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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.

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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, 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.

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The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system.

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.

The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, Y-site, tubing, clamp, needless injection site, 'twist-off' and Luer connection.

The purpose of this Special 510(k) is to add the following two new designs of IV Administration Sets to the one already cleared for sale in the US under K121269:

• TEVADAPTOR Connecting Set with ULTRASITE Injection Site
• TEVADAPTOR Spike Port Adaptor with ULTRASITE Injection Site

All components used in the two new Administration Sets were used in the predicate device cleared under K121269, except for two, which are identical to components cleared under K071741.

This document is a 510(k) summary for a "Special" submission regarding Teva Medical I.V. Administration Sets, dated May 16, 2014. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K121269) rather than presenting a study with specific acceptance criteria and performance data for a novel device.

Therefore, the requested information, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training data details, are not explicitly provided or applicable in the context of this 510(k) Special submission.

Here's an explanation based on the provided text:

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

• This document does not present a table of quantitative acceptance criteria and reported device performance in the way that would typically be seen for a new device's efficacy or accuracy study.
• Instead, the submission aims to demonstrate "substantial equivalence" of modified I.V. Administration Set designs to a predicate device. The "performance" assessment is qualitative, focusing on whether changes have a significant effect on safety and effectiveness.

2. Sample sized used for the test set and the data provenance:

• Not applicable / Not explicitly stated. This submission is not based on a new clinical or laboratory study with a defined "test set" in the traditional sense. It's a "Special 510(k)" which usually relies on a comparison to an already cleared predicate device, and verification/validation activities performed under the manufacturer's quality system.

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

• Not applicable. There is no "ground truth" establishment by external experts described for a test set in this kind of regulatory submission. The evaluation is conducted internally by the manufacturer against regulatory standards and comparison to a predicate.

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

• Not applicable. As there is no external "test set" in the context of a clinical study, there is no adjudication method 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:

• Not applicable. This document pertains to an I.V. Administration Set, which is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant to this submission.

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

• Not applicable. This is not an algorithmic or software device.

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

• The "ground truth" in this context is the safety and effectiveness profile of the predicate device (K121269), which has already been cleared by the FDA. The submission's "truth" is that the new designs are equally safe and effective.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device and therefore does not have a "training set."

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

• Not applicable. See point 8.

Summary of Device and Acceptance Criteria (as implied by a Special 510(k)):

The core "acceptance criteria" for a Special 510(k) is the demonstration of Substantial Equivalence (SE) to a predicate device. This means showing that the modified device is as safe and effective as the legally marketed predicate. For a Special 510(k), this typically involves:

• No new Indications for Use: The current device maintains the same intended use as the predicate. (Stated as identical).
• Fundamental Technology: The core operational principle remains the same. (Stated as identical).
• Performance (Safety and Effectiveness): Any changes in design, materials, or features do not adversely affect safety or effectiveness. This is assessed through internal verification and validation activities under the manufacturer's quality system (21 CFR 820). The document states: "none of the changes from the predicate device have been identified as having any significant effect on safety and effectiveness compared with the original FDA-cleared device. Where verification/validation of applicable changes was required, these have been carried out under the control of Teva Medical's quality system."
• Biocompatibility, Sterilization, Single-use only, Interconnecting features, Interaction with patient and other devices, Safety features: These aspects are stated as identical to the predicate.

Differences Noted:

• Shorter lengths of devices.
• No drip chamber, flow control, or air venting in new devices.
• Addition of a twist-off component in one device.
• Changed labeling.
• Changed packaging materials and process.

The document implicitly states that these differences were evaluated under the quality management system and found to not raise any additional safety and effectiveness issues, leading to the conclusion of substantial equivalence.

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