Predicate Devices

K072516, K101445, K060576, K110028, K011291

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities.

Therapeutic

No

The device is described as a monitoring device that measures various vital signs. It does not perform any therapeutic action or treatment.

Diagnostic

No

Explanation: The device measures and monitors vital signs (blood pressure, pulse rate, SpO2, and temperature), which are data collection functions, not diagnostic capabilities. It provides information for clinicians but does not interpret or diagnose conditions itself.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as a touch screen display, a power on/off button, a rechargeable lithium ion battery, mounting options (mobile cart and wall mount), and a serially connected Temperature Probe.

IVD (In Vitro Diagnostic)

Based on the provided information, the IQvitals Zone is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
IQvitals Zone Function: The IQvitals Zone measures and monitors physiological parameters directly from the patient's body (blood pressure, pulse rate, SpO2, and temperature at the temporal artery). It does not analyze specimens in vitro.

Therefore, the IQvitals Zone falls under the category of a non-invasive vital signs monitor, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI, DXN, DOA, FLL

Device Description

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 includes Midmark NIBP module, Masimo or Nellcor OEM SPO2 module, and Exergen temporal thermometer.

The Midmark NIBP module uses oscillometric blood pressure estimation algorithm to estimate patient's systolic, diastolic and mean arterial blood pressure. The SPO2 module is Masimo Radical 7 or Nellcor NELL-1. The Main Board is the center controller for the IQvitals Zone. Internally it communicates with Wireless Board, NIBP Board, SPO2 module, Display Board, with UART (Universal Asynchronous Receiver/Transmitter) interface. It also provides RS232 interfaces for Exergen temporal thermometer and compatible scales like Midmark's IQscale or Fairbanks scale.

The Alarm Module is controlled directly by the IO ports on the Main Board.

The IQvitals Zone can communicate with a laptop/PC through a USB 2.0 compliant full speed port and/or a low energy Bluetooth wireless interface. The device has a LCD touch screen that provides graphical user interface to operate the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Temporal Artery (for temperature)

Indicated Patient Age Range

Adult and pediatric patients (3 years and above)

Intended User / Care Setting

Clinicians and medically qualified personnel; general medical locations, hospitals and alternative care environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The safety and performance of the IQvitals Zone is demonstrated through compliance with numerous standards, including those for basic safety and essential performance, electromagnetic compatibility, alarm systems, automated non-invasive sphygmomanometers, multifunction patient monitoring equipment, clinical thermometers for body temperature measurement, and pulse oximeter equipment.

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.

Key results from performance specification tables:
NIBP Measurement Accuracy: +/- 5 mmHg (standard deviation

Regulation Number and Section

§ 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).

Summary

0

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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)
1. Device Description

4

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

Configurations	Features
	Non-invasive
Blood Pressure
Monitor Module	Exergen
Temporal
Thermometer
Module	Nellcor
SpO₂
Module	Masimo
SpO₂
Module	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.

5

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
IQmark Vital Signs
Monitor (K072516)	Vital Signs Monitor
VSM 6000 Series;
(K101445)
Submitter	Midmark Corporation	Midmark Diagnostics
Group	Welch Allyn, Inc.
Classification	Device Class: 2
Product Code: MWI
21 CFR 870.2300	Device Class: 2
Product Code: MWI
21 CFR 870.2300	Device Class: 2
Product Code: MWI
21 CFR 870.2300
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.	The Midmark Diagnostics
IQmark Vital Signs Monitor
is intended to be used by
clinicians and medically
qualified personnel for
monitoring adult, pediatric
and neonatal patients for
noninvasive blood
pressure, pulse rate
noninvasive functional
oxygen saturation of
arteriolar hemoglobin (Sp0
2), and body temperature.
In adults and pediatric
patients, temperature is
monitored orally, rectally,
or at axillary sites. In
neonates (to 1 month)
temperature is monitored
at axillary sites only.
The most likely locations
for patients to be
monitored are general
medical locations,
hospitals, and alternative
care environments.	The VSM 6000 series of
monitors is intended to be
used by clinicians and
medically qualified
personnel for monitoring of
noninvasive blood
pressure, pulse rate,
noninvasive functional
oxygen saturation of
arteriolar hemoglobin
(SpO2), and body
temperature in normal and
axillary modes of neonatal,
pediatric, and adult
patients.
The most likely locations
for patients to be
monitored are general
medical and surgical
floors, general hospital,
and alternate care
environments. This
product is available for
sale only upon the order of
a physician or licensed
health care professional.
Prescription /
Over-The-
Counter (OTC)
Use	Prescription	Prescription	Prescription
Characteristic	Subject Device	Predicate Devices
	IQvitals Zone Wireless	Midmark Diagnostics
IQmark Vital Signs
Monitor (K072516)	Vital Signs Monitor
VSM 6000 Series;
(K101445)
Device Design
(components
and parts)	The IQvitals Zone includes
Midmark NIBP module,
Masimo or Nellcor OEM
SPO2 module, and
Exergen temporal
thermometer.

The Midmark NIBP module
uses oscillometric blood
pressure estimation
algorithm to estimate
patient's systolic, diastolic
and mean arterial blood
pressure. The SPO2
module is Masimo Radical
7 or Nellcor NELL-1. The
Main Board is the center
controller for the IQvitals
Zone. Internally it
communicates with
Wireless Board, NIBP
Board, SPO2 module,
Display Board, with UART
(Universal Asynchronous
Receiver/Transmitter)
interface. It also provides
RS232 interfaces for
Exergen temporal
thermometer and
compatible scales like
Midmark's IQscale or
Fairbanks scale.

The Alarm Module is | The IQmark Vital Signs
Monitor includes CAS Med
OEM NIBP module,
Masimo OEM SPO2
module, and Midmark
predictive temperature
module.

The CAS Med NIBP
modules uses oscillometric
blood pressure estimation
algorithm to estimate
patient's systolic, diastolic
and mean arterial blood
pressure. The SPO2
module is Masimo's MS-
11. The Midmark
thermometer is a
predictive temperature
module. All modules are
interfaced to the main
board through UART ports.

The IQmark Vital Signs
Monitor can communicate
with the laptop/PC through
a USB 1.1 port and /or an
Inferred wireless port.
The device uses numerical
LED display and buttons to
control the device
operation. | The Welch Allyn VSM
6000 Series Device
incorporates Oscillometric
Blood Pressure
Measurement (BP)
module, thermometer and
SPO2 modules

A power button is located
on the side of the device.
A LCD with a touch screen
is prominent on the front of
the device and provides
the primary interface for
the user to interact with
the device. Internal and
external communications
is primarily by USB. A user
accessible client USB
connection for data
transfer is on the side of
the device. | |
| | controlled directly by the
IO ports on the Main
Board. | | | |
| | The IQvitals Zone can
communicate with a
laptop/PC through a USB
2.0 compliant full speed
port and/or a low energy
Bluetooth wireless
interface. The device has a
LCD touch screen that
provides graphical user
interface to operate the
device. | | | |
| Characteristic | Subject Device
IQvitals Zone Wireless | Predicate Devices
Midmark Diagnostics
IQmark Vital Signs
Monitor (K072516) | Vital Signs Monitor
VSM 6000 Series;
(K101445) | |
| Accessories &
Peripheral
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
Module
Configurations | Noninvasive Blood
Pressure (NIBP)
Pulse Oximeter
Temperature | Noninvasive Blood
Pressure (NIBP)
Pulse Oximeter
Temperature | Noninvasive Blood
Pressure (NIBP)
Pulse Oximeter
Temperature | |
| Device
Operational
Modes | Adult, Pediatric | Adult, Neonatal | Adult, Pediatric, Neonatal | |
| Noninvasive
Blood Pressure
(NIBP) Monitor
Module
Specifications | | | | |
| Operating
Principle /
Measurement Method | Oscillometric | Oscillometric | Oscillometric | |
| NIBP
Modes and
Range | Adult Mode
Systolic: 50-260 mmHg
Mean: 30-230 mmHg
Diastolic: 20-210 mmHg

Pediatric Mode
Systolic: 50-260 mmHg
Mean: 30-230 mmHg
Diastolic: 20-210 mmHg | Adult Mode
Systolic: 30-255 mmHg
Mean: 20-235 mmHg
Diastolic: 15-220 mmHg

Neonate Mode:
Systolic: 30-135mmHg
Mean: 20-125mmHg
Diastolic: 15-110mmHg | Adult Mode
Systolic: 30-260 mmHg
Mean: 280 mmHg
Diastolic: 20-220 mmHg

Pediatric Mode
Systolic: 30-260 mmHg
Mean: 280 mmHg
Diastolic: 20-220 mmHg