(54 days)
No
The description details a simple, hand-held mechanical instrument for rotating heart valves and makes no mention of any computational or algorithmic components, let alone AI/ML.
No
The device is described as an instrument used to rotate heart valves to avoid anatomical obstruction, which is a surgical tool rather than a therapeutic device that directly treats a disease or condition.
No
The document describes a surgical instrument used to rotate a heart valve, not a device used for diagnosis.
No
The device description clearly states it is a "one-piece, injection molded rotator" made from physical materials (polysulfone or polyetherimide) and is a "hand-held instrument," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to rotate mitral heart valves in situ (within the body) during surgery to avoid anatomical obstruction. This is a surgical instrument used directly on the patient.
- Device Description: The description clearly states it's a "hand-held instrument" used for a mechanical manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
Not Found
Device Description
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. Polysulfone and polyetherimide have a history of use in medical device applications, including various instrumentation approved with the CarboMedics® Prosthetic Heart Valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/3 description: The image shows the word "CarboMedics" in a stylized font. To the left of the word is a hexagon-like shape with lines inside. The word is in bold, black font, and the last letter, "s", has a quotation mark after it.
·1300 East Anderson Lane. Austin, Texas 78752-1793 · 512 435 3200 · 512 435 3350 FAX
APR 2 9 1996
510(4) K960923 SUMMARY CARBOMEDICS MITRAL ROTATOR
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. Polysulfone and polyetherimide have a history of use in medical device applications, including various instrumentation approved with the CarboMedics® Prosthetic Heart Valve. Biocompatibility tests were conducted on the blue polysulfone and blue polyetherimide in accordance with Tripartite Guidance and meet requirements of ISO 10993 for biomaterial testing. Acceptable results were obtained from all biocompatibility tests.
The hand-held CarboMedics Mitral Rotators have been used in clinical applications since 1986. CarboMedics purports that based on the chinical usage of this device, including its clinical application under IDE G880074, the CarboMedics Mitral Rotators are capable of performing their function in-a safe and effective manner.
CarboMedics considers the reusable CarboMedics Mitral Rotators safe, effective, and substantially equivalent in intended use, design, composition (polysulfone and polyetherimide) and function to the CarboMedics Extended Mitral Rotator heads approved for market on June 20, 1995, 510(k) #K951368. : 网站 利来
Common name of the device:
Valve Rotator
Trade Name or Proprietary Name:
CarboMedics Mitral Rotator
Submitter and Contact person:
Joy Fisher Shugart Regulatory Affairs Specialist 1300 E. Anderson Lane Austin, Tx 78752 Phone: (512) 435-3219 (512) 435-3350 Fax:
Submission Prepared/Submitted on:
March 5, 1996
CarboMedics Prosthetic Heart Valve - Celebrating a Decade of Clinical Performance