(73 days)
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients.
The BD Vacutainer™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.
The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection and IV administration. It contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks.
The provided text is a 510(k) summary for the BD Vacutainer™ Push Button Blood Collection Set. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or an analytical study proving the device meets particular performance metrics.
Instead, it states:
"Based upon previously demonstrated performance and successful completion of biocompatibility testing, Push Button Blood Collection Set will perform as intended."
This indicates that the safety and effectiveness are supported by:
- Previously demonstrated performance: This implies that the device's design is similar to existing, already cleared devices (predicate devices listed in the summary, K980414 and K022875) and is expected to perform comparably. No new performance study with specific acceptance criteria is detailed for this specific submission.
- Successful completion of biocompatibility testing: This is a standard requirement for medical devices that come into contact with the body.
Therefore, many of the requested points regarding acceptance criteria and a specific study cannot be answered from the provided text. The document focuses on regulatory compliance through substantial equivalence, rather than detailing a de novo performance study with quantitative acceptance criteria.
Summary of Information NOT Found in the Provided Text:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set.
- Data provenance for a test set.
- Number of experts used to establish ground truth for a test set, and their qualifications.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
- Details of a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a performance study.
- Sample size for a training set.
- How ground truth for a training set was established.
Information that can be extracted or inferred:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics. The implicit acceptance criterion is that the device "will perform as intended" based on similarity to predicate devices and biocompatibility.
- Reported Device Performance: No specific quantitative performance data is reported. The document relies on the "previously demonstrated performance" of predicate devices and "successful completion of biocompatibility testing."
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. (The document refers to "previously demonstrated performance," implying reliance on historical data or characteristics of predicate devices, but no details are given for this device's specific testing related to performance.)
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified as no such test set or ground truth establishment process is described beyond biocompatibility testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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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 MRMC study was mentioned. This device is a blood collection set and does not involve AI or human image interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, the "ground truth" would be established by standardized laboratory tests according to ISO 10993 standards, not expert consensus or pathology in the context of diagnostic accuracy. For performance, it relies on the established performance of predicate devices.
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The sample size for the training set:
- Not applicable. No "training set" in the machine learning sense is mentioned or relevant for this type of device submission.
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How the ground truth for the training set was established:
- Not applicable.
In conclusion, the document emphasizes the device's substantial equivalence to previously cleared devices and successful biocompatibility testing as the basis for its safety and effectiveness, rather than providing a detailed performance study with specific acceptance criteria.
§ 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.