Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories

K212161 · Masimo Corporation · MWI · Mar 6, 2023 · Cardiovascular

Device Facts

Record IDK212161
Device NameRadical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
ApplicantMasimo Corporation
Product CodeMWI · Cardiovascular
Decision DateMar 6, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2300
Device ClassClass 2
AttributesPediatric

Intended Use

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. 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.

Device Story

Rad-97 and Radical-7 are multi-parameter patient monitors; input signals include optical sensors for pulse oximetry (SpO2, PR, SpCO, SpMet, SpHb, PVi, RRp), acoustic sensors for respiration (RRa), capnography for CO2, and oscillometric cuffs for NiBP. Devices transform physiological signals via Masimo SET technology; output data displayed on touchscreen LCD or transmitted to central stations. Used in hospitals, mobile, and home environments by clinicians or patients. Output supports clinical decision-making for vital sign monitoring and fluid responsiveness assessment. Benefits include non-invasive, continuous, or spot-check monitoring of critical physiological parameters.

Clinical Evidence

No clinical data required; submission relies on existing clearance and labeling updates for spot-checking functionality. Bench testing only.

Technological Characteristics

Masimo SET pulse oximetry technology; spectrophotometry for blood constituents; photoplethysmography for pulse/respiration; infrared spectrometry for capnography; oscillometric method for NiBP. Touchscreen LCD interface; visual/audible alarms. Network connectivity for remote viewing. No patient-contacting materials.

Indications for Use

Indicated for non-invasive spot-checking and continuous monitoring of SpO2, PR, SpCO, SpMet, SpHb, RRa, RRp, and PVi in adult, pediatric, infant, and neonatal patients (depending on parameter) in hospital, mobile, and home environments. Includes NiBP for arterial blood pressure and NomoLine Capnography for CO2/breath rate. Contraindicated as sole diagnostic basis for CO poisoning.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K212161 Device Name Rad-97 and Accessories Indications for Use (Describe) 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 {3}------------------------------------------------ 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. 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." {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K212161 Device Name Radical-7 and Accessories #### Indications for Use (Describe) 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. 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.* 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." {5}------------------------------------------------ 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 of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: (949) 297-7000<br>FAX: (949) 297-7592 | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | February 22, 2023 | | Contact: | Kertana Shankar<br>Senior Regulatory Specialist<br>Masimo Corporation<br>Phone: (949) 297-7260 | | Trade Name: | Rad-97 and Accessories | | Common Name: | Patient Monitor | | Classification Regulation/<br>Product Code: | 21 CFR 870.2300, Class II/MWI | | Additional Product Code: | 21 CFR 870.2700, Class II/DQA<br>21 CFR 868.2375, Class II/BZQ<br>21 CFR 862.3200, Class II/JKS<br>21 CFR 868.1400, Class II/CCK<br>21 CFR 870.2710, Class II/DPZ<br>21 CFR 870.1130, Class II/DXN<br>21 CFR 880.2910, Class II/FLL | | Establishment Registration<br>Number: | 3011353843 | | Reason for Premarket<br>Notification: | 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 been<br>promulgated pursuant to Section 514. | | Trade Name: | Radical-7 and Accessories | |---------------------------------------------|-------------------------------| | Common Name: | Oximeter | | Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/DQA | {6}------------------------------------------------ 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/BZQ<br>21 CFR 862.3200, Class II/JKS<br>21 CFR 870.2710, Class II/DPZ | |---------------------------------------|-------------------------------------------------------------------------------------------------| | Establishment Registration<br>Number: | 3011353843 | | Reason for Premarket<br>Notification: | 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 been<br>promulgated 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. 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. 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: {7}------------------------------------------------ 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,<br>4-120 rpm | 1 rpm, adults/ pediatrics<br>1 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:<br>0-15 volume %: ±(0.2 volume% +2% or reading)<br>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 | {8}------------------------------------------------ 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 | *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. #### 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. 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 be connected to other medical backboard devices for monitoring of breath rate and CO2. The NomoLine Capnography product family is {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-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<br>(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. 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. 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 {10}------------------------------------------------ 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 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 hospitals and 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 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. {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 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-97<br>Subject Device | Rad-97,<br>Predicate device | Comparison to the Predicate Device | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K212161 | K193626 | | | General<br>Information | | | | | Primary<br>Classification<br>Regulation/ Product<br>code | 21 CFR 878.2300, Class II/MWI | 21 CFR 878.2300, Class II/MWI | Same | | Additional<br>Classification<br>Regulation/ Product<br>Code(s) | 21 CFR 870.2700, Class II/DQA<br>21 CFR 862.3200, Class II/JKS<br>21 CFR 868.1400, Class II/CCK<br>21 CFR 868.2375, Class II/BZQ<br>21 CFR 870.2710, Class II/DPZ<br>21 CFR 870.1130, Class II/DXN<br>21 CFR 880.2910, Class II/FLL | 21 CFR 870.2700, Class II/DQA<br>21 CFR 862.3200, Class II/JKS<br>21 CFR 868.1400, Class II/CCK<br>21 CFR 868.2375, Class II/BZQ<br>21 CFR 870.2710, Class II/DPZ<br>21 CFR 870.1130, Class II/DXN<br>21 CFR 880.2910, Class II/FLL | Same | | Indications for Use | The Rad-97 and Accessories is a multi-<br>parameter patient monitor that is<br>intended for multi-parameter<br>physiological patient monitoring in<br>hospital, hospital type facilities, mobile<br>and home environments.<br><br>The Rad-97 and Accessories can<br>communicate with network systems for<br>supplemental remote viewing and<br>alarming (e.g., at a central station). | The Masimo Rad-97 and Accessories<br>are indicated for hospitals, hospital-type<br>facilities, mobile, and home<br>environments.<br><br>The Masimo Rad-97 and Accessories<br>can communicate with network systems<br>for supplemental remote viewing and<br>alarming (e.g., at a central station). | Same with addition of indications for<br>spot-checking. The update in the<br>indications for use for spot-checking<br>was not found to result in a new<br>intended use.<br><br>The indications for use for the subject<br>device have also been revised to include<br>the cleared indications for the<br>Respiratory Rate from<br>photoplethysmogram (RRp) parameter | | The Rad-97 and Accessories are<br>indicated for the non-invasive spot-<br>checking and continuous monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate (PR)<br>of adult, pediatric, and neonatal patients<br>during both no motion and motion<br>conditions, and for patients who are well<br>or poorly perfused. | The Masimo Rad-97 and Accessories<br>are indicated for the continuous non-<br>invasive monitoring of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) of adult, pediatric,<br>and neonatal patients during both no<br>motion and motion conditions, and for<br>patients who are well or poorly<br>perfused.. | based on the subject device's clearance<br>as part of K193242. | | | The Rad-97 and Accessories are<br>indicated for the non-invasive continuous<br>monitoring of carboxyhemoglobin<br>saturation (SpCO) of adult, pediatric, and<br>infant patients during no motion<br>conditions. | The Masimo Rad-97 and Accessories<br>are indicated for the continuous non-<br>invasive monitoring of pulse rate (PR)<br>of adult, pediatric, and neonatal patients<br>during both no motion and motion<br>conditions, and for patients who are<br>well or poorly perfused. | | | | The Rad-97 and Accessories are<br>indicated for the non-invasive continuous<br>monitoring of methemoglobin saturation<br>(SpMet) of adult, pediatric, and neonatal<br>patients during no motion conditions. | The Masimo Rad-97 and Accessories<br>are indicated for the continuous non-<br>invasive monitoring of<br>carboxyhemoglobin saturation (SpCO)<br>of adult, pediatric, and infant patients<br>during no motion conditions. | | | | The Rad-97 and Accessories are<br>indicated for the non-invasive continuous<br>monitoring of total hemoglobin<br>concentration (SpHb) of adult and | The Masimo Rad-97 and Accessories<br>are indicated for the continuous non-<br>invasive monitoring of methemoglobin | | | {12}------------------------------------------------ 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". {13}------------------------------------------------ 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 motion<br>conditions. | saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The Rad-97 and Accessories are<br>indicated for the continuous monitoring<br>of respiratory rate (RRa) for adult,<br>pediatric, and neonatal patients during no<br>motion conditions. | The Masimo Rad-97 and Accessories<br>are indicated for the continuous non-<br>invasive monitoring of total<br>hemoglobin concentration (SpHb) of<br>adult and pediatric patients during no<br>motion conditions. | | In addition, the Rad-97 and Accessories<br>are indicated to provide the non-invasive<br>spot-checking and continuous monitoring<br>data obtained from the Rad-97 and<br>Accessories for functional oxygen<br>saturation of arterial hemoglobin (SpO2)<br>and pulse rate (PR) to multi-parameter<br>devices for the display on those devices. | The Masimo Rad-97 and Accessories<br>are indicated for the continuous non-<br>invasive monitoring of respiratory rate<br>(RRa) for adult, pediatric, and neonatal<br>patients during no motion conditions. | | The Rad-97 and Accessories are not<br>intended to be used as the sole basis for<br>making diagnosis or treatment decisions<br>related to suspected carbon monoxide<br>poisoning; it is intended to be used in<br>conjunction with additional methods of<br>assessing clinical signs and symptoms. | In addition, the Masimo Rad-97 and<br>Accessories are indicated to provide the<br>continuous non-invasive monitoring<br>data obtained from the Masimo Rad-97<br>and Accessories for functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate (PR) to multi-<br>parameter devices for the display on<br>those devices. | | The optional NomoLine Capnography<br>product family is intended to be | | | connected to other medical backboard<br>devices for monitoring of breath rate and CO2. The NomoLine Capnography<br>product family is intended to be<br>connected to a patient breathing circuit<br>for monitoring of inspired/expired gases<br>during anesthesia, recovery and<br>respiratory care. The environment is the<br>operating suite, intensive care unit and<br>patient room. The intended patient<br>population is adult, pediatric and infant<br>patients. | The Masimo Rad-97 and Accessories<br>are not intended to be used as the sole<br>basis for making diagnosis or treatment<br>decisions related to suspected carbon<br>monoxide poisoning; it is intended to<br>be used in conjunction with additional<br>methods of assessing clinical signs and<br>symptoms. | | The optional non-invasive blood<br>pressure (NiBP) module is indicated for<br>the noninvasive measurement of arterial<br>blood pressure. The NiBP module is<br>designed to measure blood pressure for<br>patient population described in the<br>following table: | The optional NomoLine Capnography<br>product family is intended to be<br>connected to other medical backboard<br>devices for monitoring of breath rate<br>and CO2. The NomoLine Capnography<br>product family is intended to be<br>connected to a patient breathing circuit<br>for monitoring of inspired/expired gases<br>during anesthesia, recovery and<br>respiratory care. The environment is the<br>operating suite, intensive care unit and<br>patient room. The intended patient<br>population is adult, pediatric and infant<br>patients. | | The optional non-invasive blood<br>pressure (NiBP) module is indicated for<br>the noninvasive measurement of arterial<br>blood pressure. The NiBP module is | | | Patient<br>Population | Approximate Age<br>Range | | Newborn<br>(neonate) | Birth to 1 month of<br>age | | Infant | 1 month to 2 years<br>of age | | Child | 2 to 12 years of<br>age | {14}------------------------------------------------ Image /page/14/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 word "Masimo" in black, bold font. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618" in a smaller, gray font. {15}------------------------------------------------ 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. | Patient<br>Population | Approximate Age<br>Range | | | | Newborn<br>(neonate) | Birth to 1 month of<br>age | | | | Infant | 1 month to 2 years<br>of 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 and<br>older | | | 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.<br>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<br>PVi may be used as a noninvasive dynamic indicator of fluid | | | should not be based solely on PVi.<br>The Masimo Rad-97 and Accessories are<br>indicated for the continuous non-invasive<br>monitoring of Respiratory Rate from<br>photoplethysmogram (RRp) for adult and<br>pediatric patients during no motion<br>conditions in hospitals, hospital-type<br>facilities, home environments, and<br>transport within healthcare facilities. | mechanically ventilated adult patients.<br>Accuracy of PVi in predicting fluid<br>responsiveness is variable and<br>influenced by numerous patient,<br>procedure and device related factors.<br>PVi measures the variation in the<br>plethysmography amplitude but does<br>not provide measurements of stro…
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