(174 days)
CorMatrix(R) Cor Patch is intended for epicardial tissue support and repair.
CorMatrix Cor Patch is intended for epicardial tissue support and repair.
CorMatrix Cor Patch is derived from the same multi-laminate SIS-ECM material as the CorMatrix Tyke (2-ply, non-pressed). The CorMatrix® Cor Patch will be supplied as a 4-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts and a change to the manufacturing process for the Cor Patch which does not result in a change to the fundamental technology of the device, the device design and construction are identical to the FDA-cleared CorMatrix® Tyke™ (K152127).
This document is a 510(k) premarket notification for a medical device called CorMatrix Cor Patch. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device, the CorMatrix Tyke.
However, this document does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.
Here's why and what's missing:
- Device Type: The CorMatrix Cor Patch is a biological patch made from porcine extracellular matrix material for epicardial tissue support and repair. It is a physical medical device, not an AI/ML algorithm or software.
- Study Type: The "Non-clinical Testing" section describes material property testing (tensile strength, suture retention, burst strength) to demonstrate adequate material properties, not a clinical study involving human or even simulated human-in-the-loop performance with an AI system.
- Acceptance Criteria: The document mentions that the testing "demonstrates that the sterile SIS-ECM of the Cor Patch possesses adequate material properties for use in the indicated applications" and "exceeds the biomechanical requirements for its intended use." However, it does not provide a specific table of acceptance criteria with quantitative thresholds for AI performance metrics (like sensitivity, specificity, AUC, human reader improvement).
- Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to the evaluation of AI/ML algorithms, where the performance of the algorithm is compared against a "ground truth" established by human experts, pathology, or outcomes data. This document does not describe such studies because the device is a physical patch.
- Sample Size (for AI training/test sets): The document refers to "testing" but does not specify sample sizes in the context of test or training sets for an AI algorithm.
- Data Provenance: Not applicable in the context of material property testing for a physical device.
In summary, the provided text is about a physical medical device (a tissue patch) and its material properties, not about an AI/ML medical device and its performance evaluation against established acceptance criteria.
Therefore, I cannot extract the requested information from this document. If you provide a document that describes the development and validation of an AI/ML medical device, I would be happy to help answer your questions.
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October 10, 2018
CorMatrix Cardiovascular, Inc. % Wendv Perreault Owner/Principal New South Regulatory, LLC 223 Coventry Road Decatur, Georgia 30030
Re: K181038
Trade/Device Name: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene Regulatory Class: Class II Product Code: PSO Dated: April 18, 2018 Received: April 19, 2018
Dear Wendy Perreault:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachel E. Neubrander -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181038
Device Name CorMatrix(R) Cor Patch
| Indications for Use (Describe) | CorMatrix(R) Cor Patch is intended for epicardial tissue support and repair. |
|---|---|
| -------------------------------- | ------------------------------------------------------------------------------ |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K181038
| Company Information | |
|---|---|
| Company Name: | CorMatrix Cardiovascular, Inc. |
| Contact Name: | Wendy Perreault |
| Contact Title: | Regulatory Consultant |
| Address: | 1100 Old Ellis Rd. |
| Roswell, GA 30076 | |
| Phone (office): | 678-566-2628 |
| Phone (mobile): | 404-542-5854 |
| Fax: | 678-736-5082 |
| Date Prepared: | April 18, 2018 |
| Product Information | |
| Trade Name: | CorMatrix® Cor Patch |
| Common Name: | Patch, Pledget and Intracardiac |
| Classification Name: | Patch, Pledget and Intracardiac, 21 CFR 870.3470 |
| Product Code PSQ, Class II | |
| Classification Panel: | Cardiovascular |
Predicate Devices
The CorMatrix® Cor Patch is substantially equivalent to the CorMatrix® Tyke®, K152127.
Device Description
CorMatrix Cor Patch is intended for epicardial tissue support and repair.
CorMatrix Cor Patch is derived from the same multi-laminate SIS-ECM material as the CorMatrix Tyke (2-ply, non-pressed). The CorMatrix® Cor Patch will be supplied as a 4-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts and a change to the manufacturing process for the Cor Patch which does not result in a change to the fundamental technology of the device, the device design and construction are identical to the FDA-cleared CorMatrix® Tyke™ (K152127).
Indications for Use
The CorMatrix Cor Patch is intended for epicardial tissue support and repair.
Substantial Equivalence
The device is constructed from the same SIS-ECM material used for construction of the CorMatrix Tyke (K152127). The device differs from the CorMatrix Tyke only in the number of ECM layers from which
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each device is constructed, and additional processing (wash) steps for the Cor Patch device which serve to further remove impurities from the SIS-ECM.
The CorMatrix Cor Patch is a four-layer ECM material, and the CorMatrix Tyke is a two-layer ECM material. The CorMatrix Tyke is intended for use in neonates and infants, and is therefore provided in a maximum size of 4 cm x 7 cm, whereas the CorMatrix Cor Patch is provided in sizes up to 7 cm x 10 cm. Each layer of the Cor Patch device is identical to the ECM layers in the predicate device, with the exception of the additional processing step performed for the Cor Patch product.
The Indications for Use for the predicate CorMatrix Tyke include use as an epicardial covering for damaged or repaired cardiac structures; the Cor Patch is intended for epicardial tissue support and repair.
Non-clinical Testing
The CorMatrix Cor Patch is intended for epicardial tissue support and repair. The performance testing that supports the Cor Patch includes tensile strength, suture retention, and burst strength testing. The testing demonstrates that the sterile SIS-ECM of the Cor Patch possesses adequate material properties for use in the indicated applications.
Conclusion
Performance testing of the SIS-ECM material of the Cor Patch demonstrated that it exceeds the biomechanical requirements for its intended use.
The CorMatrix Cor Patch is substantially equivalent to the CorMatrix Tyke; both are intended for epicardial support and repair and are made from porcine SIS-ECM. The Cor Patch undergoes an additional processing step which serves to further remove impurities from the base material, but does not result in a change to the fundamental technology of the 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).