(134 days)
An intravascular administration set intended to administer fluids from a fluid container (IV bag) to a patient's vascular system through a needle or catheter inserted into a vein.
AnesFlow™ Dual Drip Intravenous Infusion Set is an intravenous infusion set incorporating two drip chambers of different flow characteristics (micro and macro drip chambers), intended to provide the operator with a greater flexibility of controlling the intravenous fluids infusion rate (i.g., slow rate through the micro-drip and/or fast rate through the macro-drip).
Acceptance Criteria and Device Performance for AnesFlow™ Dual Drip Intravenous Infusion Set (K990496)
This 510(k) summary for the AnesFlow™ Dual Drip Intravenous Infusion Set focuses on establishing substantial equivalence to predicate devices rather than proving specific device performance criteria through a dedicated study with pre-defined acceptance criteria. The submission aims to demonstrate that the new device is as safe and effective as legally marketed predicate devices. Therefore, the information provided primarily addresses the functional equivalence and intended use alignment.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicit, quantifiable "acceptance criteria" presented as one might find in a performance study for a novel device. Instead, the "performance" is implicitly deemed acceptable if the device aligns with the predicate devices in its intended use and fundamental operating principles.
| Feature / Criterion | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|---|
| Intended Use | Administration of intravenous (IV) fluids from a fluid container to a patient's vascular system. | "Disposable device, intended for administration of intravenous (IV) fluids." |
| Basic Functionality | Ability to safely and effectively administer IV fluids. | "intravenous infusion set incorporating two drip chambers of different flow characteristics (micro and macro drip chambers), intended to provide the operator with a greater flexibility of controlling the intravenous fluids infusion rate..." |
| Flow Characteristics (Micro-drip) | Should be comparable to existing micro-drip IV sets (e.g., 60 drops/ml). | Incorporated a "60 drop" chamber, similar to predicate device #1. |
| Flow Characteristics (Macro-drip) | Should be comparable to existing macro-drip IV sets (e.g., 15 drops/ml). | Incorporated a "15 drops/ml" chamber, similar to predicate devices #2 and #3. |
| Fluid Infusion Rate Control | Should allow for controlled infusion rates. | "provide the operator with a greater flexibility of controlling the intravenous fluids infusion rate (i.g., slow rate through the micro-drip and/or fast rate through the macro-drip)." |
| Safety | No new safety concerns identified compared to predicate devices. | Implicitly deemed safe through substantial equivalence to legally marketed devices. |
| Material/Design Characteristics | Materials and design should be suitable for IV fluid administration and compatible with existing standards. | "Although the physical characteristics differ among the devices, the devices are substantially functionally equivalent in their intended use for administering IV fluids." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific test set or a study with a defined sample size for the AnesFlow™ device itself. The submission relies on the established safety and efficacy of the predicate devices. Therefore, there's no information on:
- Sample size: Not applicable, as no new performance study data is presented.
- Data provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As no new performance study was conducted for the AnesFlow™ device, there was no need for experts to establish a "ground truth" for a test set. The substantial equivalence argument relies on the well-established clinical use and regulatory approval of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No new test set data was presented or adjudicated.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is rarely required for 510(k) submissions focusing on substantial equivalence for devices like IV sets, as they generally don't involve interpretation tasks by multiple readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The AnesFlow™ device is a medical device (intravenous infusion set), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the legally marketed predicate devices. The claim of substantial equivalence means that the AnesFlow™ device is considered as safe and effective because its intended use, fundamental technological characteristics, and performance are similar to devices already found acceptable by the FDA.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-driven device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of 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.