(101 days)
The device is indicated for use in the distention and irrigation of venous vessels prior to use as a bypass graft.
The device is comprised of 10 biocompatible components including a syringe stopper, a oring and rod, a green acetal ring, a black acetal pusher, a white acetal knob and body. The device is packaged in a Tyvek blister peel pouch. The device is used for the preparation and irrigation of venous vessels prior to use as a bypass graft. The device has three settings which allow the user to limit the nominal pressure up to 150 mmHg, 250 mmHg or 350 mmHg.
The provided 510(k) summary for the "Distention and Irrigation Syringe" does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document discusses the device's description, materials, indications for use, and its substantial equivalence to a previously cleared device (K000704). It also cites two review articles (Bonchek, 1980; Okon et al., 2004) to support the clinical rationale for controlled pressure distention during venous vessel preparation. However, these articles are literature reviews and do not present specific performance data or a study conducted on this particular device to demonstrate its performance against predefined acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies for this device based on the provided text. The submission focuses on establishing substantial equivalence based on design and intended use, rather than a detailed performance study with acceptance criteria.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.