(164 days)
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Not Found
No
The provided text describes a monitor that measures and calculates various hemodynamic parameters and connects to modules for additional monitoring. There is no mention of AI, ML, or any related technologies in the intended use or other sections. The calculations described are standard physiological derivations.
No
The device is used for monitoring physiological parameters and does not directly treat a disease or condition.
Yes.
The device is intended for the measurement and monitoring of various physiological parameters, which fall under the scope of diagnostic procedures.
No
The intended use and device description clearly indicate the device is a "Monitor" that connects to "Modules" (BIS Module, LiDCO CNAP Module) and utilizes "pre-inserted arterial and venous catheters" and "pre-existing peripheral arterial line access" for data acquisition, which are hardware components.
Based on the provided information, the LiDCOunity Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended uses of the LiDCOunity Monitor, as described, involve direct measurements and monitoring of physiological parameters within the patient (blood pressure, cardiac output, brain activity via EEG).
- The device description and intended uses focus on monitoring and measuring physiological functions in a living patient. There is no mention of analyzing samples taken from the patient.
Therefore, the LiDCOunity Monitor falls under the category of a physiological monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
-
- The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
-
- When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
-
- When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
- The measurement of cardiac output via Lithium Indicator Dilution in adult patients 4. (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access
-
- In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index
Product codes
DXG, GWQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients, pediatric (>4yrs) patients, adult patients (>40Kg/88lbs)
Intended User / Care Setting
direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use
Locations of Use:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping profiles, creating a sense of depth and movement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2016
LiDCO Ltd. Eric Mills Product Development Manager 16 Orsman Road London, N1 5QJ GB
Re: K152935
Trade/Device Name: LiDCOunity Monitor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG, GWQ Dated: February 15, 2016 Received: February 16, 2016
Dear Eric Mills:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 yours,
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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K152935
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: LiDCOunity Monitor
Indications For Use:
The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
-
- The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
-
- When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
-
- When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
- The measurement of cardiac output via Lithium Indicator Dilution in adult patients 4. (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access
-
- In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index
Locations of Use:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories
Prescription Use X (Part 21CFR 801 Subpart D) AND / OR
Over-The-Counter Use (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)