(248 days)
The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.
The K-Shield Port Access Infusion Set with High Pressure Tubing is a sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The set can withstand injection pressures to 300 psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors.
Here's an analysis of the acceptance criteria and study information for the Kawasumi Laboratories Port Access Infusion Set with High Pressure Tubing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical testing data to determine the safety and effectiveness of the high-pressure tubing and its substantial equivalence to predicate devices. The acceptance criteria are implied by the "Pass" result for each test, indicating the device successfully met the established standards.
| Test Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material/Design Integrity: | |
| ISO 8536-4 Compliance (likely general infusion set standards) | Pass |
| ASTM D2240 -05 (likely standard for durometer hardness of rubber) | Pass |
| ISO 594-2: 1998 (likely conical fittings with a 6% taper) | Pass |
| ASTM F 1929 -98 (likely standard for detecting an open seal) | Pass |
| EN-868-5 (likely standard for sterilisation packaging) | Pass |
| ASTM F 1608-00 (likely standard for sterile barrier systems) | Pass |
| High Pressure Performance: | |
| ISO 8536-4: additional Pressure Testing (withstand specified pressure) | Pass |
| ISO 8536-4: tubing elongation testing (maintain integrity under elongation) | Pass |
| ISO 8536-4: Maximum tubing pressure (withstand maximum specified pressure) | Pass |
| Kawasumi internal test to validate flow rate (achieve specified flow rate) | Pass |
| Kawasumi internal test to validate pinch clamp pressure (maintain integrity under pinch clamp pressure) | Pass |
| Packaging/Sterility: | |
| ISTA (International Safe Transit Association) 2A Transportation Test 2008 (maintain integrity during transport) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for each specific test. For non-clinical tests like material and performance evaluations, typically multiple samples are subjected to each test.
- Data Provenance: The tests were performed internally by Kawasumi Laboratories, or according to international standards (ISO, ASTM, ISTA, EN). The country of origin for the studies is implied to be Japan, where Kawasumi Laboratories, Inc. is based, or potentially other locations if testing was outsourced. The data is retrospective in the sense that it was generated prior to the 510(k) submission, but it represents prospective testing conducted to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This section is largely not applicable as the studies described are non-clinical engineering and materials tests, not studies involving human subjects or expert assessment of clinical images/diagnoses. The "ground truth" for these tests is defined by the specific parameters and requirements of the international standards (e.g., ISO, ASTM) and Kawasumi's internal validation protocols. No human experts were involved in establishing "ground truth" in the way understood for medical diagnostic devices.
4. Adjudication Method for the Test Set:
This section is not applicable as the tests are objective, pass/fail engineering and material science evaluations against defined standards. There is no subjective interpretation or need for 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:
This is not applicable. The device is an infusion set with high-pressure tubing, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study was conducted, and the concept of "human readers improve with AI" does not apply.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device (infusion set), not an algorithm or software. No standalone algorithm performance study was done.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests is based on:
- Defined Standards and Specifications: The reference to ISO, ASTM, ISTA, and EN standards indicates that the ground truth is the performance criteria established within these internationally recognized specifications.
- Engineering Specifications: Kawasumi's internal tests (flow rate, pinch clamp pressure) would have had pre-defined, measurable specifications as their ground truth.
- Essentially, the ground truth is quantifiable, objective measurements against established benchmarks for material properties, pressure resistance, and functionality.
8. The Sample Size for the Training Set:
This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are validated against established engineering principles and standards.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the reasons stated above. The "ground truth" for the device's design and manufacturing is established through adherence to recognized engineering standards, material science principles, and quality control processes, not through a "training set" with established ground truth in the AI sense.
§ 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.