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The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) is intended for the mixing of an approved two component drug and for delivering the mixed drug (according to the drug labeling) to a receptacle such as an IV Bag for subsequent patient administration.

Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-The Reconstituting-System) is made up of three components: 1) a syringe adapter assembly, 2) a vial adapter assembly, and 3) a syringe.

The syringe adapter assembly attaches to the piston syringe via a Luer lock connector. The syringe adapter assembly consists of a central cavity which houses an elastomeric valve. The needle cannula is situated within the elastomeric valve and is held in place by a retaining plate. A cannula carrier and coil compression springs are also contained in the syringe adapter assembly and are engaged when the three components are coupled together. When coupled the cannula passes through and is fixed to the cannula carrier. Movement of the cannula and cannula carrier against the coil compression spring causes extension into the interior and opens end of the barrel of the conventional syringe.

The piston syringe that attaches to the syringe adapter assembly is composed of a conventional piston syringe (21 CFR 880.5860). The syringe to be used with the S.A.R.S. II™ will be purchased from a manufacturer of legally marketed syringes. The S.A.R.S. II™ is compatible with any size piston syringe with a standard Luer lock fitting.

The vial adapter assembly attaches to the syringe adapter assembly via an interlocking This consists of inwardly extending lugs positioned in the vial adapter mechanism. assembly that are aligned with outer slots of a retainer ring on the syringe adapter assembly. The interlock of the two components cause an automatic alignment of the activation pin.

The vial adapter assembly includes the threaded vial adapter, safety cup, spring arms to secure the vial, needle cannula, and elastomeric seal. The spring arms activate the piercing mechanism after the components are threaded together. The safety cup size and shape is conformable to conventional drug vials. The syringe adapter assembly includes the elastomeric valves, needle cannula, and latches for attachment to vial adapter assembly or IV Bag. The needle cannula provides a stainless steel fluid pathway between the piston syringe and the vial of an approved drug component or drug.

The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) will be commercialized in the following configurations:

• . S.A.R.S. II™ including the vial and syringe adapter assemblies. This device will be packaged in a blister pack and provided sterile.
• . S.A.R.S. II™ including the vial assembly and syringe adapter assemblies and a piston syringe having a volume of 5, 10, 20 or 30 ml.

The provided text describes a medical device, the Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System), but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a 510(k) summary, which typically focuses on describing the device, its intended use, and substantial equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided input. The input primarily details:

• Submitted By/Contact Person/Date Prepared: Administrative information.
• Device Name & Classification: Identification and regulatory status.
• Predicate Devices: Other similar devices on the market.
• Intended Use: What the device is designed for.
• Device Description: A detailed explanation of the device's components and how they work.
• Configurations: How the device will be packaged and sold.

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