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

The DEVICE, the subject of this 510 (k), MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready (0.9% Sodium Chloride Flush Syringe, USP) will be sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, inspected, plunger rod inserted, labeled and then pouched in steam sterilizable paper pouch prior to terminally sterilization as compared to its predicate device which is sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, steam sterilized and then inspected, plunger rod inserted and labeled prior to packaging. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

The provided text is a 510(k) summary for the MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data for the device itself in terms of clinical outcomes or diagnostic accuracy.

Therefore, many of the requested categories for device evaluation (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of regulatory submission, as it does not involve an AI/ML-based diagnostic or prognostic device requiring such studies.

The acceptance criteria for this type of device are primarily related to its physical and chemical properties, manufacturing processes, and sterility, ensuring it functions as intended and is safe for use. The "study" proving it meets acceptance criteria is primarily an equivalence comparison to a legally marketed predicate device, coupled with quality control measures for manufacturing and sterilization.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable for this type of 510(k) submission. There is no specific "test set" in the context of diagnostic performance or clinical trials. The submission relies on demonstrating substantial equivalence to a predicate device already on the market and adherence to manufacturing and sterility standards.

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

This is not applicable. Ground truth establishment by experts is relevant for diagnostic devices that interpret data (e.g., medical images). This product is a medical device for flushing IV lines.

4. Adjudication Method for the Test Set

This is not applicable.

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 not an AI/ML-based diagnostic tool.

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

This is not applicable.

7. The Type of Ground Truth Used

This is not applicable in the context of diagnostic accuracy. The "ground truth" for this device relates to:

• Established physical/chemical properties: 0.9% Sodium Chloride solution meeting USP standards.
• Sterility: Demonstrated through validated sterilization processes (e.g., steam sterilization cycle validation) and LAL testing for endotoxins.
• Functional equivalence: Comparison to the predicate device for its ability to maintain patency of IVADs, implying that its design and basic function are proven.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

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

The DEVICE, the subject of this 510(k), Normal Saline I. V. Flush Syringes (0.9% Sodium Chloride Injection, USP) will be terminally sterilized as compared to its predicate device which was aseptically filled. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

This document is a 510(k) premarket notification for a medical device called "MEDEFIL'S NORMAL SALINE I. V. FLUSH SYRINGE". It focuses on establishing substantial equivalence to a predicate device, primarily due to a change in the sterilization process and polypropylene material.

Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a diagnostic AI device would. This is not a study or performance report for an AI device.

Instead, it's a regulatory submission demonstrating that the modified device (now terminally sterilized) is as safe and effective as its previously cleared version, which was aseptically filled. The "performance standard" mentioned refers to general regulatory standards, not specific performance metrics for an AI algorithm.

To directly answer your request based on the type of document provided, which is a 510(k) summary for a physical medical device (flush syringe), not an AI diagnostic tool:

Since the provided document is a 510(k) summary for a physical medical device (Normal Saline I.V. Flush Syringe) and not an AI diagnostic device, the requested information about acceptance criteria, study details, and AI-specific metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or present in this document.

The document states:

• "No performance standard(s) applicable to this device has been promulgated under Section 514 of the Food, Drug, and Cosmetic Act."
• The device "shall be pyrogen free per the LAL test method for bacterial endotoxin." This is a quality control test, not a performance study in the context of diagnostic accuracy.

The submission aims to demonstrate "substantial equivalence" of the new manufacturing process and material to the previously cleared predicate device (Medefil, Inc. Normal Saline I. V. Flush Syringe K020999), not to prove performance against specific diagnostic accuracy criteria through a study.

Therefore, the specific elements you've asked for (such as a table of acceptance criteria vs. device performance, sample sizes for test/training sets, details on expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not included within this type of regulatory submission for this particular device.

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

The Heparin Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and Heparin Lock Flush Solution USP. Heparin I. V. Flush Syringe is manufactured in three different concentrations - 1 Unit/mL; 10 Units/mL and 100 Units/mL. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:

1 mL fill in 6 mL Syringe LL
2 mL fill in 6 mL Syringe LL
2.5 mL fill in 6 mL Syringe LL
3 mL fill in 6 mL Syringe LL
3 mL fill in 12 mL Syringe LL
5 mL fill in 6 mL Syringe LL
5 mL fill in 12 mL Syringe LL
10 mL fill in 12 mL Syringe LL

The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The 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 aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap, Heparin Sodium Injection and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors.

The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod. resulting in the expulsion of the fluid from the luer tip.

This document is a 510(k) summary for Medefil's Heparin Flush Syringe, submitted to the FDA in 2002. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The provided document is not about an AI/ML-driven medical device or a diagnostic system that would typically have the kind of "acceptance criteria" and "study" you're asking for (e.g., sensitivity, specificity, clinical outcome studies).

This document describes a physical medical device (a pre-filled syringe with Heparin flush solution) and a 510(k) submission, which is a premarket submission made to the FDA to demonstrate that the new device is as safe and effective, or "substantially equivalent," to a legally marketed predicate device.

Therefore, many of your requested points regarding acceptance criteria, study design for AI, expert numbers, ground truth, etc., do not apply to this type of device and submission.

However, I can extract information relevant to "acceptance criteria" in the context of a physical medical device and how its performance is "proven" for a 510(k) submission:

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

In the context of this physical device and a 510(k) substantial equivalence submission, "acceptance criteria" are not reported as specific clinical performance metrics (like sensitivity/specificity for a diagnostic). Instead, the acceptance criteria are implicitly that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that its changes do not raise new questions of safety or effectiveness.

The document demonstrates this by comparing various attributes of the new device to the predicate device.

Regarding the other points, as they are largely inapplicable to this type of device and submission, here's why, or how they might be interpreted in a non-AI context:

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

• Not applicable for an AI device. For a physical device like this, "data" often refers to engineering tests (e.g., LAL test for pyrogenicity mentioned), material compatibility studies, or sterility validations. The document provides no details on sample sizes for such tests, nor their provenance, which are usually part of the underlying design and manufacturing validation, not typically summarized in this specific 510(k) document unless specifically requested or if it's the core focus of the 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)

• Not applicable. There is no "ground truth" in the diagnostic sense here. The "truth" is established by adherence to USP standards for the Heparin solution, validated manufacturing processes, and accepted engineering principles for medical devices.

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

• Not applicable. No expert adjudication process is detailed or expected for this type of device.

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 medical device, not an AI diagnostic tool.

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

• Not applicable. This is a physical medical device.

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

• Not applicable in the diagnostic sense. The "ground truth" for this device's safety and efficacy relies on adherence to pharmaceutical standards (USP for Heparin solution, pyrogenicity testing), material science (biocompatibility, chemical compatibility), mechanical engineering (plunger function, luer compatibility), and manufacturing quality control (aseptic technique, Class 100 environment).

8. The sample size for the training set

• Not applicable. There is no AI model or algorithm being "trained" for this device.

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

• Not applicable. There is no AI model or algorithm being "trained" for this device.

In summary: The provided document is a 510(k) submission for a modified pre-filled Heparin flush syringe. The "acceptance criteria" and "proof" of meeting them are primarily demonstrated through a detailed comparison to a legally marketed predicate device, asserting "substantial equivalence" based on similar intended use, solution, principle of operation, materials, and manufacturing practices, with differences explicitly addressed as not adversely affecting safety or effectiveness. The detailed requirements for AI/ML performance studies you listed are not relevant here.

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

The Normal Saline Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and 0.9% Sodium Chloride Iniection, USP. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:

1 mL fill in 6 mL Syringe LL
2 mL fill in 6 mL Syringe LL
2.5 mL fill in 6 mL Syringe LL
3 mL fill in 6 mL Syringe LL
3 mL fill in 12 mL Syringe LL
5 mL fill in 6 mL Syringe LL
5 mL fill in 12 mL Syringe LL
10 mL fill in 12 mL Syringe LL

The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The 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 aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors.

The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The provided text describes a 510(k) summary for Medefil's Normal Saline Flush Syringe, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the request. The document describes the device, its intended use, and how it differs from a predicate device.

Therefore, I cannot provide the requested information based on the given text.

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

Sterile Heparin I. V. Flush Syringe

This document is a 510(k) clearance letter from the FDA for a medical device: "Medefil's Heparin I.V. Flush Syringe". It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.

Therefore, this document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document, not a scientific study report.

The request asks for specific details about acceptance criteria, device performance, study design (sample sizes, data provenance, expert involvement, adjudication), MRMC studies, standalone performance, ground truth establishment, and training set information. None of this information is present in the provided text.

To answer your request, you would need a scientific or clinical study report for the "Medefil's Heparin I.V. Flush Syringe", not this FDA clearance letter.

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

Normal Saline I. V. Flush Syringe

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Normal Saline I.V. Flush Syringe." This document does not describe any acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a legally marketed predicate device, rather than a study demonstrating its performance against specific acceptance criteria. The 510(k) pathway for medical device clearance often relies on demonstrating equivalence rather than conducting new clinical trials with performance metrics and acceptance criteria for novel devices.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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