(78 days)
The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.
The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed bovine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered.
This submission is a 510(k) premarket notification for the CorRestore™ Patch System. The device is an intracardiac patch made from glutaraldehyde-fixed bovine pericardium. The purpose of this submission is to introduce a new suture supplier, Genzyme, for the sutures packaged with the CorRestore™ Patch System.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This is a 510(k) submission for a change in suture supplier for an existing device. It does not involve performance criteria for the device itself or a study to demonstrate such performance against specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to the predicate device despite the change in suture supplier.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance testing was conducted that would require a test set. The submission states, "The CorRestore patch is equivalent in indications for use, size, shape, material, manufacturing processes, sterilization, packaging, instructions and intended use to the predicate CorRestore Patch System, K011487. The only change is the addition of a new suture supplier, Genzyme."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No new clinical or performance study was conducted that would require expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a medical implant, not a software algorithm.
7. Type of Ground Truth Used
Not applicable. No new ground truth was established as no new performance study was conducted. The ground for substantial equivalence rests on the comparison to the existing predicate device.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device requiring a training set.
Summary of the Study and Acceptance Criteria:
The "study" in this context is the 510(k) submission process itself, where the manufacturer demonstrates that the modified device (CorRestore™ Patch System with Genzyme sutures) is substantially equivalent to a legally marketed predicate device (CorRestore™ Patch System with previous sutures, K011487).
Acceptance Criteria for Substantial Equivalence (Implicit in 510(k) Process):
The device must meet the following criteria (as implied by the 510(k) summary):
- Same Indications For Use: The CorRestore™ Patch with Genzyme sutures is intended for the same use as the predicate device: "as an intracardiac patch for cardiac reconstruction and repair."
- Same Technological Characteristics, OR Different Technological Characteristics with Evidence of Safety and Effectiveness: The submission explicitly states "The only change is the addition of a new suture supplier, Genzyme." It then argues that the new sutures are packaged in the same way with appropriate labeling, and the packaging prevents liquid sterilant from contacting the sutures. This implies that the change in suture supplier does not alter the fundamental safety or effectiveness of the CorRestore™ Patch itself. The sutures themselves would have their own pre-market notification (510k) status.
Reported Device Performance (in the context of this submission):
The "performance" demonstrated is that the device, with the new suture supplier, maintains substantial equivalence to the predicate device. This is primarily a regulatory and manufacturing assessment, not a performance study in the traditional sense of clinical outcomes or diagnostic accuracy.
The key statement is: "The CorRestore™ Patch is substantially equivalent to the predicate device." This assertion, accepted by the FDA in their approval letter (K031586), serves as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence under this 510(k). The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification...and have determined the device is substantially equivalent...to legally marketed predicate devices."
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).