(50 days)
INFUSION OF FLUIDS, INCLUDING THOSE CONTAINING MEDICATIONS, FROM A CONTAINER TO A PORT IMPLANTED IN, OR OTHERWISE ATTACHED TO, A PATIENT TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS.
A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device K974829:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility requirements | Device meets all biocompatibility test requirements. |
| Pyrogenicity requirements | Device meets all pyrogenicity test requirements. |
| Limulus Amebocyte Lysate ("LAL") Test (USP XXII) | Device meets the LAL test described at "(85) Bacterial Endotoxins Test", USP XXII, pp 1493-1495. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The document only mentions that Kawasumi Laboratories "conducted biocompatibility tests on the body fluid contacting material portions of the device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not contain information regarding the number of experts used to establish ground truth or their qualifications. The studies mentioned are laboratory tests (biocompatibility, LAL) and do not appear to involve expert-driven ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
The provided text does not contain information regarding an adjudication method. The tests described are objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence to a predicate device based on material characteristics and basic safety tests, not on improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device is an "Infusion Set," which is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm study is not applicable and was not performed.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established through objective laboratory tests, specifically:
- Biocompatibility tests: These typically involve in-vitro and sometimes in-vivo toxicology assessments against established ISO standards or similar guidelines.
- Pyrogenicity testing: This refers to the LAL test, which is a standardized method to detect bacterial endotoxins.
8. The Sample Size for the Training Set
The provided text does not contain information regarding a training set sample size. As the device is not an AI/ML algorithm, the concept of a "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
As the device is not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it is not applicable. The "ground truth" for the device's safety and performance was established through the aforementioned laboratory tests on the device materials.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.