(85 days)
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the anti-needlestick protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and anti-needle stick protector (ANSP).
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety device used to administer solutions to surgically implanted ports. The device was modified from a previously cleared version (K123344), with minor enhancements to strengthen the safety device feature, improve the gripping point for easy cannulation, and reduce the bulkiness of the needle cap.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Bench Tests | ||
| Transportation | Pass (ISTA 2A) | Pass |
| Packaging test - Seal strength | Pass (ISO 11607-1:2006 (Amd 2014)) | Pass |
| Packaging test - Dye penetration test | Pass (ISO 11607-1:2006 (Amd 2014)) | Pass |
| Visual inspection | Pass (In-house standard) | Pass |
| Functionality of Anti-needle stick protector (ANSP) | Pass (In-house standard) | Pass |
| Test for tensile strength (ISO 8536-4) | Pass (ISO 8536-4:2010 (Amd 2013)) | Pass |
| Test for tensile strength (In-house) | Pass (In-house standard) | Pass |
| Test for tensile Strength (ISO 7864) *Cannula and hub | Pass (ISO 7864:2016) | Pass |
| Leak test | Pass (ISO 8536-9:2016) | Pass |
| Chemical test | Pass (ISO 8536-4:2010 (Amd. 2013)) | Pass |
| Needle Cap Evaluation (Cap functionality) | ||
| Cap Removal Force | The removal resistance of straw cap is lower than T-cap (In-house criteria). (No cap detachment during transportation). | Conforms (Lower force for straw cap; no detachment during transportation). |
| Simulated Use Testing (Sharps Injury Prevention) | Proper activation of ANSP for effective samples. (Implied: Meets or exceeds the pre-defined acceptance criteria). | For all effective samples (n=599), proper activation of ANSP was observed. This result exceeds the pre-defined acceptance criteria. |
2. Sample Size and Data Provenance (Test Set):
- Needle Cap Evaluation: N=30 for each cap type (straw cap and T-cap). The data provenance is not explicitly stated but is implicitly from bench testing conducted by Kawasumi Laboratories, Inc.
- Simulated Use Testing: N=599 "effective samples." Data provenance is from simulated use testing conducted by Kawasumi Laboratories, Inc.
3. Number of Experts used to establish the ground truth for the test set and their qualifications:
This information is not provided in the document. The tests performed are primarily bench and simulated use tests based on established international and in-house standards, not expert assessments of performance.
4. Adjudication method for the test set:
This information is not applicable as the tests are objective measurements against defined criteria, not subjective human assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (infusion set), not an imaging or diagnostic AI device that would typically involve human readers.
6. Standalone (algorithm only without human-in-the-loop performance) study:
No, a standalone study was not done. This refers to algorithmic performance, which is not relevant for a physical medical device. The "standalone" concept applies to AI/software as a medical device (SaMD).
7. Type of ground truth used (test set):
The "ground truth" for the test set is established by objective technical standards and in-house criteria for physical performance characteristics (e.g., tensile strength, leak test, cap removal force) and functional activation (ANSP). For the simulated use testing, the ground truth is the observable proper activation of the ANSP.
8. Sample size for the training set:
This information is not applicable. This device is a physical product, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for a physical medical 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.