(217 days)
The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.
The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible shaft, and tip. The Handle includes two knobs that control the orientation and position of the tip. The proximal knob tightens the cable that adjusts the tip between 0 and 90 degrees. The distal knob rotates the tip between 0 and 360 degrees.
The provided document describes a 510(k) premarket notification for the Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle. This type of submission is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic algorithm would.
The document primarily focuses on establishing "substantial equivalence" based on operational and technological characteristics. Therefore, many of the requested categories are not applicable to this type of regulatory submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics with thresholds (e.g., accuracy > 90%). The "acceptance criteria" for a 510(k) submission like this are essentially demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness.
- Reported Device Performance: The document provides a comparison of characteristics between the proposed device and predicate devices. This isn't "performance" in the statistical sense, but rather a functional comparison.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Indicated for minimally invasive cardiovascular surgery | Must be "Yes" to be equivalent to K960400 | Yes |
| Indicated for valve repair/replacement | Must be "Yes" to be equivalent to K951368/K962154 | Yes |
| Materials: ASTM Surgical Stain steel and Aluminum | Must be "Yes" to be equivalent to K960400 | Yes |
| Sterility Status: Reusable | Must be "Yes" to be equivalent to predicate devices | Yes |
| Sterilization Process | Must be "Steam" to be equivalent to predicate devices | Steam |
| Intended Use | Must be equivalent or nearly equivalent to predicate devices | Indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator. (Matches predicate devices' function) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission. There is no "test set" in the context of evaluating a diagnostic algorithm's performance. The submission relies on comparative analysis with predicate devices and descriptive information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. There is no "ground truth" establishment in the context of a performance study for this type of mechanical surgical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a surgical instrument, not an AI or diagnostic tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable.
8. The sample size for the training set
This information is not applicable. There is no "training set" for this type of mechanical surgical instrument.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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.