(406 days)
KDL Disposable Infusion Set is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The proposed device, KDL Disposable Infusion Set, is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The proposed device consists of protective cap, air filtration membrane, air-inlet set, closure-piercing device, drip chamber, medicine fluid filter, locked clamp, tubing, check valve, flow regulator, clamp, injection sites, two-part luer lock connector, infusion needle.
The protective cap is intended to protect the needle; the closure-piercing device is used to pierce the container; the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution; the locked clamp is used to control the flow of the medicine solution; the tubing is used to connect various components; the check valve is used to make the medicine solution flow in one direction; the flow regulator is used to adjust the flow rate from zero to maximum; there are two injection sites, one is needleless and the other is needle access, which are used to inject solution into the tubing; two-part luer lock connector is used to connect the infusion needle with the tubing; infusion needle is inserted into human vessel for medical solution transfusion and it is made of stainless steel.
It is provided EO sterilized.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KDL Disposable Infusion Set:
Based on the provided 510(k) Summary (K112204), the device is a KDL Disposable Infusion Set, which is a typically low-risk medical device. For such devices, "acceptance criteria" are usually met by demonstrating compliance with recognized international standards and proving substantial equivalence to a predicate device through non-clinical (bench) testing. There isn't typically a "study" involving human subjects or complex statistical analysis for performance metrics in the same way one would find for diagnostic AI.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| ISO 8536-4: 2010: Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed | Device complies with this standard. |
| ISO 594-1:1986: Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment, Part 1: General requirements | Device complies with this standard. |
| ISO 594-2 Second edition 1998-09-01: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. | Device complies with this standard. |
| Design Specifications: Ensure the device meets all specified design requirements. | "Bench tests were conducted to verify that the proposed device met all design specifications." |
| Substantial Equivalence: Demonstrate that the proposed device is as safe and effective as the predicate device. | "The proposed device...is determined to be Substantially Equivalent (SE) to the predicate device, BAIXINTM Intravascular Administration Set, in respect of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "bench tests." For medical devices like infusion sets, bench testing typically involves a sufficient number of units to ensure statistical confidence in the results for each specific test (e.g., fluid flow rate, leakage, strength of connections).
- Data Provenance: The tests were non-clinical (bench tests) conducted to assess compliance with international standards. The country of origin for the data generation would likely be China, where the manufacturer (Shanghai Kindly Enterprise Development Group Co., Ltd) is located, although this is not explicitly stated for the testing itself. The data is prospective for the device being tested but not in the context of human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts, especially clinical experts like radiologists, is relevant for diagnostic devices or AI algorithms where clinical interpretations are being evaluated. For an infusion set, the "ground truth" for its performance is determined by meeting the objective criteria set forth in the international standards through physical and mechanical testing.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods involving multiple experts (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretations, particularly in clinical studies for diagnostic tools. For bench testing of a physical device, the results are typically quantitative measurements and either pass or fail predetermined criteria, not subject to expert adjudication of interpretation in the same manner.
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
- This question is not applicable. MRMC studies are specifically designed for evaluating the performance of diagnostic imaging devices or AI algorithms used in conjunction with human readers. The KDL Disposable Infusion Set is a mechanical device for fluid administration, not a diagnostic tool or an AI-powered system that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The KDL Disposable Infusion Set is a physical medical device; it does not contain an algorithm or AI component to be evaluated in a standalone performance study.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is objective compliance with established international engineering and medical device standards (ISO standards). This is confirmed through physical and mechanical bench testing, where quantifiable parameters (e.g., material strength, dimensions, flow rates, luer lock integrity) are measured against predefined specifications within the standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of evaluating the device's basic functional performance for 510(k) submission.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" for the KDL Disposable Infusion Set as it is not an AI/machine learning device. The design, development, and testing process does not involve training an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #8.
§ 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.