(79 days)
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. The EXTENSION SET will provide a tubing extension to increase the length of an I.V. set or a syringe. The Extension Set consists of various parts such as: drip chamber, luer adapter/connectors, clamp, tubing, flow controller, Y-site, latex-free injection port, needleless injection port, stopcock, flashbulb, filter and manifold.
Based on the provided text, the device is the AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET. The document is a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets new acceptance criteria. The performance data presented refers to the predicate devices and the current device's compliance with established standards and internal testing.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. Instead, it refers to the predicate devices meeting "Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria." The listed "performance criteria" are general categories of tests.
| Acceptance Criteria (from predicate/Standards) | Reported Device Performance (Summary) |
|---|---|
| Closure Piercing Device (Spike) Features | Demonstrated to meet requirements (via predicate & current device testing) |
| Air Inlet Device Characteristics | Demonstrated to meet requirements (via predicate & current device testing) |
| Connector Performance (i.e. to prevent leakage) | Demonstrated to meet requirements (via predicate & current device testing) |
| Drip Chamber and Drip Tube Performance | Demonstrated to meet requirements (via predicate & current device testing) |
| Flow Regulator Performance | Demonstrated to meet requirements (via predicate & current device testing) |
| Flow characteristics | Demonstrated to meet requirements (via predicate & current device testing) |
| Tensile Strength of Connectors | Demonstrated to meet requirements (via predicate & current device testing) |
| Self-sealing injection site challenge test | Demonstrated to meet requirements (via predicate & current device testing) |
| Number of injection port access to failure for needleless port with valves, diaphragms or membrane. | Demonstrated to meet requirements (via predicate & current device testing) |
| Leakage (Vacuum Tightness and Air Tightness) for Extension Sets | "Additional testing for Leakage...was performed to demonstrate the stability of the extension set." |
| Flow Rate of Infusion Fluid for Extension Sets | "Additional testing for...Flow Rate of Infusion Fluid...was performed to demonstrate the stability of the extension set." |
| Biocompatibility (via K093773) | Meets guidelines for prolonged duration, indirect blood path containing device assessment (Cytotoxicity, Sensitization, Irritation, Systemic Cytotoxicity and Hemocompatibility testing). |
| Sterility (via K093773 and ISO 11135-1:2007) | Sterilized by Ethylene Oxide, validated per ISO 11135-1:2007. |
| Pyrogenicity (via K093773) | Tested for pyrogenicity. |
| Microbial Ingress Testing (via K093773) | Demonstrates a 4-Log reduction of gram positive organisms using proper aseptic technique. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the performance tests conducted for this submission or those referenced in the predicate devices. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The "Bench performance testing" implies laboratory testing rather than human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The performance data relates to engineering and biological testing, not diagnostic or interpretive tasks requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing described does not involve tasks requiring adjudication.
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
No such study was conducted or mentioned. This device is an I.V. administration set, not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device for fluid administration, not an algorithm. The performance testing described is for the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering performance tests (e.g., leakage, flow rate, tensile strength), the "ground truth" would be the measurable physical parameters according to the relevant ISO standards or internal AMSINO specifications. For biocompatibility, it's based on established biological safety testing protocols. For sterility, it's the absence of viable microorganisms according to validated sterilization processes.
8. The sample size for the training set
Not applicable. This device does not involve training data or machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable, as 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.