(135 days)
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Not Found
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that typically indicate the use of AI/ML in medical devices. The description focuses on standard physiological monitoring parameters.
No
The device is indicated for monitoring arterial blood pressure, not for providing therapy or treatment.
No
Explanation: The device is described as a continuous, non-invasive monitor of arterial blood pressure and heart rate. It provides parameters but does not indicate diagnosis of a disease or condition.
No
The description explicitly states the device is a "Module" intended to be used "with, and display on, the LiDCOrapid V2 Monitor." This implies a hardware component (the module) that interfaces with another hardware component (the monitor), making it more than just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LiDCO CNAP Module is described as a device for the continuous, non-invasive monitoring of arterial blood pressure. This involves measuring a physiological parameter directly from the patient's body, not analyzing a sample taken from the body.
- Intended Use: The intended use clearly states "monitoring of arterial blood pressure in adults and pediatric patients". This is a direct physiological measurement.
Therefore, the LiDCO CNAP Module falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LiDCO CNAP Module is Indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric patients from the age of 4 years by medical professionals.
The LiDCO CNAP Module is intended to be used with, and display on, the LiDCOrapid V2 Monitor.
The LiDCO CNAP Module supports the following parameters:
Continuous and oscillometric arterial blood pressure
Arterial systolic pressure
Arterial diastolic pressure
Arterial mean pressure
Heart rate
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
Product codes
DXG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults and pediatric patients from the age of 4 years
Intended User / Care Setting
medical professionals /
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 seal of the Department of Health and Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2013
LiDCO Ltd. c/o Mr. Gregory Speller Quality & Regulatory Manager 16 Orsman Road London, NI 5QJ UNITED KINGDOM
રિc: K131048
Trade/Device Names: LiDCO CNAP Module Regulatory Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DXG Dated: July 23, 2013 Received: July 24, 2013
Dear Mr. Speller:
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 cither 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
1
Page 2 - Mr. Gregory Speller
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen-P.Earis -S
- for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K131048
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: LiDCO CNAP Module
Indications For Use:
The LiDCO CNAP Module is Indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric patients from the age of 4 years by medical professionals.
The LiDCO CNAP Module is intended to be used with, and display on, the LiDCOrapid V2 Monitor.
The LiDCO CNAP Module supports the following parameters:
Continuous and oscillometric arterial blood pressure Arterial systolic pressure Arterial diastolic pressure Arterial mean pressure Heart rate
Locations of Use:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units Operative Sultes 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)
Digitally signed by
Owen P. Faris -S
Date: 2013.08.28
10:12:04-04'00'
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