(128 days)
The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:
· Noninvasive blood pressure for adult and pediatric patients (3 years and above)
- · Pulse rate for adult and pediatric patients
- · Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients
- · Body temperature measured at Temporal Artery for adult and pediatric patients
The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
The IQvitals Zone is designed to be used for measuring and monitoring systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. All functions of the device are performed via the touch screen display, except the power on/off function, which is a separate button on the back of the device.
The IQvitals Zone can be wirelessly connected with low energy Bluetooth to mobile computers or be connected with a USB cable to computers and has the ability to send the measurement results to the computers.
The device has a rechargeable lithium ion battery and two mounting options: a mobile cart and a wall mount. All vitals parameters can be simultaneously measured and easily viewed on the touch screen display or the connected computer. Temperature is measured at Temporal Artery and the Temperature Probe is connected serially to the IQvitals Zone.
The IQvitals Zone is a multi-parameter vital signs monitor intended for use by clinicians and medically qualified personnel for measuring and monitoring noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature at the temporal artery for adult and pediatric patients (3 years and above).
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The provided document presents the performance characteristics of the IQvitals Zone and compares them to predicate devices. This comparison implicitly serves as the acceptance criteria for the device, demonstrating that its performance is substantially equivalent to legally marketed devices. Since the device is a vital signs monitor designed to directly measure physiological parameters, the "algorithm only" or "standalone" performance is inherent in these functional specifications.
| Characteristic | Acceptance Criteria (Predicate Device K072516, K101445, K060576, K110028) | Reported Device Performance (IQvitals Zone) |
|---|---|---|
| NIBP Monitor Module | ||
| Measurement Accuracy | ± 5 mmHg (standard deviation < 8 mmHg) Meets ANSI.AAMI SP10:2002 standard accuracy range | ± 5 mmHg (standard deviation < 8 mmHg) Meets ANSI.AAMI SP10:2002 standard accuracy range |
| Measurement Resolution | 1 mmHg | 1 mmHg |
| Pulse Rate Range | K072516: 30 – 240 BPM; K101445: 30 – 200 BPM (adult, pediatric) / 35 – 220 BPM (neonate) | 40 – 200 BPM |
| Pulse Rate Accuracy | K072516: ± 2 bpm or ± 2%, whichever is greater; K101445: ±3 bpm or ±5%, whichever is greater | ±3 bpm or ±5%, whichever is greater |
| Pulse Rate Resolution | 1 bpm | 1 bpm |
| Initial Cuff Pressure | K072516: User-selectable; K101445: Automatic | Automatic or User-selectable |
| Maximum Cuff Pressure | K072516: 290 mmHg (adult mode), 145 mmHg (neonatal mode); K101445: 280 mmHg (adult, pediatric), 130 mmHg (neonate) | 280 ± 5 mmHg |
| Overpressure Cutoff | K072516: Adult Mode: 290 mmHg, Neonatal Mode: 145 mmHg; K101445: 300 mmHg ±15 mmHg (adult, pediatric), 150 mmHg maximum (neonate) | 300 ± 30 mmHg |
| Pulse Oximetry Specifications | ||
| SpO2 Measurement Range | 0-100% | 0-100% |
| SpO2 Measurement Accuracy | Adult: 70 - 100% (± 2%); Pediatric: 70 - 100% (± 3%) | Adult: 70 - 100% (± 2%); Pediatric: 70 - 100% (± 3%) |
| Pulse Rate Measurement Range (from SpO2) | K060576: 20 - 240 BPM; K110028: 25 - 240 BPM | 20 - 240 BPM (Nellcor NELL-1) / 25 - 240 BPM (Masimo) |
| Pulse Rate Measurement Accuracy (from SpO2) | ± 3 BPM (no motion); ± 5 BPM (with motion) | ± 3 BPM (no motion); ± 5 BPM (with motion) |
| SpO2 / Pulse Rate Resolution | SpO2: 1%; Pulse Rate: 1 bpm | SpO2: 1%; Pulse Rate: 1 bpm |
| Thermometer Specifications | ||
| Measurement Range | K011291: 15.5°C to 43°C (61°F to 110°F) | 15.5°C to 43°C (61°F to 110°F) |
| Measurement Accuracy | K011291: +/-0.1°C (+/- 0.2°F) [within the +/- 0.6°C (+/-1.0°F) range specified by ASTM E1112 standard] | +/-0.1°C (+/- 0.2°F) |
| Resolution | 0.1 °C / 0.1 °F | 0.1 °C / 0.1 °F |
| Response Time | K011291: ~0.04 seconds | ~0.04 seconds |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that the clinical validation of the Midmark Non-invasive Blood Pressure (NIBP) module was conducted per ANSI / AAMI / ISO 81060-2:2013. This standard "specifies requirements for the clinical investigation of all automated sphygmomanometers, with the exception of those for neonates." It typically requires a minimum of 85 participants for NIBP clinical investigations to ensure statistically meaningful data for accuracy and precision against a reference measurement. The document does not explicitly state the exact number of participants in their study or the country of origin of the data. Given it's a 510(k) submission to the FDA, it is likely the studies either followed international standards that are acceptable to the FDA or were conducted in the US or in a region that meets FDA requirements. The clinical validation would be prospective.
For the SpO2 and temperature modules, the document relies on the prior clearance of the OEM modules (Nellcor NELL-1, Masimo MX-5 OEM board, and Exergen TemporalScanner) and their established performance characteristics, indicating that these components have already undergone their own clinical validations. Therefore, specific new clinical studies for these modules within the IQvitals Zone device are not detailed in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
For the NIBP clinical validation conducted according to ANSI / AAMI / ISO 81060-2:2013, the ground truth is established by two or more trained observers who simultaneously take conventional auscultatory blood pressure measurements (using a mercury or other validated sphygmomanometer and stethoscope) without knowledge of the device's readings. These observers are highly trained healthcare professionals (e.g., physicians, nurses, or technicians) with demonstrated proficiency in indirect blood pressure measurement. Their qualifications and training for consistency across readings are crucial and typically outlined in the study protocol. The document does not specify the exact number of observers or their detailed qualifications, but adherence to the standard implies these criteria were met.
For the SpO2 and temperature modules, the ground truth would have been established during their original clinical validations using appropriate reference methods (e.g., CO-oximetry for SpO2, and calibrated thermometers for temperature).
4. Adjudication Method for the Test Set:
For NIBP validation under ANSI / AAMI / ISO 81060-2:2013, if there are discrepancies between the two trained observers' readings that exceed predefined limits, a third independent adjudicator or reading typically intervenes, or the measurement is discarded. This "2+1" or similar method ensures the accuracy of the reference blood pressure. The document does not explicitly state the adjudication method, but adherence to the standard implies a method for resolving observer discrepancies was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, the provided documentation describes a 510(k) premarket notification for a vital signs monitor. This type of device directly measures physiological parameters and is not an AI-assisted diagnostic imaging tool that would typically undergo MRMC comparative effectiveness studies to evaluate human reader improvement with AI assistance. Therefore, this section is not applicable.
7. The Type of Ground Truth Used:
- Noninvasive Blood Pressure (NIBP): The ground truth for NIBP was established through concurrent auscultatory measurements by trained human observers, as required by the ANSI / AAMI / ISO 81060-2:2013 standard. This is a form of expert consensus/reference measurement.
- SpO2 and Temperature: The ground truth for the SpO2 and temperature modules would have been established during their original clinical validations. For SpO2, this typically involves CO-oximetry as a reference method. For temperature, it involves highly accurate calibrated reference thermometers.
8. The Sample Size for the Training Set:
The document does not explicitly state a "training set" as it would for a machine learning algorithm. For vital sign monitors, the core algorithms (e.g., oscillometric for NIBP, pulse oximetry principles) are typically developed and refined using extensive engineering and physiological data, rather than being "trained" on a discreet dataset in the same way modern AI algorithms are. The "training" in this context refers to the development and internal validation of the algorithms and hardware, which predates the clinical validation detailed. The NIBP clinical validation study serves as the primary external validation of the device's accuracy.
9. How the Ground Truth for the Training Set Was Established:
As elaborated in point 8, the concept of a "training set" in the context of this traditional medical device is different from that of modern AI. The ground truth for initial algorithm development and internal validation would involve:
- NIBP: Use of reference pressure manometers and simulated pulse waveforms, as well as testing on human subjects where reference auscultatory and/or invasive blood pressure measurements are simultaneously obtained.
- SpO2: In vitro testing against known oxygen saturation levels and in vivo testing with reference CO-oximetry.
- Temperature: Calibration against known temperature sources and clinical studies comparing to reference thermometers (e.g., rectal, internal core temperature).
This ground truth is established through rigorous engineering and physiological testing, often involving controlled environments and direct comparison to highly accurate reference standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Midmark Corporation Ms. Maria Moreno Manager, Ouality Management System 690 Knox Street, Suite 100 Torrance, California 90502
Re: K161909 Trade/Device Name: IQvitals Zone: Models: 1-200-0310, 1-200-0320, 1-200-0330, 1-200-0340, 1-200-0350, 1-200-0360 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DOA, FLL Dated: September 30, 2016 Received: October 11, 2016
Dear Ms. Maria Moreno,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mada Yellen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161909
Device Name
IQvitals Zone Models: 1-200-0310, 1-200-0320, 1-200-0330, 1-200-0340, 1-200-0350, 1-200-0360
Indications for Use (Describe)
The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:
· Noninvasive blood pressure for adult and pediatric patients (3 years and above)
- · Pulse rate for adult and pediatric patients
- · Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients
- · Body temperature measured at Temporal Artery for adult and pediatric patients
The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
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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SECTION 5
510(k) Summary
1. Sponsor
Midmark Corporation 690 Knox Street, Suite 100 Torrance, CA 90502 Phone: (800) 624-8950 Fax: (310) 516-6517 Contact: Mr. Asad Abu-Tarif; Vice President (R&D) Email: aabutarif@midmark.com Alternate Contact: Ms. Maria Moreno; Manager (Quality) Email: mmoreno@midmark.com
Summary Preparation Date: July 7, 2016
2. Device
| Trade Name | IQvitals Zone |
|---|---|
| Models | 1-200-0310, 1-200-0320, 1-200-0330, 1-200-0340,1-200-0350, 1-200-0360 |
| Common Name | Patient Physiological Monitor |
| Classification | Class II |
| Product Code | MWI |
| Regulation Number | 21 CFR 870.2300 |
| Review Panel | Cardiovascular |
3. Predicate Device
- Midmark Diagnostics IQmark Vital Signs Monitor (K072516)
- · Vital Signs Monitor VSM 6000 Series; (K101445)
- · Nellcor OxiMax Pulse Oximetry System with N-600x Pulse Oximeter and OxiMax Sensors and Cables (K060576)
- · Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028)
- · Exergen TemporalScanner Thermometer (K011291)
-
- Device Description
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The IQvitals Zone is designed to be used for measuring and monitoring systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. All functions of the device are performed via the touch screen display, except the power on/off function, which is a separate button on the back of the device.
The IQvitals Zone can be wirelessly connected with low energy Bluetooth to mobile computers or be connected with a USB cable to computers and has the ability to send the measurement results to the computers.
The device has a rechargeable lithium ion battery and two mounting options: a mobile cart and a wall mount. All vitals parameters can be simultaneously measured and easily viewed on the touch screen display or the connected computer. Temperature is measured at Temporal Artery and the Temperature Probe is connected serially to the IQvitals Zone.
| Device ModelConfigurations | Features | ||||
|---|---|---|---|---|---|
| Non-invasiveBlood PressureMonitor Module | ExergenTemporalThermometerModule | NellcorSpO₂Module | MasimoSpO₂Module | Alarms&Wireless | |
| 1-200-0310 | X | X | --- | --- | --- |
| 1-200-0320 | X | X | X | --- | --- |
| 1-200-0330 | X | X | --- | X | --- |
| 1-200-0340 | X | X | --- | --- | X |
| 1-200-0350 | X | X | X | --- | X |
| 1-200-0360 | X | X | --- | X | X |
The IQvitals Zone is offered in following models:
5. Indications for Use
The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:
- Noninvasive blood pressure for adult and pediatric patients (3 years and above)
- · Pulse rate for adult and pediatric patients
- Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for . adult and pediatric patients
- · Body temperature measured at Temporal Artery for adult and pediatric patients
The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
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6. Technological Characteristics and Substantial Equivalence
The proposed 'IQvitals Zone' is substantially equivalent to the referenced predicate devices in regard to the intended use, fundamental scientific technology, design, and technological characteristics, as outlined in the following table:
| Characteristic | Subject Device | Predicate Devices | ||
|---|---|---|---|---|
| IQvitals Zone Wireless | Midmark DiagnosticsIQmark Vital SignsMonitor (K072516) | Vital Signs MonitorVSM 6000 Series;(K101445) | ||
| Submitter | Midmark Corporation | Midmark DiagnosticsGroup | Welch Allyn, Inc. | |
| Classification | Device Class: 2Product Code: MWI21 CFR 870.2300 | Device Class: 2Product Code: MWI21 CFR 870.2300 | Device Class: 2Product Code: MWI21 CFR 870.2300 | |
| Indications forUse | The IQVitals Zone isintended to be used byclinicians and medicallyqualified personnel formeasuring and monitoring:• Noninvasive bloodpressure for adult andpediatric patients (3years and above)• Pulse rate for adult andpediatric patients• Noninvasive functionaloxygen saturation ofarteriolar hemoglobin(SpO2) for adult andpediatric patients• Body temperaturemeasured at TemporalArtery for adult andpediatric patientsThe most likely location forIQvitals Zone device to beused is for monitoringpatient in general medicallocations, hospitals andalternative careenvironments. | The Midmark DiagnosticsIQmark Vital Signs Monitoris intended to be used byclinicians and medicallyqualified personnel formonitoring adult, pediatricand neonatal patients fornoninvasive bloodpressure, pulse ratenoninvasive functionaloxygen saturation ofarteriolar hemoglobin (Sp02), and body temperature.In adults and pediatricpatients, temperature ismonitored orally, rectally,or at axillary sites. Inneonates (to 1 month)temperature is monitoredat axillary sites only.The most likely locationsfor patients to bemonitored are generalmedical locations,hospitals, and alternativecare environments. | The VSM 6000 series ofmonitors is intended to beused by clinicians andmedically qualifiedpersonnel for monitoring ofnoninvasive bloodpressure, pulse rate,noninvasive functionaloxygen saturation ofarteriolar hemoglobin(SpO2), and bodytemperature in normal andaxillary modes of neonatal,pediatric, and adultpatients.The most likely locationsfor patients to bemonitored are generalmedical and surgicalfloors, general hospital,and alternate careenvironments. Thisproduct is available forsale only upon the order ofa physician or licensedhealth care professional. | |
| Prescription /Over-The-Counter (OTC)Use | Prescription | Prescription | Prescription | |
| Characteristic | Subject Device | Predicate Devices | ||
| IQvitals Zone Wireless | Midmark DiagnosticsIQmark Vital SignsMonitor (K072516) | Vital Signs MonitorVSM 6000 Series;(K101445) | ||
| Device Design(componentsand parts) | The IQvitals Zone includesMidmark NIBP module,Masimo or Nellcor OEMSPO2 module, andExergen temporalthermometer.The Midmark NIBP moduleuses oscillometric bloodpressure estimationalgorithm to estimatepatient's systolic, diastolicand mean arterial bloodpressure. The SPO2module is Masimo Radical7 or Nellcor NELL-1. TheMain Board is the centercontroller for the IQvitalsZone. Internally itcommunicates withWireless Board, NIBPBoard, SPO2 module,Display Board, with UART(Universal AsynchronousReceiver/Transmitter)interface. It also providesRS232 interfaces forExergen temporalthermometer andcompatible scales likeMidmark's IQscale orFairbanks scale.The Alarm Module is | The IQmark Vital SignsMonitor includes CAS MedOEM NIBP module,Masimo OEM SPO2module, and Midmarkpredictive temperaturemodule.The CAS Med NIBPmodules uses oscillometricblood pressure estimationalgorithm to estimatepatient's systolic, diastolicand mean arterial bloodpressure. The SPO2module is Masimo's MS-11. The Midmarkthermometer is apredictive temperaturemodule. All modules areinterfaced to the mainboard through UART ports.The IQmark Vital SignsMonitor can communicatewith the laptop/PC througha USB 1.1 port and /or anInferred wireless port.The device uses numericalLED display and buttons tocontrol the deviceoperation. | The Welch Allyn VSM6000 Series Deviceincorporates OscillometricBlood PressureMeasurement (BP)module, thermometer andSPO2 modulesA power button is locatedon the side of the device.A LCD with a touch screenis prominent on the front ofthe device and providesthe primary interface forthe user to interact withthe device. Internal andexternal communicationsis primarily by USB. A useraccessible client USBconnection for datatransfer is on the side ofthe device. | |
| controlled directly by theIO ports on the MainBoard. | ||||
| The IQvitals Zone cancommunicate with alaptop/PC through a USB2.0 compliant full speedport and/or a low energyBluetooth wirelessinterface. The device has aLCD touch screen thatprovides graphical userinterface to operate thedevice. | ||||
| Characteristic | Subject DeviceIQvitals Zone Wireless | Predicate DevicesMidmark DiagnosticsIQmark Vital SignsMonitor (K072516) | Vital Signs MonitorVSM 6000 Series;(K101445) | |
| Accessories &PeripheralDevices | SpO2 Sensors and cables Temperature Probes Temperature Probe Covers Blood Pressure Hose Blood Pressure Cuffs AC Power Adapter Lithium ion battery USB Cable Mobile Cart for IQvitals Zone IQvitals® Zone™ Wall Mount Articulating Arm 15" Laptop Tray 12" Tablet Tray | SPO2 sensors and cables Temperature Probes Temperature Probe Covers Temperature calibration key Blood Pressure Hose Blood Pressure Cuffs AC Power Adapter Lead acid battery USB cable | SPO2 sensors and cables Temperature Probes Temperature Probe Covers Temperature calibration key Blood Pressure Hose Blood Pressure Cuffs Lithium ion battery | |
| AvailableModuleConfigurations | Noninvasive BloodPressure (NIBP)Pulse OximeterTemperature | Noninvasive BloodPressure (NIBP)Pulse OximeterTemperature | Noninvasive BloodPressure (NIBP)Pulse OximeterTemperature | |
| DeviceOperationalModes | Adult, Pediatric | Adult, Neonatal | Adult, Pediatric, Neonatal | |
| NoninvasiveBlood Pressure(NIBP) MonitorModuleSpecifications | ||||
| OperatingPrinciple /Measurement Method | Oscillometric | Oscillometric | Oscillometric | |
| NIBPModes andRange | Adult ModeSystolic: 50-260 mmHgMean: 30-230 mmHgDiastolic: 20-210 mmHgPediatric ModeSystolic: 50-260 mmHgMean: 30-230 mmHgDiastolic: 20-210 mmHg | Adult ModeSystolic: 30-255 mmHgMean: 20-235 mmHgDiastolic: 15-220 mmHgNeonate Mode:Systolic: 30-135mmHgMean: 20-125mmHgDiastolic: 15-110mmHg | Adult ModeSystolic: 30-260 mmHgMean: 280 mmHgDiastolic: 20-220 mmHgPediatric ModeSystolic: 30-260 mmHgMean: 280 mmHgDiastolic: 20-220 mmHgNeonate ModeSystolic: 20 to 120 mmHgMean: 130 mmHgDiastolic: 10-110 mmHg | |
| Characteristic | Subject Device | Predicate Devices | Vital Signs MonitorVSM 6000 Series;(K101445) | |
| IQvitals Zone Wireless | Midmark DiagnosticsIQmark Vital SignsMonitor (K072516) | |||
| •MeasurementAccuracy | +/- 5 mmHg(standard deviation < 8 mmHg)Meets ANSI.AAMISP10:2002 standardaccuracy range | +/- 5 mmHg(standard deviation < 8 mmHg)Meets ANSI.AAMISP10:2002 standardaccuracy range | ±5 mmHg(standard deviation < 8 mmHg)Meets ANSI.AAMISP10:2002 standardaccuracy range | |
| •MeasurementResolution | 1 mmHg | 1 mmHg | 1 mmHg | |
| •Pulse RateRange | 40 – 200 BPM | 30 – 240 BPM | 30 – 200 BPM (adult, pediatric)35 – 220 BPM (neonate) | |
| •Pulse RateAccuracy | ±3 bpm or ±5%, whicheveris greater | ± 2 bpm or ± 2%,whichever is greater | ±3 bpm or ±5%, whicheveris greater | |
| •Pulse RateResolution | 1 bpm | 1 bpm | 1 bpm | |
| •Initial CuffPressure | Automatic or User-selectable | User-selectable | Automatic | |
| •MaximumCuffPressure | $280 \pm 5$ mmHg | 290 mmHg (adult mode)145 mmHg (neonatalmode) | 280 mmHg (adult, pediatric)130 mmHg (neonate) | |
| •OverpressureCutoff | $300 \pm 30$ mmHg | Adult Mode: 290 mmHgNeonatal Mode: 145mmHg | 300 mmHg ±15 mmHg(adult, pediatric)150 mmHg maximum(neonate) | |
| •Cuff Types | Reusable and single usecuffs | Single Use and Reusable | Single Use and Reusable | |
| •Cuff Sizes | ChildSmall AdultAdultAdult LongLarge AdultLarge Adult LongThigh | InfantNeonatalAdult | InfantSmall ChildChildSmall AdultAdultLarge AdultThighNeonatal | |
| Characteristic | Subject Device | Predicate Devices | Vital Signs MonitorVSM 6000 Series;(K101445) | |
| IQvitals Zone Wireless | Midmark DiagnosticsIQmark Vital SignsMonitor (K072516) | |||
| PulseOximeterySpecifications | ||||
| • | PulseOximeter | Masimo MX-5 OEMboard (previouslycleared as part ofMasimo Radical 7Pulse CO-Oximeterand Accessories,under K110028)Nellcor NELL-1(previously cleared aspart of OxiMax™ N-600x™ PulseOximeter, underK060576) | Masimo OEM MS-11Module | Welch Allyn NIBP module |
| • | SpO2Modes | Continuous Monitoring andOff | Continuous Monitoring andOff | Continuous Monitoring andOff |
| • | SpO2SensorTypes | Reusable and Disposable | Reusable and Disposable | Reusable and Disposable |
| • | SpO2Sensorsizes | Adult, Pediatric | Adult, Infant and Neonatal | Adult, Infant and Neonatal |
| • | SpO2Measurement Range | 0-100% | 0-100% | 1 to 100% |
| • | SpO2MeasurementAccuracy | Adult: 70 - 100% (± 2%)Pediatric: 70 - 100% (±3%) | Adult: 70 - 100% (± 2%)Neonate: 70 - 100% (±3%) | Adult: 70 - 100% (± 2%)Pediatric, Neonate: 70 -100% (± 3%) |
| • | Pulse RateMeasurement Range | 20 - 240 BPM (NellcorNELL-1)25 - 240 BPM (Masimo) | 25 - 240 BPM | 20-250 BPM (Nellcor)25-240 BPM (Masimo) |
| • | Pulse RateMeasurementAccuracy | ± 3 BPM (no motion)± 5 BPM (with motion) | ± 3 BPM | ± 3 BPM |
| • | SpO2 /Pulse RateResolution | SpO2: 1%Pulse Rate: 1 bpm | SpO2: 1%Pulse Rate: 1 bpm | SpO2: 1%Pulse Rate: 1 bpm |
| Characteristic | Subject Device | Predicate Devices | ||
| IQvitals Zone Wireless | Midmark DiagnosticsIQmark Vital SignsMonitor (K072516) | Vital Signs MonitorVSM 6000 Series;(K101445) | ||
| ThermometerSpecifications | ||||
| • Thermometer | Exergen TemporalScanner(previously cleared underK011291) | Midmark thermometer | Welch Allyn SureTemp | |
| • Type | Temporal | Oral, Axillary, and Rectal | Oral, Axillary, and Rectal | |
| • Measurement Range | 15.5°C to 43°C(61°F to 110°F) | 28.9°C to 42.2°C(84°F to 108°F) | 20°C to 42.2°C(68°F to 108°F) | |
| • MeasurementAccuracy[within the+/-0.6°C (+-1.0°F)rangespecifiedby ASTME1112standard] | +/-0.1°C (+/- 0.2°F) | ±0.1°C (±0.2°F) | ±0.2°C (±0.4°F)for temperatures rangingfrom 95.9°F to 107.6°F(35. 5°C to 42°C)±0.25°C (±0.5°F)for temperatures outside ofthis range | |
| • Resolution | 0.1 °C / 0.1 °F | 0.1 °C / 0.1 °F | 0.1 °C / 0.1 °F | |
| • ResponseTime | ~0.04 seconds | 15 seconds | Not specified | |
| OtherSpecifications | ||||
| AlarmConditions | High priority: NIBPsystolic, MAP, diastolichigh or low; SPO2 high orlow, and some high prioritytechnical alarmsMedium priority: SPO2high or low; pulse rate highor low, and some mediumpriority technical alarmsLow priority: Temperaturehigh or low, and some lowpriority technical alarms. | Pulse rate, systolic andDiastolic BP, MAP andSpO2; high and low alarms | High priority: NIBP, SpO2,SpHb limit exceeded, andsome technical alarmsMedium priority: Pulse ratelimit exceeded, and sometechnical alarmsLow priority: Temperaturelimit exceeded and sometechnical alarms | |
| Product Weight | 3.9 lbs (1.77 kg) | Not specified | 9.5 lbs (4.31 kg) | |
| Characteristic | Subject Device | Predicate Devices | ||
| IQvitals Zone Wireless | Midmark DiagnosticsIQmark Vital SignsMonitor (K072516) | Vital Signs MonitorVSM 6000 Series;(K101445) | ||
| Dimensions | 10.5" x 4" x 7" (LxWxH) | Not specified | 10x11x6 (HXWXD) | |
| Power Supply | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50 - 60 Hz | |
| OR | OR | OR | ||
| Lithium Ion Battery (7.2V) | Charged sealed lead acidbattery | Lithium Ion Battery | ||
| EnvironmentalConditions | ||||
| Temperature(Operating) | 10°C to 40°C(50°F to 104°F) | 10°C to 40°C(50°F to 104°F) | 10°C to 40°C(50°F to 104°F) | |
| Humidity(Operating) | 15-90% RH(non-condensing) | 15-90% RH(non-condensing) | 15-95% RH(non-condensing) | |
| Altitude(Operating) | Up to 10,000 feet | Up to 10,000 feet | -557 to 10,000 feet | |
| Temperature(Storage) | -20°C to 50°C(-4°F to 122°F) | -20°C to 65°C(-4°F to 149°F) | -20°C to 50°C(-4°F to 122°F) | |
| Humidity(Storage) | 15-95% RH(non-condensing) | 15-95% RH(non-condensing) | 15-95% RH(non-condensing) | |
| Altitude(Storage) | Up to 40,000 feet | Up to 40,000 feet | Not specified |
Table 1: Substantial Equivalence Comparison between IQvitals Zone and Predicate Devices - K072516, K1010445
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Table 2: Substantial Equivalence Comparison between IQvitals Zone and K060576
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| IQvitals Zone Wireless | OxiMax Pulse Oximetry Systemwith N-600x Pulse Oximeter andOxiMax Sensors and Cables(K060576) | |
| Pulse Oximeter Module | Nellcor NELL-1 | Nellcor NELL-1 |
| SpO2 Modes | Continuous Monitoring and Off | Continuous Monitoring and Off |
| SpO2 Sensor Types | Reusable and Disposable | Reusable and Disposable |
| SpO2 Sensor sizes | Adult, Pediatric | Adult, Pediatric |
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| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| IQvitals Zone Wireless | OxiMax Pulse Oximetry Systemwith N-600x Pulse Oximeter andOxiMax Sensors and Cables(K060576) | |
| SpO2 MeasurementRange | 0-100% | 0-100% |
| SpO2 MeasurementAccuracy | Adult: 70 - 100% ( $\pm$ 2%)Pediatric: 70 - 100% ( $\pm$ 3%) | Adult: 70 - 100% ( $\pm$ 2%)Pediatric: 70 - 100% ( $\pm$ 3%) |
| Pulse RateMeasurement Range | 20 - 240 BPM | 20 - 240 BPM |
| Pulse RateMeasurementAccuracy | $\pm$ 3 BPM (no motion)$\pm$ 5 BPM (with motion) | $\pm$ 3 BPM (no motion)$\pm$ 5 BPM (with motion) |
| SpO2 / Pulse RateResolution | SpO2: 1%Pulse Rate: 1 bpm | SpO2: 1%Pulse Rate: 1 bpm |
Table 3: Substantial Equivalence Comparison between IQvitals Zone and K110028
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| IQvitals Zone Wireless | Masimo Radical 7 Pulse CO-Oximeter and Accessories(K110028) | |
| Pulse OximeterModule | Masimo (SET) MX-5 OEM board | Masimo (SET) MX-5 OEM board |
| SpO2 Modes | Continuous Monitoring and Off | Continuous Monitoring and Off |
| SpO2 Sensor Types | Reusable and Disposable | Reusable and Disposable |
| SpO2 Sensor sizes | Adult, Pediatric | Adult, Pediatric |
| SpO2 MeasurementRange | 0-100% | 0-100% |
| SpO2 MeasurementAccuracy | Adult: 70 - 100% (± 2%)Pediatric: 70 - 100% (± 3%) | Adult: 70 - 100% (± 2%)Pediatric: 70 - 100% (± 3%) |
| Pulse RateMeasurement Range | 25 - 240 BPM | 25 - 240 BPM |
| Pulse RateMeasurementAccuracy | ± 3 BPM (no motion)± 5 BPM (with motion) | ± 3 BPM (no motion)± 5 BPM (with motion) |
| SpO2 / Pulse RateResolution | SpO2: 1%Pulse Rate: 1 bpm | SpO2: 1%Pulse Rate: 1 bpm |
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| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| IQvitals Zone Wireless | Exergen TemporalScannerThermometer (K011291) | |
| Thermometer Module | Exergen TemporalScanner | Exergen TemporalScanner |
| Thermometer Type | Temporal | Temporal |
| Measurement Range | 15.5°C to 43°C (61°F to 110°F) | 15.5°C to 43°C (61°F to 110°F) |
| MeasurementAccuracy[within the +/-0.6°C (+/-1.0°F) rangespecified by ASTME1112 standard] | +/-0.1°C (+/- 0.2°F) | +/-0.1°C (+/- 0.2°F) |
| Resolution | 0.1 °C / 0.1 °F | 0.1 °C / 0.1 °F |
| Response Time | ~0.04 seconds | ~0.04 seconds |
Table 4: Substantial Equivalence Comparison between IQvitals Zone and K011291
7. Non-clinical Bench (Performance) testing
The safety and performance of the IQvitals Zone is demonstrated through compliance with following standards:
- AAMI/ANSI ES 60601-1, Medical Electrical Equipment -- Part 1: General . Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- . IEC 60601-1-8, Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems
- · IEC 80601-2-30, Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers
- · IEC 60601-2-49, Medical Electrical Equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- . ISO 80601-2-56, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement
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- · ISO 80601-2-61, Medical Electrical Equipment Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment
8. Clinical Testing
The clinical validation of the Midmark Non-invasive Blood Pressure (NIBP) module was conducted per ANSI / AAMI / ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.
9. Conclusion:
Based on the intended use, design, technological characteristics and performance data provided in the submission; the proposed 'IQvitals Zone' is substantially equivalent to the referenced predicate devices, and does not raise any new concerns of safety of effectiveness.
§ 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).