K Number
K962918
Device Name
LIDCO SYSTEM
Manufacturer
Date Cleared
1999-01-08

(925 days)

Product Code
Regulation Number
870.1435
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTENDED USE: LIDCO SYSTEM for CARDIAC OUTPUT MONITORING Indications for Use - Diagnostic aid (cardiac output determination). The LiDCO System is intended for the monitoring of cardiac output (blood flow in litres per minute) in patients of greater than 88 lbs (40 kg) in weight.
Device Description
The LIDCo System revisits and improves the indicator dilution technique of cardiac output determination. It avoids the complications of pulmonary artery catheterisation. The LIDCo System will have clinical utility in patients with pre-placed arterial and venous lines, where the determination of cardiac output is required minimally invasively without the insertion of a pulmonary artery catheter. The lithium cation sensor is biocompatible, thermally compensated and unaffected by changes in arterial blood pressure. Despite the potential complication of secondary marker recirculation, the LIDCo System software has been demonstrated in a number of bench and clinical studies to calculate the area under the primary indicator dilution curve. Flow cell moulded from polycarbonate. Lithium ion selective electrode made from PVC membrane cast onto polyurethane. Blood contact material PVC - blood not returned to patient. Monitor CM-31/32: Power supply is by + 5VDC AC to DC Power Supply Unit. Recorder and digital outputs by optical circuits and transformer. Blood Withdrawal Pump CM-33: Connection with sensor interface is optically isolated. Power supply is by battery operation (6v DC). Low battery warning. Fail safe against arterial blood pressure. "One way" only insertion of pump tubing. Dimensions & Weight: 320 mm x 260 mm x 40 mm, < 5 lbs. Display of CO value: Numeric in litres / minute. Possible to display dilution curve: Yes. Digital output of CO: Yes - via RS232 port. Calculation method: Band-Linton derived equation involving area integration of the lithium cation dilution curve with lognormal approach - curve cut at 10% down from peak. Measurement range: 0.1 to 20 litres / minute. Self test and/or calibration possible: Yes. Power source - for power supplied to CO sensor: No power is supplied; not required by LiDCo sensor. Battery charger/PSU: LiDCo Model CM-34 PSU 115/230 V AC, 50 - 60 hz.
More Information

Not Applicable

No
The device description and calculation method are based on a traditional indicator dilution technique and a specific mathematical equation (Band-Linton derived equation). There is no mention of AI or ML in the document.

No
The device is described as a diagnostic aid for cardiac output determination, which monitors blood flow, rather than providing therapy.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic aid (cardiac output determination)." This indicates the device is used to diagnose or aid in the diagnosis of a patient's cardiac output.

No

The device description clearly outlines multiple hardware components, including a lithium cation sensor, flow cell, monitor, blood withdrawal pump, and power supply unit, in addition to the software.

Based on the provided information, the LiDCO System is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
  • LiDCO System Function: The LiDCO System measures cardiac output by analyzing the dilution curve of a lithium indicator injected into the patient's bloodstream. While it involves blood, the measurement is performed in vivo (within the living body) by analyzing the concentration changes in the circulating blood, not by examining a specimen in vitro (outside the body).
  • Anatomical Site: The description states the device is "External to body, connected to peripheral arterial line via luer lock fitting." This further supports that it's interacting with the blood flow within the patient, not processing a collected sample.
  • Intended Use: The intended use is "monitoring of cardiac output," which is a physiological measurement taken directly from the patient.

Therefore, the LiDCO System falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

INTENDED USE: LIDCO SYSTEM for CARDIAC OUTPUT MONITORING

  • Indications for Use - Diagnostic aid (cardiac output determination). The LiDCO System is intended for the monitoring of cardiac output (blood flow in litres per minute) in patients of greater than 88 lbs (40 kg) in weight.

Product codes

74 DXG

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

External to body, connected to peripheral arterial line via luer lock fitting

Indicated Patient Age Range

patients of greater than 88 lbs (40 kg) in weight.

Intended User / Care Setting

  • Suitable Patients - To operate the LiDCo System it is required that suitable patients will have available pre-placed peripheral arterial and central venous catheters.
  • Locations of Use - Suitable patients will be receiving treatment/hospital care in the following areas:
    • Medical and Surgical Intensive Care Units
    • Operative Suites
    • Step Down/High Dependency Units
    • Trauma/Accident & Emergency Units
    • Coronary Intensive Care Units

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)

Clinical investigations show close correlation between the LiDCo System and current clinical standard methods:

Patient No'sCorrelationBias (L/Min)Precision (L/Min)
Pulmonary Artery Catheter510.9630.190.38
Continuous Cardiac Output110.9490.010.55

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K810352, K760192

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

JAN 8 1999

Confidential - LiDCo System 510(k)

LiDCo LTD

----------- CARDIAC SENSOR SYSTEMS ----------

16 Orsman Road, London, NI 50J, ENGLAND.

1.12 Summary of Safety and Effectiveness

Statement: This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

(i) Concept: There are numerous clinical indications for cardiac output measurement. In general, the methods are either unreliable (oesophageal Doppler, thoracic impedance), difficult to perform (indocyanine green and Fick) or hazardous (thermodilution). There has long been the need for a simple safe and reliable method. The LIDCo System revisits and improves the indicator dilution technique of cardiac output determination. It avoids the complications of pulmonary artery catheterisation. The LIDCo System will have clinical utility in patients with pre-placed arterial and venous lines, where the determination of cardiac output is required minimally invasively without the insertion of a pulmonary artery catheter

(ii) Indicator & Lithium Sensor: The lithium cation provides an excellent signal (log of concentration) against a very stable baseline in blood. The indicator is not significantly lost in its first pass to the pulmonary, or systemic circuit . The lithium cation sensor is biocompatible, thermally compensated and unaffected by changes in arterial blood pressure

(iii) Software: Despite the potential complication of secondary marker recirculation, the LIDCo System software has been demonstrated in a number of bench and clinical studies to calculate the area under the primary indicator dilution curve.

(iv) Accuracy: Clinical investigations show close correlation between the LiDCo System and current clinical standard methods:

Patient No'sCorrelationBias (L/Min)Precision (L/Min)
Pulmonary Artery Catheter510.9630.190.38
Continuous Cardiac Output110.9490.010.55

(v) Safety: In most patients for whom cardiac output measurements are indicated, central venous and arterial catheters are already in place. To make a measurement with the LIDCo System there is no need for further cannulation with its attendant risks. Approximately 3 ml of blood are needed per determination - an insignificant amount for an adult. The dose of lithium chloride used is extremely small and has no known effects. Awake patients experience no sensation of any sort in response to the injection. Lithium pharmacology is well described in the literature with over 50 years of experience of chronic administration of high doses. LIDCo System dosing recommendations are conservative and make worst case assumptions - pathological compartmental volumes, accumulation of lithium, maximum dose given at maximum frequency. No side-effects/complications have been noted in critical care/post operative patience to date at: single doses or total doses 2-3 times final product recommendations. The LIDCo System reduces the risks associated with cardiac output determination compared to pulmonary artery thermodilution.

(vi) Truthful & Accurate Certification: " I certy that, in my capacity as Managing Director, I believe to the best of my knowledge that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omlitted."

Signed by Applicant:

Date: 20/06/1996

1

1.13 Comparison Tables With Predicate Devices

Table 1 Comparison of Features of the LiDCo System (CM-10;20;40 & 50) and Baxter Edwards Model 93B - 131 - 7F Flow Directed Thermodilution Catheter

CRITERIALIDCO SYSTEM FEATUREBAXTER / EDWARDS MODEL 93B - 131 - 7F FEATURE
1. Registration Status
Class 11 510 (K)Applied forGranted # K810352
2. Intended Use & Target Population
(i) Intended use:cardiac output determinationCardiac output determination & measurement of hemo-dynamic pressures in the heart and pulmonary artery
(ii) Target Population: Critical care anaesthesia and cardiology patients with pre-placed arterial and central venous linesCritical care, anaesthesia and cardiology patients
3.Construction/Materials of:
(i) Device BodyFlow cell moulded from polycarbonate4 lumen radiopaque polyurethane extrusion
(ii) SensorLithium ion selective electrode made from PVC membrane cast onto polyurethaneThermistor with lead wires
(iii) Blood Bag & TubeBlood contact material PVC - blood not returned to patientN/A
4. Anatomical Sites
Required location of sensor or catheter to measure cardiac outputExternal to body, connected to peripheral arterial line via luer lock fittingPulmonary artery via right side of heart

:

2

BAXTER / EDWARDS MODEL 93B - 131 - 7F FEATURE

5. Physical Safety

(i) Warnings/Complications

Clinical: Number of determinations limited to a cumulative dose of 3 mmol and worse case plasma level of 0.33 mmolA. All iniections of lithium including flushes should be noted Lithium chloride is toxic at a plasma concentration of > 1.5 mmolA A minimum of 5 minutes should be allowed between sequential administrations of lithium chloride Waste blood/saline should not be returned to patient Avoid bolus administrations or infusions of muscle relaxants 1 hour prior to determination

Clinical: Rupture of the pulmonary artery resulting in vascular injury and on occasion death, carbon dioxide or air embolus, thromboembolic and infectious complications, ventricular arrhythmias, anti coagulation & antibiotic protection should be considered in cases with increased risks & when long-term catheterization (>48hrs) is necessary

Product: Loss of patency of sensor flow-through-cell due to blood clotting

Storage: Single use, not to be stored in direct sunlight, fluorescent or incandescent lighting conditions

knotting of catheter, stretching of body of catheter with resultant loss of electrical connection, loss of patency through blood clotting

Product:The following catheter

complications may occur: kinking &

Storage: Single use, not to be stored in direct sunlight, fluorescent or incandescent lighting conditions

((i) Contra-Indications

Contra - indicated in: patients currently under lithium therapy for control of manic depressive psychosis , patients OR Over-the-Counter Use (Optional Format 1-2-96) |

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