(115 days)
The CryoSeal® FS Applicator System is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection.
The CryoSeal® FS Applicator System is composed of a thermoplastic polystyrene applicator handle, and two types of dispensing tips with a Y-body manifolds for application of the fibrin sealant: line/drop tips (5 and 10 cm lengths) and spray tips (3 configurations).
The provided text is a 510(k) summary for the CryoSeal® FS Applicator System. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, study details, or performance data to prove the device meets such criteria.
The document primarily focuses on the regulatory submission process, including:
- Applicant and contact information
- Device trade name, classification, and product code
- Predicate devices
- Statement of intended use
- Device description
- Comparison to predicate devices
- The FDA's decision letter confirming substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text.
The 510(k) summary states that "This device, with respect to material composition, device characteristics, principles of operation, and intended use, is substantially equivalent to the predicate devices." This implies that the device's performance is considered equivalent to already approved devices, but specific performance criteria and the studies demonstrating them are not detailed here.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).