(249 days)
The Masimo 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 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 multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients 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 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 in hospitals and hospital-type facilities. 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 Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatal patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.
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 in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
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, pediativ and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. 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 |
The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.
The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide 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), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The subject of this submission is the update to the SpO2 performance specification for the RD SET Disposable sensors for the neonate population to match that of the cleared 1.5% Arms for adults (K180046).
The document describes a 510(k) premarket notification for the "Masimo Rad-97 and Accessories" with a focus on an update to the SpO2 performance specification for the neonate population. The primary goal of the submission is to demonstrate that the device, specifically the RD SET Disposable sensors, maintains its performance for neonates consistent with previously cleared specifications for adults.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format with a pass/fail. Instead, it refers to the "SpO2 performance specification" which the device is being updated to match, implying this as the target. The key performance metric cited is ARMS (Accuracy Root Mean Square).
The acceptance criteria for SpO2 accuracy are implicitly set by the previously cleared performance for adults, which is 1.5% ARMS. The submission aims to align the neonate performance with this.
Reported Device Performance:
| Parameter | Range | Bias | Precision | ARMS | Subjects |
|---|---|---|---|---|---|
| Initial Study Data (Neonates) | |||||
| SaO2 | 70-100% | 0.08 | 2.58 | 2.59 | 19 |
| SaO2 | 85-100% | -0.09 | 1.39 | 1.40 | 12 |
| SaO2 | 70-85% | 0.37 | 3.83 | 3.85 | 7 |
| Aggregated Study Data (Neonates) | |||||
| All Data | 70-100% | 0.129 | 3.182 | 3.185 | 42 |
While the aggregated data shows an ARMS of 3.185%, the document states, "The analysis of the clinical data further supported the safe form, fit, and function of the RD SET Disposable Sensor on neonates. The Arms performance was calculated for reference purposes." And "The results of the clinical testing supported the subject device did not raise any different questions of safety and effectiveness as compared to the predicate device." This suggests that the clinical data, despite not strictly meeting the 1.5% ARMS in all ranges for neonates in the initial and aggregated studies, was deemed sufficient to support substantial equivalence due to the nature of the submission (labeling update, not a new device or significant modification) and the "reference purposes" of the ARMS calculation in this context. The core assertion is that the same device is being used, and the form, fit, and function for neonates are supported.
2. Sample size used for the test set and the data provenance
- Initial Study: 19 neonatal subjects.
- Aggregated Study: 42 neonatal subjects (including 22 pre-term neonates). This aggregation combines data from the initial study with data from "prior studies."
- Data Provenance: The studies collected "convenience blood samples from an arterial line" in a "clinical environment." The document specifies that the aggregated data was from "3 different sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically assumed to be conducted in the US or under comparable ethical/clinical standards acceptable to the FDA. The data is prospective clinical data collected for the purpose of verifying the device's performance on neonates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for SpO2 measurements was established using a reference co-oximeter from arterial blood samples. This is a direct, objective measurement, not one established by human expert consensus or interpretation. Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth as typically applied to image-based AI studies (e.g., radiologists interpreting images) is not applicable here. The accuracy of the co-oximeter itself would be the relevant qualification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the ground truth is established by a reference co-oximeter on arterial blood samples, there is no adjudication method involving human experts for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physiological monitor (pulse oximeter), not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting AI outputs. The "AI" aspect is not explicitly mentioned or studied in the context of human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself provides the SpO2 measurements. The study assesses the accuracy of these measurements against a reference standard. While the device (Masimo Rad-97 with RD SET Disposable sensors) operates without human intervention in generating the SpO2 reading, the study framework is not typically referred to as a "standalone" or "algorithm only" study in the context of AI regulatory submissions. It's a performance validation study for a medical device. The "algorithm" here is the signal processing within the oximeter. The ARMS metric specifically reflects this standalone device accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was objective reference measurements of SaO2 (arterial oxygen saturation) from arterial blood samples analyzed by a reference co-oximeter.
8. The sample size for the training set
The document does not mention a training set in the context of model development or machine learning. This submission is for a medical device (pulse oximeter) that relies on established physiological principles and signal processing, not a de novo AI/ML algorithm that requires distinct training and test sets in the typical sense. The device's underlying algorithms were presumably developed and validated in prior clearances (K180046). This submission is an update to the labeling for a specific patient population (neonates) using an existing sensor, justifying it with clinical performance data on that population.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, this question is not applicable based on the provided document. The device's core technology and its existing cleared performance for adults underpin the rationale for extending the performance specifications to neonates.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
Masimo Corporation Linus Park Vice President, Regulatory 52 Discovery Irvine. California 92618
Re: K191059
Trade/Device Name: Masimo 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, DQA, DPZ, DXN, CCK, BZQ, FLL Dated: November 26, 2019 Received: November 27, 2019
Dear Linus Park:
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.
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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 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191059
Device Name Masimo Rad-97 and Accessories
Indications for Use (Describe)
The Masimo 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 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 multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients 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 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 in hospitals and hospital-type facilities. 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 Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatal patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.
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 in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
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, pediativ and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. 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 |
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Adolescent 12-21 years of age Adult 21 years of age and older
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)
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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the Masimo symbol on the left, followed by the word "Masimo" in a bold, sans-serif font. To the right of the name is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".
| Submitter and Address ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592 |
|---|---|
| Date: | December 27, 2019 |
| Contact: | Linus ParkVice President, Regulatory AffairsMasimo CorporationPhone: (949) 297-7337 |
| Trade Name: | Masimo Rad-97 and Accessories |
| Common Name: | Patient Monitor |
| Classification Regulation/Product Code: | 21 CFR 870.2300, Class II/MWI |
| Additional Product Code: | 21 CFR 870.2700, Class II/DQA21 CFR 868.1400, Class II/CCK21 CFR 862.3220, Class II/JKS21 CFR 868.2375, Class II/BZQ21 CFR 870.1130, Class II/DXN21 CFR 880.2910, Class II/FLL |
| Establishment RegistrationNumber: | 2031172 |
| Reason for PremarketNotification: | Apply the previously cleared SpO2 performance specification tothe neonate population |
| Predicate Device: | K180046 – Masimo Rad-97 and Accessories |
| Performance Standards | No performance standards for the above device have beenpromulgated pursuant to Section 514. |
5.1. Device Description
The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.
The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen
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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
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), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The subject of this submission is the update to the SpO2 performance specification for the RD SET Disposable sensors for the neonate population to match that of the cleared 1.5% Arms for adults (K180046).
| Feature | Rad-97 Specification |
|---|---|
| Display | |
| Display type | Touchscreen, Color LCD (Backlit Active Matrix TFT LCD) |
| Measurement range | Functional Oxygen Saturation (SpO2): 0-100% |
| Pulse Rate (PR): 25-240 beats per minute (bpm) | |
| Perfusion Index (Pi): 0.02-20% | |
| Pleth Variability Index (PVi): 0-100% | |
| Respiration Rate (RRa): 0-70 breaths per minute | |
| Carboxyhemoglobin Saturation (SpCO): 0-99% | |
| Methemoglobin Saturation (SpMet): 0-99.9% | |
| Total Hemoglobin (SpHb): 0-25g/dL; 0-250g/L(0-15.52 mmol/dL) | |
| Oxygen Concentration (SpOC): 0-35ml of O2/dL | |
| Carbon Dioxide (CO2); 0 vol%-15 vol % | |
| End Tidal CO2 (EtCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Fractional Inspired CO2 (FiCO2): 0-25 %, 0-32.5 kPa, 0-244mmHg | |
| Respiratory Rate (RR): 0-150 breaths/min | |
| Adult , Systolic: 40-260 mmHg, Diastolic: 20-200 mmHg, MAP 26-220mmHg | |
| Pediatric , Systolic: 40-230 mmHg, Diastolic: 20-160 mmHg, MAP26-183 mmHg | |
| Neonatal , Systolic: 40-130 mmHg, Diastolic: 20-100 mmHg, MAP26-110mmHg | |
| Display resolution | SpO2: 1% |
| PR: 1 bpm | |
| RRa: 1breath per minute | |
| SpCO: 1% | |
| SpMet: 0.1% | |
| SpHb: 0.1 g/dL | |
| SpOC: 0.1 ml/dL | |
| Accuracy (ARMS)* | Masimo Rainbow SET/ Masimo SET Parameters |
| SpO2, no motion | 70-100%, 1.5%, adults/pediatrics/infants/neonates ** |
| SpO2, motion | 70-100%, 1.5% adults/pediatrics/infants/neonates ** |
| Feature | Rad-97 Specification |
| 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 breaths per minute, 1 breath per minute, 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 |
| Accuracy | Optional Nomoline Capnography or Optional NIBP Parameters |
| CO2 | Single dry gasses at 22+ 5°C and 1013 + hPa:0-15 volume % +0.2 volume% +2% or readingAll conditions: 0.3 kPa + 4% of reading |
| Respiration rate | 0-150 breaths/min + 1 breaths/min |
| NIBP | 0-300 mmHg, +3 mmHg |
| Displays/ Indicators | |
| Data displayed | SpO2, PR, SpCO, SpMet, SpHb, Rra, Pi, PVi, SpOC, NIBP, CO2,pleth waveform, alarm status, status messages, sensor status, SignalIQ, APOD, FastSat |
| Alarm | Alarm limits (audible and visual), 3D alarm, alarm silence, sensorcondition alarms, system failure alarms, low battery alarms |
| Averaging time | SpO2: 2-4, 4-6, 8, 10, 12, 14 and 16 seconds;RRa: Trending, No Averaging, Fast, Medium, or SlowPVi: Short or LongPi: Short or LongSpHb: Short, Medium, or Long |
| Sensitivity mode | Normal, APOD, and MAX |
| Sleep study mode | 10 seconds |
| Electrical | |
| AC power | Input voltage: 100-240 VAC, 47-63 Hz; input power: 60 VA |
| Internal battery power | Rechargeable lithium ion battery |
| Input/Output Interface | |
| Patient applied part connection | M-20 connectorNomoline Capnography input connectorNIBP Nib |
| Analog output | Nurse call output |
| USB interface | SatShare module and external devices (e.g. barcode reader/scanner)connection |
| Wired (Ethernet) and wireless (Wi-Fi/Bluetooth) interface | • Wired/wireless connection with networked Patient SafetyNetand/or EMR systems• Wireless connection with presence tag, Kite, external devices(e.g. Caregiver thermometer) |
| Feature | Rad-97 Specification |
| Audio | Microphone supporting video/audio modes for surveillance/conferencing capabilities with Patient SafetyNet |
| Mechanical | |
| Enclosure Material | Thermoplastic |
| Dimensions | 9×4×6.5 inch (22.9×10.2×16.5cm) |
| Weight | 0.92 kg. (2.03 lbs.) without Capnography and NIBP |
| Environmental | |
| Operating Temperature | 0 to 35 °C (32 to 95 °F) |
| Storage/Transport Temperature | -20 to 60 °C (-4 to 140 °F) |
| Operating HumidityNon NiBP/Nomoline Capnography | 10% to 95%, non-condensing |
| Operating HumidityNiBP/Nomoline Capnography | 15% to 95%, non-condensing |
| Storage/Transport HumidityNon NiBP/Nomoline Capnography | 10% to 90%, non-condensing |
| NiBP/Nomoline Capnography | 15% to 90% non-condensing |
| Operating Atmospheric PressureNon-NiBP/NomolineCapnography | 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) |
| Nomoline Capnography | 525 mbar to 1,200 mbar (525 hPa to 1200 hPa) (corresponding to a max altitude of 4572 m / 15 000 feet) |
| Compliance | |
| Electrical Safety/EMC | IEC 60601 compliant |
| Type of Protection | Class I, when on AC power; internally powered, when on battery power |
| Degree of Protection | Defibrillation proof, BF-applied part |
| Protection against harm fromliquid ingress | IPX1, protection vertically falling water dropsIPX2, protection against falling water drops when enclosure is tilted at 15 degrees |
| Mode of Operation | Continuous operation |
The specifications for Rad-97 are as follows:
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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in bold, black letters, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
*Аямs ассигасу 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 to compatible sensors. Arws validated in healthy adult volunteer subjects. See Section 5.5.5 for real world performance data collected in neonatal patients.
Note: RD SET Disposable sensors are same as RD SET Adhesive sensors. In order to be consistent with the clearance obtained under K180046 and also the current branding (Directions for Use) for the sensors,
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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
510k summary has been revised to reflect the subject of the submission as RD SET Disposable sensors in place of RD SET Adhesive sensors.
5.2. Intended Use/ Indications for Use
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). 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 multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carbox yhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. 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 Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
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 hospitals and hospital-type facilities.
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 in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
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 in hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
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| 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 |
5.3. Technological Characteristics
Principle of Operation
The principle of operations for the measurement capabilities of the Rad-97 product family does not change from the predicate (K180046) for the update to the RD SET Disposable sensor specifications for the neonate population. The principles of operation are still based upon the use of red and infrared wavelengths of light provided by an emitter and the detection of the signal from the light absorption of oxygenated blood and deoxygenated blood to provide functional oxygen saturation of hemoglobin (SpO2).
Mechanism of Action for Achieving the Intended Effect
The mechanism of action did not change from the predicate. The sensor is applied in the same way and to the same measurement sites as the predicate.
5.4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device
The only difference between the subject device and the predicate is the SpO2 performance specification is updated to match that as it was previously cleared for the adult population as part of the predicate. There are no other difference between the predicate RD SET Disposable sensors to that of the subject device.
The subject device, RD SET Adhesive sensors with updated SpO2 specifications for the neonate population and the predicate device, have the following key similarities:
- · Both devices have the same indicated populations;
- · Both sensors have the same form factor and components;
- · Both sensors have the same measurement application sites
The subject device, RD SET Adhesive sensor with update SpO2 performance specifications for the neonate population and the predicate device, have the following difference:
- · Subject device has an updated SpO2 performance specification of 1.5% Arms. The SpO2 specification is being updated to match the adult population SpO2 performance specification previously cleared as part of the predicate.
5.5. Performance Data
As part of this submission, there were no physical changes to the RD SET Disposable sensor. The
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changes was to the update of the labeling to align the performance specification for the neonate population to that of the adult population.
Biocompatibility Testing 5.5.1.
As there were no changes associated with this submission, no additional biocompatibility testing was required to support the substantial equivalence.
Electrical Safety and EMC 5.5.2.
As there were no hardware changes associated with this submission, no additional electrical safety or EMC testing was required to support the substantial equivalence.
5.5.3. Software Verification and Validation Testing
As there were no software changes associated with this submission, no additional software verification and validation testing was required to support the substantial equivalence.
5.5.4. Mechanical Testing
As there were no mechanical changes associated with this submission, no additional mechanical testing was required to support the substantial equivalence.
5.5.5. Clinical Testing
As part of the submission, there was no changes made to the devices from the previous clearance in which the accuracy performance of the RD SET Disposable sensors was established to be 1.5% Arms validated on adults. As part of this submission, Masimo performed clinical testing on neonates using convenience arterial blood samples in accordance with the FDA guidance for Pulse Oximeters to verify the form. fit. and function of the RD SET Disposable sensors on neonate population. Although the RD SET Disposable sensors are not new or significantly modified the convenience samples were collected on neonatal population in order to provide greater assurance of the safe form, fit, and function on neonates.
As part of the study, convenience blood samples were collected from an arterial line of 19 neonatal subject's that were ≤ 1 month and weighing ≤ 4.5 kg. The SaO2 measurements from the blood samples using a reference co-oximeter were compared to the SpO2 measurements using a RD SET Disposable sensor. As the convenience blood samples were collected in a clinical environment dependent upon the availability of subjects, the results were subject to greater amounts of testing variability than would be expected in a controlled laboratory setting.
The analysis of the clinical data further supported the safe form, fit, and function of the RD SET Disposable Sensor on neonates. The Arms performance was calculated for reference purposes. See summary of Arms performance in table 5.5.1 below.
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| Table 5.5.1 | ||||
|---|---|---|---|---|
| SaO2 | Bias | Precision | RMS | Subjects |
| 70-100% | 0.08 | 2.58 | 2.59 | 19 |
| 85-100% | -0.09 | 1.39 | 1.40 | 12 |
| 70-85% | 0.37 | 3.83 | 3.85 | 7 |
To further support the safe form, fit, and function of the RD SET Disposable sensor on neonates, additional convenience arterial blood samples collected on neonates using the subject sensor from prior studies were aggregated with the data from the above study resulting in 70 data pairs collected on 42 subjects (including 22 Pre-term neonates with gestational ages ≤ 37 weeks) from 3 different sites. See summary of the observed results in table 5.5.2 below.
| Table 5.5.2 | |||||||
|---|---|---|---|---|---|---|---|
| Description | Age(days) | Gest. Age(weeks) | No.Subjects | Samples | Bias | Precision | ARMS |
| All Data | 1-31 | 27-41 | 42 | 70 | 0.129 | 3.182 | 3.185 |
The results of the clinical testing supported the subject device did not raise any different questions of safety and effectiveness as compared to the predicate device.
5.6 Conclusion
The data supports the substantial equivalence of the subject device with the predicate.
§ 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).