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The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.

0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration.

This document pertains to the 510(k) premarket notification for the "0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe," a medical device, not an AI/ML-driven device or an imaging system. Therefore, the questions regarding AI/ML performance metrics, expert consensus for ground truth, MRMC studies, or training/test set details are not applicable to this submission.

This submission focuses on demonstrating substantial equivalence to a predicate device (K153481) through bench performance testing, packaging integrity, and biocompatibility tests. The "acceptance criteria" here refer to the specifications for these non-clinical tests, rather than diagnostic performance metrics of an AI model.

Here's the information extracted that aligns with the request, re-interpreting "acceptance criteria" and "study" in the context of this device's submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note 1: Result is a qualitative statement, not a numerical pass/fail against a specific threshold listed in the table.

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

The document does not specify numerical sample sizes for each of the performance, packaging, or biocompatibility tests. It only states that "appropriate performance tests and biocompatibility tests were performed" and the gamma sterilized test samples were evaluated. The data provenance (country of origin, retrospective/prospective) is also not specified, as these are bench and lab-based tests, not clinical studies involving patient data.

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

Not applicable. This submission is for a physical medical device, not an AI/ML imaging device. Ground truth, in this context, refers to the established standards, monograph requirements (e.g., USP, ISO), and validated internal specifications to which the device performance is measured against. Experts here would be the laboratory personnel and engineers performing the tests and
interpreting results against these defined criteria, but their specific number or detailed qualifications are not provided in the summary.

4. Adjudication Method for the Test Set:

Not applicable. Since this is not an AI/ML diagnostic device, there is no "adjudication" of expert opinions on image interpretation. The tests performed are laboratory or bench-based, with results measured against predetermined quantitative or qualitative acceptance criteria.

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/ML device, and no MRMC study was performed. The device's safety and effectiveness are demonstrated through non-clinical performance, packaging, and biocompatibility testing.

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

Not applicable. This device is a physical product (saline syringe), not an algorithm or software. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily based on:

• Established Standards: e.g., ISO 10993 series for biocompatibility, ASTM F2096-11 for vacuum bubble leak, ANSI AAMI ST72:2019 for Bacterial Endotoxins.
• Pharmacopoeia Monographs: e.g., USP43-NF38 for NaCl Injection, pH, Iron, Heavy Metals, Particulate Matter, Bacterial Endotoxin.
• Validated Internal Specifications: "BD validated force" or "BD validated internal value" for mechanical/physical properties like tip cap removal torque, reflux, breakout force, sustaining force, retaining ring force, and seal strength.
• Qualitative Observations: e.g., "No evidence of Tip Cap leakage," "No leakage of solution past the stopper ribs," "Solution and components are clear," "No defects in packaging seals when visually inspected."

Essentially, the ground truth is defined by recognized industry standards, pharmacopoeial requirements, and the manufacturer's own validated specifications for product performance and safety.

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. As there is no training set for an AI/ML model, this question does not apply.

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The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.

BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. The subject device is available only in 10mL syringe configuration.

The provided text describes the acceptance criteria and the results of various tests conducted for the BD PosiFlush™ SafeScrub device (K213955). This device is a pre-filled saline syringe with an integrated disinfection unit.

Here's the breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each test in the provided table. It mentions "BD validated force" for several tests, implying internal validation studies by the manufacturer. The document details that "The subject device is also evaluated throughout its shelf life by bench performance testing to ensure that the device meets the predetermined acceptance criteria."

The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, but it implies a prospective testing approach as part of the device's development and regulatory submission.

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)

This section is not applicable. The tests performed are primarily bench performance, engineering, chemical, and biological evaluations, not requiring human expert interpretation in the way, for example, a medical imaging AI product would. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ISO, ASTM, USP guidelines) rather than expert consensus on diagnostic interpretations.

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

Not applicable. As described in point 3, these are objective physical and chemical tests, not requiring human interpretation or adjudication panels. The "Pass" results are based on meeting predetermined quantitative or qualitative criteria from recognized standards.

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 medical product (a pre-filled syringe with a disinfection unit), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improve with AI" are not relevant to this submission.

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

Not applicable. As mentioned, this is not an AI algorithm. The performance of the device itself (standalone) is what was tested through the various bench performance tests, antimicrobial efficacy, and biocompatibility studies.

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

The "ground truth" for the various tests relies on:

• Established scientific and engineering principles: e.g., for container closure integrity, leakage, torque, pull force.
• Recognized industry standards and guidelines: ISO 10993 series for biocompatibility, ASTM F2096 for package integrity, USP for particulate ingress, USP 43-NF38 for LAL Endotoxin.
• Predetermined chemical concentrations: 70±7% for IPA concentration.
• Microbiological reduction targets: ≥ 4-log reduction for antimicrobial efficacy, based on established efficacy standards for disinfectants.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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The 0.9% Sodium Chloride Injection, USP, Pre-filled Syringe is intended for flushing of IV catheters and IV tubing only. The syringe is provided to convenience kit packers/OEMs to be placed in surgical procedure kits that may undergo ethylene oxide (EO) sterilization according to their validated processes per ANSI/AAMI/ISO 11135:2014.

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

This FDA 510(k) clearance letter pertains to a medical device: 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe, specifically for flushing IV catheters and IV tubing. This document is a regulatory approval and does not contain information about a study that assesses the device's performance against detailed acceptance criteria in the manner requested (e.g., using AI, human readers, ground truth, sample sizes for training/testing).

The information provided describes the regulatory classification, intended use, and general compliance requirements for the device. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory and often bench-testing-based comparison, not a clinical performance study with the metrics you've requested.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria in terms of metrics like sensitivity, specificity, or reader improvement.
• Sample sized used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
• Adjudication method: Not applicable as no test set is discussed.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a pre-filled syringe, not an AI algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe received 510(k) clearance (K191378) from the FDA. The clearance indicates that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or has different technological characteristics but does not raise different questions of safety and effectiveness.

Indications for Use: The device is intended for flushing of IV catheters and IV tubing only. It is also noted that the syringe is provided to convenience kit packers/OEMs to be placed in surgical procedure kits that may undergo ethylene oxide (EO) sterilization according to their validated processes per ANSI/AAMI/ISO 11135:2014.

Regulatory Class: Class II
Product Code: NGT
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)

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0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies related to the 0.9% Sodium Chloride Injection, USP.

The document is a US FDA 510(k) clearance letter for the device, which essentially states that the FDA has reviewed the manufacturer's premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory information, requirements, and contact details, but it does not include any performance data or study details.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study
6. Standalone performance study
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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The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP (also referred to as BD PosiFlush™ SP Syringe) is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The BD PosiFlush™ SP Syringe is provided with a sterile fluid path, which is sterilized via moist heat.

The change described in this submission is the qualification of a supplier specific formulation for stopper material for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes.

This document describes a Special 510(k) submission for a medical device called "0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe" (K161552). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K141311) due to a change in the supplier specific formulation for the stopper material.

I will focus on the provided information to answer your request, specifically looking for acceptance criteria and the study proving it.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly 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 enumerating the acceptance criteria values themselves or the quantitative performance measurements obtained for each test. Instead, it states that the device "met predetermined acceptance criteria per BD's internal specification" and "have been verified to meet the established performance criteria above."

• Container Closure Integrity
• Break Out/Sustaining force
• Stopper Separation
• Leakage
• Pump Force
• Ship Test
• Dead Space
• Syringe Induced Reflux |

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

The document does not specify the sample sizes used for any of the tests (biocompatibility or design verification). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. The studies were conducted by Becton, Dickinson and Company.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the clearance is for a pre-filled syringe (a medical device, not an AI or diagnostic tool that requires human expert interpretation for ground truth). The "ground truth" for the performance tests would be based on established engineering and biological standards and verified by internal testing protocols.

4. Adjudication Method:

This is not applicable for the same reasons as point 3.

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

This is not applicable as the device is a pre-filled syringe, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

This is not applicable as the device is a pre-filled syringe and does not involve an algorithm.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" would be established by:

• Established industry standards and regulations (e.g., ISO 10993 for biocompatibility).
• BD's internal specifications and engineering requirements for device functionality and integrity (e.g., for leakage, break force, dead space).

8. Sample Size for the Training Set:

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable for the same reasons as point 8.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed across two main categories:

1. Biocompatibility Testing:

   • Methodology: Evaluated in accordance with FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016.
   • Tests Performed: Cytotoxicity (per ISO10993-5), Hemolysis (per ISO10993-4), Acute systemic toxicity (per ISO10993-11), Sub-Chronic Toxicity (Per ISO10993-11), Intracutaneous reactivity (per ISO10993-10), Ocular irritation (per ISO 10993-10), Partial thromboplastin Time (ISO 10993-4), Sensitization (per ISO10993-10), Pyrogenicity (per ISO 10993-11), Genotoxicity (per ISO 10993-3), and Chemical extractable analysis (per ISO 10993-18).
   • Conclusion: The tests confirmed that the device met the requirements outlined in the standards, indicating it is biocompatible.

2. Design Verification Testing:

   • Methodology: Conducted to ensure the device met "predetermined acceptance criteria per BD's internal specification." The specific methodologies for each test (e.g., how "Container Closure Integrity" was tested) are not detailed but would be standard industry practices for syringe manufacturing.
   • Tests Performed: Container Closure Integrity, Break Out/Sustaining force, Stopper Separation, Leakage, Pump Force, Ship Test, Dead Space, Syringe Induced Reflux.
   • Conclusion: The testing demonstrated that the subject device "met predetermined acceptance criteria."

Overall Conclusion from the Document:

The submission concludes that the BD PosiFlush™ SP Syringes "have been verified to meet the established performance criteria above." The results of this design verification and biocompatibility testing "demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device and demonstrated the same intended use, fundamental scientific technology and operating principles" as the predicate device, thereby proving substantial equivalence.

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The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SF Syringe is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is sterilized via moist heat and provided externally sterile for use on a sterile field.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe:

This document is a 510(k) summary for a medical device that claims substantial equivalence to a predicate device, rather than a study proving the device meets novel acceptance criteria through a comparison against a primary ground truth. It focuses on demonstrating that the subject device (with new packaging) performs identically to the predicate device, which has already been deemed safe and effective.

Therefore, many of the typical questions asked for an AI/diagnostic study (like sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission. This is a submission for a modification to an existing device (packaging change), where the primary goal is to show that the modified device maintains the performance characteristics of the original device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device (K121050). The reported device performance for the subject device is consistently "Identical to predicate" or "Equivalent to predicate".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document states that "Performance Testing conducted to support substantial equivalence." It details the types of tests performed (Functional, Chemical, Biocompatibility) but does not specify the sample sizes for these tests or the data provenance. These tests would typically be laboratory-based rather than involving patient data.

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)

This is not applicable as this is not a study requiring expert interpretation of results for ground truth establishment. The performance criteria are objective measurements as per recognized standards (e.g., USP, ISO).

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

This is not applicable. The tests performed are objective, quantitative or qualitative measurements against established specifications/standards, not subjective assessments 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

This is not applicable. This device is a pre-filled saline syringe, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This device is a manual medical device, not an algorithm.

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

The "ground truth" or acceptance criteria for this medical device are based on:

• Established standards and regulations: e.g., USP (United States Pharmacopeia) for chemical properties and bacterial endotoxin, ISO (International Organization for Standardization) for biocompatibility and package integrity.
• Performance of the predicate device: The subject device is designed to perform "Identical to predicate" or "Equivalent to predicate" in all tested characteristics. The predicate device's performance already demonstrates its safety and effectiveness.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This is not applicable. As above, no training set is relevant for this type of device.

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0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. 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.

0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:

• 2.5 mL in 3 mL Syringe
• 3 mL in 10 mL Syringe
• 5 mL in 10 mL Syringe
• 10 mL in 10 mL Syringe
  The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

The provided text does not describe an acceptance criteria or a study proving that a device meets the acceptance criteria for a medical device that utilizes artificial intelligence (AI). The document is a 510(k) premarket notification for a 0.9% Sodium Chloride Injection, USP (a saline vascular access flush). This is a physical, sterile medical product, not an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be extracted from this document.

The document discusses non-clinical testing performed for the saline solution and prefilled syringes, which includes:

• Raw material qualification
• Stability Studies
• Sterilization validation
• Extractables/Leachables

These tests are standard for a sterile drug product/device combination and are not related to AI performance. Biocompatibility testing was deemed not required because the products were considered the same as predicate devices, except for the source of the sodium chloride raw material.

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