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The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a non-sterile single-use plastic tube holder. It is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® QUICKSHIELD with SNAPPY Tube Holder helps secure VACUETTE® tubes in place during collection. Note: Always follow tube manufacturer's specimen collection instructions for holding tube in place to ensure a complete vacuum draw. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

The provided text is a 510(k) summary for a medical device (VACUETTE® QUICKSHIELD with SNAPPY Tube Holder) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and performance of an AI/algorithm-based device. Therefore, most of the requested information cannot be extracted from this document.

However, I can extract the general acceptance criteria for showing substantial equivalence and the "device performance" in terms of its characteristics compared to the predicate.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device K102774. This means the device must be shown to have the same intended use, fundamental scientific technology, and materials, and any differences do not raise new questions of safety or effectiveness.

• Reported Device Performance: The document doesn't present a quantitative performance metric in the way you might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, it compares the characteristics of the modified device to the predicate.

  Acceptance Criteria / Characteristic	Reported Device Performance (Subject Device)	Predicate Device (K102774) Performance/Characteristics
  Substantial Equivalence	The device is deemed substantially equivalent to the predicate. This is the overarching "acceptance criterion" of the 510(k) process.	N/A (The predicate device itself was cleared as substantially equivalent previously).
  Intended Use	To be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures by properly trained healthcare professionals.	To be used together only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures by properly trained healthcare professionals. (Note: The change in intended use to broadened needle type is the subject of this 510(k), but the fundamental use is the same)
  Holder	SNAPPY Tube Holder (21CFR880.5570, Product Code FMI)	Same
  Holder Material	Polypropylene, with tabs	Same
  Sharp Safety Feature	Polypropylene holder with polypropylene needle locking shield	Same
  Safety Feature Activation	Stable surface or thumb	Same
  Sterilization	Non-sterile	Same
  Needle Recommendation	VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483) and VACUETTE® Multi-Sample Needles (K973620)	VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483)
  Technological Characteristics	The device is "substantially equivalent to the predicate device in fundamental scientific technology and materials." The modification is specifically to include an additional recommended needle type (VACUETTE® Multi-Sample Needles). The overall design and safety mechanism (QUICKSHIELD with SNAPPY Tube Holder) are maintained from the predicate.	The predicate device shares the same fundamental scientific technology and materials for the holder and safety features. The difference is the original predicate was only cleared with VACUETTE® VISIO PLUS Blood Collection Needle.

Missing Information (Not applicable to this document as it's not an AI/algorithm study):

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

Reason for Missing Information:

This document is a 510(k) summary for a physical medical device (blood collection tube holder), not an AI or algorithm-based device. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies" as they relate to AI performance are not applicable and are not discussed in this type of submission. The "study" here is primarily a comparison of device specifications and intended use against a legally marketed predicate device to demonstrate substantial equivalence, rather than a performance study with clinical outcomes or accuracy metrics.

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VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.

VACUETTE® VISIO PLUS Blood Collection Needles are manufactured from stainless steel and are fitted with a safety valve at one end. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. The perforated label not only serves to simplify identification, but also acts as a seal of integrity. VACUETTE® VISIO PLUS Blood collection needles are a sterile single-use product. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions. The VACUETTE® VISIO PLUS Blood Collection Needles will be available in four configurations to include two needle gauge sizes (21G and 22G) and two corresponding needle lengths (25 mm [1 inch] and 38 mm [ 1 ½ inches]): - Needle gauge = 21G; Front needle length = 25 mm [1 inch] . - Needle gauge = 22G; Front needle length = 25 mm [1 inch] . - Needle gauge = 21G; Front needle length = 38 mm [1 ½ inch] . - Needle gauge = 22G; Front needle length = 38 mm [1 ½ inch] . The needles are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices.

This document, K061483, is a 510(k) summary for a blood collection needle and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way envisioned by the prompt for AI/diagnostic devices.

Instead, it's a submission for a medical device (a blood collection needle) seeking clearance based on substantial equivalence to a predicate device. For such devices, the "acceptance criteria" are related to safety, effectiveness, and substantial equivalence, often demonstrated through comparison to a legally marketed predicate device and adherence to recognized standards, rather than numerical performance metrics from a dedicated study.

Therefore, many of the requested categories related to AI/diagnostic device performance studies (sample sizes, ground truth, expert opinions, MRMC studies) are not applicable or extractable from this type of regulatory document.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The primary "acceptance criteria" for K061483 is demonstrating substantial equivalence in intended use, materials, and general design to the predicate device, Greiner VACUETTE® Multi-Sample Needle (K973620), and compliance with general controls for Class II devices. Specific numerical performance metrics for the device itself (like sensitivity/specificity for a diagnostic) are not detailed as this is a physical medical device.
• Reported Device Performance: This document does not contain a study with reported performance metrics for the VACUETTE® VISIO PLUS Blood Collection Needles beyond stating its design features. The clearance is based on its similarity to an already approved device.

Table (Not Applicable for detailed numerical performance results in this context):

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

• Not Applicable. This submission does not describe a "test set" or a performance study with a sample size in the context of diagnostic accuracy or AI model evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not Applicable. This document pertains to regulatory clearance of a physical medical device, not a diagnostic or AI algorithm requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. See point 3.

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 a physical blood collection needle, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical blood collection needle, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. The "ground truth" for this device would be its physical properties, sterility, and functionality as a blood collection needle, which are assessed through engineering and biocompatibility testing, manufacturing controls, and comparison to existing standards/devices, not expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. There is no training set for this type of device.

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