(87 days)
These cuvettes are to be used with the CDI 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System, which is intended for use during cardiopulmonary bypass procedures when continuous monitoring og blood hematocrit, hemoglobin, and oxygen saturation is desired.
The 3M CDI H/S Cuvettes with Heparon Treatment are sterile, single-use medical devices. They are available in 1/4", 1/8", and 1/2" diameter sizes. Additionally, the 3M CDI H/S Cuvettes with Heparon Treatment have a covalently bound heparin coating.
The provided 510(k) summary for the K973472 device, the 3M CDI H/S Cuvettes with Heparon Treatment, does not contain explicit acceptance criteria and a detailed study report demonstrating the device meets these criteria in the format typically used for AI/ML device submissions. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device through nonclinical performance testing.
Here's an attempt to extract and infer the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table. However, it indicates the overarching performance expectation and reported outcome:
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Perform as intended according to performance specifications (i.e., equivalent to predicate) | The 3M CDI H/S Cuvettes with Heparon Treatment perform as intended according to their performance specifications. All new and existing performance characteristics have been validated. |
| Functionality and safety equivalent to the predicate device, especially regarding hematocrit, hemoglobin, and oxygen saturation monitoring during cardiopulmonary bypass. | "Substantially equivalent to their predicate devices." |
| No significant difference in technological characteristics (beyond the heparin coating). | "The only difference... is the application of a covalently bound heparin coating... There are no dimensional changes." |
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 for test set: Not explicitly stated. The "Nonclinical Performance" section describes "exhaustively tested" and "compared with the performance characteristics of the currently marketed 3M CDI H/S Cuvettes." This implies laboratory or bench testing rather than a clinical human data test set.
- Data Provenance: Not applicable in the context of human data. The testing was nonclinical, likely performed in an engineering or laboratory setting.
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)
Not applicable. This device is not an AI/ML diagnostic device requiring expert interpretation of results to establish ground truth. Its performance relates to physical characteristics and measurement accuracy, likely validated against calibrated standards or established laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this involves nonclinical performance testing of a physical device component, adjudication by experts for a test set is not relevant.
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
No. This device is an in-line monitoring system component, not an AI/ML diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the cuvettes with heparin treatment) rather than an algorithm. The "Nonclinical Performance" section describes standalone testing of the cuvettes to validate their performance characteristics against the predicate. The device operates automatically without a human-in-the-loop for its core measurement function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical testing would refer to:
- Established laboratory standards: For parameters like dimensions, material properties, and potentially coating efficacy.
- Performance of the predicate device: The primary comparison was against the "currently marketed 3M CDI H/S Cuvettes," implying the predicate's established performance served as a benchmark for equivalence.
- Internal performance specifications: The device was tested to perform "according to their performance specifications," suggesting predefined criteria based on engineering and physiological requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary of Device-Specific Information:
The 510(k) K973472 for the 3M CDI H/S Cuvettes with Heparon Treatment is a predicate-based submission focusing on demonstrating substantial equivalence. The key difference from the predicate device is the addition of a covalently bound heparin coating. No clinical testing was performed, and the evaluation rested entirely on nonclinical performance tests proving that the heparin-coated cuvettes performed "as intended" and were "substantially equivalent" to the previously cleared, non-heparin-coated cuvettes.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).