(175 days)
The indication for use is when the patient's condition requires the peripheral intusio
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Peripherally Inserted Central Catheter.
This 510(k) submission (K964929) describes a Peripherally Inserted Central Catheter (PICC) and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about the performance of an AI/ML powered device, nor does it detail a study that establishes acceptance criteria for such a device. Instead, it describes general safety and effectiveness testing for a medical device.
Therefore, many of the requested sections regarding acceptance criteria for an AI device, specific study designs, data provenance, expert ground truth, and comparative effectiveness studies cannot be answered from the provided text.
Here's an attempt to answer the applicable sections based only on the provided text, while making it clear where the information is not present or not relevant to AI/ML device performance.
Acceptance Criteria and Study for K964929 (Peripherally Inserted Central Catheter)
This 510(k) submission is for a conventional medical device (Peripherally Inserted Central Catheter) and not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, ground truth, and specific study designs for AI systems is not present in the provided text. The "acceptance criteria" and "device performance" described relate to the physical and functional characteristics of the catheter, not an algorithm's output.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with quantitative performance metrics for an AI/ML component. Instead, it states that "All finished products are tested and must meet all required release specifications before distribution." and lists general categories of testing:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Suitability | Materials tested according to ISO Standard 10993; suitable for intended use. |
| Physical Testing | Meets defined Quality Control Test Procedure documents and product design specifications. |
| Visual Examination | Meets required standards during in-process and finished product inspection. |
| Sterility & Biocompatibility | (Implied by ISO 10993 and general medical device standards, but not explicitly detailed as a performance metric in the text beyond material suitability) |
2. Sample size used for the test set and the data provenance
Not applicable to an AI/ML powered device. For this physical device, testing is conducted on "all finished products" before distribution, indicating a 100% inspection or testing rate for release. The data provenance is intrinsic to the manufacturing process of the medical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to an AI/ML powered device. The "ground truth" for this device relates to its physical properties and functionality, verified through standardized tests and design specifications rather than expert interpretation of data.
4. Adjudication method for the test set
Not applicable to an AI/ML powered device. The "adjudication method" for this device involves established testing procedures and parameters defined by Quality Control Test Procedure documents, with approval, release, and revision in accordance with GMP's.
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
No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML powered device.
7. The type of ground truth used
For this medical device, the "ground truth" is based on:
- Compliance with ISO Standard 10993 for material biocompatibility.
- Adherence to product design specifications.
- Fulfillment of Quality Control Test Procedure documents.
- Results from physical testing and visual examinations.
8. The sample size for the training set
Not applicable, as this is not an AI/ML powered device. There is no concept of a "training set" for a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML powered device.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”