(414 days)
Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients.
The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
Blosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of catheter is either of 90 or 110 cm. The extensions include a proximal, a distal, a thermistor and an inflation extension, where the distal end of the inflation extension ends with a tip mounted with a balloon.
Here's a summary of the acceptance criteria and the study details based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Functionality | ISO 10555-1 | Meets ISO 10555-1 standard |
| Biocompatibility | ISO 10993-1 Part 1 | Biocompatible and safe |
| USP 27 | Biocompatible and safe |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the test set of the Thermodilution Catheter models with PU catheter tubing. However, it indicates "performance tests were performed on the Thermodilution Catheter models with PU catheter tubing". The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but given the applicant is Biosensors International Pte Ltd based in Singapore, the testing would likely have originated from or been managed by them.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes performance testing against standards (ISO 10555-1, ISO 10993-1, USP 27 ), not a study requiring expert-established ground truth in the context of diagnostic accuracy. Therefore, information regarding the number and qualifications of experts for ground truth establishment is not applicable to this type of performance assessment.
4. Adjudication Method for the Test Set
Not applicable as it's not a study involving human adjudication of results. The performance was assessed against established technical and biological standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes engineering and biocompatibility testing for a medical device (thermodilution catheter), not a diagnostic algorithm where human readers would improve with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI-based diagnostic algorithm but a physical medical device. The "standalone" performance refers to the device's inherent functionality and biocompatibility as tested against standards.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established by recognized international and national standards:
- ISO 10555-1: For functionality and integrity of intravascular catheters.
- ISO 10993-1 Part 1: Evaluation & Testing: For biocompatibility.
- USP 27 Biological Reactivity Tests, In Vivo: For biocompatibility.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).