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The Vial Adapter is indicated for the transfer of drugs contained in a vial.

The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.

The provided text describes a 510(k) premarket notification for a medical device called "Vial Adapter 20mm". This is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria in the typical academic or clinical trial sense.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context, as they pertain to clinical or AI/algorithm performance studies. This document focuses on bench testing and regulatory comparisons.

Here's a breakdown of the information that can be extracted:

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

The document lists various performance tests conducted. For each test, the acceptance criteria are implicitly defined by the referenced standard or the success of the "in-house test method." The reported device performance is indicated by statements like "meets all applicable design and performance requirements," "conforms to applicable external and internal standards," and "successfully conducted." Specific numerical performance data or detailed results are not provided in this summary.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The tests are "non-clinical performance data" and "bench performance tests." The manufacturing facility is in Ra'anana, Israel. The data would be prospective for the purpose of this submission (i.e., new testing done for this device).

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. This is not a study relying on expert interpretation for ground truth. It's an engineering and regulatory compliance submission based on physical and chemical testing.

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

• Not Applicable. No human adjudication of results is described for these bench tests; results are objective measurements against 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 passive, non-electrical, non-software-enabled mechanical component (Vial Adapter), not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. As mentioned above, this is a mechanical medical device, not an algorithm.

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

• The "ground truth" for the performance tests outlined is defined by the specified international and in-house standards (e.g., ISO, USP, ASTM) that the device must comply with. For biocompatibility and sterilization, it's compliance with safety thresholds and validation standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning study, so there is no training set.

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

• Not Applicable. As there is no training set, this question is irrelevant.

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Transfer of drugs contained in a vial.

The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life.

The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter.

The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.

The provided document is a 510(k) premarket notification for a medical device called the "Vented Vial Adapter 20mm". This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring a full clinical trial for safety and efficacy. Therefore, the information typically found in a study proving acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert consensus, and comparative effectiveness studies, is not present here.

Instead, the document focuses on non-clinical performance data and biocompatibility testing to demonstrate that the new device meets relevant standards and is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the provided information within the context of your request:

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

The document does not explicitly provide a table of acceptance criteria alongside reported device performance in the typical sense of a clinical study measuring a specific outcome (e.g., sensitivity, specificity for an AI diagnostic). Instead, it lists various performance tests conducted and indicates that the device "met the applicable design and performance requirements" and that "all product design requirements are verified."

Below is a table summarizing the types of tests conducted, which implicitly serve as criteria for performance, and the general statement of their success:

Regarding the other requested information:

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

  • The document does not specify sample sizes for each non-clinical performance test. It mentions that an "in-house test method" was often used.
  • The data provenance is not explicitly stated in terms of country of origin for the non-clinical tests. The manufacturer is West Pharma. Services IL, Ltd. in Ra'anana, Israel. The tests are non-clinical bench tests, not involving human 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 question is not applicable to a device submission of this nature. The "ground truth" for these tests are objective measurements against defined standards or specified functional parameters, not subjective expert interpretations.

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

  • This is not applicable. The performance testing is based on objective measurements against engineering and biological standards, not on human adjudication of subjective findings.

• 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 MRMC or comparative effectiveness study was done. This device is a passive medical device (a vial adapter), not an AI/ML diagnostic or assistive technology.

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

  • Not applicable, as this is not an AI/ML algorithm or software device.

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

  • For performance testing, the "ground truth" refers to the established specifications, international standards (e.g., ISO, BS EN ISO), or in-house defined criteria for mechanical properties, fluid dynamics, and biological safety. For biocompatibility and sterilization, the ground truth is defined by specific ISO standards and their associated pass/fail criteria (e.g., for cytotoxicity, sensitization, sterility assurance level).

• 8. The sample size for the training set:

  • Not applicable, as this is not an AI/ML device that requires training data.

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

  • Not applicable, as this is not an AI/ML device that requires a training set or associated ground truth.

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The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial

The Swabable Vial Adapter is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.

The Swabable Vial Adapter is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a luer connection) is attached to the sub-assembly.

This document is a 510(k) summary for the "Swabable Vial Adapter" by Medimop Medical Projects Ltd. It describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not contain information about a medical device that performs a diagnostic or prognostic function capable of being proven through a study. Therefore, the information needed to answer the comprehensive questions about acceptance criteria and a study proving device performance is not present in the provided text.

Specifically, the document focuses on:

• Device Description: How the Swabable Vial Adapter works (allowing safe and easy transfer of liquid drugs from and into vials).
• Indications for Use: To allow multiple needleless accesses to an injection medication vial for facilitating withdrawal or addition of drugs/solutions.
• Technological Comparison to Predicate Devices: Claims substantial equivalence in indications for use, design, material, sterility, and packaging with predicate devices like the Robertsite Vial Adapter and Smartsite Vented Vial Access Device.
• Safety and Effectiveness: States that finished products are tested to meet required release specifications, including physical testing and visual examination.
• Conclusion: Asserts substantial equivalence to predicate devices and that it introduces no new issues of safety and effectiveness.

Key Missing Information:
The document does not describe:

• Specific acceptance criteria for "performance" as one would for a diagnostic or prognostic device (e.g., sensitivity, specificity, accuracy). The "acceptance criteria" mentioned are related to release specifications for manufacturing and safety (e.g., meeting ISO 10993-1, USP VI, physical testing, visual examination), not clinical performance.
• A study that proves the device meets specific performance criteria related to diagnostic or prognostic capabilities. The "study" mentioned is conformity to safety standards and comparison to predicates for substantial equivalence.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or details about training sets. These are all irrelevant for a device whose primary function is drug transfer and access rather than diagnostic interpretation.

Therefore, I cannot populate the table or provide the requested details about a study focusing on performance metrics like accuracy, sensitivity, or specificity. The provided document concerns a medical device accessory whose "performance" is primarily assessed through engineering, material, and safety standards, and equivalency to existing devices, rather than clinical diagnostic efficacy.

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