(84 days)
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No
The description details a simple mechanical handle for a valve holder and does not mention any computational or data-driven capabilities.
No.
The device is a handle used to facilitate sewing ring exposure of a valve, which is an accessory tool rather than a device intended to treat or diagnose a condition.
No
The device is described as a handle used to grasp a valve and facilitate sewing ring exposure, which is an operative function, not a diagnostic one.
No
The device description clearly indicates it is a physical, injection-molded handle made of polysulfone and stainless steel, requiring cleaning and sterilization. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the surgical implantation of a heart valve by providing a firm grasp and facilitating sewing ring exposure. This is a surgical instrument used in vivo (within the body) during a procedure.
- Device Description: The description details a physical handle used to manipulate another surgical tool (the Valve Holder). It's a mechanical device, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to diagnose diseases or conditions. This device is a surgical tool used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/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 Shugart |
| Regulatory Affairs Specialist | |
| 1300 E. Anderson Lane | |
| Austin, Texas 78752 | |
| Phone: (512) 435-3219 Fax: (512) 435-3350 | |
| Submission Prepared/Submitted on: | May 29, 1996 |
CarboMedics Prosthetic Heart Valve - Celebrating a Decade of Clinical Performan