(41 days)
Not Found
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description or intended use. The calculations described are standard hemodynamic parameters.
No
The device is described as a "diagnostic aid" for the measurement of hemodynamic parameters, which means it helps in identifying conditions rather than treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as a diagnostic aid."
No
The device description mentions "pre-inserted and venous catheters and preexisting peripheral arterial line access," which are hardware components required for the device's function. The summary does not indicate the device is solely software.
Based on the provided text, 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 description: The LiDCOplus Hemodynamic Monitor measures blood pressure, cardiac output, and associated hemodynamic parameters directly from the patient using pre-inserted catheters and arterial lines. It calculates derived parameters based on these direct measurements.
- Lack of sample analysis: There is no mention of analyzing samples taken from the patient. The measurements are taken from the patient directly.
Therefore, the LiDCOplus Hemodynamic Monitor is a device that performs measurements in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The LiDCOp/us Hemodynamic Monitor is intended for use as a diagnostic aid for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in patients greater than 88lb (40kg) in weight.
Product codes
DXG
Device Description
Not Found
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
Not Found
Intended User / Care Setting
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
LiDCO Limited c/o Mr. Gregory Speller Quality and Regulatory Manager 16 Orsman Road London N1 5QJ United Kingdom
Re: K023960
Trade Name: LiDCOplus Hemodynamic Monitor Regulation Number: 21 870.1435 Regulation Name: Single-Function, Preprogrammable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: December 17, 2002 Received: December 18, 2002
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
Page 2 - Mr. Gregory Speller
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
N. Deatell
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
023960
Page 1 of 1
INDICATIONS FOR USE STATEMENT
LiDCO Ltd., London, U.K. Applicant:
510(k) Number (if known): K023960
Device Name: LiDCOplus Hemodynamic Monitor
INDICATIONS FOR USE:
The LiDCOp/us Hemodynamic Monitor is intended for use as a diagnostic aid for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in patients greater than 88lb (40kg) in weight.
SUITABLE PATIENTS:
Patients requiring cardiovascular monitoring who have pre-inserted and venous catheters and preexisting peripheral arterial line access.
USUAL DOSE RANGE FOR CALIBRATION WITH LITHIUM CHLORIDE:
Lithium Chloride -- 0.075, 0.15 or 0.3 mmol lithium chloride per cardiac output determination. The total amount of lithium chloride administered should not exceed 3mmol.
DESCRIPTION / ROUTE OF ADMINISTRATION OF LITHIUM:
Sterile lithium chloride (0.15mmol/mi, 10ml per ampoule) suitable for parenteral (i.v.) administration
DERIVED PARAMETERS:
In addition to arterial blood pressure parameters and cardiac output, the LiDCOplus Hemodynamic Monitor calculates a number of derived parameters: Body Surface Area, Systolic Pressure Vanation, 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
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------ncurrence of CDRH, Office of Device Evaluation (ODE)
Ozlartill
of Cardiovascular Devices
510(k) Number K023160
Prescription Use
(Per 21CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)