(72 days)
The ICU Medical, Inc. Core Resistant Huber Needle Infusion Set, Core Resistant Huber Infusion Set with Y Site and Core Resistant Huber Infusion Set with Y Site and Clave are intended for use to deliver solutions and drugs through vascular implant ports.
The ICU Medical, Inc. Core Resistant Huber Infusion Set, Core Resistant Huber Infusion Set with Y Site and Core Resistant Huber Infusion Set with Y Site and CLAVE® are used to deliver solutions and drugs into vascular implant ports.
The ICU Medical Core Resistant Huber Infusion Sets are single use, sterile and non pyrogenic devices intended for use as an accessory to deliver solutions and drugs into a patient's vascular implant port. Components used in the sets may be either manufactured by ICU Medical or purchased from approved contract manufacturers. Components will be assembled into standard configurations or configurations specified by the customer and packaged.
The provided text is a 510(k) summary for the ICU Medical Inc. Core Resistant Huber Infusion Sets. This document establishes the safety and effectiveness of a medical device by demonstrating its substantial equivalence to a predicate device already on the market.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics typically found in AI/ML medical device submissions.
The document specifically focuses on:
- Applicant and Device Information: Name, address, contact, device name, and classification.
- Intended Use: What the device is designed to do.
- Comparison to Predicate Device: A table detailing physical characteristics and intended use in comparison to an existing similar device. This is the primary method of demonstrating substantial equivalence for this type of device.
- FDA Clearance Letter: Formal notification from the FDA that the device is substantially equivalent and can be marketed.
Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
This 510(k) pertains to an intravascular administration set (a physical medical device), not an AI/ML diagnostic or therapeutic device. The regulatory pathway for this type of device relies on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than performance metrics from a clinical study with acceptance criteria as you've described.
§ 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.