(126 days)
SPECIFIC INDICATION OF USE: PATENT DUCTUS ARTERIOSUS INTERRUPTION
INTENDED USES: intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury.
INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA)
CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.
These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.
The provided document is a summary of safety and efficacy for a medical device (Burke Congenital Thoracoscopy Instruments) from 1996. It describes the device, its intended use, indications, and contraindications. It does not contain any information about acceptance criteria, performance studies, or clinical trial data.
Therefore, I cannot answer your request for the specified information as it is not present in the provided text.
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(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 the limitations in § 870.9.