(68 days)
The Direct Antibiotic Infusion Kit is intended for direct administration of mediation and/or fluids into the body. The Direct Antibiotic Infusion kit is intended for use by a physician or by a trained individual under the supervision of a physician. Any drug(s) used with this kit is (are) at the discretion of the physician and the indications for the drug should be verified and followed.
The Direct Antibiotic Infusion kit product line is a convenience kit for doctors. The Direct Antibiotic Infusion kit is designed to allow a physician or heath care provider to have the devices needed to administer antibiotics. The Direct Antibiotic Infusion kit consists of the following components: 1. Short or long term in-dwelling Catheter. 2. Suture. 3. Tubing anchor. 4. Tegaderm dressing. 5. Providone Iodine 10% ointment
The provided text describes a 510(k) premarket notification for a medical device called the "Direct Antibiotic Infusion Kit" by Summit Medical Products, Inc. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or specific study designs (like MRMC or standalone performance).
The document is a communication from the FDA regarding the "substantial equivalence" of the device to existing predicate devices. It focuses on regulatory aspects, classification, and general controls, noting that there is "no substantial equivalence for the Direct Antibiotic Infusion kit" but then states the FDA has reviewed the 510(k) and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This apparent contradiction might be explained if components of the kit are individually substantially equivalent, even if the kit as a whole has no direct equivalent.
Crucially, the FDA's letter states: "Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component." This indicates that the Povidone Iodine 10% Ointment, a drug component, falls under a different regulatory pathway.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because this document does not contain that level of detail about device testing. The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than requiring new, extensive performance studies that would typically be described with the requested metrics.
If this were a document about a new algorithm or AI device, it would be expected to include such detailed performance metrics. As it stands, this is a regulatory clearance document for a medical kit.
§ 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.”