(72 days)
The Adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support.
The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors.
The materials used in the manufacturing of these adapters includes polycarbonate, acrylic, and Acrylonitrile-Butadiene-Styrene (ABS). The cleared Medtronics adapters are comprised of plexiglas and Note: polyvinyIchloride.
The provided text describes a 510(k) submission for medical device adapters, focusing on demonstrating substantial equivalence to previously cleared devices rather than a typical performance study with acceptance criteria and reported metrics for a new, innovative device.
Therefore, the requested information elements (1-9) which typically relate to a performance study for a novel device, are not directly applicable or available in this document.
Instead, the document highlights:
- Intended Use: The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
- Device Description: Various generic types of adapters (straight, large bore, three-way, four-way) made from polycarbonate, acrylic, and ABS.
- Substantial Equivalence Claim: The adapters are substantially equivalent in intended use, design, technology, principles of operation, materials, and performance to the cleared Medtronics "Y" adapter (K790563) and Medtronics 3/16″ Large Bore Male adapter (K830728).
- Validation of Safety Aspects:
- Sterilization conditions validated according to AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10-6.
- Ethylene oxide residuals will not exceed maximum limits.
- Blood contacting materials tested for biocompatibility according to FDA General Program Memorandum #G95-1 (ISO-10993 Part 1) for External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours).
- Expiration dating controlled by the shortest expiry component in a kit or two years, whichever is shorter.
The core of this submission is the argument that differences in design and materials raise no new issues of safety and effectiveness, and that the performance is substantially equivalent to the predicate devices. There is no independent performance study described with specific acceptance criteria in terms of clinical metrics (e.g., accuracy, sensitivity, specificity) for this type of component.
To directly answer your numbered points:
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A table of acceptance criteria and the reported device performance: Not applicable. The "acceptance criteria" here are demonstrating substantial equivalence and meeting safety standards (sterilization, biocompatibility, residuals), not achieving specific performance metrics in a clinical trial. The "reported device performance" is essentially that it performs equivalently to the predicate devices and meets safety standards.
- Acceptance Criteria for Substantial Equivalence:
- Intended use is the same as the predicate device.
- Technological characteristics are the same as the predicate device, OR technological characteristics are different but do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate device.
- Reported Device Performance (based on 510(k) claim):
- Performance is "substantially equivalent" to Medtronics adapters.
- Sterilization: SAL of 10-6 achieved.
- Ethylene oxide residuals: Will not exceed maximum limits.
- Biocompatibility: Blood contacting materials found to be biocompatible per ISO-10993.
- Expiration dating: Controlled by shortest expiry component or two years.
- Acceptance Criteria for Substantial Equivalence:
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Sample sized used for the test set and the data provenance: Not applicable. No test set for performance comparison in the traditional sense is described. The "testing" refers to safety validations (sterilization, biocompatibility).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of submission relies on established safety guidelines and direct comparison to predicate devices, not expert-adjudicated ground truth for a test set.
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Adjudication method: Not applicable.
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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 is not about AI assistance or human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (adapters), not an algorithm.
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The type of ground truth used: For safety aspects, the ground truth is established by recognized standards (AAMI, FDA GPM #G95-1, Federal Register regulations) for sterilization, residuals, and biocompatibility. For "performance," the ground truth is the established performance of the predicate devices.
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The sample size for the training set: Not applicable. No training set for an algorithm is involved.
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How the ground truth for the training set was established: Not applicable.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.