(32 days)
The Maersk Medical Contour infusion set is indicated for subcutaneous delivery of appropriately labeled fluids or solutions from an external infusion pump.
The Contour Infusion Set is an infusion administration set, connecting to a medicine reservoir syringe (such as the MiniMed® reservoir, model 103, that is placed in an external infusion pump such as the MiniMed insulin pump) and inserted in the subcutaneous tissue of a user. The Maersk Medical Contour Infusion Set may be used with any microbore infusion pump reservoir which utilizes a standard Luer connector.
The administration set attaches to the reservoir/syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane.
The 25 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub.
It appears that the provided document is a 510(k) Premarket Notification for the Maersk Medical Contour Infusion Set.
Based on the content, this document is a submission to the FDA seeking clearance for a medical device by demonstrating its substantial equivalence to a predicate device. It is not a study reporting on the device's performance against specific acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such a study is not presented in this document.
The document primarily focuses on:
- Description of the new device: Maersk Medical Contour Infusion Set.
- Identification of a predicate device: Maersk Medical Comfort Infusion Set.
- Comparison of technological features: Stating substantial similarity to the predicate device.
- Intended Use/Indications for Use: Subcutaneous infusion of medicine from an external infusion pump.
- FDA's response: Letter confirming substantial equivalence and clearance to market.
In summary, there is no information in the provided text to fulfill your request regarding acceptance criteria and a study proving the device meets them. The 510(k) process is about demonstrating substantial equivalence, not typically about presenting a detailed performance study with acceptance criteria in the format you've requested.
§ 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.