the brain or other
tissue beneath the sensor. It is intended to
be used on patients greater than 40 kg (88
lbs) at risk for reduced-flow or no-flow
ischemic states.
CARESCAPE ONE is intended for use
under the direct supervision of a licensed
healthcare practitioner, or by personnel
trained in the proper use of the equipment
in a professional healthcare facility.
Contraindications for using CARESCAPE
ONE:
The CARESCAPE ONE is not intended
for use within a controlled MR
environment. | |
| Classification
Regulation/ Product
Code | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | 21 CFR 870.1025/ MHX | Same. |
| Table 4-1 | | | | |
| Feature | CARESCAPE SpO2 – Masimo with
SpHb | CARESCAPE SpO2 – Masimo
Primary Predicate (K212876) | CARESCAPE ONE - GE
CARESCAPE SpO2 - Masimo
Secondary Predicate (K213234) | Comparison to
Predicate Device |
| 510(k) Number | Subject Device | | | |
| Principle of Operation | 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, Masimo rainbow SET technology uses multiple wavelengths light (red to infrared) to identify the differences in absorption at the different wavelengths to determine SpO2 and SpHb. The periodic variations in the absorption of light are used to determine the pulse rate. | CARESCAPE SpO2 – Masimo relies on the 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. | 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, Masimo rainbow SET technology uses multiple wavelengths light (red to infrared) to identify the differences in absorption at the different wavelengths to determine SpO2 and SpHb. The periodic variations in the absorption of light are used to determine the pulse rate. | Same. |
| Performance Specifications (Arms) | | | | |
| SpO2, No Motion
(70-100%) | 2% (Adults, Pediatrics, and Infants)
3% (Neonates) | 2% (Adults, Pediatrics, and Infants)
3% (Neonates) | 2% (Adults, Pediatrics, and Infants)
3% (Neonates) | Same. |
| SpO2, Motion
(70-100%) | 3% (Adults, Pediatrics, Infants, and Neonates) | 3% (Adults, Pediatrics, Infants, and Neonates) | 3% (Adults, Pediatrics, Infants, and Neonates) | Same. |
| SpO2, Low Perfusion
(70-100%) | 2% (Adults, Pediatrics, and Infants)
3% (Neonates) | 2% (Adults, Pediatrics, and Infants)
3% (Neonates) | 2% (Adults, Pediatrics, and Infants)
3% (Neonates) | Same. |
| Pulse Rate, No Motion | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) | Same. |
| Table 4-1 | | | | |
| Feature | CARESCAPE SpO2 – Masimo with SpHb | CARESCAPE SpO2 – Masimo | CARESCAPE ONE – GE CARESCAPE SpO2 - Masimo | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Primary Predicate (K212876) | Secondary Predicate (K213234) | |
| Pulse Rate, Motion
(25 - 240 bpm) | 5 bpm (Adults, Pediatrics, and Neonates) | 5 bpm (Adults, Pediatrics, and Neonates) | 5 bpm (Adults, Pediatrics, and Neonates) | Same. |
| Pulse Rate, Low Perfusion
(25 - 240 bpm) | 3 bpm (Adults, Pediatrics, and Neonates) | 3 bpm (Adults, Pediatrics, and Neonates) | 3 bpm (Adults, Pediatrics, and Neonates) | Same. |
| SpHb (8-17 g/dL) | 1 g/dL (Adults and Pediatrics) | Not applicable. | 1 g/dL (Adults and Pediatrics) | Same. |
| Mechanical | | | | |
| Overall Dimension | 5.40" by 2.68" by 1.00" | 5.40" by 2.68" by 1.00" | 5.40" by 2.68" by 1.00" | Same. |
| 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. |
| Electromagnetic compatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Same. |
| Environmental | | | | |
| Operating Temperature | 0°C to 35°C | 0°C to 35°C | 0°C to 35°C | Same. |
| Mode of Operation per IEC 60601-1 | | | | |
| Mode of Operation | Continuous | Continuous | Continuous | Same. |
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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 bold black letters. 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/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in bold, black letters, with a red circle containing a white checkmark to the left of the word. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, 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 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".
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Image /page/11/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. Below the logo is the address "52 Discovery, Irvine, CA 92618".
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5. Performance Data
Performance Bench Testing
As there were no performance changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no performance bench testing was included in this submission.
Biocompatibility Testing
As no changes were made to patient-contacting materials in the subject device, compared to the previously cleared CARESCAPE SpO2 - Masimo (K212876), no biocompatibility testing was included in this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no software or hardware changes made to the subject device, compared to the previously cleared CARESCAPE SpO2 - Masimo (K212876), no Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning testing was included in this submission.
Software Verification and Validation Testing
As there were no software changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no software testing was included in this submission.
Wireless and Cybersecurity Testing
As the CARESCAPE SpO2 – Masimo uses wired communication for the transfer of parameter data and alarms status and does not have wireless features at this time, no wireless testing was included in this submission.
Human Factors and Usability Testing
As there were no user interface changes made to the subject device compared to the previously cleared CARESCAPE SpO2 - Masimo (K212876), no human factors and usability testing was included in this submission.
Clinical Testing
As the subject device uses the same monitoring technology as the predicate device, additional testing was not considered necessary to support substantial equivalence.
6. Conclusion
The subject device was found to be substantially equivalent.