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.

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

Device Description

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the LiDCOplus Hemodynamic Monitor, outlining its regulatory classification and indications for use. It primarily focuses on the substantial equivalence of the device to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Summary

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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.

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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

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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:

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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).