(140 days)
The InnerDyne, Inc., RED® device is intended for use during minimally invasive surgery to provide temporary dilation access to the abdominal/peritoneal cavity and to the lumen of specified internal organs to establish a port of entry for diagnostic, therapeutic, and operative instruments. Typical procedures for product use include:
- Laparoscopic access to the abdominal/peritoneal cavity; .
- Percutaneous gastrostomy; .
- Percutaneous enterostomy; ●
- Percutaneous cystostomy; .
- . Percutaneous cholescystostomy; and
- . Dilation of biliary and urethral strictures.
The RED® device is an expandable dilator sheath assembly, consisting of a radially expanding sleeve, inflation syringe, cannula (with integral valve system), dilator, and insertion instrument (either an access needle or guidewire). The tubular member of the expandable sleeve is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the dilator assembly is inserted through the radially expandable sleeve, penetrating the tissue into the target cavity (e.g., abdominal/peritoneal) or hollow organ.
The provided text describes a medical device, the InnerDyne, Inc., Radially Expanding Dilation "RED®" Device, and its intended use. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
This document is a Summary of Safety & Effectiveness Information (510(k) submission) to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on this input. The document explicitly states:
"From the foregoing, we conclude that the subject RED® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications."
This statement highlights that the submission is based on a claim of substantial equivalence to existing devices, meaning its safety and effectiveness are established by comparison to already approved devices, rather than through independent studies with explicit acceptance criteria provided in this document.
To answer your questions, I would need a different type of document, such as a clinical study report or a detailed device validation plan.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.