(264 days)
PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement.
PiCCO Catheters are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
The PiCCO Catheter uses a thermistor to measure the blood temperature change during thermodilution. This thermistor is located in one of the two catheter lumen. The second catheter lumen ends in a Luer-Lock for connection to a pressure monitoring kit.
The thermistor is connected to a patient monitor via a dedicated plug.
The placement of the catheter into a large arterial vessel is done using the Seldinger Technique and is intended to use of up to 10 days.
The PiCCO Catheter Sets contain the following parts:
- PiCCO Catheter,
- Guidewire with dispenser and advancer,
- Introducer needles,
- Dilator (exception: the 3F Set does not include a dilator).
Five PiCCO Catheter models are available which differ in diameter and length. The PiCCO catheter set contains accessories fitting to the respective PiCCO catheter model in size.
The Catheter Set is packed into a preformed blister (PET), sealed with a Tyvek® lid and EtO sterilized.
The provided text describes a 510(k) submission for the PiCCO Catheter, which is a thermodilution probe. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, study design for proving performance, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission as presented. The document focuses on demonstrating that the new device is as safe and effective as an already legally marketed predicate device, primarily through non-clinical performance and biocompatibility testing, along with a comparison of technological characteristics.
Here's an analysis of the provided text in response to your request, indicating where information is not applicable (N/A) to this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one would for a new device's efficacy study. Instead, it states that various tests were conducted and their results "demonstrate that the functionality and performance characteristics of the device are comparable to the predicate device."
For instance, performance testing for mechanical properties (e.g., gauging, leakage, separation force) were conducted against standards like ISO 594-1:1986 and ISO 594-2:1998, and shelf life testing was conducted according to ISO 10555-1:2013. The acceptance criterion for these tests is simply compliance with the applicable standard or demonstrated comparability, rather than specific quantitative performance targets against clinical metrics.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (ISO 10993-1) | Compliant (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Chemical Characterization, Hemolysis, Pyrogenicity tests passed) |
| Performance Testing (ISO 594-1, ISO 594-2) | Compliant (Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking tests passed) |
| Shelf Life (ISO 10555-1) | Supports 60 months expiry (Accelerated aging data) |
| Guidewire Friction Force | Testing conducted (Result not quantified but implied compliant) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant |
| Functionality and Performance | Comparable to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- No specific sample sizes for clinical test sets are mentioned as clinical data were not required.
- For biocompatibility and performance testing, the sample sizes would be those dictated by the respective ISO standards for material and device testing. These are not explicitly stated in the document.
- Data Provenance:
- The testing was performed according to international standards (e.g., ISO, IEC). The location where the tests were physically performed is not specified, but the device owner is PULSION Medical Systems SE in Germany.
- The data is non-clinical performance data from laboratory and material tests, not patient data.
- It is prospective in the sense that these tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. This is a non-clinical 510(k) submission. The "ground truth" for the test set is established by the specifications of the standards (ISO, IEC) for material and device performance, not by expert medical opinion in a diagnostic or clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Since this is a non-clinical submission, there is no "adjudication" of results in the sense of multiple clinical reviewers reaching consensus. Test results are objective measurements against defined standards.
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
N/A. This device is a physical catheter, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a physical catheter and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is based on adherence to recognized international standards and specifications for medical device materials (biocompatibility) and functional performance (e.g., mechanical integrity, shelf-life, EMC). There is no clinical ground truth (like pathology or outcomes data) directly used for this submission to prove efficacy, as clinical data was not required.
8. The sample size for the training set
N/A. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
N/A. As there is no training set, this question is not applicable.
§ 870.1915 Thermodilution probe.
(a)
Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.(b)
Classification. Class II (performance standards).