(14 days)
BD Preset™ and BD A-Line™ Blood Collection Syringe are intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry, and other tests
The BD Preset™ and BD A-Line™ Blood Collection Syringes are sterile, single use devices designed to collect whole blood specimens for diagnostic testing.
BD A-Line™ Blood Collection Syringe is specifically designed for aspiration of blood samples from arterial lines.
BD Preset™ Blood Collection Syringe is a specifically designed (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the selfventing membrane (as blood fills the syringe), which ensures rapid filling.
The medical device in question is the BD Preset™ and BD A-Line™ Blood Collection Syringes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria for the device. Instead, it relies on a qualitative statement of "equivalence" to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical performance and equivalence to predicate devices | "All results from the studies show equivalence between the principal devices and the predicate devices." |
| Intended Use: Collect whole blood for diagnostic testing (pH, blood gases, electrolytes, metabolites, co-oximetry, and other tests) | The device is "designed to collect whole blood specimens for diagnostic testing" as listed in the intended use. The equivalence study supports this implicitly. |
| Sterility | "sterile, single use devices" (stated in device description) |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size used for the test set in the performance studies.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. Since the studies focus on device performance and equivalence to a predicate, it's likely that analytical results from the collected blood specimens were compared, rather than expert evaluation of images or clinical diagnoses.
4. Adjudication Method
- The document does not describe any adjudication method. This is consistent with a performance study focused on analytical equivalence rather than diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not performed or reported. This type of study is more relevant for diagnostic AI tools where human readers interpret patient data (e.g., images) with and without AI assistance to measure improvements in diagnostic accuracy or efficiency. The BD Preset™ and BD A-Line™ Blood Collection Syringes are collection devices, not diagnostic interpretation tools.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- A standalone performance study was implicitly done in the sense that the "principal devices" (the new syringes) were tested directly to assess their performance and compare them to the predicate devices. There is no "algorithm" in the context of these blood collection syringes. The performance study evaluates the physical and functional attributes of the syringe itself.
7. Type of Ground Truth Used
- The document implies that the ground truth for the performance studies was based on the results of diagnostic tests performed on the collected blood specimens. The study aimed to show that the new syringes collected blood specimens that yielded comparable diagnostic test results to those collected by the predicate device. This would likely involve:
- Analytical data: Measurements of pH, blood gases, electrolytes, metabolites, co-oximetry, etc., from blood samples.
- Comparison to predicate device: The predicate device's performance, which is presumably well-established and accepted, serves as a de-facto "ground truth" or reference point for equivalence.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable to this device. This is a physical medical device (blood collection syringe), not an AI algorithm that requires a training set of data.
9. How Ground Truth for the Training Set Was Established
- As a training set is not applicable, this question is not relevant for this medical device.
§ 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.