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510(k) Data Aggregation
(575 days)
The Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
Diana ChemoLock Transfer Set is intended for use with the Diana Compounding System. It is a disposable, single use ancillary device for Pharmacy Compounding Devices (PCD).
The transfer set is comprised of multiple components bonded together to form a single device. These components include the following: stopcock, tubing, ChemoLock, syringe, and cassette handle. When placed in the Diana Compounding System, the Diana ChemoLock Transfer Set allows the transfer of fluids from one container to the other container for reconstitution of lyophilized drug or transfer of stock drug solution to prepare medications.
The purpose of this submission is to release a new closed system transfer device (CSTD) drug transfer set to be used with Diana Pharmacy Compounding System
The provided text describes a 510(k) premarket notification for the Diana ChemoLock Transfer Set, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and performance data for a standalone AI/algorithm device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text. The document details various functional and safety tests performed on the device to ensure its performance and safety, but these are not presented as "acceptance criteria" in the context of an AI/algorithmic performance study.
Here's what can be extracted, framed as general performance data rather than specific acceptance criteria for an AI/algorithm:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list acceptance criteria in a tabular format with corresponding reported performance for AI/algorithmic measures. Instead, it lists various performance tests conducted.
| Test Category | Description of Test Conducted |
|---|---|
| Functional Testing | Demonstrated functionality of ChemoLock, stopcock, tubing, syringe, and cassette handle. Included: Fluid Flow, Accuracy Testing, Positive Pressure, Chemical Compatibility, Internal Seal Integrity, Stopcock Handle Torque, Component Bond Strength Testing, Visual Inspection. (Follows FDA guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)]") |
| Packaging Integrity and Shelf Life | Conducted according to ASTM D4169, ASTM F1980, ASTM F2096, and ASTM F88 standards. |
| Biocompatibility | Evaluated according to FDA Guidance and ISO 10993-1. Included: Hemocompatibility, Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity. |
| Microbial Ingress Testing | Demonstrated that the needless access site maintains physical integrity and prohibits environmental contaminant transfer after access. (Consistent with FDA guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)]") |
| Emission, Dry Disconnection, and CSTD Hazardous Drug Exposure Evaluation | Performed to validate no escape of drug from the device outside the closed system. |
| Particulates | Testing performed following USP (method 1) to demonstrate particulate levels meet USP 788 requirements. |
| Sterility Testing | E-beam sterilization process validation conducted according to ISO 11137-1 and ISO 11137-2. Bacterial endotoxin testing conducted based on AAMI ST72 and USP , and followed FDA Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers. Achieved Sterility Assurance Level (SAL) of 10-6. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes physical and chemical testing, not a test set for an AI/algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to AI/algorithm validation, not to the functional testing of a transfer set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI/algorithm validation.
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 drug transfer set, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The testing described relies on established engineering and medical device standards (e.g., ASTM, ISO, USP, FDA guidance), rather than ground truth in the context of an AI model.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI/algorithm.
In summary, the provided document is a 510(k) submission for a physical medical device, not for an AI/algorithmic device. Therefore, the questions related to AI/algorithm performance and validation are not addressed within this text. The "performance data" section outlines various physical, chemical, and biological tests conducted to demonstrate the device's safety and functionality in accordance with relevant standards.
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(235 days)
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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