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The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.

The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.

The provided text describes a 510(k) premarket notification for the Ecomed® Scalp Vein Set, focusing on its substantial equivalence to an existing device. However, it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study design as typically associated with proving a device meets acceptance criteria in a technical sense.

The document primarily focuses on:

• Intended Use: Withdrawal of venous blood.
• Material Equivalence: The Ecomed® needle is stainless steel, the same as the predicate device (Becton Dickinson's VACUTAINER® Brand Blood Collection Set). The needle protector sleeves and shields are also made from comparable materials (rubber and extruded plastic, respectively).
• Biocompatibility Testing: Non-cytotoxicity was demonstrated in testing performed in accordance with ISO 10993, along with endotoxin testing. This is the closest mention of performance testing, but specific acceptance criteria or detailed results are not provided beyond "demonstrated."

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides very high-level assertions. Specific quantitative acceptance limits (e.g., maximum allowable cytotoxicity, specific endotoxin limits) and detailed performance results are not included in this summary.

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified in the provided text. The document only mentions that testing was performed (e.g., for non-cytotoxicity, endotoxin).
• Data Provenance: Not specified. It does not mention country of origin or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not mentioned. This type of information is typically relevant for studies involving human interpretation or subjective assessments (e.g., image-based diagnostics), which is not the primary focus of the information provided for this simple medical device. The "ground truth" for material equivalence or biocompatibility comes from standardized tests and material specifications.

4. Adjudication Method for Test Set

• Not applicable/Not mentioned. Adjudication is typically used when multiple human experts provide opinions that need to be reconciled for a ground truth, which is not the case here.

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

• No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for AI algorithms aiding human readers, which is not the nature of the Ecomed® Scalp Vein Set.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study in the context of an "algorithm only" device was not performed or mentioned. The Ecomed® Scalp Vein Set is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

• The ground truth for the claims made (material equivalence, biocompatibility) would be based on:
  • Manufacturer Specifications & Material Certificates: For material composition.
  • Standardized Assay Results: For biocompatibility (e.g., ISO 10993 cytotoxicity assay results, endotoxin assay results).

8. Sample Size for the Training Set

• Not applicable/Not mentioned. The Ecomed® Scalp Vein Set is a physical device, not a machine learning model, so there is no "training set."

9. How Ground Truth for the Training Set Was Established

• Not applicable/Not mentioned (as there is no training set).

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The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.
The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.

The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.

The provided text is a 510(k) summary for the Greiner MiniCollect® Coagulation tube. It focuses on demonstrating substantial equivalence to a predicate device, the Greiner VACUETTE® Coagulation tube (K971221). The primary method of demonstrating this equivalence is through a comparative study of assay results using paired samples.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the number of paired samples used in the equivalence study. It only mentions "testing paired samples."
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

This type of information is not relevant or typically provided for a device like a blood collection tube. The "ground truth" here is the assay results themselves, which are generated by laboratory instruments, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of device and study. The comparison is between quantitative assay results, not subjective interpretations requiring adjudication.

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

No, this was not an MRMC comparative effectiveness study. This type of study is used to evaluate the impact of a device or algorithm on human reader performance, typically in diagnostic imaging. The Greiner MiniCollect® is a blood collection tube, and its evaluation focuses on analytical performance.

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

Yes, in a sense, the primary study was a "standalone" evaluation of the device's impact on assay results, independent of human interpretation or human-in-the-loop involvement during the device's operation (i.e., the tube itself doesn't have an algorithm). The performance being assessed is the analytical performance of the tube in preserving blood quality for coagulation testing.

7. The Type of Ground Truth Used

The ground truth was established by analytical results from standard coagulation assays performed on blood collected in the predicate device (Greiner VACUETTE® Coagulation tube). The paired samples allowed for a direct comparison of the tested device against an established, legally marketed standard.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or algorithms that require a "training set." The study evaluated the physical characteristics and chemical properties of the tube and its effect on blood samples.

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

Not applicable, as there is no training set for this device.

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To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory.

The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing lithium heparin anticoagulant and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.

The provided text describes a 510(k) summary for the Greiner MiniCollect® Lithium Heparin Gel tube. The study focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria for a new clinical performance claim. Therefore, the requested information about acceptance criteria for a device, MRMC studies, ground truth establishment, and training set details are not fully applicable or available in the provided text.

However, based on the provided text, here's an attempt to extract relevant information and note what is not applicable or provided:

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

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

• Sample Size: "paired samples for 22 analytes and 4 hormones" were evaluated. The exact number of patients or individual samples is not specified, but it implies multiple samples for each of the 26 assessed parameters.
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

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

• Not applicable/provided. The study compared the performance of two blood collection tubes rather than relying on expert interpretation for a "ground truth" diagnosis. The "ground truth" for the analytes/hormones would be established by standard assay methods, which are inherently part of the test.

4. Adjudication method for the test set

• Not applicable/provided. There was no expert adjudication process described as the study compared analytical results from two devices.

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 device is a blood collection tube, not an AI-powered diagnostic system involving human readers.

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. The performance evaluation was based on analytical results of blood collected in the tubes.

7. The type of ground truth used

• The "ground truth" in this context refers to the analytical results obtained from the predicate device, Becton Dickinson's Microtainer® Brand heparin tubes with gel separator. The study aimed to show that the new device yielded comparable analytical results. The "ground truth" for the analytes themselves would be the accuracy and precision of the respective laboratory assays.

8. The sample size for the training set

• Not applicable. This study does not involve a training set as it's a comparison of two physical medical devices, not a machine learning model.

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

• Not applicable, as there is no training set.

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To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.

The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.

The provided text describes a 510(k) submission for a labeling change to the Greiner VACUETTE® blood collection tube. The change is to include therapeutic drug monitoring (TDM) as an indicated use. The submission aims to demonstrate substantial equivalence to both Greiner's previously cleared device (K960858) and Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for agreement, bias, or precision). However, the implicit acceptance criterion is "no significant clinical difference" between the modified Greiner VACUETTE® tubes and the predicate devices.

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

• Sample Size: Not explicitly stated. The document mentions "clinical tests" and "comparison studies" but does not provide details on the number of samples or subjects involved.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable. This device is a blood collection tube, and the "ground truth" for its performance comparison would typically involve laboratory measurements and statistical analysis of collected blood samples, not expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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

Not applicable for this type of device. MRMC studies are typically used for evaluating diagnostic imaging or AI devices where human reader performance is a key outcome.

6. Standalone (Algorithm Only) Performance Study:

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

7. Type of Ground Truth Used:

The "ground truth" in this context refers to the results obtained from analyses of blood samples collected in the predicate devices. The study compares the performance of the Greiner VACUETTE® tubes (with and without gel separator, and with the proposed TDM indication) against these established methods. The comparison likely involved measuring various analytes relevant to therapeutic drug monitoring and other clinical laboratory tests.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set. The "studies" mentioned are performance comparison studies, not model training.

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

Not applicable. See point 8.

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To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory.

The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a clot activator and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.

This document describes the Greiner MiniCollect® Serum Gel tube, a blood collection device, and its substantial equivalence to a predicate device. The information provided heavily focuses on the regulatory submission and does not detail specific acceptance criteria or a dedicated study report with detailed performance metrics beyond a statement of "good correlation."

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria (e.g., specific thresholds for correlation coefficients, bias, or agreement). Instead, it relies on demonstrating "good correlation" to the predicate device for assay results.

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

• Sample Size: The document states that "paired samples" were used, but it does not specify the number of samples or patients included in this testing.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's likely a retrospective or prospective study performed by the manufacturer, but this is not detailed.

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

This question is not applicable in the typical sense for this type of device. The "ground truth" here is the performance of the predicate device (Becton Dickinson's Microtainer® Brand tubes with gel separator). The assay results are objective measurements from laboratory instruments, not subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective assessment requiring adjudication. The comparison is based on quantitative assay results.

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

No. This type of study is typically for imaging devices or diagnostics that involve human interpretation. This device is a blood collection tube, and its performance is evaluated by chemical analysis, not human reader interpretation. Therefore, no MRMC study or effect size for human reader improvement is relevant or mentioned.

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

This question is not applicable. This device is a medical product (blood collection tube) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth or reference standard for comparison was the assay results obtained from the predicate device, Becton Dickinson's Microtainer® Brand tubes with gel separator. The aim was to demonstrate that results from the Greiner MiniCollect® tubes correlate well with those from the established predicate device.

8. The Sample Size for the Training Set

This concept is not directly applicable. This is not an AI/ML device that requires a training set. The "evaluation" mentioned refers to the comparison of the new device's performance against a predicate device.

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

Not applicable, as this is not an AI/ML device with a training set.

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To collect, transport, store, and evaluate capillary blood specimens for hematology and lead tests.

The Greiner MiniCollect® EDTA K3 tube is a non-sterile, non-evacuated blood collection device containing EDTA K3 anticoagulant additive, and is intended for use in evaluations of capillary blood specimens. The Greiner MiniCollect® tube cap is made from rubber and has "cross-cuts" to allow for direct collection into and sampling from the tube without having to remove the cap.

The provided text is a 510(k) summary for a blood collection tube (Greiner MiniCollect® EDTA K3 tube) and does not describe an AI medical device. Therefore, much of the requested information, such as acceptance criteria for AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

However, I can extract the relevant information regarding the device's equivalency study.

Acceptance Criteria and Study for Greiner MiniCollect® EDTA K3 Blood Collection Tube

This device is a blood collection tube and not an AI medical device. The "acceptance criteria" in this context refers to demonstrating substantial equivalence to a legally marketed predicate device, rather than performance metrics for an AI algorithm. The study aimed to show that the new device yielded comparable assay results to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "paired samples" were used, but it does not specify the number of samples (n) involved in the study.
• Data Provenance: Not specified, but generally, such studies involve prospective collection of samples for comparison. The country of origin is not mentioned.

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

This is not applicable as the study involved comparing assay results from two different blood collection tubes, not establishing ground truth for an AI algorithm's predictions. The "ground truth" here would be the actual values obtained from laboratory analysis, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison of analytical results, not an assessment requiring expert adjudication.

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 device, and no MRMC study was conducted.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

The "ground truth" was the analytical results from standard laboratory assays for 15 hematology parameters and lead tests. These results were obtained from blood specimens collected in both the investigational device and the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI device, and therefore, no training set was used.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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For use in venous blood collection with attached butterfly needle or luer needle.

The Greiner Vacuette® Multiple Sample Luer Adapter is a device of which one end is a plastic male luer adapter and the other end is a sharpened stainless steel needle. The needle end of the luer adapter is epoxy bonded to the plastic upper end (hub) and is covered by a rubber sheath. The luer adapter is threaded into a needle holder for the purposes of attaching a butterfly needle for use in venous blood collection. The luer adapter is a sterile, single-use disposable device.

This is a 510(k) premarket notification for a Class II medical device, the Greiner Vacuette® Multiple Sample Luer Adapter. The submission claims substantial equivalence to a predicate device, the Greiner Medical's SURESHARP® Luer Adapter (K950159).

Therefore, the submission does not contain information on acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The basis for claiming substantial equivalence is that both luer adapters "have the same intended use and contain the same material," and "are the same and purchased from the same supplier in Japan." This suggests that the substantial equivalence is being claimed primarily on the basis of material and design similarity to an already approved device, rather than through new performance studies.

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To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.

The VACUETTE® Holdex® Holder is a single-use disposable plastic device to be used in routine venipuncture procedures using butterfly needles or luer needles. Sterile and non-sterile versions are available. The sterile version of VACUETTE® Holdex® is manufactured from polystyrene plastic and is sterilized by electronic beam. The non-sterile version is autoclavable and is manufactured from polycarbonate plastic.

The provided text is a 510(k) summary for the Greiner VACUETTE® Holder and the FDA's response letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Becton Dickinson's VACUTAINER® Brand holder). This means it's a regulatory submission to show the new device is as safe and effective as a device already legally marketed, rather than a report on specific performance testing against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information on a multi-reader, multi-case comparative effectiveness study.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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To be used in routine venipuncture procedures

non-sterile reusable plastic device to be used in routine venipuncture procedures.

This device is a Greiner VACUETTE Multi-use Holder, which is a non-sterile reusable plastic device used in routine venipuncture procedures. In this 510(k) summary, the manufacturer is claiming substantial equivalence to Becton Dickinson's preamendment VACUTAINER® Brand holder. The summary does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.

Here's why and what information is missing:

• Type of Device: This is a physical, reusable plastic medical device for venipuncture, not a software-driven or AI-based diagnostic tool. The detailed questions about acceptance criteria, performance studies, sample sizes, ground truth (pathology, outcomes data), expert consensus, MRMC studies, and training sets are primarily relevant to diagnostic algorithms, AI, or imaging devices.
• Submission Type: This is a 510(k) premarket notification claiming "substantial equivalence" to a predicate device. For devices like this, substantial equivalence is typically demonstrated through comparisons of material, manufacturing process, intended use, and general performance characteristics that do not involve complex clinical or algorithmic efficacy trials.
• Content of the Document: The provided text is a 510(k) summary and the FDA's response letter. These documents describe the device, its intended use, and the FDA's finding of substantial equivalence. They do not typically include detailed study designs, acceptance criteria tables, or performance metrics in the way your questions are structured for AI/diagnostic devices. The regulatory pathway for this type of device does not usually require such studies for 510(k) clearance, especially given the predicate device was preamendment.

Therefore, the requested information cannot be extracted from the provided text for the following points:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized 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 (i.e. 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.

For this type of device, a "study"proving acceptance criteria would likely involve:

• Material compatibility testing: Ensuring the plastic does not react adversely with blood or commonly used cleaning agents.
• Manufacturing quality control: Demonstrating consistent production to specifications.
• Dimensional compatibility: Ensuring it fits standard collection tubes and needles.
• Functional tests: E.g., ensuring it can hold a tube securely during venipuncture without accidental dislodgement, or that the needle connection is secure.

However, none of these specific details are included in the provided 510(k) summary. The summary focuses on comparing the new device to the predicate device in terms of material (polypropylene plastic) and intended use (routine venipuncture procedures) to demonstrate substantial equivalence, rather than providing detailed performance metrics from a formal study.

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For use in venous blood collection

a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube.

This device, the Greiner Vacuette® Multi-sample needle (K973620), is a Class II medical device that received 510(k) clearance based on substantial equivalence to an existing predicate device, Gainor Medical's Suresharp® needles (K950159).

Therefore, this submission does not contain acceptance criteria in the traditional sense of performance metrics with thresholds that the device must meet through a new study. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is identical in materials and intended use to a previously cleared device.

Here's a breakdown of the information requested, 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

• Sample Size: Not applicable. No new performance testing in a "test set" was conducted or reported for this 510(k) submission.
• Data Provenance: Not applicable. The submission relies on a statement of material and supplier identity, not new data.

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

• Not applicable. As no new "test set" was evaluated, no experts were needed to establish ground truth for performance.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" was evaluated.

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

• No. This type of study is not relevant for a device seeking clearance based on substantial equivalence of materials and intended use.

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

• Not applicable. This device is a manual blood collection needle; it does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on material composition and supplier identity, verified through a statement by the manufacturer. The core assumption is that if the materials and supplier are the same as a legally marketed predicate device, the performance will be substantially equivalent.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm or a device requiring such data.

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

• Not applicable. No "training set" was used.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this case is a comparative analysis of device characteristics against a predicate device, rather than a clinical or performance study involving human subjects or data analysis. The manufacturer, Greiner Meditech, Inc., established substantial equivalence by reporting that their Vacuette® Multi-sample needle:

• Has the same intended use (venous blood collection) as the predicate device (Gainor Medical's Suresharp® needles - K950159).
• Is made of the same materials for each of its components (stainless steel for the needle, polypropylene for the hub and shield, rubber for the sleeve) as the predicate device.
• Is purchased from the same supplier in Japan as the predicate device, further supporting the claim of identicality.

This approach is common for straightforward Class II devices where the risks are well-understood and the device is a direct copy or very minor modification of an already cleared product. The FDA's acceptance of this submission indicates they found these claims sufficient to establish substantial equivalence.

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