IQVITALS AND IQVITALS SYSTEM

K100913 · Brentwood Medical Technology Corp. · DXN · May 26, 2010 · Cardiovascular

Device Facts

• Record ID: K100913
• Device Name: IQVITALS AND IQVITALS SYSTEM
• Applicant: Brentwood Medical Technology Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: May 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The IQvitals and IQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SpO2), temperature and weight. Patient information such as name, age, height, pain score etc. can be entered manually.

Device Story

IQvitals and IQvitals System are patient monitors for spot-check physiological measurements; inputs include noninvasive blood pressure, pulse oximetry (SpO2), temperature, and weight; clinicians manually enter additional patient data (height, respiration, pain level) via user interface; device processes physiological signals to provide patient vitals; used in clinical settings by medical personnel; output assists clinicians in patient assessment and monitoring; benefits include efficient, consolidated collection of patient vital signs.

Clinical Evidence

Bench testing only. The device underwent non-clinical testing for NIBP, temperature, SpO2, pulse rate, display, electrical, environmental, software, and biocompatibility. Results indicated compliance with predetermined requirements and standards.

Technological Characteristics

Non-invasive physiological monitor; parameters: NIBP, SpO2, temperature, weight. Connectivity: manual data entry interface. Software: embedded firmware for data processing and display. Testing performed against standards for electrical, environmental, and biocompatibility.

Indications for Use

Indicated for adult and pediatric patients for spot-check monitoring of noninvasive blood pressure, pulse rate, SpO2, temperature, and weight by clinicians and qualified medical personnel.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Well@Home System (K040012)

Submission Summary (Full Text)

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1009/3

### 5. 510(k) Summary

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MAY 2 6 2010

Submitter: Midmark Diagnostics Group

Trade Names: IQvitals and IQvitals System

Common Name: Patient Physiological Monitor (without arrhythmia detection or alarms)

Classification Name: Non-invasive Blood Pressure Measurement System

Classification Regulation: 21 CFR 870.1130

Product Code: DXN

### Device Description

The IQvitals and IQvitals System are patient monitors intended to be used by clinicians and qualified medical personnel for spot check monitoring of noninvasive blood pressure (NIBP), pulse oximetry (SpOz), temperature and for the IQvitals device, weight.

Patient Record information, such as height, respiration rate and pain level, can be manually entered by clinicians via the user interface.

### Technology Comparison

The IQvitals and IQvitals System utilizes the same or similar technology for each parameter as utilized by the predicate device. There are no different technologies between the IQvitals and IQvitals System and the predicate Well@Home System.

The legally marketed predicate device is the Well@Home System (K040012).

#### Intended Use

The IQvitals and IQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SpO2), temperature and weight.

Patient information such as name, age, height, pain score etc. can be entered manually.

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# Performance Testing

The IQvitals and IQvitals System was tested in accordance with requirements and procedures, and test results indicated that the device complies with the predetermined requirements.

The following non-clinical areas were thoroughly tested or evaluated to both standards and the predicate:

Non Invasive Blood Pressure Temperature SpO2 Pulse Rate Display Electrical Environmental Software Biocompatibility

## Conclusion

Based upon a comparison of devices and performance testing results, the IQvitals and IQvitals System is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2 5 2010

Brentwood Medical Technology Corp. c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ

Re: K100913

Trade/Device Name: IQ Vitals and IQ Vitals System Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 12, 2010 Received: May 13, 2010

Dear Mr. Holland:

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.

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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Page 2 - Mr. Greg Holland

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

&-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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### 4. Indications for Use Statement

# Indications for Use

510(k) Number: _ K /009/3

Device Name: IQvitals and IQvitals System

Indications for Use:

The IQvitals and IQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SpO2), temperature and weight.

Patient information such as name, age, height, pain score etc. can be entered manually.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M. West.

Division Sign-C Division of Cardiovascular Devices

510(k) Number LC100913