(235 days)
The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.
The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction. The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series. The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.
This document is a 510(k) premarket notification for a medical device called the Sulzer Carbomedics Low Profile Mitral Rotator. It's an application for clearance to market an equivalent device, not a study reporting on the performance of an AI/ML system. Therefore, most of the requested information regarding AI/ML performance metrics, studies, and ground truth establishment is not applicable to this document.
However, I can extract information related to the device's intended use and equivalence claim, which can be seen as meeting its "acceptance criteria" for market clearance based on substantial equivalence.
Here's the breakdown of what can be extracted or inferred from the provided text:
Acceptance Criteria and Device Performance (in the context of 510(k) substantial equivalence):
For a 510(k) submission, the primary "acceptance criterion" is to demonstrate substantial equivalence to a previously legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criterion (for 510(k) clearance) | Reported Device Performance (as claimed in 510(k)) |
|---|---|
| Intended Use Equivalence: | The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction. This is stated to be equivalent to the predicate device, the Sulzer Carbomedics Extended Mitral Rotator (K951368, June 20, 1995), which performs the same function. |
| Technological Characteristics Equivalence: | Manufactured from polyetherimide, a material previously used in approved CPHV™ instrumentation and with a history of use in medical device applications. The design includes a socket for inserting and locking a bendable component to orient the valve. This implies that the materials and basic function are comparable to the predicate device. The document explicitly states the "results indicate that the Sulzer Carbomedics Low Profile Mitral Rotator is substantially equivalent to the Sulzer Carbomedics Extended Mitral Rotator." |
| Safety and Effectiveness Equivalence: | The submission asserts that the device is substantially equivalent to the predicate device. In a 510(k), this typically means that any differences in technological characteristics do not raise new questions of safety or effectiveness. The FDA's clearance letter confirms this by stating "we have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device is deemed as safe and effective as the predicate. |
| Product Code and Regulatory Class: | Product Code: MOP. Regulatory Class: unclassified. (This is a classification assigned by the FDA based on the equivalence determination, not an acceptance criterion per se, but an outcome of meeting the criteria). |
Since this is a 510(k) submission for a non-AI/ML medical device, the following points are not applicable:
- Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. Testing would typically involve mechanical bench testing or biocompatibility assessments, not a "test set" of patient data in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI sense is established.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided text:
The document describes a 510(k) premarket notification for a mechanical medical device, the Sulzer Carbomedics Low Profile Mitral Rotator. The primary study and "acceptance criteria" focus on demonstrating substantial equivalence to an existing predicate device (Sulzer Carbomedics Extended Mitral Rotator, K951368). The equivalence is based on similar intended use and technological characteristics (e.g., material, function). The FDA's letter (K974648) confirms that the device was deemed substantially equivalent, allowing its marketing. No AI/ML-specific performance metrics or studies are mentioned in this submission.
§ 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.