(86 days)
The Edwards Bovine Pericardial Patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following open-heart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.
The Edwards Bovine Pericardial Patch is comprised of a rectangular sheet of bovine pericardium that has been preserved in a buffered glutaraldehyde solution. The pericardial patch is in the form of a 10 cm x 15 cm size, and may be tailored during surgery to meet the specific configuration needs of individual circumstances.
The provided text is a 510(k) Summary for the "Edwards Bovine Pericardial Patch." This document outlines the device's characteristics, intended use, and its assertion of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or details of a study that objectively proves the device meets such criteria through quantitative performance metrics.
Instead, the submission relies on the concept of substantial equivalence to previously approved devices. This regulatory pathway asserts that the new device is as safe and effective as a legally marketed predicate device because it shares similar technological characteristics and/or intended use.
Therefore, the following points address what can be gleaned from the text, and where information is missing based on your request:
Acceptance Criteria and Study Details
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | The device is considered safe and effective if it demonstrates substantial equivalence to predicate devices, meaning it has "the same intended medical use, operates using the same fundamental scientific technology, similar shape, similar processing method, similar sterilization method, and similar packaging and labeling." | The device is manufactured from glutaraldehyde fixed bovine pericardium, the same material used for predicate devices. "The safety and effectiveness of bovine pericardial patches for reconstruction and repair is well established. Pericardial patches have been proven to be effective in achieving the desired result and well tolerated by the host tissue." |
| Material | Glutaraldehyde fixed bovine pericardium. | Glutaraldehyde fixed bovine pericardium. |
| Processing Method | Similar to predicate devices. | Similar to predicate devices. |
| Sterilization Method | Similar to predicate devices. | Similar to predicate devices. |
| Packaging and Labeling | Similar to predicate devices. | Similar to predicate devices. |
Study that proves the device meets the acceptance criteria:
The provided document does not describe a specific study with quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other measurable outcomes) that would typically be associated with proving a device meets acceptance criteria.
Instead, the submission for the Edwards Bovine Pericardial Patch relies on the established safety and effectiveness of its predicate devices and the demonstration of substantial equivalence. The "Functional/Safety Testing" section states, "The safety and effectiveness of bovine pericardial patches for reconstruction and repair is well established. Pericardial patches have been proven to be effective in achieving the desired result and well tolerated by the host tissue." This indicates that the regulatory body accepts the principle that if the new device is materially and functionally identical to previously approved devices from a well-understood class, then specific new clinical studies to re-prove fundamental safety and effectiveness are not required for this type of submission (510(k)).
Additional Information based on Request:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a "test set" in the context of a performance study with a specific sample size. The substantial equivalence argument relies on prior knowledge and established clinical use of similar materials rather than new data from a specific test set for this submission.
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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):
- N/A. As no specific performance study with a test set is described, there is no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or performance study requiring adjudication is mentioned.
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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:
- N/A. This device is a medical implant (bovine pericardial patch), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly relied upon for this 510(k) submission is the long-standing clinical experience and historical outcomes data for predicate bovine pericardial patches. The document states, "The safety and effectiveness of bovine pericardial patches for reconstruction and repair is well established." This suggests that the clinical utility and safety of this class of devices have been confirmed through collective medical experience and perhaps prior studies on similar products that established their efficacy and biocompatibility.
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The sample size for the training set:
- N/A. No training set is applicable as this is not an algorithm-based device.
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How the ground truth for the training set was established:
- N/A. No training set is applicable.
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510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 | OCT 23 2008 |
|---|---|---|
| Contact Person: | Daryl Richardson, Regulatory Affairs Associate III | |
| Date Prepared: | July 18, 2008 | |
| Trade name: | Edwards Bovine Pericardial Patch | |
| ClassificationName: | Intracardiac Patch or Pledget (21 CFR 870.3470, Product Code DXZ) | |
| Predicate Devices: | Edwards Bovine Pericardial Patch, K833763PeriPatchTM Sheet, K040835CV Peri-Guard Cardiovascular Patch, K971726Glycar Pericardial Patch, K963967Vascu-Guard, K942010 | |
| DeviceDescription: | The Edwards Bovine Pericardial Patch is comprised of a rectangular sheet ofbovine pericardium that has been preserved in a buffered glutaraldehyde solution.The pericardial patch is in the form of a 10 cm x 15 cm size, and may be tailoredduring surgery to meet the specific configuration needs of individual circumstances. | |
| Indications forUse: | The Edwards Bovine Pericardial Patch is intended for use as a surgical patchmaterial for: augmenting the patient's own pericardium to assist in closure followingopen-heart surgery; intracardiac defects; septal defects and annulus repairs;cardiac and vascular reconstruction and repairs; peripheral vascular reconstructionand repairs; great vessel reconstruction and repairs; and suture-line buttressing. | |
| ComparativeAnalysis: | The Edwards Bovine Pericardial Patch is manufactured from glutaraldehyde fixedbovine pericardium; this is the same material used for the predicate devices.The Edwards Bovine Pericardial Patch is considered to be similar to the predicates because:Same raw material Same intended medical use Operates using the same fundamental scientific technology Similar shape Similar processing method Similar sterilization method Similar packaging and labeling | |
| Functional/SafetyTesting: | The safety and effectiveness of bovine pericardial patches for reconstruction andrepair is well established. Pericardial patches have been proven to be effective inachieving the desired result and well tolerated by the host tissue. | |
| Conclusion: | The Edwards Bovine Pericardial Patch is substantially equivalent to the predicate devices. |
Appendix B – Page 1 of 1
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without the written permission from Edwards Lifesciences, LLC.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 23 2008
Edwards Lifesciences LLC c/o Mr. Daryl Richardson Regulatory Affairs Heart Valve Therapy One Edwards Way Irvine, CA 92614
Re: K082139
Edwards Bowine Pericardial Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II Product Code: DXZ Dated: July 28, 2008 Received: July 29, 2008
Dear Mr. Richardson:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Daryl Richardson
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number 800-638-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dma R. bohner
Bram D. Zuckerman, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): KO82139
Device Name: Edwards Bovine Pericardial Patch
Indications for Use:
The pericardial patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following openheart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.
Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko82139
Page 1 of 1
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Appendix A - Page 1 of 1
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without the written permission from Edwards Lifesciences, LLC.
§ 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).