(236 days)
The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. The COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines.
This 510(k) submission (K080116) for the Transonic COstatus System surprisingly does not include any explicit acceptance criteria or a detailed study section demonstrating the device's performance against such criteria. Instead, the submission relies heavily on a claim of substantial equivalence to predicate devices (K023960 and K980906) and general statements about internal testing and manufacturing processes.
Therefore, many of the requested sections about specific study design parameters cannot be filled as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence rather than defining specific performance metrics and acceptance thresholds for the new device. | Not explicitly stated as performance against defined acceptance criteria. The document states that "All finished products are tested and must meet all required release specifications before distribution," including "physical testing" and "visual examination." It also mentions "product performance parameters conform to the product design specifications." However, what these specifications are and the results of testing against them for the COstatus System are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. No specific test set for performance evaluation is described.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable, as there's no mention of a clinical or expert-validated test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no test set requiring ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, nor does it mention evaluating human reader improvement with or without AI assistance. The device is a diagnostic computer for cardiovascular status, not an AI-assisted diagnostic imaging or interpretation tool in this context.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No specific standalone performance study comparing the algorithm's output to a ground truth with quantitative metrics is described. The device is described as an "apparatus using an indicator dilution technique" to measure fluid volumes, implying a direct measurement system rather than a complex algorithm whose standalone performance would typically be evaluated in isolation.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated or described. The document refers to "product design specifications" for performance parameters, but not how these were validated externally or against an established ground truth.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is not described as an AI/ML product that undergoes a "training" phase.
9. How Ground Truth for Training Set Was Established
- Method for Establishing Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model.
Summary of the Study:
Based on the provided text, the submission for the Transonic COstatus System does not describe a traditional clinical performance study with explicit acceptance criteria, a defined test set, or a ground truth established by experts. Instead, the entire submission hinges on demonstrating substantial equivalence to two predicate devices:
- K023960: LiDCOplus Hemodynamic Monitor
- K980906: Transonic Hemodialysis Monitor, Cardiac Output (Measurement)
The primary "study" or evidence presented for safety and effectiveness is through this comparison, highlighting:
- Similar Materials, Form, and Intended Use: The COstatus System is stated to be similar to the HD01 (K980906) in these aspects.
- Mechanism of Action: Both the COstatus and the HD01 use an indicator dilution technique. The COstatus differs from the HD01 by using a peristaltic pump instead of a hemodialysis circuit, allowing for use on any patient with arterial and venous lines.
- Comparison to LiDCOplus (K023960): The COstatus also uses a peristaltic pump like the LiDCOplus, but uses saline as an indicator instead of lithium chloride. Crucially, the COstatus runs as a closed loop, returning drawn blood to the patient, unlike the LiDCOplus which does not.
- Conclusion on Differences: The submission states that these differences "do not raise any new issues of safety or effectiveness regarding the Transonic COstatus System."
- Internal Testing: The document mentions that "All finished products are tested and must meet all required release specifications before distribution," including "physical testing" and "visual examination" to ensure performance parameters conform to "product design specifications." However, these specifications and specific results are not detailed.
In essence, the "study" proving the device meets criteria is primarily the argument for substantial equivalence based on engineering design comparison and internal product quality control, rather than a clinical trial with performance metrics.
§ 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).