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TEVADAPTOR® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allows the safe reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.

The components of the previously cleared TEVADAPTOR® system are:

• . Vial Adaptor 20 mm with 13 mm Vial Converter
• . Vial Adaptor 28 mm
• . Syringe Adaptor
• Spike Port Adaptor .
• . Connecting Set
• . Luer Lock Adaptor
• . Syringe Adaptor Lock

Each of the above component parts is available separately.

The purpose of this 510(k) is to add an additional component to the TEVADAPTOR® system already cleared for sale in the US, the description of which is:

• New component: TEVADAPTOR® Catheter Adaptor
  The Catheter Adaptor provides closed system protection and disconnection of the fluid path between the Syringe Adaptor of the TEVADAPTOR® system and a bladder catheter (not supplied), while allowing safe administration of cytotoxic drugs to the bladder.

The Catheter Adaptor connects to the TEVADAPTOR® Syringe Adaptor, the short length of polymeric tubing of the adaptor is connected to the adaptor main body, which in turn is connected to the universal bladder catheter connector. A vented cap is supplied over the universal connector. The universal bladder catheter connector connects to a bladder catheter (not supplied).

The provided text describes the TEVADAPTOR® Closed Drug Reconstitution and Transfer System, specifically focusing on the addition of a new component: the TEVADAPTOR® Catheter Adaptor. The document details performance tests conducted to demonstrate the safety and effectiveness of this new component and its substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size: The document repeatedly mentions "no failures observed at T0 and T12mo" for several tests, indicating a sample of devices were tested both at initial production (T0) and after accelerated aging equivalent to 12 months (T12mo). However, the specific number of samples tested for each criterion is not provided.
• Data Provenance: The manufacturer is Teva Medical Ltd. from Israel. The testing was described as "Performance tests have been conducted," implying prospective testing within a laboratory setting. Details about the specific test facilities or country of origin for the data are not explicitly stated, but are presumably conducted by or on behalf of Teva Medical Ltd.

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 device is a medical accessory (Closed System Drug Transfer Device), not an AI/imaging device requiring expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the context of this 510(k) submission. The ground truth for performance relied on objective measurements and adherence to engineering and sterility standards.

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

This information is not applicable and not provided for this type of device and testing. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation, which is not the primary focus for evaluating the mechanical performance and safety of a CSTD.

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

As noted previously, this is a medical device for drug transfer, not an AI or imaging diagnostic tool. Therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are not applicable and not mentioned.

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

Again, this is a hardware device. No standalone algorithm performance study was conducted or is relevant.

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

The ground truth for the performance tests was based on:

• Objective Measurements: E.g., pressure readings for air leakage, force measurements for disconnection, observation of air bubbles for unclogged device.
• Adherence to Standards: Compliance with ISO 8536-4:2010 for connector sealing, ISO 10993 and FDA guidance for biocompatibility, and an SAL of 10-6 for sterility.
• Chemical Compatibility: Direct observation or analytical testing to confirm the device's compatibility with cytotoxic drugs.

8. The sample size for the training set

This device did not involve machine learning or AI, so there was no training set. The testing involved physical samples of the manufactured device.

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

Since there was no training set, this question is not applicable. The "ground truth" for the device's performance was established through rigorous bench testing against predefined engineering specifications and regulatory standards.

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TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.

The purpose of this Special 510(k) is to add an additional design of one of the components, the TEVADAPTOR® Syringe Adaptor Lock.

The Syringe Adaptor (SA) Lock is one component of the system which is intended for connection to a standard Luer lock syringe. A non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor Lock to ther components of the TEVADAPTOR® system. The TEVADAPTOR® Syringe Adaptor Lock includes a stainless steel needle that is shielded at all times during preparation, use and disposal. The Syringe Adaptor Lock is supplied with a cap.

Disconnection of a syringe is not possible with the Syringe Adaptor Lock, because of a design change from the syringe adaptor that introduces a two-component distal hub. One of these components attaches, and rotates within the second component, together with the syringe, if disconnection is attempted.

The components of the TEVADAPTOR® system available separately are:

• Vial Adaptor 20 mm with 13 mm Vial Converter
• Vial Adaptor 28 mm
• Syringe Adaptor
• Syringe Adaptor Lock
• Spike Port Adaptor
• Connecting Set
• Luer Lock Adaptor

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study conducted was a bench testing evaluation to demonstrate equivalence of the new TEVADAPTOR® Syringe Adaptor Lock with the existing TEVADAPTOR® Syringe Adaptor (predicate device).

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

• Sample Size for Test Set: The document does not explicitly state a specific numerical sample size for the bench tests. It broadly mentions "bench testing has been carried out."
• Data Provenance: The study was conducted by Teva Medical Ltd., which is based in Israel (North Industrial Zone, Kiryat Shmona 10258, ISRAEL). The data is retrospective in the sense that it's a submission for clearance of a modified device, and the testing was performed to demonstrate equivalence to a previously cleared predicate device.

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

This type of information is not applicable to this submission. The device is a Closed System Drug Transfer Device, and the performance evaluation relies on objective physical and mechanical tests (e.g., flow rates, leakage, disconnection forces, ISO compliance) rather than expert interpretation of medical images or clinical outcomes. The "ground truth" for these tests is defined by established engineering standards and specifications.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements and compliance with engineering standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is not an AI-powered diagnostic tool, but rather a medical device for drug transfer. Therefore, no MRMC study or AI-related effectiveness assessment was performed.

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

This is not applicable. The device is not an algorithm or software; it is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for this evaluation consists of:

• Established engineering specifications and standards, particularly ISO 594/1 & 2 for Luer fittings.
• The performance characteristics of the predicate device (TEVADAPTOR® Syringe Adaptor cleared under K141448), as the goal was to demonstrate equivalence.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set."

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

This is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

TEVADAPTOR® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

The TEVADAPTOR® Closed Drug Reconstitution and Transfer System, developed by Teva Medical, is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for infusion, injection, or instillation. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allow the safe reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.

The components of the TEVADAPTOR® system are:

• Vial Adaptor 20 mm with 13 mm Vial Converter
• Vial Adaptor 28 mm
• Syringe Adaptor
• Spike Port Adaptor
• Connecting Set
• Luer Lock Adaptor

Each of the above component parts is sold separately.

The provided document is a 510(k) summary for the TEVADAPTOR® Closed Drug Reconstitution and Transfer System. It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to predicate devices, focusing on meeting the definition of a Closed System Drug Transfer Device (CSTD). However, it does not detail specific acceptance criteria for performance metrics in a table or present a study comparing device performance against those criteria in a quantitative manner that would allow for a direct comparison as requested.

The document discusses various bench tests and compliance with applicable standards to demonstrate the device meets the criteria for a CSTD, but it does not provide acceptance criteria values, performance values, sample sizes for test sets, data provenance, expert involvement for ground truth, or adjudication methods for any specific performance study. It also does not mention an MRMC comparative effectiveness study or a standalone algorithm-only performance study.

Instead, the document focuses on demonstrating that the device prevents the release of drugs and maintains sterility, aligning with the definition of a CSTD. The "studies" mentioned are bench tests and validations against standards rather than clinical performance studies with quantitative outcomes.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text:

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

This information is not explicitly provided in the document in a table format with specific quantitative acceptance criteria and corresponding reported performance values. The document states that "A number of bench tests have been carried out to confirm compliance with applicable standards and demonstrate that the subject device meets the criteria for a Closed Drug Reconstitution and Transfer System, in accordance with the requirements of FDA Product Code ONB." It lists the types of tests performed and gives a general conclusion that the device meets the NIOSH and ISOPP definition of a CSTD. Specific pass/fail criteria or performance metrics for each test are not listed.

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

• Sample Size: The document does not specify sample sizes for any of the bench tests mentioned (e.g., Bidirectional flow, Airtightness test, Fluid tightness test, Microbiological ingress test, Filter efficiency test).
• Data Provenance: The manufacturer is Teva Medical Ltd. in Kiryat Shmona, ISRAEL. The studies are bench tests, implying they were conducted in a lab setting, likely by the manufacturer or a contract lab. The document does not specify if the data is retrospective or prospective, but for bench tests, this distinction is less relevant than for clinical studies.

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

This information is not applicable as the "studies" are bench tests demonstrating physical and mechanical properties, sterility, and biocompatibility, not clinical evaluations requiring expert interpretation for ground truth. Ground truth for these tests would be defined by the physical properties being measured and the standards referenced.

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

This information is not applicable for the bench tests described.

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 information is not applicable. The device is a Closed System Drug Transfer Device, not an AI-powered diagnostic tool requiring human reader comparison.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

The ground truth for the bench tests mentioned would be based on physical measurements, chemical analysis, microbiological assays, and compliance with established industry standards (e.g., ISO 11135-1:2007 for sterilization, ISO 10993 series for biocompatibility). For example, for the "Microbiological ingress test," the ground truth would be the confirmed presence or absence of microbial contamination based on laboratory methods. For "Fluid tightness test," the ground truth would be the absence of fluid leakage under defined conditions.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

The TEVADAPTOR™, Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

The device comprises of the following components:

• Vial Adaptor System with 13 mm Vial converter
• Syringe Adaptor System
• Connecting Set
• Spike Port Adaptor
• Luer Lock Adaptor
  The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic, sterile, pressure equalization within the vial, preventing drug particle and aerosol escape into the environment. The Vial Adaptor is also effective when used with Radionuclide drugs. A special charcoal layer within the venting system prevents also drug vapor from escaping, ensuring the system is closed to all toxic species. The air entering the vial is sterile due to this combination of filters. An elastomeric, nonlatex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The interface for connecting with the Syringe Adaptor is designed so that it can be easily cleaned and disinfected when required.
  The Syringe Adaptor System is intended for connection to a standard luer lock syringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components. The design incorporates a Passive-Needle protection that eliminates chances of needle-stick injuries.
  The Spike Port Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. Capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.
  The Connecting set is similar to the Spike Port Adaptor, except for a female luer lock connection at the distal end.
  The Luer Lock Adaptor enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

The provided text is a 510(k) summary for the TEVADAPTOR™, Closed Drug Reconstitution and Transfer System. It details the device's description, intended use, and its substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria, study methodologies, or performance metrics in the format requested (e.g., a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, or details on comparative effectiveness studies).

Such detailed information is typically found in the full submission documents, often referred to as validation or verification reports, which are not included in this publicly available 510(k) summary. The summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing the granular data of performance studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
2. Sample sizes used for the test set and the data provenance: Not explicitly stated for performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for performance data is not detailed.
4. Adjudication method: Not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable to this type of device (a drug reconstitution and transfer system) and not mentioned in the summary.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not specified for performance testing.
8. The sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

The document primarily states that the device "has equivalent performance characteristics" to its predicate device, the PhaSeal® closed system (K980381), and concludes that "The evaluation... does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices." This implies that the performance characteristics were deemed acceptable, likely based on similarity to the predicate and internal testing, but the specifics of how these were tested and what the acceptance criteria were are not detailed here.

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The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

The device comprises of the following components:

• Vial Adaptor System with 13 mm Vial converter
• Syringe Adaptor System
• Infusion Bag Adaptor
• -I Connector

The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic. sterile, pressure equalization within the vial, preventing drug particle escape into the environment. An elastomeric, non-latex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid.

The Syringe Adaptor System is intended for connection to a standard luer lock svringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components.

The Infusion Bag Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. A capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.

An injection accessory enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

I apologize, but the provided text from the 510(k) submission for the TEVADAPTOR™ Drug Reconstitution and Transfer System does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (PhaSeal®) and describes the device's components and indications for use. It lacks:

• A specific table of acceptance criteria.
• Reported device performance metrics against defined criteria.
• Details about a study's methodology (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set specifics).

Therefore, I cannot generate the table or provide the detailed study information you requested based on the given text.

The closest information related to performance is the statement: "The TEVADAPTORTM, Drug Reconstitution and Transfer System... has equivalent performance characteristics" to the predicate device. However, it does not elaborate on what these performance characteristics are, how they were measured, or what specific acceptance criteria were used.

Ask a specific question about this device