IQvitals Zone

K161909 · Midmark Corporation · MWI · Nov 17, 2016 · Cardiovascular

Device Facts

• Record ID: K161909
• Device Name: IQvitals Zone
• Applicant: Midmark Corporation
• Product Code: MWI · Cardiovascular
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

IQvitals Zone is a multi-parameter patient monitor for clinical environments; measures noninvasive blood pressure (NIBP), pulse rate, SpO2, and temporal artery temperature. Inputs: oscillometric NIBP cuff, SpO2 sensor (Masimo or Nellcor), and Exergen temporal thermometer probe. Device uses a main controller board to process signals from modules via UART; displays results on integrated touch screen. Connects to computers via USB or Bluetooth Low Energy for data transmission. Operated by clinicians/medically qualified personnel in hospitals or alternative care settings. Output provides real-time vital signs to assist clinicians in patient assessment and monitoring. Benefits include simultaneous measurement and centralized viewing of patient vitals.

Clinical Evidence

Clinical validation of the NIBP module was conducted per ANSI/AAMI/ISO 81060-2:2013. Other parameters supported by bench testing and compliance with standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-30, IEC 60601-2-49, ISO 80601-2-56, and ISO 80601-2-61.

Technological Characteristics

Class II device; 21 CFR 870.2300. Components: Midmark NIBP module, Masimo/Nellcor SpO2 modules, Exergen temporal thermometer. Connectivity: USB 2.0, Bluetooth Low Energy. Power: 100-240 VAC or rechargeable lithium-ion battery. Form factor: Touch screen display, mobile cart or wall mount. Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-30, IEC 60601-2-49, ISO 80601-2-56, ISO 80601-2-61.

Indications for Use

Indicated for adult and pediatric patients (3 years and older) in clinical settings for noninvasive blood pressure, pulse rate, SpO2, and temporal artery temperature monitoring.

Regulatory Classification

Identification

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

Predicate Devices

• 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)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] Contact: Mr. Asad Abu-Tarif; Vice President (R&D) Email: [e-mail] Alternate Contact: Ms. Maria Moreno; Manager (Quality) Email: [e-mail]

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,<br>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)
- 4. 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 Model<br>Configurations | Features | | | | |
|--------------------------------|--------------------------------------------------|----------------------------------------------|---------------------------|--------------------------|-------------------------|
| | Non-invasive<br>Blood Pressure<br>Monitor Module | Exergen<br>Temporal<br>Thermometer<br>Module | Nellcor<br>SpO₂<br>Module | Masimo<br>SpO₂<br>Module | Alarms<br>&<br>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 Diagnostics<br>IQmark Vital Signs<br>Monitor (K072516) | Vital Signs Monitor<br>VSM 6000 Series;<br>(K101445) | |
| Submitter | Midmark Corporation | Midmark Diagnostics<br>Group | Welch Allyn, Inc. | |
| Classification | Device Class: 2<br>Product Code: MWI<br>21 CFR 870.2300 | Device Class: 2<br>Product Code: MWI<br>21 CFR 870.2300 | Device Class: 2<br>Product Code: MWI<br>21 CFR 870.2300 | |
| Indications for<br>Use | The IQVitals Zone is<br>intended to be used by<br>clinicians and medically<br>qualified personnel for<br>measuring and monitoring:<br>• Noninvasive blood<br>pressure for adult and<br>pediatric patients (3<br>years and above)<br>• Pulse rate for adult and<br>pediatric patients<br>• Noninvasive functional<br>oxygen saturation of<br>arteriolar hemoglobin<br>(SpO2) for adult and<br>pediatric patients<br>• Body temperature<br>measured at Temporal<br>Artery for adult and<br>pediatric patients<br>The most likely location for<br>IQvitals Zone device to be<br>used is for monitoring<br>patient in general medical<br>locations, hospitals and<br>alternative care<br>environments. | The Midmark Diagnostics<br>IQmark Vital Signs Monitor<br>is intended to be used by<br>clinicians and medically<br>qualified personnel for<br>monitoring adult, pediatric<br>and neonatal patients for<br>noninvasive blood<br>pressure, pulse rate<br>noninvasive functional<br>oxygen saturation of<br>arteriolar hemoglobin (Sp0<br>2), and body temperature.<br>In adults and pediatric<br>patients, temperature is<br>monitored orally, rectally,<br>or at axillary sites. In<br>neonates (to 1 month)<br>temperature is monitored<br>at axillary sites only.<br>The most likely locations<br>for patients to be<br>monitored are general<br>medical locations,<br>hospitals, and alternative<br>care environments. | The VSM 6000 series of<br>monitors is intended to be<br>used by clinicians and<br>medically qualified<br>personnel for monitoring of<br>noninvasive blood<br>pressure, pulse rate,<br>noninvasive functional<br>oxygen saturation of<br>arteriolar hemoglobin<br>(SpO2), and body<br>temperature in normal and<br>axillary modes of neonatal,<br>pediatric, and adult<br>patients.<br>The most likely locations<br>for patients to be<br>monitored are general<br>medical and surgical<br>floors, general hospital,<br>and alternate care<br>environments. This<br>product is available for<br>sale only upon the order of<br>a physician or licensed<br>health care professional. | |
| Prescription /<br>Over-The-<br>Counter (OTC)<br>Use | Prescription | Prescription | Prescription | |
| Characteristic | Subject Device | Predicate Devices | | |
| | IQvitals Zone Wireless | Midmark Diagnostics<br>IQmark Vital Signs<br>Monitor (K072516) | Vital Signs Monitor<br>VSM 6000 Series;<br>(K101445) | |
| Device Design<br>(components<br>and parts) | The IQvitals Zone includes<br>Midmark NIBP module,<br>Masimo or Nellcor OEM<br>SPO2 module, and<br>Exergen temporal<br>thermometer.<br><br>The Midmark NIBP module<br>uses oscillometric blood<br>pressure estimation<br>algorithm to estimate<br>patient's systolic, diastolic<br>and mean arterial blood<br>pressure. The SPO2<br>module is Masimo Radical<br>7 or Nellcor NELL-1. The<br>Main Board is the center<br>controller for the IQvitals<br>Zone. Internally it<br>communicates with<br>Wireless Board, NIBP<br>Board, SPO2 module,<br>Display Board, with UART<br>(Universal Asynchronous<br>Receiver/Transmitter)<br>interface. It also provides<br>RS232 interfaces for<br>Exergen temporal<br>thermometer and<br>compatible scales like<br>Midmark's IQscale or<br>Fairbanks scale.<br><br>The Alarm Module is | The IQmark Vital Signs<br>Monitor includes CAS Med<br>OEM NIBP module,<br>Masimo OEM SPO2<br>module, and Midmark<br>predictive temperature<br>module.<br><br>The CAS Med NIBP<br>modules uses oscillometric<br>blood pressure estimation<br>algorithm to estimate<br>patient's systolic, diastolic<br>and mean arterial blood<br>pressure. The SPO2<br>module is Masimo's MS-<br>11. The Midmark<br>thermometer is a<br>predictive temperature<br>module. All modules are<br>interfaced to the main<br>board through UART ports.<br><br>The IQmark Vital Signs<br>Monitor can communicate<br>with the laptop/PC through<br>a USB 1.1 port and /or an<br>Inferred wireless port.<br>The device uses numerical<br>LED display and buttons to<br>control the device<br>operation. | The Welch Allyn VSM<br>6000 Series Device<br>incorporates Oscillometric<br>Blood Pressure<br>Measurement (BP)<br>module, thermometer and<br>SPO2 modules<br><br>A power button is located<br>on the side of the device.<br>A LCD with a touch screen<br>is prominent on the front of<br>the device and provides<br>the primary interface for<br>the user to interact with<br>the device. Internal and<br>external communications<br>is primarily by USB. A user<br>accessible client USB<br>connection for data<br>transfer is on the side of<br>the device. | |
| | controlled directly by the<br>IO ports on the Main<br>Board. | | | |
| | The IQvitals Zone can<br>communicate with a<br>laptop/PC through a USB<br>2.0 compliant full speed<br>port and/or a low energy<br>Bluetooth wireless<br>interface. The device has a<br>LCD touch screen that<br>provides graphical user<br>interface to operate the<br>device. | | | |
| Characteristic | Subject Device<br>IQvitals Zone Wireless | Predicate Devices<br>Midmark Diagnostics<br>IQmark Vital Signs<br>Monitor (K072516) | Vital Signs Monitor<br>VSM 6000 Series;<br>(K101445) | |
| Accessories &<br>Peripheral<br>Devices | 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 | |
| Available<br>Module<br>Configurations | Noninvasive Blood<br>Pressure (NIBP)<br>Pulse Oximeter<br>Temperature | Noninvasive Blood<br>Pressure (NIBP)<br>Pulse Oximeter<br>Temperature | Noninvasive Blood<br>Pressure (NIBP)<br>Pulse Oximeter<br>Temperature | |
| Device<br>Operational<br>Modes | Adult, Pediatric | Adult, Neonatal | Adult, Pediatric, Neonatal | |
| Noninvasive<br>Blood Pressure<br>(NIBP) Monitor<br>Module<br>Specifications | | | | |
| Operating<br>Principle /<br>Measurement Method | Oscillometric | Oscillometric | Oscillometric | |
| NIBP<br>Modes and<br>Range | Adult Mode<br>Systolic: 50-260 mmHg<br>Mean: 30-230 mmHg<br>Diastolic: 20-210 mmHg<br><br>Pediatric Mode<br>Systolic: 50-260 mmHg<br>Mean: 30-230 mmHg<br>Diastolic: 20-210 mmHg | Adult Mode<br>Systolic: 30-255 mmHg<br>Mean: 20-235 mmHg<br>Diastolic: 15-220 mmHg<br><br>Neonate Mode:<br>Systolic: 30-135mmHg<br>Mean: 20-125mmHg<br>Diastolic: 15-110mmHg | Adult Mode<br>Systolic: 30-260 mmHg<br>Mean: 280 mmHg<br>Diastolic: 20-220 mmHg<br><br>Pediatric Mode<br>Systolic: 30-260 mmHg<br>Mean: 280 mmHg<br>Diastolic: 20-220 mmHg<br><br>Neonate Mode<br>Systolic: 20 to 120 mmHg<br>Mean: 130 mmHg<br>Diastolic: 10-110 mmHg | |
| Characteristic | Subject Device | Predicate Devices | Vital Signs Monitor<br>VSM 6000 Series;<br>(K101445) | |
| | IQvitals Zone Wireless | Midmark Diagnostics<br>IQmark Vital Signs<br>Monitor (K072516) | | |
| •<br>Measurement<br>Accuracy | +/- 5 mmHg<br>(standard deviation < 8 mmHg)<br>Meets ANSI.AAMI<br>SP10:2002 standard<br>accuracy range | +/- 5 mmHg<br>(standard deviation < 8 mmHg)<br>Meets ANSI.AAMI<br>SP10:2002 standard<br>accuracy range | ±5 mmHg<br>(standard deviation < 8 mmHg)<br>Meets ANSI.AAMI<br>SP10:2002 standard<br>accuracy range | |
| •<br>Measurement<br>Resolution | 1 mmHg | 1 mmHg | 1 mmHg | |
| •<br>Pulse Rate<br>Range | 40 – 200 BPM | 30 – 240 BPM | 30 – 200 BPM (adult, pediatric)<br>35 – 220 BPM (neonate) | |
| •<br>Pulse Rate<br>Accuracy | ±3 bpm or ±5%, whichever<br>is greater | ± 2 bpm or ± 2%,<br>whichever is greater | ±3 bpm or ±5%, whichever<br>is greater | |
| •<br>Pulse Rate<br>Resolution | 1 bpm | 1 bpm | 1 bpm | |
| •<br>Initial Cuff<br>Pressure | Automatic or User-<br>selectable | User-selectable | Automatic | |
| •<br>Maximum<br>Cuff<br>Pressure | $280 \pm 5$ mmHg | 290 mmHg (adult mode)<br>145 mmHg (neonatal<br>mode) | 280 mmHg (adult, pediatric)<br>130 mmHg (neonate) | |
| •<br>Overpressure<br>Cutoff | $300 \pm 30$ mmHg…