(29 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as utilizing "Masimo SET Technology" which is a known signal processing technology for pulse oximetry, not typically associated with AI/ML. The performance studies section also indicates no software changes from the predicate device, further suggesting the absence of new AI/ML components.
No.
The device is indicated for monitoring physiological parameters (SpO2 and Pulse Rate) and does not actively treat or restore any bodily functions.
Yes
Explanation: The device is indicated for "monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR)," which are measurements critical for assessing a patient's physiological state and diagnosing potential issues like hypoxemia. This act of measuring and providing data for assessment falls under the definition of a diagnostic device.
No
The device is described as a "module" that connects to a patient monitor and interfaces with patient cables and sensors. It also contains a "Masimo Technology Board." These descriptions clearly indicate the presence of hardware components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring physiological parameters (Functional Oxygen Saturation and Pulse Rate) directly from a patient using a sensor applied to the body. This is a form of in vivo monitoring, not in vitro testing of samples taken from the body.
- Device Description: The device is a module that connects to a patient monitor and then to a patient cable and sensor. This setup is characteristic of devices used for direct patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological 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 IVD.
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 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.
Product codes
DQA
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).
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
Intended User / Care Setting
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)
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.
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 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)
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 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.
1
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
2
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORP" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
FAX: (949) 297-7592 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | September 7, 2021 |
| Contact: | Kertana Shankar
Regulatory Specialist II
Masimo Corporation
Phone: (949) 297-7260 |
| Trade Name: | CARESCAPE SpO2 - Masimo |
| 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: | K200494 - CARESCAPE ONE |
| Secondary Predicate: | Masimo SET IntelliVue Pulse Oximeter Module (K040259) |
| Performance Standards | There are no performance standards pursuant to Section 514 of the
Food, Drug and Cosmetic Act for the above device. |
1 Device Description
The CARESCAPE SpO2-Masimo (module) is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to monitor Masimo pulse oximeters (SpO2 and PR). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.
The CARESCAPE SpO2 - Masimo is equipped with the same Masimo Technology Board as the predicate device (K200494), which provides the Masimo SET Technology for the measurement and monitoring of pulse oximetry data.
The module is labeled CARESCAPE SpO2 – Masimo or GE CARESCAPE SpO2 – Masimo. Both versions are identical except for the labeling to distinguish the version distributed by Masimo. The purpose of this submission is to receive clearance to market CARESCAPE SpO2 - Masimo under its own 510(k).
4
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
5
Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark-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.
6
Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
| Table 2 - Comparison Table | ||||
|---|---|---|---|---|
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE | Masimo SET IntelliVue Module | Comparison to Predicate |
| Device | ||||
| (K200494) - GE CARESCAPE | ||||
| SpO2 - Masimo | (K040259) | |||
| 510(k) Number | ||||
| General | ||||
| Information | Subject Device | Primary Predicate | Secondary Predicate | |
| Intended Use | The CARESCAPE SpO2 - Masimo is | |||
| intended to be used with multi-parameter | ||||
| physiological patient monitors (e.g., GE | ||||
| CARESCAPE ONE) for use in multiple | ||||
| areas and intra-hospital transport within a | ||||
| professional healthcare facility. |
The CARESCAPE SpO2 – Masimo is
indicated for the monitoring of Functional
Oxygen Saturation (SpO2) and Pulse Rate
(PR). The CARESCAPE SpO2 – Masimo
is indicated for use on adult, pediatric, and
neonatal patients and on one patient at a
time. | The 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.
The CARESCAPE ONE is indicated
for the monitoring of hemodynamic
(including ECG, ST segment,
arrhythmia detection, invasive
pressure, non-invasive blood pressure,
SpO2, pulse rate, and temperature),
and respiratory (impedance respiration
and CO2 airway gas) physiological
parameters.
The CARESCAPE ONE can be used
as a standalone monitor. In this mode
of operation, the CARESCAPE ONE
provides ECG, ST segment,
arrhythmia detection, invasive
pressure, noninvasive blood pressure,
SpO2, pulse rate, temperature,
impedance respiration, and CO2
airway gas parameter acquisition and
monitoring. | The Masimo SET® IntelliVue Pulse
Oximeter Module is intended for the
continuous noninvasive monitoring
of functional oxygen saturation of
arterial hemoglobin (SpO2) and
pulse rate (measured by an SpO2
sensor) for adult, pediatric, and
neonatal patients in hospitals and
hospital-type facilities.
The IntelliVue Pulse Oximeter
Module is indicated for the
continuous noninvasive monitoring
of functional oxygen saturation of
arterial hemoglobin and pulse rate.
The IntelliVue Pulse Oximeter
Module is indicated for use with
adult, pediatric and neonatal patients
during both motion and no motion
conditions, and for patients who are
well or poorly perfused in hospitals
and hospital-type facilities. | Same
Intended use of the subject
device is the same as the
predicates in providing
SpO2 and Pulse Rate.
However, as this
submission is specific to
the clearance of
CARESCAPE SpO2 –
Masimo, the description
of the indications for use
is revised to be specific to
the subject device's
cleared indications for use
as part of predicate
(K200494).
The description of the
indications for use for the
subject device is revised
to align with the
secondary predicate which
has the same intended use
and same technology as
the subject device and
primary predicate but
specific language around
the indications that is |
| Table 2 – Comparison Table | | | | |
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE
(K200494) - GE CARESCAPE
SpO2 - Masimo | Masimo SET IntelliVue Module
(K040259) | Comparison to Predicate
Device |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| | | The CARESCAPE ONE can be
connected as an accessory to a
compatible CARESCAPE monitor. In
this mode of operation, the
CARESCAPE ONE provides ECG,
ST segment, arrhythmia detection,
invasive pressure, non-invasive blood
pressure, SpO2, pulse rate,
temperature, impedance respiration,
and CO2 airway gas parameter
acquisition. Visual and audible alarms,
user controls, and user interface on the
CARESCAPE ONE are not active in
this mode. | | applicable to both the
subject device and
primary predicate. |
| | | The CARESCAPE ONE is indicated
for use on adult, pediatric, and
neonatal patients and on one patient at
a time. | | |
| | | The CARESCAPE ONE is indicated
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. | | |
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE
(K200494) - GE CARESCAPE
SpO2 - Masimo | Masimo SET IntelliVue Module
(K040259) | Comparison to Predicate
Device |
| 510(k) Number | Subject Device | Primary Predicate | Secondary Predicate | |
| Classification
Regulation/ Product
Code | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | 21 CFR 870.2700/ DQA | Same |
| Principle of
Operation | Pulse oximetry is governed by 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. | Pulse oximetry is governed by 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. | Pulse oximetry is governed by 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. | 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, Low
Perfusion (70-100%) | 2% (Adults, Pediatrics, Infants)
3% (Neonates) | 2% (Adults, Pediatric, Infant)
3% (Neonates) | 2% (Adults, Pediatric, Infant)
3% (Neonates) | Same |
| Pulse Rate, No
Motion (25 - 240
bpm) | 3 bpm (Adults, Pediatrics, and Neonates) | 3 bpm (Adults, Pediatrics, and
Neonates) | 3 bpm (Adults, Pediatrics, and
Neonates) | Same |
| 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 |
| Table 2 - Comparison Table | | | | |
| Feature | CARESCAPE SpO2 - Masimo | CARESCAPE ONE
(K200494) – GE CARESCAPE
SpO2 - Masimo | Masimo SET IntelliVue Module
(K040259) | Comparison to Predicate
Device |
| 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 |
| 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 55°C | Same as primary predicate |
| Mode of Operation per IEC 60601-1 | | | | |
| Mode of Operation | Continuous | Continuous | Continuous | Same |
7
Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark 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".
8
Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white 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".
9
Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black letters. To the right of the logo is the text "MASIMO CORPORATION" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618".
10
Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark 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.
11
Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in 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.