(52 days)
The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.
The MPS Safeguard Huber Device is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets. The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.
The provided submission focuses on establishing substantial equivalence for a medical device (MPS Acacia Safeguard Huber Device) to existing predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, such as MRMC studies, effect size, standalone performance, and ground truth methodologies for training data, are not applicable here.
The document describes non-clinical testing to demonstrate safety and performance for a medical device with a sharps injury prevention feature.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility: Meets FDA requirements, method per AAMI/ANSI/ISO 11135-1994, SAL of 10⁻⁶ | Sterilized by ethylene oxide (EO). Maximum residual levels: EO 25ppm, ECH 25ppm, EG 250ppm. Labeled "Non-Pyrogenic" (LAL testing). Sterility assurance level (SAL) of 10⁻⁸ achieved during validation, exceeding minimum requirement. |
| Biocompatibility: Meets ISO 10993-1 and FDA G95-1 guidelines for external communicating devices, blood path indirect, contact duration B (>24 hours to |
§ 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.