(161 days)
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature 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® UltraTouch™ Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and a male luer adapter. The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set also contains a needle protector.
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set models available consist of a combination of different needle gauges (21G, 23G, 25G), tubing length (12-inch, 7 inch), and are available with or without a pre-attached holder.
The provided FDA 510(k) summary for the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set (K212724) indicates that no new performance testing was conducted to demonstrate that the device meets specific acceptance criteria.
The submission claims substantial equivalence to a predicate device (BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, K153309) by arguing that there have been no significant changes to the device's design, materials, manufacturing, or packaging that would affect its performance. Therefore, the information you've requested regarding specific acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment is not available within this document for the K212724 submission.
Instead, the submission focuses on justifying two differences from the predicate device without requiring new performance studies:
- Expanded intended population to include Difficult Vein Access (DVA) patients: The applicant argues that DVA patients are a subset of the general use population and that existing clinical literature, BD's sponsored studies, and investigator-sponsored studies (not detailed in this document) support this.
- Availability of models with a pre-attached holder: This is considered a user convenience and not a change affecting safety or effectiveness.
Therefore, I cannot provide the requested table and detailed study information based directly on this specific 510(k) submission (K212724). The document explicitly states: "The sponsor has determined that since the subject and predicate blood collection sets are the same, and the BD Vacutainer® Brand Holder is unchanged from clearance under K181730, new performance testing is not required." and "Specifically, because there has been no significant change to design, product materials, packaging materials, processing/assembly, packaging, or manufacturing that would affect device performance no new performance testing is provided in support of this submission."
To find the kind of information you are asking for, one would typically need to refer to the original 510(k) submission for the predicate device (K153309), or any other submissions where the fundamental performance of the device was initially established.
However, based on the information provided, here's what can be inferred or stated about the nature of the submission:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated or reported for this submission (K212724) as no new testing was performed. Performance is implicitly assumed to be equivalent to the predicate device (K153309).
- Sample Size for Test Set and Data Provenance: Not applicable for this submission as no new performance testing was conducted.
- Number of Experts and Qualifications: Not applicable as no new performance testing required expert review for ground truth establishment.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not conducted for this submission.
- Standalone Performance Study: Not conducted for this submission.
- Type of Ground Truth: Not applicable, as no new studies requiring ground truth were performed.
- Sample Size for Training Set: Not applicable, as this is not an AI/ML device requiring a training set in the traditional sense, and no new studies were conducted.
- How Ground Truth for Training Set Was Established: Not applicable.
The submission relies on a "technical comparison" (Table 1: Substantial Equivalence Comparison on page 6, 7 and 8) to assert that the device components and characteristics are "Same" as the predicate, except for the "Intended Population" and the inclusion of a "Pre-attached holder," which are argued not to affect safety or effectiveness. It also lists various applicable standards (ISO, EN ISO, ASTM standards on pages 9, 10, 11) that the device complies with, which would imply certain performance benchmarks were met in previous assessments of the predicate device or its components.
§ 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.