(255 days)
The Triton Medical TMed IV-Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a ven. The device is for prescription use only.
Depending on configuration, the device may include the following; protective cap(s), drip chamber, tubing, back check valve(s), anti-siphon valve, needle free Y-site, roller clamp, 0.22 micron filter or 1.2 micron filter, male Luer lock, spike, and medi-hook.
This 510(k) summary (K073444) for the Triton Medical TMed IV-Set indicates that the device is considered substantially equivalent to a predicate device (Dragon Heart Intravascular Administration Set, K043235) based on a comparison of technical characteristics and manufacturing processes. It does not describe a study that establishes acceptance criteria through performance testing with a specific test set.
Instead, the submission argues for substantial equivalence because:
- The device is manufactured by the same manufacturer (Dragon Heart Medical Device Co., Ltd) as the predicate.
- It is made from the same materials.
- It is built to the same specifications as the predicate.
- Therefore, any testing performed on the predicate would be identical for this device, and no new tests or clinical studies were deemed necessary.
Given this, the requested information elements related to performance criteria, test sets, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.
Here's a breakdown of the requested information based on the provided document:
- Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy.
- Reported Device Performance: No quantitative performance metrics are reported. The document states, "The device is the same device as the predicate. It is manufactured by the same manufacturer, from the same materials, and to the same specifications as the predicate. Any testing is identical." This implies its performance is considered the same as the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially Equivalent to predicate device (K043235) in terms of safety and efficacy. | Device is identical to the predicate in manufacturing, materials, and specifications. No new questions of safety or effectiveness are raised. |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No new test set data was generated or used for this submission to demonstrate performance against acceptance criteria. The equivalence argument relies on the identity to the predicate.
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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. No ground truth establishment was performed for a new test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication method was used.
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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 device is an IV-set, not an AI-enabled diagnostic tool, and therefore no MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an IV-set, not an algorithm, and therefore standalone performance was not assessed in this context.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth was established for the purpose of a new performance study.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.