(55 days)
No
The document describes a standard vital signs monitor with manual data entry and does not mention any AI/ML capabilities or related concepts.
No.
The device is a patient monitor intended for measuring vital signs, not for treating or rehabilitating patients.
No
The device description indicates it is a "patient monitor" for "spot check monitoring" of vital signs like blood pressure, SpO2, temperature, and weight. It measures physiological parameters rather than diagnosing a condition or disease.
No
The device description explicitly states it is a "patient monitor" and measures physiological parameters like blood pressure, SpO2, temperature, and weight, which inherently requires hardware components to acquire these measurements. The performance studies also mention testing of hardware aspects like NIBP, Temperature, SpO2, Electrical, and Biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for measuring physiological parameters (blood pressure, pulse rate, SpO2, temperature, weight) in patients. This involves direct measurement from the patient's body, not the analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that it's a patient monitor for spot-checking these physiological parameters.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures vital signs directly from the patient.
N/A
Intended Use / 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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
clinicians and medically qualified personnel
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
1009/3
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
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.
Page 1 OF 2
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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.
Page 2 of 2
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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:
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