(602 days)
No
The document describes a multi-parameter patient monitor and its accessories, focusing on standard physiological measurements and their accuracy. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies sections. The submission is primarily for adding a spot-checking indication to previously cleared devices.
No
The device is described as a "multi-parameter patient monitor" for physiological monitoring and does not administer any therapy.
Yes
The device is a multi-parameter patient monitor that measures various physiological parameters like oxygen saturation, pulse rate, carboxyhemoglobin, and methemoglobin. These measurements provide "data obtained from the Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)" and are used in conjunction with other clinical signs and symptoms for monitoring patient conditions. While the device states it is "not intended to be used as the sole basis for making diagnosis or treatment decisions," it is clearly designed to provide critical data that aids in the diagnostic process.
No
The device description explicitly states that the submission is for the Rad-97 and Radical-7, which are described as "patient monitors" and "noninvasive monitors" capable of providing multiple physiological parameters. These are hardware devices with integrated monitoring capabilities, not software-only.
Based on the provided text, the Rad-97 and Accessories and the Radical-7 and Accessories are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that these devices are non-invasive patient monitors. They measure physiological parameters directly from the patient's body (e.g., through sensors on the skin) without requiring a sample to be taken and analyzed outside the body. The parameters measured (SpO2, PR, SpCO, SpMet, SpHb, RRa, RRp, PVi, CO2, NiBP) are all obtained non-invasively.
Therefore, these devices fall under the category of non-invasive physiological monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Rad-97 and Accessories:
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.
Radical-7 and Accessories:
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.
Product codes
MWI, DOA, BZO, JKS, CCK, DPZ, DXN, FLL
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmography (pleth), infrared spectrometry
Anatomical Site
Capillary application site for optical sensor for physiological signals.
Patient breathing circuit for capnography.
Indicated Patient Age Range
Rad-97 and Accessories:
Adult, pediatric, neonatal patients for SpO2 and PR.
Adult, pediatric, infant patients for SpCO.
Adult, pediatric, neonatal patients for SpMet.
Adult and pediatric patients for SpHb.
Adult, pediatric, and neonatal patients for RRa.
Adult, pediatric, and infant patients for NomoLine Capnography.
Newborn (neonate) Birth to 1 month of age for NiBP.
Infant 1 month to 2 years of age for NiBP.
Child 2 to 12 years of age for NiBP.
Adolescent 12-21 years of age for NiBP.
Adult 21 years of age and older for NiBP.
Adults for PVi.
Adult and pediatric patients for RRp.
Radical-7 and Accessories:
Adult, pediatric, and neonatal patients for SpO2 and PR.
Adult, pediatric, and infant patients for SpCO.
Adult, pediatric, and neonatal patients for SpMet.
Adult and pediatric patients for SpHb.
Adult, pediatric, and neonatal patients for RRa.
Adult and pediatric patients for RRp.
Intended User / Care Setting
Hospital, hospital type facilities, mobile and home environments.
Operating suite, intensive care unit and patient room for Capnography.
Transport within healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was not required for this submission as there are no product changes other than updated labeling to reflect spot-checking indications.
Clinical testing was not required for this submission as there are no product changes other than updated labeling to reflect spot-checking indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Rad-97 Specifications:
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
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/ pediatrics, 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 : 0-15 volume %: ±(0.2 volume% +2% or reading)
CO2, All conditions : ±(0.3 kPa + 4% of reading)
NiBP : 0-300 mmHg, ISO 81060-2
Radical-7 Specifications:
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
RRa, 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
SpMet, 1-15% : 1%, adults/ pediatrics/ infants/ neonates
SpHb, 8-17 g/dL : 1 g/dL, adults/ pediatrics
Predicate Device(s)
K193626 - Rad-97 and Accessories, K193242 – Radical-7 Pulse CO-Oximeter and Accessories
Reference Device(s)
K201770 - Rad-G and Accessories
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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."
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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
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 22, 2023 |
| Contact: | Kertana Shankar
Senior Regulatory Specialist
Masimo Corporation
Phone: (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/DQA
21 CFR 868.2375, Class II/BZQ
21 CFR 862.3200, Class II/JKS
21 CFR 868.1400, Class II/CCK
21 CFR 870.2710, Class II/DPZ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL |
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
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
promulgated 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/BZQ
21 CFR 862.3200, Class II/JKS
21 CFR 870.2710, Class II/DPZ |
|---------------------------------------|-------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
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
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:
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| 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/ pediatrics |
| 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: |
| 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 |
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 | |
| (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
Subject Device | Rad-97,
Predicate device | Comparison to the Predicate Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212161 | K193626 | |
| General
Information | | | |
| Primary
Classification
Regulation/ Product
code | 21 CFR 878.2300, Class II/MWI | 21 CFR 878.2300, Class II/MWI | Same |
| Additional
Classification
Regulation/ Product
Code(s) | 21 CFR 870.2700, Class II/DQA
21 CFR 862.3200, Class II/JKS
21 CFR 868.1400, Class II/CCK
21 CFR 868.2375, Class II/BZQ
21 CFR 870.2710, Class II/DPZ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL | 21 CFR 870.2700, Class II/DQA
21 CFR 862.3200, Class II/JKS
21 CFR 868.1400, Class II/CCK
21 CFR 868.2375, Class II/BZQ
21 CFR 870.2710, Class II/DPZ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL | Same |
| Indications for 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 and
alarming (e.g., at a central station). | The Masimo Rad-97 and Accessories
are indicated for hospitals, hospital-type
facilities, mobile, and home
environments.
The Masimo Rad-97 and Accessories
can communicate with network systems
for supplemental remote viewing and
alarming (e.g., at a central station). | Same with addition of indications for
spot-checking. The update in the
indications for use for spot-checking
was not found to result in a new
intended use.
The indications for use for the subject
device have also been revised to include
the cleared indications for the
Respiratory Rate from
photoplethysmogram (RRp) parameter |
| 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 Masimo Rad-97 and Accessories
are indicated for the continuous non-
invasive monitoring of functional
oxygen saturation of arterial
hemoglobin (SpO2) of adult, pediatric,
and neonatal patients during both no
motion and motion conditions, and for
patients who are well or poorly
perfused.. | based on the subject device's clearance
as part of K193242. | |
| 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 Masimo Rad-97 and Accessories
are indicated for the continuous non-
invasive monitoring of 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 methemoglobin saturation
(SpMet) of adult, pediatric, and neonatal
patients during no motion conditions. | The Masimo Rad-97 and Accessories
are indicated for the continuous non-
invasive 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 total hemoglobin
concentration (SpHb) of adult and | The Masimo Rad-97 and Accessories
are 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 motion
| conditions. | saturation (SpMet) of adult, pediatric, and neonatal 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 Masimo Rad-97 and Accessories |
| are indicated for the continuous non- | |
| invasive monitoring of total | |
| hemoglobin concentration (SpHb) of | |
| adult and pediatric 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 Masimo Rad-97 and Accessories |
| are indicated for the continuous non- | |
| invasive monitoring of respiratory rate | |
| (RRa) for adult, pediatric, and neonatal | |
| patients during no motion conditions. | |
| 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. | In addition, the Masimo Rad-97 and |
| Accessories are indicated to provide the | |
| continuous non-invasive monitoring | |
| data obtained from the Masimo 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 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 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 Masimo 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 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: | 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 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 | |
| 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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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 | ||
| Population | Approximate Age | ||
| Range | |||
| Newborn | |||
| (neonate) | Birth to 1 month of | ||
| age | |||
| Infant | 1 month to 2 years | ||
| 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 | ||
| 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. | ||
| 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 | |||
| should not be based solely on PVi. | |||
| The Masimo Rad-97 and Accessories are | |||
| indicated for the continuous non-invasive | |||
| 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. | 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 should not be | |||
| based solely on PVi. | |||
| Principle of operation Masimo Rainbow SET Technology: | |||
| Noninvasive blood constituent | |||
| measurements based on pulse oximetry | |||
| principles and respiration rate | |||
| measurement using acoustic signals. |
Capnography Technology: Respiratory
gas measurement using infrared
spectrometry
NiBP Technology: Oscillometric
measurement method | Masimo Rainbow SET Technology:
Noninvasive blood constituent
measurements based on pulse oximetry
principles and respiration rate
measurement using acoustic signals.
Capnography Technology: Respiratory
gas measurement using infrared
spectrometry
NiBP Technology: Oscillometric
measurement method | Same | |
| Display | | | |
| Display Type
Touchscreen LCD | Touchscreen LCD | Same | |
| Alarm | | | |
| Type of alarm | Visual/Audible alarm | Visual/Audible alarm | Same |
| Technological
Characteristics | | | |
| Features | Pulse CO-Oximetry: SpO2, PR, Pi, PVi, RRp, SpMet, SpHb, SpCO, SpOC.
Acoustic Respiration: RRa.
NiBP: Systolic, Diastolic and MAP
Capnography | Pulse CO-Oximetry: SpO2, PR, Pi,
PVi, RRp, SpMet, SpHb, SpCO, SpOC.
Acoustic Respiration: RRa
NiBP: Systolic, Diastolic and MAP
Capnography | 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 neonates
has been revised to reflect the subject
device'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 neonates
has been revised to reflect the subject
device'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, low
perfusion | 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".
17
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/pediatrics | ||
| 4-120 rpm, 1 rpm, infants/neonates | 4-70 rpm, 1 rpm, adults/pediatrics | ||
| 4-120 rpm, 1 rpm, infants/neonates | Same | ||
| RRp | 4-70 rpm, 3 rpm ARMS, 1 rpm Mean | ||
| Error, adults/pediatrics | --- | Different. The specification for neonates | |
| has been revised to reflect the subject | |||
| device's clearance as part of K193242. | |||
| CO2 | Single dry gasses at 22±5°C and | ||
| 1013±40 hPa: | |||
| 0-15 volume%: ± (0.2 volume% +2% | |||
| or reading) | Single dry gasses at 22±5°C and | ||
| 1013±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-7
Subject Device | Radical-7
Predicate device | Comparison to the predicate device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212161 | K193242 | |
| General Information | | | |
| Primary Classification
Regulation/ 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 |
| Classification
Regulation/ Product
Code (s) | 21 CFR 870.2710, Class II/DPZ
21 CFR 868.2375, Class II/BZQ | 21 CFR 870.2710, Class II/DPZ
21 CFR 868.2375, Class II/BZQ | |
| Indications for Use | 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 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 used as the sole basis for
making diagnosis or treatment decisions
related to suspected carbon monoxide
poisoning; it is intended to be used in | The Masimo Radical-7® Pulse CO-
Oximeter® and Accessories are
indicated for the continuous non-
invasive monitoring of functional
oxygen saturation of arterial
hemoglobin (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 are
indicated for use with adult, pediatric,
and neonatal patients during both no
motion and motion conditions, and for
patients who are well or poorly perfused
in hospitals, hospital-type facilities,
mobile, and home environments.
In addition, the Masimo Radical-7®
Pulse CO-Oximeter® and accessories
are indicated to provide the continuous
non-invasive monitoring data obtained
from the Masimo Radical-7® Pulse CO- | Same with addition of spot-checking
indications. The update in the
indications for use for spot-checking
was not found to result in a new
intended use. |
| conjunction with additional methods of
assessing clinical signs and symptoms. | Oximeter® and accessories of
functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate (PR)
to multi-parameter devices for the
display of those devices. | | |
| 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 continuous non-
invasive 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. | | |
| 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 hospitals, 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 hospitals,
hospital-type facilities, home
environments, and transport within
healthcare facilities. | | |
| Principle of operation | Masimo Rainbow SET Technology:
Noninvasive blood constituent
measurements based on pulse oximetry
principles and respiration rate
measurement using acoustic signals | Masimo Rainbow SET Technology:
Noninvasive blood constituent
measurements based on pulse oximetry
principles and respiration rate
measurement using acoustic signals | Same |
| Display | | | |
| Display Type | Touchscreen LCD | Touchscreen LCD | Same |
| Alarm | | | |
| Type of alarm | Visual/Audible alarm | Visual/Audible alarm | Same |
| Technological
Characteristics | | | |
| Features | SpO2, PR, SpCO, SpMet, SpHb,
RRa, RRp, Pi, PVi, SpOC, pleth
waveform, alarm status, status
messages, sensor status, Signal IQ | SpO2, PR, SpCO, SpMet, SpHb,
RRa, RRp, Pi, PVi, SpOC, pleth
waveform, alarm status, status
messages, 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, low
perfusion | 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/ pediatrics
4-120 bpm, 1 rpm, infants/ neonates | 4-70 bpm, 1 rpm, adults/ pediatrics
4-120 bpm, 1 rpm, infants/ neonates | Same |
| RRp | 4-70 rpm, 3 rpm ARMS, 1 rpm Mean
Error, adults/pediatrics | 4-70 rpm, 3 rpm ARMS, 1 rpm Mean
Error, 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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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.