(147 days)
Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.
Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses. Available in multiple sizes and product versions.
This document is a 510(k) summary for a medical device called "PICO Arterial Blood Sampler." It focuses on establishing substantial equivalence to a predicate device ("Smooth ETM") and does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined.
The document is a regulatory submission for premarket notification, designed to show that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically include performance studies against pre-defined acceptance criteria for clinical efficacy or accuracy in the way that, for example, an AI diagnostic device would.
Therefore, I cannot provide the requested information from this input as it does not contain the details about:
- A table of acceptance criteria and reported device performance: This document describes the intended use and technological characteristics as similar to the predicate, but doesn't quantify performance metrics or acceptance criteria for a study.
- Sample size used for the test set and data provenance: No performance study is described.
- Number of experts used to establish ground truth & qualifications: N/A, no ground truth needed for this type of submission.
- Adjudication method: N/A.
- MRMC comparative effectiveness study: N/A.
- Standalone performance study: The device is a physical sampler, not an algorithm, so "standalone performance" in the AI sense isn't applicable.
- Type of ground truth used: N/A.
- Sample size for the training set: N/A, not applicable to this physical device.
- How ground truth for the training set was established: N/A.
The content of this document is limited to demonstrating substantial equivalence for a physical medical device (an arterial blood sampler) based on its features, intended use, and technological characteristics compared to a previously cleared device. It is not an evaluation of clinical performance against specific metrics or expert-validated ground truth data.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.