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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:

1. 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.
2. 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.

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The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multiple sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or 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 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® Push Button Blood Collection Set has two models. One is a steel winged blood collection set with flexible tubing, female luer connector, with an integrated male luer adapter which connects to a Vacutainer® Brand Needle Holder and is intended to be used with blood collection tubes. The other model is sold identical except without the male luer adapter. This model allows the clinician to obtain blood sampling with a syringe, if necessary, or can be used for short-term, single infusions. The device is not to be left in place and remain under the supervision of a clinician.

The BD Vacutainer® Push Button Blood Collection Set also contains a sharps injury prevention feature. The wing set is designed with an active retraction method. When the button is actively depressed, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle is designed to protect users from an accidental needle sticks.

The BD Vacutainer® Push Button Blood Collection Set consists of:

• Stainless steel cannula (Intravenous end and Non-patient end of cannula)
• Stainless steel spring
• Hub. front and rear barrel
• Wings (color coded according to needle gauge)
• Tubing
• Female luer connector and an optional male luer adapter
• Intravenous (IV) needle protector (covers the needle before use)
• Luer Cap (provided if there is no luer adapter attached)

The intravenous needle of the blood collection set is bonded to one end of the hub. The tubing of the blood collection set is bonded to the other end of the hub and the female luer connector. A spring is assembled over the needle protector and onto the front of the hub. Once the sample is collected the user will depress the button that projects through the barrel. As soon as the button is depressed, the needle assembly moves using spring energy. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.

The optional male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for puncture of evacuated blood collection tube stoppers. The non-patient end (NP) of the cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow during collection of multiple tubes.

The purpose of this Special 510(k) is to expand the needle range to include the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set design with ultra thin wall cannula and a five bevel point. The intended use for the modified device remains the same as the predicate device.

This document describes the premarket notification (510(k)) for the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set. However, it does not pertain to an AI/ML device, nor does it describe a study involving human readers or ground truth as typically understood in the context of AI/ML performance evaluation. This document is for a medical device (blood collection set) and primarily focuses on demonstrating substantial equivalence to a predicate device through engineering performance tests.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this type of device submission.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not explicitly stated. The document refers to "design verification testing" but does not quantify the number of units tested for each characteristic.
• Data provenance: Not explicitly stated beyond "BD has performed the following design verification testing." This implies internal testing by the manufacturer (Becton, Dickinson and Company). This is a retrospective submission of data to demonstrate equivalence for a modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a physical medical device, and performance is established through engineering and material testing against established standards and predicate device performance, not expert-based ground truth.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective measurements and comparison to standards or predicate device performance.

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:

• Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For a traditional medical device like this, the "ground truth" for performance is typically established by:
  • Compliance with recognized standards: e.g., ISO 9626 for certain dimensions and resistance to breakage.
  • Equivalence to a legally marketed predicate device: Demonstrating that the modified device performs similarly to or better than a device already cleared by the FDA.
  • Internal BD requirements/test methods: Such as VS10362 and TP700279.
• This does not involve expert consensus, pathology, or outcomes data in the context of clinical interpretation, but rather verifiable physical and chemical properties and functional performance tests.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device; there is no "training set" in the AI sense.

9. How the ground truth for the training set was established:

• Not applicable.

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