(29 days)
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.
The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor. The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
The provided text describes a 510(k) summary for a Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system. The submission focuses on modifications to a previously cleared device, asserting substantial equivalence. However, the document does not present comprehensive acceptance criteria or detailed study results in the format requested.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily states that testing "confirmed the modified device met or exceeded the same specifications as that of the predicate device." It does not provide explicit, quantifiable acceptance criteria (e.g., accuracy within X%, precision within Y%) or specific performance metrics for the new device. It only refers to matching the predicate device's performance.
| Acceptance Criteria | Reported Device Performance (Modified Device) |
|---|---|
| Same specifications as the predicate device (K993245) | Met or exceeded the same specifications as the predicate device |
| Specific quantitative criteria are not detailed in this document. | Specific quantitative performance metrics are not detailed in this document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The document mentions "In-vivo testing in Swine Models" and "In-vitro testing in Right Hand…Circulatory System."
- Sample Size: The exact number of swine models or in-vitro tests is not specified.
- Data Provenance: The studies were conducted as part of the device modification and submission, indicating they are prospective studies for this specific submission. The country of origin for the studies is not explicitly stated beyond the company being in the UK.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not provided in the document. The studies mentioned (in-vitro and in-vivo) would typically involve engineering and animal care/veterinary expertise, but the document does not detail how specific "ground truth" for the device's output was established or if human experts were involved in interpreting results in a way that aligns with typical "ground truth" establishment for diagnostic devices.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical trials involving human interpretation of diagnostic results, which is not the primary focus of the described in-vitro/in-vivo engineering-focused testing here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
This information is not applicable and not provided. This device is a medical monitor and catheter system, not an AI-powered diagnostic imaging tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document describes the "Continuous Cardiac Output Monitor, (truCCOM)" as a "microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output." This implies a standalone algorithm performance as its primary function is to calculate and display cardiac output. The in-vitro and in-vivo testing described would be assessing this standalone algorithm's accuracy and performance.
7. The Type of Ground Truth Used:
For the in-vitro and in-vivo testing, the "ground truth" would likely be derived from:
- Reference standards/measurements: In the in-vitro circulatory system, this would involve highly accurate, established methods for measuring flow, temperature, and other physiological parameters that the device is designed to assess.
- Physiological measurements in swine models: In-vivo (swine models), ground truth would be established using reference methods for cardiac output measurement (e.g., thermodilution with known injectate volumes, direct flow measurement techniques, or other validated invasive methods) against which the truCCOM's continuous output is compared.
The document does not explicitly detail these reference methods, but they are implied by the nature of the testing.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The device is an updated version of a previously cleared device, focusing on "User Interface Improvements," "Re-formatting of history files," "analogue output," "updated equation for the calculation of cardiac output," and "Optimization of system response." This is not a machine learning or AI device that typically involves a distinct "training set" in the context of deep learning. The "updated equation" and "optimization of system response" would have been developed based on engineering principles and potentially previous data, but not in the sense of an ML training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of a distinct "training set" for a machine learning model. The ground truth for the device's underlying principles (thermodynamic principle of heat transfer) would be established through scientific research, physics, and empirical data collected during development and previous iterations of the device.
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JUL 2 2 2008
510(k) Summary
This summary information is being submitted in accordance with the requirments of
| 21 CFR 807.92(c) | ||
|---|---|---|
| Owner: | ||
| Name: | Omega Critical Care | |
| Address: | 2 Cairn CourtWest NerstonEast KilbrideG74 4NBUnited Kingdom | |
| Telephone: | +44 1355 265733 | |
| Facsimile: | +44 1355 239094 | |
| Contact: | Alan Short,Director of Quality & Regulatory AffairsOmega Critical Care | |
| Date of Summary: | 19th June 2008 |
Device Information:
| Trade Name: | Continuous Cardiac Output PulmonaryArtery Catheter and ContinuousCardiac Output Monitor |
|---|---|
| Common Name: | Pulmonary Artery Catheter andCardiac Output Monitor |
| ClassificationName: | Flow-directed catheter and singlefunction, pre-programmed diagnosticcomputer per 21 CFR 870.1240 and870.1435 respectively |
| Predicate Device: | The modified device is substanttiallyequivalent to the previously clearedContinuous Output Pulmonary ArteryCatheter and Continuous OutputMonitor, 510(k) number K993245 |
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Device Description:
The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor.
The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
The continuous cardiac output Pulmonary Artery Catheter and Continuous Cardiac Outoput monitor systems intended use is for the assessment of the patients haemodynamic condition though direct intra-cardiac (right heart) and pulmonary artery pressure monitoring, cardiac outut determination and for infusing solutions. The distal port on the catheter also allows for the sampling of veous blood.
Intended Use:
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Comparison to Predicate Device:
The modifications in comparison to the previously cleared device are as follows (these modification do not affect the intended use of the device or alter the fundemental scientific technology of the device)
Monitor
- -User Interface Improvements
- -Re-formatting of history files
- -Enable analogue output
- Implementation of an updated equation for the calculation of cardiac output
- Optomisation of system response
- Modification of audible alarms to default enabled
- Correction of minor bugs .
The following outlines the testing performed, as a result of the risk analysis, to demonstrate substantial equivelance to the predicate device
Monitor
- Software Verification & -Validation
- In-vitro testing in Right Hand … Circulatory System .
- In-vivo testing in Swine Models t
The above test results confirmed the modified device met or exceeded the same specifications as that of the predicate device and is therefore substantially equivalent with respect to safety and efficacy to the predicate device
Summary of nonclinical tests:
Conclusion:
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2008
Omega Critical Care Limited c/o Mr. Lucio E. Jannetta Omega House 2 Cairn Court Nerston West East Kilbride Scotland G74 4NB
Re: K081776
Trade/Device Name: Continuous Cardiac Pulmonary Artery Catheter (truCATH & truCATH.ip) & Continuous Cardiac Output Monitor (truCCOM) Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, preprogrammed diagnostic computer Regulatory Class: Class II Product Code: DXG Dated: June 5, 2008 Received: June 23, 2008
Dear Mr. Janetta:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosale) w regard intent date of the Medical Device Amendments, or to conninered pror to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices that have boom require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 on may, therefore, mains. of the Act include requirements for annual registration, listing of general controls profice, 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. Lucio E. Jannetta
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 Fodcral 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
comple
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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Indications for Use
510(k) Number (if known):
Device Name: Continuous Cardiac Output Pulmonary Artery Catheter (truCATH & truCATH.ip) & Continuous Cardiac Output Monitor (truCCOM)
The Continuous Cardiac Output Pulmonary Artery Catheter Indications for Use: and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
VOR Over-The
(21 CFR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDR Office of Device Evaluation (ODE)
Q.mbe
ivision Sign-Off) sion of Cardiovascular Devices
510(k) Number K081776
Page 1 of 1
§ 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).