LIDCO SYSTEM

{0} JAN 8 1999 702715 Confidential - LIDCo System 510(k) LIDCo LTD CARDIAC SENSOR SYSTEMS 16 Orsman Road, London, N1 5QJ, 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 patient experience 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 omitted." Signed by Applicant:  {1} Confidential - LIDCo System 510(k) 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 | {2} CRITERIA LIDCo SYSTEM FEATURE BAXTER / EDWARDS MODEL 93B - 131 - 7F FEATURE Confidential - LIDCo System 510(k) # 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 mmol/l. All injections of lithium including flushes should be noted. Lithium chloride is toxic at a plasma concentration of > 1.5 mmol/l. 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. **Product:** The following catheter complications may occur: kinking & knotting of catheter, stretching of body of catheter with resultant loss of electrical connection, loss of patency through blood clotting. **Storage:** Single use, not to be stored in direct sunlight, fluorescent or incandescent lighting conditions. **Storage:** Single use, not to be stored in direct sunlight, fluorescent or incandescent lighting conditions. ## (ii) 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) Biocompatibility **Patient contacting Materials:** Polycarbonate contacts patient dermis. **Patient Contacting Materials:** Polyurethane bonded with heparin - contacts directly with blood and cardiac tissues. Indicator - lithium chloride injected into blood system Indicator - 5% dextrose or saline injected into blood system. {3} Confidential - LIDCo System 510(k) 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 {4} Confidential - LIDCo System 510(k) Table 2 Comparison of Features of the LIDCo System Electronics Package CM-30 and Baxter Edwards Model 9520 Cardiac Output Computer | CRITERIA | LIDCo SYSTEM FEATURE | BAXTER / EDWARDS MODEL 9520 FEATURE | | --- | --- | --- | | 1. Registration Status Class 11 510 (k) | Applied for | Granted # K760192 | | 2. Intended Use & Target Population (i) Intended use: cardiac output determination (ii) Target Population: Critical care anaesthesia and cardiology patients with pre-placed arterial and central venous lines | | Cardiac output determination & measurement of hemodynamic pressures in the heart and pulmonary artery Critical care, anaesthesia and cardiology patients | | 3. Patient Safety Monitor CM-31/32: • Power supply is by + 5VDC AC to DC Power Supply Unit • Connection with sensor interface is optically isolated Blood Withdrawal Pump CM-33: • Power supply is by battery operation (6v DC) • Low battery warning • Fail safe against arterial blood pressure • "One way" only insertion of pump tubing | | Baxter/Edwards 9520 • Battery operation 5 V DC • Recorder and digital outputs by optical circuits and transformer | {5} Confidential - LiDCo System 510(k) | CRITERIA | LiDCo SYSTEM FEATURE | BAXTER / EDWARDS MODEL 9520 FEATURE | | --- | --- | --- | | 4. Product Features | | | | • Dimensions & Weight | 320 mm x 260 mm x 40 mm ≤ 5 lbs | 11.5 in x 3.25 in x 10.75 in ≤ 5 lbs | | • Display of CO value | Numeric in litres / minute | Numeric in litres / minute | | • Possible to display dilution curve ? | Yes | Yes | | • Digital output of CO ? | Yes - via RS232 port | Yes - via serial 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 | Modified form of Stewart-Hamilton equation with area integration of thermo-dilution curve based on monoexponential 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 calibration possible ? | Yes | Yes | | • Power source - for power supplied to CO sensor | No power is supplied; not required by LiDCo sensor | From monitor | | • Battery charger/PSU | LiDCo Model CM-34 PSU 115/230 V AC, 50 - 60 hz | Edwards models 9521& 9522, 115/230 V5 AC, 50 - 60 hz battery charger | {6} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 8 1999 Dr. T. O'Brien Managing Director LiDCO Ltd. 16 Orsman Road London N1 5QJ United Kingdom Re: K962918 LiDCO System Regulatory Class: II (Two) Product Code: 74 DXG Dated: October 19, 1998 Received: October 20, 1998 Dear Dr. O'Brien: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined 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 Medical Device 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: {7} 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 regulation 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 regulation 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, Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8} Jan 08 99 12:13p Charles H. Kyper (301) 776-3166 p.9 08/01/1999 16:33 01712561645 LIDCO LTD PAGE 08 # 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) Mark Kraw