(67 days)
The ToxiSeal™ Vial Adaptor mechanically prohibits environments from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.
The ToxiSeal™ Vial Adaptor devices are single-use, sterile, non-pyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. Changes proposed in this Special 510(k) Submission are as follow: Removed external balloon and added activated carbon filter.
The provided document is a 510(k) summary for the ToxiSeal™ Vial Adaptor (K241823). It describes the device, its intended use, a comparison to a predicate device, and performance data supporting its substantial equivalence. However, the document does not contain information about an AI/software device or a comparative effectiveness study involving human readers with and without AI assistance.
Therefore, I cannot provide information for points 5, 8, and 9 of your request as they are not present in the document.
Based on the available information regarding the medical device itself (ToxiSeal™ Vial Adaptor), here's the information related to acceptance criteria and the studies conducted:
The ToxiSeal™ Vial Adaptor is a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are related to its functional performance, biocompatibility, and sterility, rather than AI performance metrics.
Acceptance Criteria and Device Performance (for a physical device)
The document outlines the various tests performed to demonstrate the device's conformance to recognized standards. The "acceptance criteria" are implied by the conformance to these standards and the findings that the device "met the acceptance criteria therein" or "did not raise any new or different questions of safety or effectiveness."
Here's a table summarizing the acceptance criteria (standards/tests) and the reported device performance.
| Category | Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|---|
| Functional Performance | - ISO 8536-2:2010 (Infusion equipment for medical use – Part 2: Closures for infusion bottles) - Evaluated to be in conformance. | |
| - ISO 8536-4:2019 (Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed) - Evaluated to be in conformance. | ||
| - ISO 8871-5:2016 (Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing) - Evaluated to be in conformance. | ||
| - ISO 22413:2021 (Transfer sets for pharmaceutical preparations – Requirements and test methods) - Evaluated to be in conformance. | ||
| - Leak integrity testing (air- and liquid-tightness) per ISO 8536-4:2019, paragraph 7.2 and Annex A.3 - Performed successfully on both Subject and predicate devices; differences in design (activated carbon filter, no external balloon) "did not raise any new or different questions of safety or effectiveness." | ||
| - Fragmentation study to ISO 22413 & ISO 8871-5 - Performed successfully on predicate device (K241476), implying substantial equivalence for the subject device. | ||
| - Vial Adaptor penetration force testing to ISO 22413 - Performed successfully on predicate device (K241476), implying substantial equivalence for the subject device. | ||
| - Tests for leakages to ISO 8536-4:2019, Annex A.3.3 - Performed successfully on the Subject device; differences in design "did not raise any new or different questions of safety or effectiveness." | ||
| - Testing to (draft) NIOSH CSTD Test Protocol and NIOSH 2016, Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs - Performed successfully on the Subject device and a previously cleared device (K222929); differences in design "did not raise any new or different questions of safety or effectiveness." | ||
| - Microbial ingress/ microbiological integrity testing - Conducted successfully on a previously cleared device (K222929), indicating prevention of microbial contamination for up to 168 hours (7 days). | ||
| Biocompatibility | - ISO 10993-1: 2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) - Classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). - Referencing previous successful testing on existing devices of the ProSeal™ CSTD system (K192075, K192075/S001, K222929) for: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), 14-day Subacute/ Subchronic Acute Systemic Toxicity (ISO 10993-11), In-vitro Hemolysis Assessment (ISO 10993-4), Material Mediated Pyrogenicity (ISO 10993-11), Chemical Characterization and Toxicological Risk Management (ISO 10993-18 and ISO 10993-17). The subject device is deemed biocompatible based on these references. | |
| - USP Particulate Matter in Injections - Testing conducted on devices under K192075 and K222929, and "found to have met the acceptance criteria therein." This performance is leveraged for the subject device. | ||
| Sterility & Shelf-Life | - ISO 11135:2014 (Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices) - "Comply with sterilization requirements." | |
| - Package Integrity Tests per ASTM F1980-21 (Standard guide for accelerated aging of sterile barrier systems for medical devices), ASTM F88/F88M-21 (Seal strength), ASTM F1929-23 (Dye Penetration), EN 868-5:2009 (Heat and self-sealable pouches and reels) - Performed on the proposed device (referencing K222929) and ensure package integrity. | ||
| - Pyrogen Tests per ANSI/AAMI ST72/2019, USP 40, USP-NF , USP-NF - Conducted under K222929, with testing to be conducted on every lot. | ||
| - Validated shelf-life using ASTM 1980-21 - A shelf-life of 3 years (36 months) has been validated. |
Now addressing the specific points of your request based on the provided document:
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A table of acceptance criteria and the reported device performance
- See the table above. Note that for a physical medical device, "acceptance criteria" are typically defined by conformance to established performance standards and successful completion of specified tests.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Sizes: The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for leak integrity, biocompatibility, etc.). It mentions that tests were "performed on the Subject devices," "on devices under K241476," or "on device under K222929," implying samples were used from these device types.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, the data would typically be generated by the manufacturer or contract labs following international and US standards. The studies, being part of device verification and validation prior to market clearance, are generally prospective in nature for the tests conducted on the subject device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this type of medical device submission. Ground truth established by experts (like radiologists for imaging AI) is relevant for diagnostic accuracy studies of software/AI. For a physical device like a vial adaptor, the "ground truth" is based on objective measurements against established engineering and biological standards. There are no human "experts" establishing a diagnostic ground truth here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This question is not applicable as there is no diagnostic test set or human interpretation being adjudicated. The tests are quantitative and involve laboratory measurements.
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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 describes a physical medical device, not an AI software. No MRMC study was conducted or is relevant for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm/AI device. The device's performance is standalone in the sense that its mechanical and biological properties are tested independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device is the objective measurement of physical properties, chemical properties, and biological safety against predefined engineering, material, and biocompatibility standards. Examples include:
- Meeting specific leakage rates.
- Absence of fragmentation.
- Demonstrating specified penetration force.
- Absence of microbial ingress.
- Absence of cytotoxicity, sensitization, systemic toxicity, pyrogenicity, and meeting particulate matter limits.
- Maintaining sterility over shelf-life.
- It's based on quantitative laboratory testing results compared to acceptance criteria defined by recognized standards (ISO, ASTM, USP, NIOSH).
- The "ground truth" for this medical device is the objective measurement of physical properties, chemical properties, and biological safety against predefined engineering, material, and biocompatibility standards. Examples include:
-
The sample size for the training set
- Not applicable. This is not an AI/machine learning device; there is no "training set."
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How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this question does not apply.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.