(89 days)
The kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above.
The subject kit contains a long term, single use, single or dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It also contains drugs and devices for preparing the insertion site, placing the catheter, securing the catheter and dressing the site.
This document (K964048) is a 510(k) Premarket Notification for a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.
The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This is primarily done by comparing technological characteristics, intended use, and safety/efficacy profiles. It is not typically the place where detailed clinical performance studies proving acceptance criteria are presented in the format you've requested.
Therefore, I cannot provide the information you asked for based on the provided text. The document focuses on:
- Device Identification: Name, manufacturer, classification.
- Predicate Device: Identification of a similar, already marketed device.
- Description: Physical characteristics of the device.
- Intended Use: What the device is designed to do.
- Technological Comparison: How the new device is similar to (and differs slightly from) the predicate, emphasizing the "shorter" length as the primary difference from the "FIRST PICC™" catheter while maintaining similar materials and design.
To find information on acceptance criteria and performance studies, you would typically need to look for:
- Clinical trial reports: If a clinical study was conducted.
- Design Validation documentation: Internal company documents detailing testing and validation.
- Performance Standards: Industry or regulatory standards that the device might need to meet (though these are not explicitly listed as "acceptance criteria" for this specific device's performance in the provided text).
- Subsequent regulatory filings or literature: If the device has been studied further or evaluated after its initial clearance.
In summary, the provided K964048 document does not offer the details required to fill out your table and answer your specific questions regarding acceptance criteria and performance studies.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).