Search Results

The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.

The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.

The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.

The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.

This document is an FDA 510(k) Premarket Notification summary for a medical device, not a study describing AI algorithm performance. Therefore, most of the requested information regarding acceptance criteria for AI algorithms, sample size, ground truth expert establishment, MRMC studies, and training set details are not applicable.

However, I can extract the acceptance criteria and performance data for this physical medical device based on the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Requirement" and "Outcome" columns in the "PERFORMANCE DATA" section. The document states that performance testing was conducted to demonstrate substantial equivalency and that the device performs as intended. All listed requirements passed.

Additionally, the following were met:

• Sterility: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ via e-beam irradiation, in accordance with ISO 11137-1 and ISO 11737-1.
• Biocompatibility: Demonstrated compliance with ISO 10993 series standards and FDA guidance for:
  • Cytotoxicity (ISO 10993-5)
  • Sensitization (ISO 10993-10)
  • Irritation (ISO 10993-23)
  • Hemocompatibility (ISO 10993-4)
  • Material mediated pyrogenicity (ISO 10993-11)
  • Acute Systemic Toxicity (ISO 10993-11)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were tested for "Force to remove shield"). It refers to "Simulated use tests" and "Performance testing" in general.

Data provenance is not specified in terms of country of origin for the testing, and the testing described is prospective for demonstrating compliance with standards for the device being submitted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The document describes the testing of a physical medical device (blood collection system) against engineering and biological performance standards, not an AI algorithm requiring expert ground truth for classification or detection.

4. Adjudication Method for the Test Set

This information is not applicable as the device performance is measured against objective engineering and biological standards, not requiring human adjudication of subjective data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This information is not applicable. MRMC studies are typically performed for imaging diagnostics or AI-assisted diagnostic tools to assess the impact on human reader performance. This document is for a physical blood collection device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable. The device is a physical product, not an algorithm. The performance tests ("Torque to rotate shield," "Puncture force," etc.) are inherent to the device's design and function in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by recognized consensus standards (e.g., ISO 23908, ISO 7864, ISO 9626, ISO 11137-1, ISO 11737-1, ISO 10993 series) and internal specifications. This means that the device was tested to meet predefined physical, mechanical, and biological properties, not a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of an AI study.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI algorithm; there is no training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable.

Ask a specific question about this device

The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.

The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a while shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.

The Blood Culture Holder is a single-use, non-sterile, plastic holder with threads which are compatible with male luer adapters. The holder can be used with all VACUETTE® Multiple Sample Luer Adapters and Safety Blood Collection Sets for routine venipuncture into various manufacturers' evacuated blood culture bottles and tubes. It is supplied alone or with the Greiner sterile Safety Blood Collection Set with Luer Adapter.

The Blood Culture Holder does not come into contact with the blood specimen. It is an external holder for the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Safety Blood Collection Set consists of tubing with a blood collection needle at one end and a female luer at the other. The VACUETTE® Multiple Sample Luer Adapter consists of a male luer at one end and a cannula covered with a sheath. The luer adapter is threaded into the Blood Culture Holder, with the male luer end on the outside and the covered cannula on the inside of the holder barrel. The blood flows through the blood collection needle and tubing of the Safety Blood Collection Set, into the male luer of the VACUETTE® Multiple Sample Luer Adapter, through the luer into the cannula, and into the blood culture tube or holder when punctured by the cannula. The fluid path consists of the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Blood Culture Holder never comes into contact with the blood specimen during conditions of use.

When the Blood Culture Holder is supplied attached to the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter, it undergoes sterilization as part of the entire system because the fluid path must be sterilized. However, when the Blood Culture Holder is provided alone, it is not sterilized and the user attaches their own sterile blood collection needle and luer adapter.

The Safety Blood Collection Set with Blood Culture Holder is non-pyrogenic and tested according to ISO-10993-11 rabbit pyrogen test. The devices also are below the limit for endotoxin and tested according to ISO-10993-11 LAL Turbidimetric Method.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blood Culture Holder:

Acceptance Criteria and Device Performance Study for Greiner Bio-One North America, Inc. Blood Culture Holder

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Twenty (20) Blood Culture Holders were connected to 20 Safety Blood Collection Sets with Luer Adapters.
• Data Provenance: The study was a simulated blood draw testing conducted by the manufacturer, Greiner Bio-One North America, Inc. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Greiner Bio-One North America, Inc. is located. It is a prospective study as it involved testing new devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The document does not mention the use of experts to establish ground truth for the simulated blood draw testing. The evaluation of proper fit, leakage, and function appears to have been performed internally by the manufacturer's testing personnel, based on pre-defined criteria.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluation seems to be a direct assessment against the defined acceptance criteria.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This study focuses on the performance of a medical device (Blood Culture Holder) in a standalone, mechanical/functional context, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study

• Yes, a standalone study was done. The "Product Performance" section describes a study of the Blood Culture Holder and Safety Blood Collection Set with Luer Adapter's performance in simulated blood draws. This study evaluates the algorithm's (in this case, the device's) function without human intervention influencing the fundamental mechanical performance being assessed.

7. Type of Ground Truth Used

• The ground truth used was based on pre-defined engineering and functional specifications/acceptance criteria for fit, leakage, and function. This is a form of empirical ground truth where the device's physical performance is directly observed and measured against established performance standards. For pyrogenicity and endotoxin, the ground truth was based on adherence to ISO-10993-11 standards.

8. Sample Size for the Training Set

• The document does not mention a training set as this is a physical medical device, not an AI or algorithmic system that requires machine learning training. The focus is on product performance validation, not algorithm development.

9. How the Ground Truth for the Training Set Was Established

• As there is no training set mentioned or required for this type of device, this question is not applicable.

Ask a specific question about this device

The VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® SAFETY Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle 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.

The Greiner VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged infusion and blood collection needle bonded to flexible tubing with a female luer adapter. The VACUETTE® SAFETY Infusion Set is used for short-term administration of intravenous fluids and/or for blood collection. The winged needle 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. The product is to be used by appropriately trained healthcare professionals only in accordance with manufacturer's instructions. It can be used in conjunction with an intravascular administration set or with a syringe or other device in order to administer fluids. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

Here's an analysis of the provided text regarding the Greiner VACUETTE® SAFETY Infusion Set (K121908), focusing on the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided documents are 510(k) Pre-market Notification summaries and FDA letters, not a detailed study report. Therefore, information typical of a comprehensive study (like specific sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or training set details) is generally not present in these types of regulatory submissions, especially for device modifications. These submissions primarily demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (as inferred from the submission)

The primary acceptance criteria for this 510(k) submission are related to demonstrating substantial equivalence to the predicate device, specifically after a modification. This means the modified device must perform equivalently, without raising new questions of safety or effectiveness.

Study Details to Prove Acceptance Criteria:

Given the nature of the primary document (510(k) Summary for a device modification involving different sizes), a "study" in the traditional sense of a clinical trial with human subjects testing AI performance is not applicable here. The "study" is more accurately a design verification and validation process, primarily relying on non-clinical performance testing and comparison to a legally marketed predicate device.

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

   • Sample Size: Not specified in the provided documents. For device modifications involving physical dimensions (like needle gauge and tubing length), the "test set" would typically involve multiple units of each new configuration manufactured and subjected to various engineering and performance tests (e.g., flow rate, safety activation force, material integrity, bond strength). The specific number of units tested would be detailed in the sponsor's test reports, which are not included in this summary.
   • Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Greiner Bio-One North America, Inc. at their facilities or through qualified contract labs, consistent with manufacturing quality systems. This would be prospective testing of the modified device's technical specifications.

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

   • Not Applicable. This is a medical device modification related to physical dimensions and core safety features, not a diagnostic AI tool requiring expert image interpretation. Ground truth would be established by objective measurements (e.g., flow rates, force measurements, dimensional checks) against engineering specifications and regulatory standards, not expert consensus on diagnostic interpretations.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective data (e.g., imaging reads). For this device, performance is evaluated against objective, measurable criteria and pre-defined acceptance limits in a controlled testing environment.

4. 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 device is a manual medical instrument (an infusion set), not an AI diagnostic tool. Therefore, MRMC studies are irrelevant.

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

   • Not Applicable. No algorithms or AI are mentioned or implied for the function of this infusion set.

6. The type of ground truth used:

   • The "ground truth" for this device modification would be based on objective engineering specifications, material properties, performance standards (e.g., ISO standards for medical devices), and a comparison to the established performance of the predicate device. This involves:
     • Dimensional measurements for new needle gauges and tubing lengths.
     • Mechanical strength tests (e.g., bond strength of tubing to luer, integrity of safety mechanism).
     • Flow rate testing for infusion and blood collection (to ensure new dimensions don't hinder performance outside acceptable ranges).
     • Safety mechanism activation/lock tests to confirm user-friendliness and security.
     • Sterility testing (biological indicators or validated sterilization processes).
   • These are all objective, verifiable data points rather than subjective expert consensus.

7. The sample size for the training set:

   • Not Applicable. As this is not an AI/ML device, there is no "training set."

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

   • Not Applicable. No training set.

Summary of the "Study" (Design Verification & Validation):

The documentation states that the device is "substantially equivalent to the predicate device in fundamental scientific technology, intended use, and materials." This is the core "proof" presented in a 510(k) for a minor modification.

For this specific modification (additional needle gauges and tubing length), the sponsor (Greiner Bio-One) would have conducted various non-clinical performance tests to demonstrate that these changes maintain the safety and effectiveness profile of the cleared predicate device (K080235). These tests would typically include:

• Mechanical testing: To ensure the integrity of the new configurations and the safety mechanism.
• Flow rate testing: To confirm the functionality for blood collection and fluid infusion across the new sizes.
• Dimensional verification: To ensure manufacturing accuracy.
• Material compatibility: Confirmation that the materials for the new sizes are the same or equivalent to the predicate.
• Biocompatibility: (If new materials were introduced, though not implied here).
• Sterilization validation: To confirm the sterilization process remains effective for the new sizes.

The FDA's clearance (JUL 25 2012) indicates they reviewed these underlying test results (summarized by the sponsor) and agreed that substantial equivalence was demonstrated, and the modifications did not raise new safety or effectiveness concerns.

Ask a specific question about this device

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.

Ask a specific question about this device

VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.

VACUETTE Evacuated Blood Collection Tubes are plastic tubes with a pre-defined vacuum for exact draw volumes. They are fitted with color coded VACUETTE Safety Caps (green for heparin tubes). The tubes, additive concentrations, volumes of liguid additives, and their permitted tolerances, as well as the blood-to-additive ratio, are in accordance to the requirements and recommendations of the international standards ISO 6710 "Single use containers for venous blood specimen collection" and the Clinical and Laboratory Standards Institute's Approved Standards (CLSI). VACUETTE Evacuated Blood Collection Tubes with Lithium Heparin and Gel contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel barrier moves upward, where it forms a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, which eliminates the need for transfer to another container. The changes for the VACUETTE Evacuated Blood Collection Tube with Lithium Heparin and Gel are in the Instructions for Use (IFU): - Recommended g-force (relative centrifugal force, rcf) change from 2200 g to . a range of 1800 - 2200 g. - Recommended tube spin time change from 15 minutes to a range of 10 15 . minutes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel:

Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel Study Analysis

This 510(k) submission describes verification studies performed to demonstrate that a modified centrifugation speed and time for the Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel does not affect laboratory results compared to the original parameters.

1. Acceptance Criteria and Reported Device Performance

1. Deming slope of $1.0 \pm 0.1$
2. No statistically significant difference between results: using Deming Method, the 95% confidence intervals include the ideal values (i.e. 0.00 in constant bias or 1.00 in proportional bias). | Passed: All met acceptance criteria. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 40 patients
• Data Provenance: Not explicitly stated, but assumed to be from a clinical laboratory context as it involves analyzing patient samples for various analytes. It is a prospective study as it involves actively performing comparisons between two centrifugation conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The ground truth for this study is not established by human experts but by quantitative laboratory measurements and statistical analysis.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This study involves quantitative measurements and statistical comparisons, not subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This study does not involve human readers evaluating images or data with and without AI assistance. It focuses on the physical performance of a medical device (blood collection tube) under different operating conditions.
• Effect Size of AI improvement: Not applicable.

6. Standalone Performance Study

• Standalone Study Done: Yes, in a way. The study assesses the performance of the modified centrifugation parameters (the "device" being tested in terms of its new operating conditions) in isolation by comparing results obtained under these new conditions against results obtained under the predicate device's conditions. It's an "algorithm-only" or "device-only" performance in the sense that it doesn't involve a human-in-the-loop for decision-making based on the output.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth is the scientific and statistical determination of equivalence based on:
  • Visual inspection for gel barrier formation: This serves as a qualitative "ground truth" for physical separation.
  • Quantitative analytical results for 51 analytes: The "ground truth" for these measurements is the established accuracy and precision of the laboratory analytical instruments used, and the comparison to the existing (predicate) centrifugation method within specified statistical bounds (Deming regression, confidence intervals).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This study is a verification and validation study comparing a modified process to an existing one. It does not involve machine learning or AI models that require a separate training set. The "training" here could be conceptualized as the initial development and optimization of the centrifugation parameters, but no specific data set is mentioned as a "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the context of machine learning. The "ground truth" for establishing the original operating parameters would have been through prior research, development, and validation studies that determined optimal centrifugation settings for the device.

Ask a specific question about this device

Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window 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.

Here's a summary of the acceptance criteria and the study details for the Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: 500 devices were tested.
• Data Provenance: The text does not specify the country of origin. It indicates it was a "simulated blood drawing" test, which implies a prospective, internal validation study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The text states "multiple users employing the thumb activation option." It does not specify the exact number of users or their qualifications (e.g., healthcare professionals, engineers, etc.). The "ground truth" here is the functionality of the device during simulated use.

4. Adjudication Method for the Test Set:

• The text does not explicitly detail an adjudication method. It simply states "No failures occurred," implying a direct observation of device function rather than a need for multiple expert opinions to resolve discrepancies.

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:

• This device is a medical instrument (blood collection tube holder), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI or human readers is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable as the device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used:

• The ground truth was based on direct observation of device functionality (absence of failure) during simulated venipuncture procedures.

8. The Sample Size for the Training Set:

• The document describes a modification to an existing device (predicate device K033478) and a test of the modified device. There is no mention of a separate "training set" in the context of machine learning or algorithm development, as this device's performance is not based on such models. The 500 devices tested were for verification of the modification.

9. How the Ground Truth for the Training Set Was Established:

• As this is not an AI-based device, the concept of a "training set" and its associated ground truth establishment is not applicable. The study described is a performance verification test.

Ask a specific question about this device

VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).

Greiner VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL)

This document is an FDA 510(k) clearance letter for a blood collection tube. It does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI-powered medical device.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device

The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device 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® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.

The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device 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® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.

The provided text is a 510(k) summary for a medical device (VACUETTE® QUICKSHIELD Complete) and does not describe a study with acceptance criteria for device performance, ground truth establishment, or sample sizes related to AI/algorithm performance.

This document is primarily concerned with establishing substantial equivalence to previously cleared predicate devices for regulatory approval, focusing on intended use, materials, and sterilization processes. It is a submission to the FDA for a new medical device, not a report on a study comparing performance against specific metrics or historical data.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions revolve around clinical study design, AI performance, and data analysis which are not discussed in this regulatory submission.

Ask a specific question about this device

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred.

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are non-evacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.

The provided 510(k) summary for K063357 (Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA)) mentions a study conducted to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or detailed results in the format requested.

The summary states: "A study was conducted to demonstrate substantial equivalence of the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA with the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) when samples from these tubes are used in hematology assays."

And the conclusion: "The conclusion from the study is that the hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes."

This indicates that the study aimed to show that key hematology parameters measured from blood collected in the new device were comparable to those from predicate devices. However, the exact metrics for "substantial equivalence" (e.g., specific ranges for acceptable differences in cell counts, hemoglobin, etc.) are not detailed in this document.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Note: The document states that the conclusion of the study was substantial equivalence. It does not provide the specific numerical acceptance criteria (e.g., "difference in WBC count must be within +/- X%") or the actual numerical results obtained for each hematological parameter for a direct comparison.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study was "conducted," implying it was likely prospective, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This study is a performance comparison of blood collection tubes for hematology assays, not an AI device requiring expert ground truth for interpretation. The "ground truth" would be the measurements obtained from the predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. This study is a performance comparison of blood collection tubes for hematology assays, not an AI device requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an MRMC study. It is a study comparing the performance of a medical device (blood collection tube) against predicate devices for analytical performance in hematology assays.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This is a physical medical device (blood collection tube), not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this study would be the hematology assay results obtained from samples collected in the predicate devices. The new device's performance is compared against these established results.

8. Sample Size for the Training Set:

• Not applicable. This is a performance study for a physical device, not an AI/machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established:

• Not applicable. As above, no training set for an AI model.

Ask a specific question about this device

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.

Ask a specific question about this device