(434 days)
The TK 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 TK Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap.
The provided document is a 510(k) summary for the "TK Intravascular Administration Set". This document primarily focuses on establishing substantial equivalence to a predicate device (U&U Intravascular Administration Set, K151151) rather than detailing a specific clinical study with acceptance criteria and reported device performance directly.
The document lists "Non Clinical Performance Testing" and references various ISO standards and FDA guidance documents. These standards likely define the acceptance criteria for physical, chemical, and biological properties of the device. However, the document does not explicitly list a table of acceptance criteria alongside reported device performance for these non-clinical tests. It states that evaluations were performed using industry consensus standards and evaluated per the performance requirements of the device, and that the results for pyrogenicity and sterility were in line with requirements.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary, as it is a premarket notification for a Class II medical device focused on substantial equivalence to a predicate, not a detailed clinical study report.
However, I can extract the information that is present and indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not provide a table with explicit acceptance criteria and corresponding reported performance results for a device study. Instead, it outlines the non-clinical tests performed to demonstrate substantial equivalence to the predicate device, relying on compliance with recognized standards.
Implicit Acceptance Criteria (based on referenced standards) and Partial Reported Performance:
| Feature/Test | Acceptance Criteria (Implicitly from Standards) | Reported Device Performance (Partial) |
|---|---|---|
| Pyrogenicity | ) | In line with USP requirements: No microbial growth was observed. (Same as predicate) |
| Biocompatibility | Compliance with ISO 10993-1, -4, -5, -10, -11 | Tested per these standards, but specific results/acceptance criteria for each sub-test are not detailed in this summary. |
| Packaging Integrity | Compliance with ISO 11607-1, 11607-2, ASTM F1980, F1929, F88 | Tested per these standards, but specific results/acceptance criteria for each sub-test are not detailed in this summary. |
| EO Residuals | Compliance with ISO 10993-7 | Tested per this standard, but specific results/acceptance criteria are not detailed in this summary. |
| Particulate Matter | Compliance with USP 788 | Tested per this standard, but specific results/acceptance criteria are not detailed in this summary. |
| Functional Performance | Compliance with ISO 8536-4, ISO 80369-7, ISO 80369-20 (e.g., flow rate, connection integrity) | Tested per these standards, but specific results/acceptance criteria are not detailed in this summary. The summary states "evaluation were performed using industry consensus standards and evaluated per the performance requirements of the device." |
| Shelf Life | Demonstrated stability over 3 years (based on ASTM testing) | 3 years (Evaluated per ASTM testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) of the device components and entire product in China, performed by the manufacturer, Anhui Tiankang Medical Technology Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as this is a 510(k) summary for a Class II medical device, focusing on non-clinical performance and substantial equivalence. There is no mention of a "test set" requiring expert-established ground truth in a clinical context. The "ground truth" for the non-clinical tests would be the established scientific/engineering principles and performance requirements outlined in the referenced ISO standards.
4. Adjudication Method for the Test Set
- Not applicable. As described above, there is no clinical "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems where human readers interpret patient cases. The "TK Intravascular Administration Set" is a physical medical device (infusion set), and a clinical study with human readers would not be relevant in this context.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical administration set, not an algorithm or AI-powered system that would have a "standalone" or "human-in-the-loop" performance.
7. Type of Ground Truth Used
- The "ground truth" for the non-clinical performance evaluations described (biocompatibility, sterility, pyrogenicity, etc.) is based on recognized international standards (e.g., ISO, ASTM, USP) and FDA guidance documents. These standards define the acceptable limits and methodologies for testing.
8. Sample Size for the Training Set
- Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The product design and manufacturing processes are likely informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as 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.