(164 days)
Administration of fluids from a container to a patient's vascular system through a cannula inserted into a vein.
The AutoStart Burette is an in-line burette used for intravenous administration of fluids (either gravitational or via an infusion pump) from a container to a patient's vascular system through a cannula inserted into a vein. This is a sterile, single-use device. The device is fitted with a float system which that allows the primary infusion to restart following addition to and dispensation of medication from the burette. There is no need to manually restart the infusion as is the case with conventional in-line burettes.
1. Acceptance Criteria and Reported Device Performance
The provided document (K092965) for the Analytica AutoStart Burette does not contain a specific table of acceptance criteria and reported device performance in the format typically seen for algorithm-based devices. Instead, it demonstrates substantial equivalence based on adherence to an FDA recognized standard and risk assessment.
Here's a breakdown of the information that can be extracted or inferred regarding performance and acceptance based on the submission:
| Acceptance Criteria (Inferred from regulatory compliance) | Reported Device Performance |
|---|---|
| Compliance with ISO 8536-5:2004 | The AutoStart Burette complies with ISO 8536-5:2004 Infusion equipment for medical use Part 5 – Burette infusion sets for single use, gravity feed – the FDA recognized safety and performance standard for these devices. |
| Equivalence of Indications for Use | Identical indications for use as the predicate device (Tuta Healthcare In-Line Burette 150mL, K023595). |
| Equivalent Materials and Components | Manufactured from medical grade polymers, equivalent to the predicate device. |
| Equivalence of Operation | Both devices are 150mL capacity, graduated, flow regulated in-line burettes. |
| No Significant New Safety Concerns | Risk assessment performed in conformance with ISO 14971:2007, and no significant new safety concerns raised by the design. |
| AutoStart Flotation Feature Functionality | The device is fitted with a float system which allows the primary infusion to automatically restart following addition to and dispensation of medication. This is a key distinguishing feature and implies performance in this aspect. |
2. Sample Size for Test Set and Data Provenance
This document is for a medical device (burette) and not an AI/algorithm-based device that would typically involve test sets of data (e.g., medical images, patient records). Therefore, the concepts of "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The evaluation is based on physical device testing and compliance with established standards, not analysis of clinical data in the traditional sense for AI.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. As this is not an AI/algorithm-based device, there is no need for experts to establish ground truth from a test set of data. The "ground truth" for this device's performance is its adherence to engineering specifications and regulatory standards.
4. Adjudication Method
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted device, so there would be no human readers improving with or without AI assistance.
6. Standalone Performance Study
Yes, in a way, standalone testing of the device's physical and functional characteristics was performed to demonstrate compliance with ISO 8536-5:2004. This standard outlines tests for various aspects of infusion sets, including:
- Flow rate consistency: Ensuring the device delivers fluids at regulated rates.
- Capacity and Graduation Accuracy: Verifying the 150mL capacity and the accuracy of markings.
- Material Biocompatibility: Assessed implicitly through the use of "medical grade polymers."
- Leakage and Integrity: Implied by meeting a safety standard.
- Functionality of the AutoStart feature: Although specific test results are not detailed, the description of the feature implies it underwent testing to ensure it works as intended.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Engineering Specifications and Design Documents: The design of the Analytica AutoStart Burette.
- Regulatory Standards: ISO 8536-5:2004 ("Infusion equipment for medical use Part 5 – Burette infusion sets for single use, gravity feed").
- Predicate Device Characteristics: The performance and safety profile of the Tuta Healthcare In-Line Burette (K023595).
8. Sample Size for Training Set
Not applicable. This is not an AI/machine learning device that requires a training set of data.
9. How Ground Truth for 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.