(84 days)
The reusable CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.
The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. The CarboMedics Handle consists of a threaded polysulfone tip injection molded to a bendable handle. The reusable CarboMedics Handle is manufactured using a polysulfone injection molding process. The CarboMedics Handle consists of a white polysulfone threaded tip injection molded onto a bendable stainless steel shaft, injection molded to a white polysulfone handle. It is supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out Strength: Minimum failure load: 25 lbf | Average pull-out strength: 75.2 lbf (Standard Deviation: 19.9 lbf) |
| Push-out Strength: Minimum push-out load: 75 lbf | Average push-out strength: 113.5 lbf (Standard Deviation: 0.4 lbf) |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the pull-out and push-out tests. It mentions "the results were an average" and "a standard deviation," implying multiple measurements were taken, but the exact number of samples is not provided.
The data provenance is from internal testing conducted by CarboMedics, the manufacturer of the device. The data is retrospective as it pertains to testing performed on a device for which the design is being qualified.
3. Number of Experts and Qualifications
Not applicable. This device is a mechanical handle, and its performance is evaluated through physical tests (pull-out and push-out strength) rather than expert interpretation of data.
4. Adjudication Method
Not applicable for a physical performance test. The results are quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (handle) and not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. Standalone Performance
Yes, a standalone performance study was done. The reported pull-out and push-out strengths are direct measurements of the device's mechanical integrity under specific load conditions, without any human-in-the-loop during the testing. This assesses the algorithm/device (the handle) without human interaction influencing the outcome of the test.
7. Type of Ground Truth
The ground truth used for these tests is the physical measurement of force required to cause separation. This can be categorized as physical property measurement or engineering specification compliance. The criteria (minimum failure load) are established engineering thresholds for the device's intended function.
8. Sample Size for the Training Set
Not applicable in the context of this device and testing. This is not an AI/ML model that requires a training set. The "training" for the manufacturing process would be the established injection molding procedures.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set in the sense of an AI/ML model for this device. The ground truth for the performance tests (pull-out and push-out) is based on engineering principles and the intended use of the device, establishing minimum strength requirements that the device must meet.
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Image /page/0/Picture/0 description: The image shows the text "AUG 27 1996". The text is in bold, black font. The text is likely a date.
Image /page/0/Picture/1 description: The image shows the logo for CarboMedics. The logo consists of a black hexagon shape on the left, followed by the word "CarboMedics" in a bold, sans-serif font. The hexagon has several white lines inside of it. There is a registered trademark symbol to the right of the word.
1300 East Anderson Lane, Austin, Texas 78752-1793 ♥ 512 435 3200 ♥ 512 435 3350 FAX
962154
510(k) SUMMARY CARBOMEDICS HANDLE
The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. The CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure. The threaded end of the CarboMedics Handle is inserted into the Valve Holder. The CarboMedics Handle consists of a threaded polysulfone tip injection molded to a bendable handle. The CarboMedics Handle is a reusable instrument. It is supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.
The reusable CarboMedics Handle is manufactured using a polysulfone injection molding process. The CarboMedics Handle consists of a white polysulfone threaded tip injection molded onto a bendable stainless steel shaft, injection molded to a white polysulfone handle. Polysulfone has a history of use in medical device applications, including various instrumentation approved with the CarboMedics® Prosthetic Heart Valve. Biocompatibility tests were conducted on the white polysulfone in accordance with Tripartite Guidance and meets requirements of ISO 10993 for biomaterial testing. Acceptable results were obtained from all biocompatibility tests.
The one-piece injection molded handle is similar to handles used successfully with other CarboMedics instrumentation. The handle of a similar device has been tested to ensure that the handle exhibits torque and pull-out strengths that will exceed the requirements for the intended function. The purpose of the performance testing was to qualify the design and performance of this device. CarboMedics performed a pull-out test to determine the amount of force required to separate the molded tip from the steel shaft. Using a minimum failure load of 25 lbr, the results were an average of 75.2 lb, with a standard deviation of 19.9 lbp. CarboMedics also performed a push-out test to determine the amount of force required to separate the steel shaft from the handle. Using a minimum push-out load of 75 lb,, the results were an average of 113.5 lb, with a standard deviation of 0.4 lbs. This testing showed the design to be suitable for its intended use and capable of performing its function in a safe and effective manner.
CarboMedics considers the reusable CarboMedics Handle safe, effective, and substantially equivalent in intended use, design, and function to the CarboMedics Valve Holder Handle (VH-100), approved for market on July 6, 1994, 510(k) #K942736.
| Common name of the device: | Valve Holder Handle |
|---|---|
| Trade name or Proprietary name: | CarboMedics Handle |
| Submitter and Contact person: | Joy Fisher ShugartRegulatory Affairs Specialist1300 E. Anderson LaneAustin, Texas 78752Phone: (512) 435-3219 Fax: (512) 435-3350 |
| Submission Prepared/Submitted on: | May 29, 1996 |
CarboMedics Prosthetic Heart Valve - Celebrating a Decade of Clinical Performan
§ 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.