(925 days)
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.
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.
Here's an analysis of the acceptance criteria and study proving device performance for the LiDCo System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified manner. Instead, it presents "clinical investigations" to demonstrate close correlation with existing standard methods. The implicit acceptance criteria appear to be a strong correlation coefficient, low bias, and acceptable precision when compared to established methods.
| Acceptance Criteria (Implicit) | Reported Device Performance (LiDCo System) |
|---|---|
| High Correlation with Pulmonary Artery Catheter (PAC) | 0.963 |
| Low Bias compared to Pulmonary Artery Catheter (PAC) | 0.19 L/Min |
| Acceptable Precision compared to Pulmonary Artery Catheter (PAC) | 0.38 L/Min |
| High Correlation with Continuous Cardiac Output (CCO) | 0.949 |
| Low Bias compared to Continuous Cardiac Output (CCO) | 0.01 L/Min |
| Acceptable Precision compared to Continuous Cardiac Output (CCO) | 0.55 L/Min |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (PAC Comparison): 51 patients
- Test Set (CCO Comparison): 11 patients
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "Clinical investigations" and "clinical studies," suggesting these were conducted in a clinical setting. Given the company is based in London, UK, it's likely the studies were conducted there. The timing implies these were conducted prior to the submission date of the 510(k) in June 1996, likely making them prospective studies designed to support the regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document implicitly uses existing, established clinical methods (Pulmonary Artery Catheter and Continuous Cardiac Output monitoring) as the "ground truth." It does not mention a panel of human experts explicitly establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth was established by direct comparison with measurements obtained from established medical devices (Pulmonary Artery Catheter and Continuous Cardiac Output), rather than by expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The LiDCo System is a medical device for measuring cardiac output, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, the concept of improving human reader performance with AI assistance is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the performance presented for the LiDCo System in comparison to predicate devices is a standalone performance. The LiDCo System itself calculates the cardiac output based on its indicator dilution technique and software, without continuous human intervention or interpretation that would typically define a "human-in-the-loop" scenario in AI/diagnostic device contexts. The human operator injects the indicator and initiates the measurement, but the calculation is performed by the device's software.
7. Type of Ground Truth Used:
The ground truth used was comparison with established medical device measurements. Specifically:
- Pulmonary Artery Catheter (a widely accepted invasive method for cardiac output measurement).
- Continuous Cardiac Output (another established method, likely derived from PAC or similar continuous monitoring).
8. Sample Size for the Training Set:
The document does not explicitly mention a "training set" in the context of machine learning or AI development. The "software" is mentioned as having been "demonstrated in a number of bench and clinical studies to calculate the area under the primary indicator dilution curve." This implies iterative development and testing, but not a distinct 'training set' as understood in current AI contexts. The clinical investigation data (51 and 11 patients) would be considered the validation data for regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
Since there's no explicit "training set" described as in modern AI development, this question is not fully applicable. However, the "bench and clinical studies" that informed the software's development would have used similar methodologies to establish what a correct cardiac output measurement should be (e.g., using known flow rates in bench models or measurements from reference devices in clinical settings) to refine the software's calculation algorithms.
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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's | Correlation | Bias (L/Min) | Precision (L/Min) | |
|---|---|---|---|---|
| Pulmonary Artery Catheter | 51 | 0.963 | 0.19 | 0.38 |
| Continuous Cardiac Output | 11 | 0.949 | 0.01 | 0.55 |
(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
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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
| CRITERIA | LIDCO SYSTEM FEATURE | BAXTER / EDWARDS MODEL 93B - 131 - 7F FEATURE |
|---|---|---|
| 1. Registration Status | ||
| Class 11 510 (K) | Applied for | Granted # K810352 |
| 2. Intended Use & Target Population | ||
| (i) Intended use:cardiac output determination | Cardiac 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 lines | Critical care, anaesthesia and cardiology patients | |
| 3.Construction/Materials of: | ||
| (i) Device Body | Flow cell moulded from polycarbonate | 4 lumen radiopaque polyurethane extrusion |
| (ii) Sensor | Lithium ion selective electrode made from PVC membrane cast onto polyurethane | Thermistor with lead wires |
| (iii) Blood Bag & Tube | Blood contact material PVC - blood not returned to patient | N/A |
| 4. Anatomical Sites | ||
| Required location of sensor or catheter to measure cardiac output | External to body, connected to peripheral arterial line via luer lock fitting | Pulmonary artery via right side of heart |
:
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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 < 40 kg in weight
Use of thermodilution catheters is cautioned in patients with pulmonary hypertension
(iii) Biocompatability
| Patient contacting Materials: | Patient Contacting Materials: |
|---|---|
| Polycarbonatecontacts patient dermis | Polyurethane bonded with heparin- contacts directly withblood and cardiac tissues |
| Indicator - lithium chlorideinjected into blood system | Indicator - 5% dextrose or saline injectedinto blood system |
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CRITERIA
LIDCo SYSTEM FEATURE
:
BAXTER / EDWARDS MODEL 93B - 131 - 7F FEATURE
6. Performance
(i) Indicator detection technique
Dilution of injectate of salt solution - 0.075 to 0.3 mmol lithium chloride. 3 - 4 mls of blood sampled per cardiac output determination Temperature based indicator 5% dextrose or saline injectate Thermistor centrally positioned no blood sample required
(iii) Clinical performance *
Clinical investigations show close correlation between the LiDCo System and predicate devices:
| Patient No's | Correlation | Bias(L/Min) | Precision(L/Min) | |
|---|---|---|---|---|
| Pulmonary Artery Catheter | 51 | 0.963 | 0.19 | 0.38 |
| Continuous Cardiac Output | 11 | 0.949 | 0.01 | 0.55 |
- See Chapter 3.3 for full results from clinical testing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Table 2 Comparison of Features of the LiDCo System Electronics Package CM-30 and Baxter Edwards Model 9520 Cardiac Output Computer
| CRITERIA | LIDCO SYSTEMFEATURE | BAXTER / EDWARDSMODEL 9520FEATURE |
|---|---|---|
| 1. Registration Status | ||
| Class 11 510 (k) | Applied for | Granted # K760192 |
| 2. Intended Use & Target Population | ||
| (i) Intended use:cardiac outputdetermination | Cardiac outputdetermination &measurement of hemo-dynamic pressures in theheart and pulmonaryartery | |
| (ii) Target Population: Critical careanaesthesia and cardiologypatients with pre-placedarterial and central venous lines | Critical care, anaesthesiaand cardiology patients | |
| 3. Patient Safety | ||
| Monitor CM-31/32:• Power supply is by + 5VDC AC to DCPower Supply Unit | Baxter/Edwards 9520• Battery operation 5 V DC• Recorder and digital outputs |
- · Recorder and digital outputs by optical circuits and transformer
Blood Withdrawal Pump CM-33:
· Connection with sensor interface is
- · Power supply is by battery
- operation (6v DC)
optically isolated
- · Low battery warning
- · Fail safe against arterial blood pressure
- · "One way" only insertion of pump tubing
8
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| CRITERIA | |
|---|---|
| ---------- | -- |
LiDCo SYSTEM FEATURE
BAXTER / EDWARDS MODEL 9520 FEATURE
4. Product Features
| • Dimensions & Weight | 320 mm x 260 mm x 40 mm | 11.5 in x 3.25 in x 10.75 in |
|---|---|---|
| < 5 lbs | < 5 lbs | |
| • Display of CO value | Numeric in litres / minute | Numeric in litres / minute |
| • Possible to displaydilution curve ? | Yes | Yes |
| • Digital output of CO ? | Yes - via RS232 port | Yes - via serial port |
| • Calculation method | Band-Linton derived equationinvolving area integration of thelithium cation dilution curve withlognormal approach - curve cutat 10% down from peak | Modified form of Stewart-Hamilton equation witharea integration of thermo-dilution curve based onmonoexponential approach- curve cut at 30% of peak |
| • Measurement range | 0.1 to 20 litres / minute | 0.1 to 20 litres / minute |
| • Self test and/or calibrationpossible ? | Yes | Yes |
| • Power source - for powersupplied to CO sensor | No power is supplied; notrequired by LiDCo sensor | From monitor |
| • Battery charger/PSU | LiDCo Model CM-34 PSU115/230 V AC, 50 - 60 hz | Edwards models 9521&9522, 115/230 V5 AC,50 - 60 hz battery charger |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Image /page/6/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1399 JAN
Dr. T. O'Brien Managing Director LiDCO Ltd. 16 Orsman Road London N1 5QJ United Kingdom
K962918 Re: LiDCO System Regulatory Class: II (Two) Product Code: 74 DXG October 19, 1998 Dated: Received: October 20, 1998
Dear Dr. O'Brien:
We have reviewed your Section 510(k) notification of intent to market ne nave referenced above and we have determined the device is che device foreionsalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure) to regally markedow pro 88, 1976, the enactment date of the Include Sommerco ments or to devices that have been reclassified in ncarous both the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the nee (al controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit to accermined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the regarif on the Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices:
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Page 2 - Dr. T. O'Brien
General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
DA Spylh
for
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Jan 08 99 12:13p | Charles H. Kyper | (301) 776-3166 |
|---|---|---|
| 08/01/1999 16:33 | LIDCO LTD 01712561645 | PAGE 88 |
INTENDED USE: LIDCO SYSTEM for CARDIAC OUTPUT MONITORING
| 510(k) Number: | K962918 |
|---|---|
| Device Name: | LIDCO System |
- 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. - Description/Route of Administration - Sterile lithium chloride (5 ml of 0.15
mmol/ml) suitable for parenteral (iv) administration. - 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR Over-the-Counter Use (Optional Format 1-2-96) |
|---|---|
| --------------------------------------- | ------------------------------------------------------------------------------------------- |
्रा
・
.
I
§ 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).