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 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.

AI/ML Overview

The provided text describes a medical device, the IQvitals and IQvitals System, and its substantial equivalence determination by the FDA. However, it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, as understood in the context of an AI/ML medical device.

Here's why and what information is available:

The document is a 510(k) summary for a "Patient Physiological Monitor." This type of device relies on established physiological measurement principles, not AI/ML algorithms. The performance testing described is focused on validating the accuracy and reliability of these standard physiological measurements against established norms and a predicate device.

Therefore, many of the requested points, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set details," are not applicable to this document as it pertains to the evaluation of an AI-powered medical device.

Here's a breakdown of what information can be extracted or inferred from the provided text, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail numerical targets in the provided text. The general acceptance criterion is "substantially equivalent" to the predicate device. For specific parameters, compliance with "requirements and procedures" and "standards" is mentioned.

Reported Device Performance:

Parameter	Reported Performance
Non Invasive Blood Pressure (NIBP)	Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate.
Temperature	Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate.
SpO2	Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate.
Pulse Rate	Tested in accordance with requirements and procedures; results indicated compliance with predetermined requirements and substantial equivalence to the predicate.
Display	Tested or evaluated.
Electrical	Tested or evaluated.
Environmental	Tested or evaluated.
Software	Tested or evaluated.
Biocompatibility	Tested or evaluated.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified. (The context strongly suggests physiological measurements, likely from human subjects, but details are not provided).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or similar. The "ground truth" for physiological measurements would typically be established by validated reference instruments or methods.

4. Adjudication method for the test set

Not Applicable. Not an AI/ML device seeking consensus on interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-assisted interpretation device. The study type would be a typical performance validation study for a medical monitor.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physiological monitor, not an AI algorithm. Its performance is its "standalone" output of physiological parameters.

7. The type of ground truth used

The "ground truth" for physiological measurements would involve reference standards or established, validated methods for measuring NIBP, temperature, SpO2, and pulse rate (e.g., invasive blood pressure monitoring for NIBP accuracy, reference thermometers, co-oximeters for SpO2 calibration). These are implied by the statement "tested in accordance with requirements and procedures, and test results indicated that the device complies with the predetermined requirements."

8. The sample size for the training set

Not Applicable. This device does not use a training set in the context of AI/ML.

9. How the ground truth for the training set was established

Not Applicable. This device does not use a training set in the context of AI/ML.

Study Information (General)

The study described is a performance testing and comparison to a predicate device to establish substantial equivalence.

Study Type: Non-clinical areas thoroughly tested or evaluated against "standards and the predicate." This implies a series of bench tests, simulations, and likely human clinical studies (though details are not provided) to measure accuracy, precision, and reliability of the physiological measurements.
Predicate Device: Well@Home System (K040012).
Conclusion: "Based upon a comparison of devices and performance testing results, the IQvitals and IQvitals System is substantially equivalent to the predicate device."

Summary

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5. 510(k) Summary

Image /page/0/Picture/2 description: The image shows the logo for Midmark. The logo is in black and white, with the word "MIDMARK" in a bold, sans-serif font. Above the word is a design that looks like a stylized mountain range or a wave. The logo is simple and modern.

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

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

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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).