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The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.

Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy.

The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the BD PosiFlush Heparin Lock Flush Syringe. The purpose of this document is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, rather than to establish new performance criteria for a novel device or an AI/ML algorithm.

Therefore, the concepts of "acceptance criteria," "study proving the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" as they relate to AI/ML device validation are not applicable to this document.

This document describes a change to an existing device (qualifying a new stopper material) and relies on design verification testing and biocompatibility testing to demonstrate that the modified device remains substantially equivalent to the predicate device and does not affect the safety and efficacy.

Key information provided in the document relevant to device validation (though not in the context of AI/ML performance):

1. Acceptance Criteria & Reported Performance:

   • The document states that "Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests." It lists the tests but does not provide a specific table of acceptance criteria values or the reported performance data for each test. It only states that the device "met predetermined acceptance criteria per BD's internal specification" and "results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device."
   • Tests Conducted:
     • Container Closure Integrity
     • Break Loose/Break Out/Sustaining force
     • Stopper Separation
     • Leakage
     • Pump Force
     • Ship Test
     • Dead Space
     • Syringe Induced Reflux
   • Biocompatibility testing was conducted in accordance with ISO 10993-1, including: Cytotoxicity, Hemolysis, Acute systemic toxicity, Sub-Chronic Toxicity, Intracutaneous reactivity, Ocular irritation, Partial thromboplastin Time, Sensitization, Pvrogenicity, Genotoxicity, and Chemical extractable analysis. The document states "Biocompatibility evaluation was conducted..." and implies successful completion, but does not provide specific acceptance criteria or reported results.

2. Sample Size and Data Provenance: Not applicable in the context of an AI/ML test set. The document refers to "design verification testing" and "biocompatibility testing" which would have involved a certain number of manufactured units, but the sample sizes for these tests are not explicitly stated in this summary.

3. Ground Truth Experts/Adjudication Method/MRMC/Standalone Performance/Type of Ground Truth/Training Set Details: These concepts are entirely irrelevant to this type of device submission, which is for a physical medical device with a material change, not an AI/ML diagnostic or therapeutic algorithm. The "ground truth" for a device like this would be established through established physical and chemical testing standards, not expert consensus on medical images or outcomes data in the sense of AI/ML.

In summary, the provided document does not contain the information required to answer the questions as they are framed for an AI/ML device. It focuses on the substantial equivalence of a physical medical device after a material change.

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Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

This document does not contain information about acceptance criteria and device performance in the context of a study. The provided text is a 510(k) summary for the Heparin Lock Flush, USP, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a specific study with performance metrics against pre-defined acceptance criteria.

The 510(k) summary outlines the following:

• Device Description: The Heparin Lock Flush, USP
• Intended Use/Indications for Use: Flushing of IV catheters and IV tubing for maintaining patency.
• Technological Characteristics: A comparison table with predicate devices (K061497 and K023740) highlighting similarities in solution, concentrations, single-use nature, sterility, barrel material, plunger rod material, piston, tip cap material, tip cap colorants, and packaging.
• Purpose of Submission: To add alternate suppliers of the heparin sodium (USP) raw material.
• Non-Clinical Testing: A list of studies performed or relied upon:
  • Raw material qualification
  • Biocompatibility (ISO 10993-1)
  • Stability Studies
  • Sterilization validation (ISO 17665-1 and -2)
  • Extractables/Leachables
  • Testing of final product to Heparin Lock Flush Solution USP Monograph
• Conclusion: The change in heparin source is supported by the cited studies, and no new questions of safety and effectiveness are raised, leading to the conclusion of substantial equivalence.

The document does NOT include the following information, which would be necessary to answer the prompt:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for any test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This is expected as 510(k) submissions for devices like a Heparin Lock Flush typically rely on demonstrating equivalence to existing devices through material characterization, manufacturing controls, and non-clinical testing rather than clinical performance studies with specific acceptance criteria as one might see for an AI/ML diagnostic device.

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Heparin Lock Flush Solution, USP product code 505701 (10 USP units/mL) and product code 504901 (100 USP Units/mL), is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

The Heparin Lock Flush Solution, USP product code 505701 comes in concentration of 10 USP Units/mL, and in strengths of 10 USP units. The Heparin Lock Flush Solution, USP product code 504901 comes in concentration of 100 USP Units/mL, and in strength of 100 USP units. These two product codes are packaged in 3 cc plastic vials.

The provided text describes a 510(k) submission for a medical device, Heparin Lock Flush Solution USP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials as one might see for novel AI software. Therefore, the questions related to AI-specific study designs, reader performance, and ground truth establishment in a diagnostic context are not directly applicable.

Instead, the "acceptance criteria" here relate to demonstrating biocompatibility and stability, and the "study" involves laboratory testing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "patients" or "cases" but rather samples of the Heparin Lock Flush Solution, USP. For the biocompatibility tests (cytotoxicity, hemolysis) and the leachable test, specific quantities of the product were used. The document does not specify the exact number of solution samples tested, but it refers to "the sample" for cytotoxicity and "the samples" for hemolysis.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective medical data. These were laboratory tests performed on the manufactured product.

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

• Not applicable. Ground truth for these types of tests is established by adherence to recognized laboratory standards (USP, ISO, ASTM) and analytical methods, not by expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. The tests performed are objective laboratory measurements with pass/fail criteria based on established scientific standards, not subjective interpretations requiring 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:

• No. This is a medical device (a pharmaceutical solution), not an AI diagnostic tool. Therefore, MRMC studies and AI-specific effectiveness measures are not relevant or performed.

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

• No. This is a pharmaceutical solution, not an algorithm.

7. The type of ground truth used:

• Biocompatibility: Established by adherence to industry standards (USP, ISO, ASTM) for cytotoxicity and hemolysis. The "ground truth" is that the material must meet the specified safe limits as defined by these standards.
• Chemical Stability/Leachables: Established using a scientifically validated analytical method (HPLC limit test) to detect the presence of a specific compound (TMTBB). The "ground truth" is the verifiable absence (below detection limits) of the leachable.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. (See #8)

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FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

The Heparin I. V. Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic prefilled syringe. The DEVICE consists of a hypodermic syringe barrel, stopper plunger, plunger rod, luer lock (LL) tip cap and Heparin Lock Flush Solution, USP (1 Unit/mL or 10 Units/mL or 100 Units/mL in 0.9% Sodium Chloride), which meets the requirements set forth in the current USP Heparin Lock Flush Solution monograph. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in packaging. The hypodermic syringe is transparent. The barrel of the reservoir for the product and will be overfilled during manufacturing process. The plunger and plunger rod are the only two moving parts of the device. The flush solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip. The DEVICE will be filled using fully automated syringe filling machine utilizing non - sterile components. The components of the DEVICE (hypodermic syringe, tip cap and (Heparin Lock Flush Solution, USP) will be sterilized using steam in a terminal sterilizer after the syringe barrel is filled with Heparin Lock Flush Solution and sealed with Tip Cap and Plunger Stopper.

The acceptance criteria and study information for Medefil's Heparin I.V. Flush Syringe are described below, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes used for each test. However, it indicates:

• Test Sets: "The syringes tested were filled with product, sealed, steam sterilized... for dye leak testing. The microbial ingress testing was performed by filling with Tryptic Soy Broth..." and "The polypropylene was tested for Biological Reactivity Tests In Vitro and In Vivo." Also, "The stability testing was performed on Heparin I. V. Flush Syringes..." and "Heparin I. V. Flush Syringe, 100 Units/mL did not result in any hemloysis..."
• Data Provenance: The studies were conducted by Medefil, Inc. and appear to be prospective in nature, as they involve testing of the device for its performance and safety characteristics. The document does not specify a country of origin for the data, but Medefil, Inc. is located in Glendale Heights, Illinois, USA, suggesting a domestic provenance.

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

This information is not applicable to this type of device submission. The tests performed are laboratory-based and analytical (physical, mechanical, chemical, biological reactivity, sterility, stability, clinical safety markers), not involving subjective interpretation by human experts to establish "ground truth" in the way a diagnostic imaging device might.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are analytical and objective, not requiring adjudication of human interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess the AI's impact on reader performance. This device is a pre-filled syringe (a medical device), not a diagnostic imaging AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the studies performed for this device can be considered standalone performance assessments of the device itself (the pre-filled syringe) in meeting its design specifications and safety requirements. The device itself is not an algorithm, so "without human-in-the-loop performance" here means evaluating the physical, chemical, and biological properties of the syringe system.

7. Type of Ground Truth Used

The "ground truth" for the various tests was established by:

• Engineering Drawings: For dimensional criteria.
• Predicate Device Performance: For mechanical comparability.
• Established Test Methods and Standards:
  • Dye ingress test and microbial ingress test: For seal integrity.
  • USP Class VI plastic requirements: For biocompatibility of polypropylene.
  • LAL test method: For pyrogenicity.
  • USP monograph Heparin Lock Flush Solution: For chemical stability and compatibility.
  • Quantitation of free hemoglobin, LDH levels, and osmolality measurement: For clinical safety (hemolysis).

These are objective, quantifiable measures against predefined standards or comparators.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (pre-filled syringe), not an AI algorithm that requires a "training set" of data.

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

This information is not applicable for the same reason as above; there is no "training set" for this type of device.

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The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)

10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°.

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe has been modified to achieve terminal sterilization (SAL of 1066) via steam autoclave.

The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.

This submission (K090680) describes a medical device, the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe. It is important to note that this is a physical medical device (a pre-filled syringe with heparin solution) and not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML systems (such as sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment methods for observational data) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to previously approved predicate devices based on design verification tests for safety and effectiveness of the physical product, its materials, intended use, and manufacturing process.

Here's the information parsed from the provided text, adapted for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device submission focused on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device and the design verification tests. The "reported device performance" refers to the results of these tests and the overall assessment of equivalence.

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

• Sample Size: The document does not specify a numerical sample size for "design verification tests." These tests are typically laboratory-based and may involve multiple units of the device to confirm manufacturing quality, material compatibility, and performance characteristics (e.g., flow rate, integrity, sterility).
• Data Provenance: The data would be derived from internal testing conducted by Becton, Dickinson and Company. It is "prospective" in the sense that the tests were performed specifically for this 510(k) submission on the newly designed/modified device. The country of origin of the data is the USA (where BD Medical Surgical is located).

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

This concept is not directly applicable to this type of device submission. The "ground truth" for a physical device like a pre-filled syringe is established through objective engineering and chemical testing standards, manufacturing processes, and regulatory requirements (e.g., USP monographs for the heparin solution, ISO standards for syringes, sterility testing protocols). Experts would be involved in designing and executing these tests, and interpreting the results against established standards, rather than establishing a "ground truth" through consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers interpreting subjective data (e.g., medical images). For physical device testing, the results are typically objective measurements against a defined standard.

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 device, not an AI/ML system.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device would be a combination of:

• Established Standards: USP (United States Pharmacopeia) monographs for Heparin Lock Flush Solution, standards for syringe manufacturing, and sterility testing protocols.
• Predicate Device Performance: The performance characteristics and safety profile of the legally marketed predicate devices (K011967, K003553, K013556) serve as a de facto "ground truth" for what is considered safe and effective in this device class.
• Risk Analysis: A documented risk analysis would have guided the design verification tests to ensure all potential risks were mitigated and tested.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML system, so there is no "training set."

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

Not applicable.

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Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy

Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.

This is a 510(k) summary for a medical device: Excelsior Medical Heparin Lock Flush Syringes. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria in the typical clinical study format.

Therefore, many of the requested sections about clinical study details (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) cannot be fully answered from the provided text.

Here is an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that the device was tested according to "specifications documented in Design Verification Testing Reports and independent laboratory testing." It concludes that the device "functioned as intended and met all pass criteria as expected." However, the specific acceptance criteria and the detailed performance results are not provided in this 510(k) summary. The summary focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • Sample Size: Not specified. The document refers to "Design Verification Testing Reports and independent laboratory testing" but does not provide details on sample sizes for these tests.
   • Data Provenance: Not specified, but likely from laboratory testing (e.g., sterility, chemical analysis, functional tests) rather than human clinical data.

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

   • This information is not applicable or not provided. This type of detail is typically associated with clinical studies involving interpretation (e.g., imaging devices), not physical device performance testing for a syringe and its contents. The ground truth would be established by validated analytical methods, not expert consensus.

3. Adjudication method for the test set:

   • This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of results is involved (e.g., radiologists reading scans). This document describes performance testing for a physical device, where results are typically objective measurements.

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:

   • No, an MRMC study was not done. This type of study is relevant for diagnostic devices, especially those using AI, that assist human readers in interpreting clinical data. This device is a pre-filled syringe, not a diagnostic tool assisted by AI.

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

   • Not applicable. This section is for AI/algorithm-based devices. The Excelsior Medical Heparin Lock Flush Syringe is a physical medical device.

6. The type of ground truth used:

   • Laboratory Testing Parameters/Specifications: The ground truth for this device's performance would be established by predefined quality and functional specifications (e.g., sterility, pH range of the solution, heparin concentration, syringe integrity, flush volume). These are determined through established scientific and manufacturing standards for medical devices and pharmaceuticals.

7. The sample size for the training set:

   • Not applicable. This pertains to AI/machine learning models. For a physical device, there isn't a "training set" in the AI sense.

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

   • Not applicable. See point 7.

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Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml

This document is a 510(k) clearance letter for a medical device, the Syrex Pre-Filled Syringe, Heparin Lock Flush Solution. It is a regulatory approval document and does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically found in a scientific study or clinical report.

Therefore, I cannot provide the requested information based on the input text. The input text primarily deals with:

• General regulatory information regarding medical device clearance.
• Confirmation of substantial equivalence to a predicate device.
• Instructions for compliance with FDA regulations.
• Indications for Use statement for the device.

To address your request, information from a different type of document, such as a clinical study report, a scientific publication, or the device's design validation documentation, would be necessary.

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