(135 days)
The Disposable Transpac® III Integrated Transducer (IT) is intended for direct measurement and monitoring of blood pressure. The Disposable Transpac® III IT is intended for one-time use. Indications for the Disposable Transpac® III IT include: Direct arterial blood pressure monitoring - central and peripheral, Pulmonary artery monitoring, Venous pressure monitoring, Left atrial monitoring when used with an air eliminator filter, and Cardiac cathterization.
The Disposable Transpac® III Integrated Transducer (IT) is an extravascular blood pressure transducer that converts mechanical changes in pressure into electrical currents that can be input into a pressure monitor. The Disposable Transpac® III Integrated Transducer (IT) consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. The major components of the Disposable Transpace III Integrated Transducer (IT) include: - the Disposable Transpac® III Integrated Transducer (IT) module that houses a ceramic . transducer, - a Luer connector with locking collar that can connect to an intravascular catheter, . - an integrated flush valve and Luer connector that can connect a flushing fluid source to the . intravascular catheter, - a transducer or nating that can be opened and closed by the three-handled, venting stopcock . to allow equilibration of the transducer with atmospheric pressure, and - a transducer cable that can connect to a pressure monitor using a hooded RJ-11 connector. . The Disposable Transpac® III Integrated Transducer (IT) can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.
The provided text is a 510(k) summary for a medical device called the "Disposable Transpac III Integrated Transducer (IT)". It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on specific acceptance criteria and performance metrics. Therefore, much of the requested information, particularly quantitative data from a study, is not present in the document.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Summary of Substantial Equivalence") | Reported Device Performance (Inferred from "Statement of Safety and Effectiveness") |
|---|---|
| Intended Use: Direct measurement and monitoring of blood pressure. | Meets the functional claims and intended use as described in the product labeling. |
| Sterility: Provided sterile. | Safe and effective in terms of substantial equivalence. |
| Pyrogenicity: Provided non-pyrogenic. | Safe and effective in terms of substantial equivalence. |
| Single-Use: Intended for one-time use. | Safe and effective in terms of substantial equivalence. |
| Technology/Operating Principles: Extravascular transducer coupled to an intravascular catheter for pressure conversion into electrical currents. | The technology and operating principles are the same as the predicate device. |
| Biocompatibility: All fluid/blood contacting materials are biocompatible. | Biocompatibility based on the results of biocompatibility testing. |
| Functional Equivalence to Predicate Device (K831506): Similar measurement capabilities and accuracy as the predicate. | Meets the functional claims and intended use, and is as safe and effective as the predicate. |
Missing:
- Specific numerical performance metrics (e.g., accuracy, precision, drift over time, frequency response) which would typically be present in a detailed performance study. The document primarily focuses on equivalence in function, rather than absolute performance numbers against predefined criteria.
2. Sample size used for the test set and the data provenance
Missing: The document does not describe a specific test set or study with a sample size for evaluating acceptance criteria. The information provided is a 510(k) summary, which primarily establishes substantial equivalence based on design, materials, and intended use, often leveraging previous predicate device data or internal testing without detailing the specific statistical methods, sample sizes, and provenance of a rigorous performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: This information is not relevant to the content provided. The document does not describe a study involving expert assessment or ground truth establishment in the context of diagnostic accuracy.
4. Adjudication method for the test set
Missing: Not applicable, as no described test set or study requiring adjudication is present.
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
Missing: Not applicable. This device is a physical transducer for physiological measurement, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Missing: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used
Missing: Ground truth in the context of a diagnostic or algorithmic study is not applicable here. The "ground truth" for a physical device like this would typically be established by comparing its measurements against a highly accurate reference standard (e.g., a calibrated pressure manometer). The document implies that the ground truth for its performance is its functional equivalence to the predicate device, which presumably also demonstrated its performance against such reference standards.
8. The sample size for the training set
Missing: Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Missing: Not applicable. As there's no training set, there's no ground truth for it.
In summary:
This 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (Transpac® Disposable Transducer with Monitoring Kit, K831506). It highlights similarities in intended use, technology, operating principles, sterility, pyrogenicity, and biocompatibility. The "Statement of Safety and Effectiveness" asserts that the device "meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate."
The document does not describe a new, independent performance study with defined acceptance criteria and quantitative results, sample sizes, expert involvement, or adjudication methods in the way one would for a novel diagnostic device or AI application. Instead, the "proof" the device meets acceptance criteria is primarily inferred from its demonstrated substantial equivalence to a device already cleared by the FDA.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).