(21 days)
LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is a single use device for the delivery of fluids from a container to a patient's vascular system.
The intended use and indications for use are the same as other commercially available IV administration sets designated for use with the Omni-Flow® Medication Management Systems™. This set is not intended for gravity use.
The device is used with the Omni-Flow® Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.
The LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is designed to be used exclusively with Omni-Flow® Medication Management Systems™. The set is equipped with two pressure-activated anti-siphon valves. The two valves limit gravity flow (free flow) to 1ml per hour when the set is primed and attached to a solution bag hanging vertically at full set extension (72 inches).
The provided text is a 510(k) summary for a medical device (LifeShield® Latex-Free Primary IV Pump Set), focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert involvement, or comparative effectiveness studies for AI/algorithm-based devices).
The document is a regulatory submission for a physical medical device, not a software or AI-driven device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "standalone (i.e. algorithm only) performance," are not applicable to this type of submission.
The "study" referenced in this type of submission is typically a comparison of the new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial with acceptance criteria for performance metrics as might be found for a novel AI diagnostic tool.
However, based on the information provided, here's an attempt to answer the relevant sections:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance values for the new device against those criteria. Instead, it demonstrates substantial equivalence by comparing characteristics to a predicate device.
The closest equivalent to a performance claim and its fulfillment is regarding gravity flow protection:
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (Subject Device) |
|---|---|
| Provide gravity flow (free flow) protection at full vertical extension of the set (72 inches) limiting gravity flow to 1ml per hour (stated in description) | Limits gravity flow (free flow) to 1ml per hour when the set is primed and attached to a solution bag hanging vertically at full set extension (72 inches). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical IV administration set, not a data-driven device that would involve a test set of data. The submission relies on comparative analysis of specifications and design to a predicate device.
3. 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. There is no mention of experts or ground truth establishment for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process 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 is not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no concept of "ground truth" as relevant to data-driven performance in this submission. The "truth" is established through engineering specifications, material compatibility, and demonstrated functional equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.