(54 days)
The reusable CarboMedics Mitral Rotators are intended for use in rotating the CarboMedics mitral heart valves (Model 700 and S700) in sim when necessary to avoid anaromical obstruction
The CarboMedics Mirral Rotator is a one-piece, injection modeled rotator, manufactured from either blue polysulfone or blue polyetherimide. The CarboMedics Mitral Rotators are supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse. The reusable Carbo Medics Mitral Rotators are manufactured using a polysulfone or polyetherimide injection molding process. The CarboMedics Mitral Rotators are one-piece, hand-held instruments.
This document is a 510(k) summary for the CarboMedics Mitral Rotator, a reusable device intended for rotating CarboMedics mitral heart valves in situ. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study on device performance against specific acceptance criteria.
As such, the provided text does not contain the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for training or testing sets.
The document highlights the following:
- Intended Use: Rotating CarboMedics mitral heart valves (Model 700 and S700) in situ to avoid anatomical obstruction.
- Materials: Blue polysulfone or blue polyetherimide, selected for their history of use in medical device applications.
- Biocompatibility: Tests were conducted on both materials in accordance with Tripartite Guidance and ISO 10993, with "acceptable results."
- Clinical History: The device has been used in clinical applications since 1986, including under IDE G880074.
- Substantial Equivalence: CarboMedics asserts the device is safe, effective, and substantially equivalent to the CarboMedics Extended Mitral Rotator heads (510(k) #K951368, approved June 20, 1995) in intended use, design, composition, and function.
In summary, this document is a regulatory filing for market clearance based on substantial equivalence, not a detailed scientific study outlining performance metrics against specific acceptance criteria. Therefore, the requested information cannot be extracted from this text.
§ 870.3935 Prosthetic heart valve holder.
(a)
Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.