Search Results

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

Closed System drug Transfer Device (CSTD) for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

The Equashield system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the infusion bag for injection (Spike Adaptor 1), an adaptor for the infusion bag for withdrawal (Spike Adaptor W), an adaptor for female luer lock ports (Luer Lock Adaptor), nursing pair connectors for male and female luer lock ports (Female LL Connector and Male LL Connector), and a protective plug (Protective Plug). The Equashield closed system consists of 8 components that are dedicated to each other to create a system. The components are not intended to be used individually. Vial Adaptor is 48 x 31mm, 23mm at distal end. Plug is 51 x 17mm large. Female luer lock is 50 x 23 mm with a 5.2mm ID. Male luer lock is 42 x 21mm with a 15mm depth. Spike Adaptor is 75 x 42 mm and the height is 22mm.

The provided text is a 510(k) Summary for a medical device (Equashield Closed System Drug Transfer Device), which focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results. Therefore, much of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a numerical or categorical format with corresponding "reported device performance." Instead, it relies on demonstrating adherence to established consensus standards and substantial equivalence to predicate devices. The core performance claims are related to preventing microbial ingress and minimizing exposure to hazardous drugs.

Missing Information (Not available in the provided text):

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "performance data" in the context of substantial equivalence but does not provide details on specific studies, sample sizes, or data provenance.
2. 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 for this type of device and submission. There isn't "ground truth" established by experts in the sense of image interpretation or diagnosis. The "ground truth" here would be objective physical and chemical tests verifying the device's functionality.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there's no human adjudication of results in the traditional sense for this device. Performance is measured through empirical tests.
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: Not applicable. This is a physical medical device, not an AI-powered diagnostic tool engaging human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" would be established through objective laboratory testing against specified standards (e.g., measuring microbial ingress, assessing leak-proof connections, verifying pressure equalization, physical integrity tests for sharps protection). The document refers to adherence to ISO standards (e.g., ISO 22413:2010 for transfer sets, ISO 10993 for biocompatibility).
7. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable. This is a physical medical device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states that the Equashield System Generation 2, its accessories, and components follow FDA recognized consensus standards. This implies that studies (tests) were conducted to demonstrate compliance with these standards. The specific standards listed are:

• ISO 594-1:1998, ISO 594-2:1998 (Luer fittings)
• ISO 7886-1:1993 (Sterile hypodermic syringes)
• ISO 8536-4:2010 (Infusion equipment, gravity feed)
• ISO 10993-1:2009, ISO 10993-4:2002, ISO 10993-5:2009 (Biological evaluation)
• ISO 14971:2007 (Risk management)
• ISO 22413:2010 (Transfer sets for pharmaceutical preparations)
• ISO 23908:2011 (Sharps injury protection)

The document explains that "Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects." This comparison, along with adherence to recognized standards, forms the basis of their claim for substantial equivalence and, by extension, meeting the necessary performance expectations for safety and effectiveness. However, detailed results of these performance studies or comparisons are not provided in this summary.

Ask a specific question about this device