The Rad-97 and Accessories is a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital, hospital type facilities, mobile and home environments.

The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing (e.g., at a central station).

The Rad-97 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Rad-97 and Accessories are indicated for the continuous monitoring rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.

In addition, the Rad-97 and Accessories are indicated to provide the non-invasive spot-checking and continuous monitoring data obtained from the Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The optional NomoLine Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The NomoLine Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NiBP module is designed to messure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The Rad-97 and accessories are indicated for the non-invasive continuous monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions.

PV i may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PV in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate from Pleth (RRp) for adult and pediatric patients during no motion conditions.

The Radical-7 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Device Description

This premarket notification [510(k)] is for the authorization to market the previously cleared Rad-97 (K193626) and Radical-7 (K193242) with an additional indication for spot-checking.

The cleared versions of the subject devices already support both continuous monitoring and spotchecking use through the activation and deactivation of alarms. This submission updates the indications to reflect both uses of the subject devices.

Rad-97: The Rad-97 is a patient monitor capable of providing multiple parameters. The Rad-97 product family provides the integrated ability of noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), Pleth Respiration Rate (RRp), capnography parameters, and noninvasive blood pressure (NiBP) parameters.

Radical-7: The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), Pleth Variability Index (PVi), totalhemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), acoustic respiration rate (RRa), and Pleth Respiration Rate (RRp).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Masimo Radical-7 Pulse CO-Oximeter and Accessories and the Rad-97 and Accessories. The submission's primary purpose is to update the indications for use to explicitly include "spot-checking" functionality, which the devices already supported by allowing alarm deactivation.

The document asserts that the devices are substantially equivalent to their predicate devices (K193626 for Rad-97 and K193242 for Radical-7) because there are no changes to the device's fundamental technology, principle of operation, or performance specifications. The "spot-checking" capability was already inherent in the devices' design, as users could deactivate continuous monitoring alarms to achieve this function. Therefore, the update is primarily a labeling change to reflect existing functionality.

Based on the provided information, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device is not directly applicable in the way one might expect for a new AI product. This submission is for a traditional medical device (patient monitor/oximeter), and the "study" is demonstrating substantial equivalence to a predicate device, not necessarily proving a new algorithm's performance against specific acceptance criteria for AI.

However, we can infer the "acceptance criteria" not as novel performance thresholds, but as the maintenance of the same performance characteristics as the predicate devices, and the "proof" coming from the assertion that no changes were made to the core technology that would alter these.

Here's an attempt to structure the information according to the requested format, interpreting "acceptance criteria" as maintaining the predicate's performance and "study" as the justification for substantial equivalence.

Acceptance Criteria and Device Performance (Interpreted)

The core "acceptance criteria" in this 510(k) submission are that the subject devices (Rad-97 and Radical-7) maintain substantial equivalence to their predicate devices (Rad-97 K193626 and Radical-7 K193242, respectively) and that the expanded "indications for use" to include "spot-checking" does not introduce new questions of safety or effectiveness. This is because the devices already possessed the capability for spot-checking by deactivating alarms.

The "study" that proves the device meets these criteria is an assertion of no change in fundamental technological characteristics, principles of operation, or performance specifications compared to the predicate devices, supported by software verification and validation that confirm the integrity of the existing as-cleared software.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for a traditional device with an expanded indication based on existing functionality, the "acceptance criteria" are implicitly the already cleared performance specifications of the predicate devices. The reported device performance is stated to be identical to these predicate devices. The change is in the stated use (labeling), not in the core performance.

Parameter/Feature	Acceptance Criteria (from Predicate Device Specifications)	Reported Device Performance (Subject Device)
SpO2, no motion, 70-100%	Rad-97: 1.5% ARMS (adults/pediatrics/infants/neonates)**; Radical-7: 2% (adults/pediatrics/infants), 3% (neonates)	Same as Predicate
SpO2, motion, 70-100%	Rad-97: 1.5% Arms (adults/infants/pediatrics/neonates)**; Radical-7: 3% ARMS (adults/pediatrics/infants/neonates)	Same as Predicate
SpO2, low perfusion, 70-100%	Rad-97: 2% (adults/pediatrics/infants/neonates); Radical-7: 2% (adults/pediatrics/infants/neonates)	Same as Predicate
Pulse Rate, no motion, 25-240 bpm	Rad-97: 3 bpm (adults/pediatrics/infants/neonates); Radical-7: 3 bpm (adults/pediatrics/infants/neonates)	Same as Predicate
Pulse Rate, motion, 25-240 bpm	Rad-97: 5 bpm (adults/pediatrics/infants/neonates); Radical-7: 5 bpm (adults/pediatrics/infants/neonates)	Same as Predicate
Pulse Rate, low perfusion, 25-240 bpm	Rad-97: 3 bpm (adults/pediatrics/infants/neonates); Radical-7: 3 bpm (adults/pediatrics/infants/neonates)	Same as Predicate
SpCO, 1-40%	Both: 3% (adults/pediatrics/infants)	Same as Predicate
SpMet, 1-15%	Both: 1% (adults/pediatrics/infants/neonates)	Same as Predicate
SpHb, 8-17 g/dL	Both: 1 g/dL (adults/pediatrics)	Same as Predicate
RRa (Acoustic Respiration Rate)	4-70 rpm: 1 rpm (adults/pediatrics); 4-120 rpm: 1 rpm (infants/neonates)	Same as Predicate
RRp (Pleth Respiration Rate)	4-70 rpm: 3 rpm ARMS, 1 rpm Mean Error (adults/pediatrics)	Same as Predicate
CO2 (for Rad-97 with NomoLine Capnography)	Single dry gasses at 22±5°C and 1013±40 hPa, 0-15 volume%: ±(0.2 volume% +2% of reading); All conditions: ±(0.3 kPa + 4% of reading)	Same as Predicate
NiBP (for Rad-97)	0-300 mmHg, ISO 81060-2	Same as Predicate
Principle of Operation	Masimo Rainbow SET Technology, Capnography Technology, NiBP Technology (all same)	Same as Predicate
Display	Touchscreen LCD	Same as Predicate
Alarm Type	Visual/Audible alarm	Same as Predicate
Mode of Operation	Continuous operation	Same as Predicate

Note: ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.
*Applicable with RD SET Disposable sensors.

2. Sample Size for the Test Set and Data Provenance

No new clinical or non-clinical testing was conducted for this submission (K212161) because the changes were limited to labeling to include existing functionality. The predicate devices' performance data implicitly serve as the "test set" and provenance.

Sample Size for Test Set: Not applicable for this submission as no new testing was performed. The data and sample sizes supporting the original predicate clearances (K193626 and K193242) would have established these performance metrics. The document states that the devices are "the same as the predicate cleared... with exception of the updated indications for spot-checking."
Data Provenance: Not explicitly stated for new data. The original predicate device data would have come from clinical studies, often including induced hypoxia studies for oximetry, which typically occur in controlled clinical environments (e.g., US, Europe). The studies for the original clearances would have been prospective to generate the performance data.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable for this submission as no new ground truth was established. The performance specifications are based on the device's technical capabilities, validated against reference standards in prior clearances.
Qualifications of Experts: N/A for this particular submission. For the original clearances, such validation would involve highly trained clinical professionals and laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable for this submission as no new test set requiring adjudication was generated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device where human reader improvement with AI assistance would be measured. This is a traditional physiological monitor.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a medical device that measures physiological parameters. Its performance is inherent in its design and sensor technology, not a detached algorithm output. The "algorithm" here refers to the internal processing of physiological signals, which is proven through the device's accuracy specifications.

7. Type of Ground Truth Used

The ground truth for the device's performance (as established for the predicate devices) would typically be:

Reference Devices/Methods: In a controlled study, the device's measurements (e.g., SpO2) would be compared against a gold standard reference (e.g., co-oximeter for blood gas analysis).
Controlled Physiological Conditions: For SpO2 and PR, studies often involve inducing a range of oxygen saturation levels and heart rates in human volunteers under controlled conditions.

8. Sample Size for the Training Set

Not applicable in the context of traditional medical device validation. "Training set" is a concept primarily relevant to machine learning/AI models. The device's internal signal processing algorithms are engineered based on principles of physics and physiology, not "trained" on a dataset in the AI sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 6, 2023

Masimo Corporation Kertana Shankar Regulatory Specialist II 52 Discovery Irvine, California 92618

Re: K212161

Trade/Device Name: Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DOA, BZO, JKS, CCK, DPZ, DXN, FLL Dated: May 27, 2022 Received: May 31, 2022

Dear Kertana Shankar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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,

James J. Lee -S

James J. Lee, PhD Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212161

Device Name Rad-97 and Accessories

Indications for Use (Describe)

The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing (e.g., at a central station).

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Rad-97 and Accessories are indicated for the continuous monitoring rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age

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Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate from Pleth (RRp) for adult and pediatric patients during no motion conditions.

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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Indications for Use

510(k) Number (if known) K212161

Device Name Radical-7 and Accessories

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark-like shape inside, positioned to the left of the company name, "Masimo," which is written in a bold, black, sans-serif font. The overall design is clean and modern, reflecting the company's focus on innovation in healthcare.

Submitter and Address ofManufacturing Facility:	Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592
Date:	February 22, 2023
Contact:	Kertana ShankarSenior Regulatory SpecialistMasimo CorporationPhone: (949) 297-7260
Trade Name:	Rad-97 and Accessories
Common Name:	Patient Monitor
Classification Regulation/Product Code:	21 CFR 870.2300, Class II/MWI
Additional Product Code:	21 CFR 870.2700, Class II/DQA21 CFR 868.2375, Class II/BZQ21 CFR 862.3200, Class II/JKS21 CFR 868.1400, Class II/CCK21 CFR 870.2710, Class II/DPZ21 CFR 870.1130, Class II/DXN21 CFR 880.2910, Class II/FLL
Establishment RegistrationNumber:	3011353843
Reason for PremarketNotification:	Update indications for use to include spot-checking
Predicate Device:	K193626 - Rad-97 and Accessories
Reference Predicate Device	K201770 - Rad-G and Accessories
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

Trade Name:	Radical-7 and Accessories
Common Name:	Oximeter
Classification Regulation/Product Code:	21 CFR 870.2700, Class II/DQA

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Image /page/6/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark-like shape inside, followed by the company name "Masimo" in black, sans-serif font. The checkmark shape is stylized and appears to be a stylized "M".

Additional Product Code:	21 CFR 868.2375, Class II/BZQ21 CFR 862.3200, Class II/JKS21 CFR 870.2710, Class II/DPZ
Establishment RegistrationNumber:	3011353843
Reason for PremarketNotification:	Update indications for use to include spot-checking
Predicate Device:	K193242 – Radical-7 Pulse CO-Oximeter and Accessories
Reference Predicate Device	K201770 – Rad-G and Accessories
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

1. Device Description

This premarket notification [510(k)] is for the authorization to market the previously cleared Rad-97 (K193626) and Radical-7 (K193242) with an additional indication for spot-checking.

Rad-97

The Rad-97 is a patient monitor capable of providing multiple parameters. The Rad-97 product family provides the integrated ability of noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), Pleth Respiration Rate (RRp), capnography parameters, and noninvasive blood pressure (NiBP) parameters.

The subject device is the same as the predicate cleared under K193626 with exception of the updated indications for spot-checking.

Feature	Rad-97 Specification
Performance	Accuracy (ARMS)*
SpO2, no motion, 70-100%	1.5%, adults/ pediatrics/ infants/ neonates**
SpO2, motion, 70-100%	1.5% Arms, adults/ infants/ pediatrics/ neonates **
SpO2, low perfusion, 70-100%	2%, adults/ pediatrics/ infants/ neonates

The specifications for Rad-97 are as follows:

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Image /page/7/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark-like shape inside, followed by the company name "Masimo" in bold, black letters. The checkmark is stylized and appears to be formed by a curved line. The overall design is simple and modern.

Pulse Rate, no motion, 25-240 bpm	3 bpm, adults/ pediatrics/ infants/ neonates
Pulse Rate, motion, 25-240 bpm	5 bpm, adults/ pediatrics/ infants/ neonates
Pulse Rate, low perfusion, 25-240 bpm	3 bpm, adults/ pediatrics/ infants/ neonates
SpCO, 1-40%	3%, adults/ pediatrics/ infants
SpMet, 1-15%	1%, adults/ pediatrics/ infants/ neonates
SpHb, 8-17 g/dL	1 g/dL adults/ pediatrics
RRa, 4-70 rpm,4-120 rpm	1 rpm, adults/ pediatrics1 rpm, infants/ neonates
RRp, 4-70 rpm	3 rpm ARMS, 1 rpm Mean Error, adults/ pediatrics
CO2	Single dry gasses at 22±5°C and 1013±40 hPa:0-15 volume %: ±(0.2 volume% +2% or reading)All conditions: ±(0.3 kPa + 4% of reading)
NiBP	0-300 mmHg, ISO 81060-2

*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.

** Applicable with RD SET Disposable sensors

Radical-7

The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), Pleth Variability Index (PVi), totalhemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), acoustic respiration rate (RRa), and Pleth Respiration Rate (RRp).

The subject device is the same as the predicate cleared under K 193242 with exception of the updated indications for spot-checking.

The Specifications for Radical-7 are as follows:

Feature	Radical-7 Specification
Performance	Accuracy (ARMS)*
SpO2, no motion, 70-100%	2%, adults/ pediatrics/ infants; 3% neonates
SpO2, motion, 70-100%	3% adults/ pediatrics/ infants/ neonates
SpO2, low perfusion, 70-100%	2%, adults/ pediatrics/ infants/ neonates
Pulse rate, no motion, 25-240 bpm	3 bpm, adults/ pediatrics/ infants/ neonates
Pulse rate, motion, 25-240 bpm	5 bpm, adults/ pediatrics/ infants/ neonates
Pulse rate, low perfusion, 25-240 bpm	3 bpm, adults/ pediatrics/ infants/ neonates
RRa, 4-70 rpm	1 rpm, adults/ pediatrics
4-120 rpm	1 rpm, infants/ neonates
RRp, 4-70rpm	3 rpm ARMS, 1 rpm Mean Error, adults/ pediatrics
SpCO, 1-40%	3%, adults/ pediatrics/ infants

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Image /page/8/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white waveform inside, followed by the company name in bold, black letters. To the right of the name is some smaller text, but it is not legible in the image. The logo is clean and modern, and the red and black color scheme is eye-catching.

Feature	Radical-7 Specification
SpMet, 1-15%	1%, adults/ pediatrics/ infants/ neonates
SpHb, 8-17 g/dL	1 g/dL, adults/ pediatrics

2. Intended Use/ Indications for Use

Rad-97

The Rad-97 and Accessories is a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital type facilities, mobile and home environments.

The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The Rad-97 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Rad-97 and Accessories are indicated for the continuous monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.

The optional NomoLine Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO2. The NomoLine Capnography product family is

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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-like symbol inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The intended patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NiBP module is designed to measure blood pressure for patient population described in the following table:

Patient Population	Approximate Age Range
Newborn(neonate)	Birth to 1 month of age
Infant	1 month to 2 years of age
Child	2 to 12 years of age
Adolescent	12-21 years of age
Adult	21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PV in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate from Pleth (RRp) for adult and pediatric patients during no motion conditions.

Radical-7

The Radical-7 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

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Image /page/10/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo consists of a red circle with a white checkmark-like shape inside, followed by the company name "Masimo" in a bold, sans-serif font. To the right of the logo, there is some additional text, which is likely the company's address.

used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitaltype facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

3. Technological Characteristics

Principle of Operation

As part of this submission, there were no changes to the principles of operation for the Rad-97 and Radical-7 from their respective predicates, Rad-97 (K193626) and Radical-7 (K193242).

The devices use the same previously cleared Masimo SET pulse oximetry technology, which relies on the following principle:

Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (nonoxygenated 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

The mechanism of action for the subject devices is the same as that of their predicates (K193626 and K193242). The optical-based parameters still rely on the application of an optical sensor to a capillary application site to detect physiological signals. which are processed to estimate the parameters (e.g., SpO2 and Pulse Rate). Both devices already support the ability to activate and deactivate parameter alarms through the user interface.

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Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".

Feature	Rad-97Subject Device	Rad-97,Predicate device	Comparison to the Predicate Device
510(k) Number	K212161	K193626
GeneralInformation
PrimaryClassificationRegulation/ Productcode	21 CFR 878.2300, Class II/MWI	21 CFR 878.2300, Class II/MWI	Same
AdditionalClassificationRegulation/ ProductCode(s)	21 CFR 870.2700, Class II/DQA21 CFR 862.3200, Class II/JKS21 CFR 868.1400, Class II/CCK21 CFR 868.2375, Class II/BZQ21 CFR 870.2710, Class II/DPZ21 CFR 870.1130, Class II/DXN21 CFR 880.2910, Class II/FLL	21 CFR 870.2700, Class II/DQA21 CFR 862.3200, Class II/JKS21 CFR 868.1400, Class II/CCK21 CFR 868.2375, Class II/BZQ21 CFR 870.2710, Class II/DPZ21 CFR 870.1130, Class II/DXN21 CFR 880.2910, Class II/FLL	Same
Indications for Use	The Rad-97 and Accessories is a multi-parameter patient monitor that isintended for multi-parameterphysiological patient monitoring inhospital, hospital type facilities, mobileand home environments.The Rad-97 and Accessories cancommunicate with network systems forsupplemental remote viewing andalarming (e.g., at a central station).	The Masimo Rad-97 and Accessoriesare indicated for hospitals, hospital-typefacilities, mobile, and homeenvironments.The Masimo Rad-97 and Accessoriescan communicate with network systemsfor supplemental remote viewing andalarming (e.g., at a central station).	Same with addition of indications forspot-checking. The update in theindications for use for spot-checkingwas not found to result in a newintended use.The indications for use for the subjectdevice have also been revised to includethe cleared indications for theRespiratory Rate fromphotoplethysmogram (RRp) parameter
The Rad-97 and Accessories areindicated for the non-invasive spot-checking and continuous monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate (PR)of adult, pediatric, and neonatal patientsduring both no motion and motionconditions, and for patients who are wellor poorly perfused.	The Masimo Rad-97 and Accessoriesare indicated for the continuous non-invasive monitoring of functionaloxygen saturation of arterialhemoglobin (SpO2) of adult, pediatric,and neonatal patients during both nomotion and motion conditions, and forpatients who are well or poorlyperfused..	based on the subject device's clearanceas part of K193242.
The Rad-97 and Accessories areindicated for the non-invasive continuousmonitoring of carboxyhemoglobinsaturation (SpCO) of adult, pediatric, andinfant patients during no motionconditions.	The Masimo Rad-97 and Accessoriesare indicated for the continuous non-invasive monitoring of pulse rate (PR)of adult, pediatric, and neonatal patientsduring both no motion and motionconditions, and for patients who arewell or poorly perfused.
The Rad-97 and Accessories areindicated for the non-invasive continuousmonitoring of methemoglobin saturation(SpMet) of adult, pediatric, and neonatalpatients during no motion conditions.	The Masimo Rad-97 and Accessoriesare indicated for the continuous non-invasive monitoring ofcarboxyhemoglobin saturation (SpCO)of adult, pediatric, and infant patientsduring no motion conditions.
The Rad-97 and Accessories areindicated for the non-invasive continuousmonitoring of total hemoglobinconcentration (SpHb) of adult and	The Masimo Rad-97 and Accessoriesare indicated for the continuous non-invasive monitoring of methemoglobin

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Image /page/12/Picture/0 description: The image shows the Masimo Corporation logo. 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" followed by the address "52 Discovery, Irvine, CA 92618".

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Image /page/13/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white "V" inside, followed by the name "Masimo" in black, stylized font. To the right of the name is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

pediatric patients during no motionconditions.	saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.
The Rad-97 and Accessories areindicated for the continuous monitoringof respiratory rate (RRa) for adult,pediatric, and neonatal patients during nomotion conditions.	The Masimo Rad-97 and Accessoriesare indicated for the continuous non-invasive monitoring of totalhemoglobin concentration (SpHb) ofadult and pediatric patients during nomotion conditions.
In addition, the Rad-97 and Accessoriesare indicated to provide the non-invasivespot-checking and continuous monitoringdata obtained from the Rad-97 andAccessories for functional oxygensaturation of arterial hemoglobin (SpO2)and pulse rate (PR) to multi-parameterdevices for the display on those devices.	The Masimo Rad-97 and Accessoriesare indicated for the continuous non-invasive monitoring of respiratory rate(RRa) for adult, pediatric, and neonatalpatients during no motion conditions.
The Rad-97 and Accessories are notintended to be used as the sole basis formaking diagnosis or treatment decisionsrelated to suspected carbon monoxidepoisoning; it is intended to be used inconjunction with additional methods ofassessing clinical signs and symptoms.	In addition, the Masimo Rad-97 andAccessories are indicated to provide thecontinuous non-invasive monitoringdata obtained from the Masimo Rad-97and Accessories for functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR) to multi-parameter devices for the display onthose devices.
The optional NomoLine Capnographyproduct family is intended to be
connected to other medical backboarddevices for monitoring of breath rate and CO2. The NomoLine Capnographyproduct family is intended to beconnected to a patient breathing circuitfor monitoring of inspired/expired gasesduring anesthesia, recovery andrespiratory care. The environment is theoperating suite, intensive care unit andpatient room. The intended patientpopulation is adult, pediatric and infantpatients.	The Masimo Rad-97 and Accessoriesare not intended to be used as the solebasis for making diagnosis or treatmentdecisions related to suspected carbonmonoxide poisoning; it is intended tobe used in conjunction with additionalmethods of assessing clinical signs andsymptoms.
The optional non-invasive bloodpressure (NiBP) module is indicated forthe noninvasive measurement of arterialblood pressure. The NiBP module isdesigned to measure blood pressure forpatient population described in thefollowing table:	The optional NomoLine Capnographyproduct family is intended to beconnected to other medical backboarddevices for monitoring of breath rateand CO2. The NomoLine Capnographyproduct family is intended to beconnected to a patient breathing circuitfor monitoring of inspired/expired gasesduring anesthesia, recovery andrespiratory care. The environment is theoperating suite, intensive care unit andpatient room. The intended patientpopulation is adult, pediatric and infantpatients.
The optional non-invasive bloodpressure (NiBP) module is indicated forthe noninvasive measurement of arterialblood pressure. The NiBP module is
PatientPopulation	Approximate AgeRange
Newborn(neonate)	Birth to 1 month ofage
Infant	1 month to 2 yearsof age
Child	2 to 12 years ofage

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Image /page/15/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white 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".

Adolescent	12-21 years of age	designed to measure blood pressure for patient population described in the following table:
Adult	21 years of age and older

	Devices with Masimo technology are only to be used with Masimo sensors and cables.	PatientPopulation	Approximate AgeRange
		Newborn(neonate)	Birth to 1 month ofage
		Infant	1 month to 2 yearsof age
	The Rad-97 and accessories are indicated for the non-invasive continuous monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions.	Child	2 to 12 years of age
		Adolescent	12-21 years of age
		Adult	21 years of age andolder
	PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and	Devices with Masimo technology are only to be used with Masimo sensors and cables.The Rad-97 and accessories are indicated for the non-invasive continuous monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditionsPVi may be used as a noninvasive dynamic indicator of fluid
should not be based solely on PVi.The Masimo Rad-97 and Accessories areindicated for the continuous non-invasivemonitoring of Respiratory Rate fromphotoplethysmogram (RRp) for adult andpediatric patients during no motionconditions in hospitals, hospital-typefacilities, home environments, andtransport within healthcare facilities.	mechanically ventilated adult patients.Accuracy of PVi in predicting fluidresponsiveness is variable andinfluenced by numerous patient,procedure and device related factors.PVi measures the variation in theplethysmography amplitude but doesnot provide measurements of strokevolume or cardiac output. Fluidmanagement decisions should be basedon a complete assessment of thepatient's condition and should not bebased solely on PVi.
Principle of operation Masimo Rainbow SET Technology:Noninvasive blood constituentmeasurements based on pulse oximetryprinciples and respiration ratemeasurement using acoustic signals.Capnography Technology: Respiratorygas measurement using infraredspectrometryNiBP Technology: Oscillometricmeasurement method	Masimo Rainbow SET Technology:Noninvasive blood constituentmeasurements based on pulse oximetryprinciples and respiration ratemeasurement using acoustic signals.Capnography Technology: Respiratorygas measurement using infraredspectrometryNiBP Technology: Oscillometricmeasurement method	Same
Display
Display TypeTouchscreen LCD	Touchscreen LCD	Same
Alarm
Type of alarm	Visual/Audible alarm	Visual/Audible alarm	Same
TechnologicalCharacteristics
Features	Pulse CO-Oximetry: SpO2, PR, Pi, PVi, RRp, SpMet, SpHb, SpCO, SpOC.Acoustic Respiration: RRa.NiBP: Systolic, Diastolic and MAPCapnography	Pulse CO-Oximetry: SpO2, PR, Pi,PVi, RRp, SpMet, SpHb, SpCO, SpOC.Acoustic Respiration: RRaNiBP: Systolic, Diastolic and MAPCapnography	Same
Performance
SpO2, no motion	70-100%, 1.5%, adults /pediatrics/infants/ neonates	70-100%, 1.5 % Arms, adults/ infants/pediatrics; 3% neonates	Different. The specification for neonateshas been revised to reflect the subjectdevice's clearance as part of K191059.
SpO2, motion	70-100%, 1.5% Arms, adults/ infants/pediatrics/ neonates	70-100%, 1.5 % Arms, adults/ infant/pediatrics; 3% neonates	Different. The specification for neonateshas been revised to reflect the subjectdevice's clearance as part of K191059.
SpO2, low perfusion	70-100%, 2%, adults/pediatrics/infants/neonates	70-100%, 2%, adults/pediatrics/infants/neonates	Same
Pulse rate, no motion	25-240 bpm, 3 bpm, adults/ infants/pediatrics/ neonates	25-240 bpm, 3 bpm, adults/ infants/pediatrics/ neonates	Same
Pulse rate, motion	25-240 bpm, 5 bpm, adults/ infants/pediatrics /neonates	25-240 bpm, 5 bpm, adults/ infants/pediatrics /neonates	Same
Pulse rate, lowperfusion	25-240 bpm, 3 bpm, adults/ infants/pediatrics	25-240 bpm, 3 bpm, adults/ infants/pediatrics	Same
SpCO	1-40%, 3%, adults/ pediatrics/ infants	1-40%, 3%, adults/ infants/pediatrics	Same

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Image /page/16/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/17/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/18/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo features 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, the text "MASIMO CORPORATION" is displayed above the address "52 Discovery, Irvine, CA 92618".

SpMet	1-15%, 1%, adults/ infants/ pediatrics/ neonates	1-15%, 1%, adults/infants/pediatrics/ neonates	Same
SpHb	8-17 g/dL, 1g/dL adults/ pediatrics	8-17 g/dL, 1g/dL adults/ pediatrics	Same
RRa	4-70 rpm, 1 rpm, adults/pediatrics4-120 rpm, 1 rpm, infants/neonates	4-70 rpm, 1 rpm, adults/pediatrics4-120 rpm, 1 rpm, infants/neonates	Same
RRp	4-70 rpm, 3 rpm ARMS, 1 rpm MeanError, adults/pediatrics	---	Different. The specification for neonateshas been revised to reflect the subjectdevice's clearance as part of K193242.
CO2	Single dry gasses at 22±5°C and1013±40 hPa:0-15 volume%: ± (0.2 volume% +2%or reading)	Single dry gasses at 22±5°C and1013±40 hPa:0-15 volume%: ± (0.2 volume% +2%or reading)	Same
Respiration rate	All conditions:±(0.3 kPa + 4% of reading)	All conditions:±(0.3 kPa + 4% of reading)	Same
NiBP	0-300 mmHg, ISO 81060-2	0-300 mmHg, ISO 81060-2	Same
Mode of Operation
Mode of operation	Continuous operation	Continuous operation	Same

Feature	Radical-7Subject Device	Radical-7Predicate device	Comparison to the predicate device
510(k) Number	K212161	K193242
General Information
Primary ClassificationRegulation/ Product code	21 CFR 870.2700, Class II/DQA	21 CFR 870.2700, Class II/DQA	Same
Additional	21 CFR 862.3200, Class II/JKS	21 CFR 862.3200, Class II/JKS	Same
ClassificationRegulation/ ProductCode (s)	21 CFR 870.2710, Class II/DPZ21 CFR 868.2375, Class II/BZQ	21 CFR 870.2710, Class II/DPZ21 CFR 868.2375, Class II/BZQ
Indications for Use	The Radical-7 and Accessories areindicated for the non-invasive spot-checking and continuous monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate (PR)of adult, pediatric, and neonatal patientsduring both no motion and motionconditions, and for patients who arewell or poorly perfused in hospitals,hospital-type facilities, mobile, andhome environments.The Radical-7 and Accessories areindicated for the non-invasivecontinuous monitoring ofcarboxyhemoglobin saturation (SpCO)of adult, pediatric, and infant patientsduring no motion conditions in hospitalsand hospital-type facilities. TheRadical-7 and Accessories are notintended to be used as the sole basis formaking diagnosis or treatment decisionsrelated to suspected carbon monoxidepoisoning; it is intended to be used in	The Masimo Radical-7® Pulse CO-Oximeter® and Accessories areindicated for the continuous non-invasive monitoring of functionaloxygen saturation of arterialhemoglobin (SpO2), pulse rate,carboxyhemoglobin saturation (SpCO),methemoglobin saturation (SpMet),total hemoglobin concentration (SpHb),and/or respiratory rate (RRa).The Masimo Radical-7® Pulse CO-Oximeter® and accessories areindicated for use with adult, pediatric,and neonatal patients during both nomotion and motion conditions, and forpatients who are well or poorly perfusedin hospitals, hospital-type facilities,mobile, and home environments.In addition, the Masimo Radical-7®Pulse CO-Oximeter® and accessoriesare indicated to provide the continuousnon-invasive monitoring data obtainedfrom the Masimo Radical-7® Pulse CO-	Same with addition of spot-checkingindications. The update in theindications for use for spot-checkingwas not found to result in a newintended use.
conjunction with additional methods ofassessing clinical signs and symptoms.	Oximeter® and accessories offunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate (PR)to multi-parameter devices for thedisplay of those devices.
The Radical-7 and Accessories areindicated for the non-invasivecontinuous monitoring ofmethemoglobin saturation (SpMet) ofadult, pediatric, and neonatal patientsduring no motion conditions in hospitalsand hospital-type facilities.	The Radical-7 and Accessories areindicated for the continuous non-invasive monitoring of Respiratory Ratefrom photoplethysmogram (RRp) foradult and pediatric patients during nomotion conditions in hospitals, hospital-type facilities, home environments, andtransport within healthcare facilities.
The Radical-7 and Accessories areindicated for the non-invasivecontinuous monitoring of totalhemoglobin concentration (SpHb) ofadult and pediatric patients during nomotion conditions in hospitals andhospital-type facilities.
The Radical-7 and Accessories areindicated for the non-invasivecontinuous monitoring of respiratoryrate (RRa) for adult, pediatric, andneonatal patients during no motionconditions in hospitals, hospital-typefacilities, home environments, andtransport within healthcare facilities.
	The Radical-7 and Accessories areindicated for the non-invasivecontinuous monitoring of RespiratoryRate from photoplethysmogram (RRp)for adult and pediatric patients duringno motion conditions in hospitals,hospital-type facilities, homeenvironments, and transport withinhealthcare facilities.
Principle of operation	Masimo Rainbow SET Technology:Noninvasive blood constituentmeasurements based on pulse oximetryprinciples and respiration ratemeasurement using acoustic signals	Masimo Rainbow SET Technology:Noninvasive blood constituentmeasurements based on pulse oximetryprinciples and respiration ratemeasurement using acoustic signals	Same
Display
Display Type	Touchscreen LCD	Touchscreen LCD	Same
Alarm
Type of alarm	Visual/Audible alarm	Visual/Audible alarm	Same
TechnologicalCharacteristics
Features	SpO2, PR, SpCO, SpMet, SpHb,RRa, RRp, Pi, PVi, SpOC, plethwaveform, alarm status, statusmessages, sensor status, Signal IQ	SpO2, PR, SpCO, SpMet, SpHb,RRa, RRp, Pi, PVi, SpOC, plethwaveform, alarm status, statusmessages, sensor status, Signal IQ	Same
Performance
SpO2, no motion	70-100%, 2% adults/ pediatrics/infants; 3% neonates	70-100%, 2% Arms, adults/ infants/pediatrics; 3% neonates	Same
SpO2, motion	70-100%, 3% Arms, adults/ infants/	70-100%, 3 % Arms, adults/ infant/	Same
	pediatrics/ neonates	pediatrics/ neonates
SpO2, low perfusion	70-100%, 2%, adults/ pediatrics/infants/ neonates	70-100%, 2%, adults/ pediatrics/infants/ neonates	Same
Pulse rate, no motion	25-240 bpm, 3 bpm, adults/ infants/pediatrics/ neonates	25-240 bpm, 3 bpm, adults/ infants/pediatrics/ neonates	Same
Pulse rate, motion	25-240 bpm, 5 bpm, adults/ infants/pediatrics/neonates	25-240 bpm, 5 bpm, adults/ infants/pediatrics/neonates	Same
Pulse rate, lowperfusion	25-240 bpm, 3 bpm, adults/ infants/pediatrics / neonates	25-240 bpm, 3 bpm, adults/ infants/pediatrics / neonates	Same
SpCO	1-40%, 3%, adults/ infants/ pediatrics	1-40%, 3%, adults/ infants/ pediatrics	Same
SpMet	1-15%, 1%, adults/ infants/ pediatrics/neonates	1-15%, 1%, adults/ infants/ pediatrics/neonates	Same
SpHb	8-17 g/dL, 1g/dL adults/ pediatrics	8-17 g/dL, 1g/dL adults/ pediatrics	Same
RRa	4-70 bpm, 1 rpm, adults/ pediatrics4-120 bpm, 1 rpm, infants/ neonates	4-70 bpm, 1 rpm, adults/ pediatrics4-120 bpm, 1 rpm, infants/ neonates	Same
RRp	4-70 rpm, 3 rpm ARMS, 1 rpm MeanError, adults/pediatrics	4-70 rpm, 3 rpm ARMS, 1 rpm MeanError, adults/pediatrics	Same
Respiration rate	0-150 breaths/min, 1 breaths/min	0-150 breaths/min, 1 breaths/min	Same
Mode of Operation	Continuous operation	Continuous operation	Same

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Image /page/19/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black bold letters. To the right of the logo, the text "MASIMO CORPORATION" is written in gray, followed by the address "52 Discovery, Irvine, CA 92618".

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Image /page/20/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red circle containing a white 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/21/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" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

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Image /page/22/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" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

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4. Summary of Technological Characteristics of Subject Devices Compared to Predicate Devices

Similarities and Differences between Predicate and Subject Device –Rad-97 and Radical-7 with spotchecking feature

The subject devices, Rad-97 and Radical-7, and their respective predicate devices, Rad-97 (K193626) and Radical-7 (K193242), have the following key similarities:

. Same intended use:
. Same principles of operation and mechanism of action;
. Same measurement technologies:
. Same performance specifications

The subject devices, Rad-97 and Radical-7, and their respective predicate devices, Rad-97 (K193626) and Radical-7 (K193242), have the following key differences:

The subject devices include the indication for spot-checking;
Between the subject devices and the predicates, the difference is the labeling update for the addition of the indication for spot-checking. The cleared versions of the subject devices already support both continuous monitoring and spot-checking use through the activation and deactivation of alarms. This submission updates the indications to reflect both uses of the subject devices.

As the subject devices are already able to be used without alarms, the addition of the indication for spot-checking is not a new intended use as compared to the predicates does not raise different questions of safety and effectiveness.

5. Performance Data

Biocompatibilitv Testing:

Rad-97 product family and Radical-7 are not intended for patient contact and do not include patient contacting materials. Therefore, biocompatibility testing is not applicable.

Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning

Additional testing for Electromagnetic compatibility, Electrical Safety, Environmental, Mechanical and Cleaning chemical resistance was not needed to support the update to include spot-checking indications to subject devices.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and the documentation is provided as recommended by FDA's Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. The software for this device was considered as a "moderate" level of concern, as defined by the FDA guidance for Industry and FDA Staff -Pulse Oximeters - Premarket Notification Submissions [510(k)s] . dated March 3. 2013, because a failure or latent flaw in the software could directly result in minor to moderate injury to the patient.

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The testing was found to support the substantial equivalence of the subject devices.

Cybersecurity and Wireless Testing

As part of this submission, there is no change to the interconnectivity of the Rad-97 and Radical-7 as compared to the previous cleared devices. As a result, no additional cybersecurity testing was conducted. The Rad-97 and Radical-7 are still considered a Tier 2 cybersecurity risk device in accordance with FDA draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. As such the previous cybersecurity risk mitigations were still considered applicable to support the substantial equivalence of the subject devices.

Human Factors Usability Testing

There are no product changes, including how the device can be used, as a result of the update indications to include spot-checking. The subject devices had already provided the capabilities to deactivate parameter alarms to support the spot-checking indications. As a result, no new Human factors and usability risk were found.

Non-clinical Testing

There are no product changes made to the subject devices other than the updated labeling to reflect the spot-checking indications. Therefore, non-clinical testing was not required for this submission.

Clinical Testing

There are no product changes made to the subject devices other than the updated labeling to reflect the spot-checking indications. Therefore, clinical testing was not required for this submission.

6. Conclusion

Provided the subject devices have the same intended uses, not changed by the addition of the spotchecking indications, and same technological characteristics they were found substantially equivalent to their respective predicate devices.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).