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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 shortterm 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 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 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 VACUETTE® Safety Infusion Set will be available in 2 configurations of needle gauge (21G and 23G) and one tubing length (7.5 inches). The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices. The devices were tested for sterility, pyrogenicity and systemic injection testing and were found to be biocompatible.

The provided text describes a 510(k) submission for the VACUETTE® Safety Infusion Set. This is a medical device application that demonstrates substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the same way one would for a novel AI algorithm or diagnostic test.

Therefore, many of the requested categories in your prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth) are not applicable to this type of regulatory submission. The submission focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Explanation: The "acceptance criteria" for a 510(k) are primarily demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The performance is assessed against the predicate and established standards for medical devices (like sterility and biocompatibility).

Study Details (as applicable)

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing performance on a "test set" in the context of an AI algorithm or diagnostic test. The evaluation is based on comparison to a predicate device and standard device testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the sense of expert consensus for a diagnostic outcome, is not relevant here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is a physical medical device, not an AI or diagnostic tool involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is regulatory compliance, established manufacturing standards, and the safety and effectiveness profile of the predicate device. For specific tests like sterility and biocompatibility, the ground truth is defined by validated testing methodologies and acceptable limits for those tests.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary based on the document:

The VACUETTE® Safety Infusion Set gained 510(k) clearance by demonstrating substantial equivalence to a predicate device, the Nipro® SafeTouch Safety Scalp Vein Set (K011297). Furthermore, its design, safety feature mechanism, raw materials, biocompatibility, and overall performance were declared identical to the previously FDA-cleared Greiner VACUETTE® Safety Blood Collection Set (K011786), which serves as a "new intended use" predicate for those specific aspects.

The submission confirms that the device underwent standard testing for sterility, pyrogenicity, and systemic injection, and was found to be biocompatible. These tests are presumably performed on a representative sample of manufactured devices, according to established medical device standards, to ensure they meet predefined safety thresholds. The document does not specify the sample sizes for these tests, which is typical for 510(k) summaries where detailed test protocols are not typically disclosed. The data provenance for these tests would almost certainly be internal company testing.

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VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. VACUETTE® EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.

The provided document describes the 510(k) summary for the Greiner VACUETTE® EDTA K3 Tubes, which are an evacuated blood collection system. The primary goal of the submission was to demonstrate substantial equivalence to predicate devices (Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube and Glass K3 EDTA Tube) for use in molecular diagnostics.

Here's an analysis of the acceptance criteria and study information, 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: The document mentions "contractually healthy blood donors' and patients' samples," but does not specify the exact number of individuals or samples used in the studies.
• Data Provenance: The document does not explicitly state the country of origin for the data. The study appears to be prospective as it involved collecting samples (from healthy donors and patients) specifically for the purpose of the study.

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

This information is not provided in the document. The study appears to rely on PCR test results as the "ground truth" for molecular diagnostic performance, rather than expert consensus on an image or clinical assessment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study focuses on laboratory test results (HIV-1 and HCV PCR), not subjective clinical assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic tools that aid human interpretation, which is not the function of a blood collection tube. The study compared the performance of blood samples collected in different tubes on molecular diagnostic assays.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable in the context of this device. The device itself is a blood collection tube, not an algorithm. The "performance" being evaluated is the chemical and physical compatibility of the tube with subsequent molecular diagnostic tests, essentially ensuring the collected sample remains viable and produces equivalent results to samples collected in predicate devices. The PCR assays themselves are standardized laboratory procedures, not AI algorithms.

7. The Type of Ground Truth Used

The ground truth used was molecular diagnostic assay results (HIV-1 and HCV PCR results). The "truth" was established by the output of these laboratory tests performed on samples collected in both the test device and the predicate device, with the expectation that the results would be "substantially equivalent."

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set. The "studies" mentioned refer to performance validation, not machine learning model training.

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

This information is not applicable. As stated above, there is no training set for this device.

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The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and 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.

The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and 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.

The provided text describes a 510(k) summary for the VACUETTE® QUICKSHIELD Safety Tube Holder. It focuses on demonstrating substantial equivalence to a predicate device and includes a very limited study.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies "no failures" as the acceptance criterion for the safety shield's functionality. The "substantial equivalence" is a regulatory finding rather than a quantifiable performance metric in the same way.

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

• Sample Size: 500 VACUETTE® QUICKSHIELD Safety Tube Holders.
• Data Provenance: The document states "In a study of 50 users, 500 VACUETTE® QUICKSHIELD Safety Tube Holders were used in simulated venipuncture." This indicates a prospective study involving human users. The country of origin is not explicitly stated.

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

Not applicable. The study described is a performance test of a mechanical safety feature, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the safety shield was its physical activation and function.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the task involved observing a simple pass/fail outcome of the safety shield activation.

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

No. This type of study is typically for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VACUETTE® QUICKSHIELD Safety Tube Holder is a medical device for blood collection with a safety mechanism.

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

Yes, in essence. The described study evaluates the device's inherent mechanical function (safety shield activation) without human interpretation affecting its performance outcome. While "users" were involved, their role was to operate the device, not to make a diagnostic judgment. The device's performance was measured directly.

7. The Type of Ground Truth Used

The ground truth was essentially the physical functionality of the safety shield – whether it successfully activated and covered the needle. This is an objective observation of the device's mechanical design.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical safety device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this device does not involve a training set.

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Greiner VACUETTE® Trace Elements Evacuated Blood Collection Tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory.

VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® Trace Elements tube with sodium heparin may be used to collect a whole blood/plasma sample. The VACUETTE® Trace Elements tube with no additive may be used to collect a serum sample. The tubes are composed of clear plastic. The caps are roval blue and made of plastic and rubber: the inner cap rings are black and made of plastic. The tubes' size is 13 x 75 mm. 6mL draw. The tubes are equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.

The Greiner VACUETTE® Trace Elements Tubes were evaluated through two studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Test Set): 40 blood donors for the comparison testing with blood samples. The sample size for the deionized water testing is not specified, but it implies multiple tubes were tested.
• Data Provenance: Not explicitly stated, but given the submission is to the FDA, it is highly likely the studies were conducted in the US. The studies were likely prospective, as they involved collecting blood from donors specifically for the purpose of testing the new device.

3. Number of Experts and Qualifications

• This information is not provided in the document. The studies focused on analytical performance (presence of trace elements, comparison of results) rather than diagnostic interpretation requiring expert consensus.

4. Adjudication Method

• Not applicable. The studies involved analytical testing of trace element levels, not subjective interpretations requiring adjudication.

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

• No. This type of study (comparing human reader performance with and without AI assistance) is not relevant for this device, which is a blood collection tube and not an AI diagnostic tool.

6. Standalone Performance Study

• Yes, implicitly. The study testing for the "background presence of trace elements in the tubes using deionized water" functions as a standalone performance assessment to ensure the tubes themselves do not contribute contaminants. The comparison testing with blood samples also assesses the device's performance in its intended use, albeit in comparison to a predicate.

7. Type of Ground Truth Used

• The ground truth for the deionized water study was the absence of trace elements in the deionized water itself. The device's performance was measured against this known clean baseline.
• The ground truth for the comparison testing with blood samples was the predicate device's performance. The results obtained from the Greiner VACUETTE® tubes were compared to those obtained using the Becton Dickinson Vacutainer® Trace Elements tube. The assumption is that the predicate device provides accurate (or substantially equivalent) measurements of trace elements in blood.

8. Sample Size for the Training Set

• Not applicable. This device is a blood collection tube, not an algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• Not applicable. As stated above, there is no training set for this device.

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VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.

VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for Greiner VACUETTE® Evacuated Blood Collection Tubes with Sodium Heparin (K011699)

This 510(k) summary focuses on demonstrating "substantial equivalence" of the new device to a predicate device, rather than explicit, numerical acceptance criteria for various performance metrics. The core acceptance criterion is that the new device (sodium heparin tube) performs equivalently to the predicate device (lithium heparin tube) for commonly tested plasma analytes.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Blood collected from 40 donors.
• Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study, as blood was collected specifically for this comparison.

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

Not applicable. This study does not involve human readers establishing ground truth for diagnostic accuracy, but rather a direct comparison of analytical equivalence between two medical devices for laboratory assays. The "ground truth" here is the measured analyte concentration/activity, determined by an assay performed in a clinical laboratory setting. The experts involved would be laboratory personnel performing the analyses, but their qualifications and numbers are not detailed as they would be for image interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is an analytical equivalence study, not an diagnostic accuracy study involving multiple readers and adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms interpreting medical images or other diagnostic data, where human readers interact with the AI. This 510(k) is for a basic blood collection device comparing the performance of different anticoagulant additives.

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

Not applicable. This device is a blood collection tube, not an AI algorithm. Its performance is intrinsic to the chemical and physical characteristics of the tube and its additives, affecting subsequent laboratory analyses.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured values of 27 analytes commonly tested in plasma. This is essentially laboratory reference measurements obtained from clinical laboratory assays. The comparison is between the values obtained from blood collected in the sodium heparin tube versus the lithium heparin tube.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

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

Not applicable. As above, this device is not an AI/machine learning algorithm.

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