(73 days)
Not Found
No
The device description and intended use clearly describe a biological patch material with no mention of software, algorithms, or any computational processing that would indicate AI/ML.
Yes.
The device is used for vascular reconstruction and repairs, which are therapeutic interventions aimed at treating a medical condition.
No
Explanation: The device is described as a surgical patch material for reconstruction and repair, not for diagnosing conditions.
No
The device description clearly states it is comprised of a piece of bovine pericardium, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a surgical patch material intended for direct implantation into the body during surgical procedures to repair or reconstruct blood vessels. It is a surgical implant, not a device used to test samples outside the body.
- Intended Use: The intended use clearly states "surgical patch material for: vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; and suture-line buttressing." This describes a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, this bovine pericardial vascular patch is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The bovine pericardial vascular patch is intended for use as a surgical patch material for: vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; and suture-line buttressing.
Product codes (comma separated list FDA assigned to the subject device)
PS0
Device Description
The pericardial patch is comprised of a piece of bovine pericardium that has been preserved in a phosphate buffered glutaraldehyde solution. The Duravess patch comes in three sizes and configurations for vascular reconstruction and repair purposes. Model DP08X8: 0.8 cm x 8 cm, rectangular with round corners and a tapered end Model DP1X6: 1 cm x 6 cm, rectangular with round corners Model DP2X9: 2 cm x 9 cm, rectangular with round corners
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and other appropriate clinical environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Duravess bovine pericardial vascular patch has successfully passed functional and performance testing, demonstrating that the subject device satisfies the same performance requirements as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Edwards bovine pericardial patch; K082139
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
November 17, 2017
Edwards Lifesciences, LLC Christine Chun Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K172660
Trade/Device Name: Duravess Bovine Pericardial Vascular Patch 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: September 20, 2017
I
Received: September 21, 2017
Dear Christine Chun:
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. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172660
Device Name
Duravess Bovine Pericardial Vascular Patch
Indications for Use (Describe)
The bovine pericardial vascular patch is intended for use as a surgical patch material for: vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; and suture-line buttressing.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201.5 Subject to Rx) | Over-The-Counter Use (21 CFR 201.6 Subject to OTC) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5 - 510(K) SUMMARY
| Duravess Bovine Pericardial Vascular Patch | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| One Edwards Way, Irvine, CA, USA 92614 | |
| (949) 250-2773 | |
| Contact Person | Christine Chun |
| Date Prepared | September 1, 2017 |
| Trade Name | Duravess Bovine Pericardial Vascular Patch |
| Common Name | Vascular Patch |
| Classification | Class II |
| Name | 21 CFR 870.3470 |
| Regulation Class / Product Code | PSQ; intracardiac patch or pledget, biologically derived |
| Predicate Device(s) | Edwards bovine pericardial patch; K082139 |
| Device Description | The pericardial patch is comprised of a piece of bovine pericardium that |
| has been preserved in a phosphate buffered glutaraldehyde solution. The | |
| Duravess patch comes in three sizes and configurations for vascular | |
| reconstruction and repair purposes. | |
| Model DP08X8: 0.8 cm x 8 cm, rectangular with round corners and a | |
| tapered end | |
| Model DP1X6: 1 cm x 6 cm, rectangular with round corners | |
| Model DP2X9: 2 cm x 9 cm, rectangular with round corners | |
| Indications for Use/Intended Use | The bovine pericardial vascular patch is intended for use as a surgical |
| patch material for: vascular reconstruction and repairs; peripheral vascular | |
| reconstruction and repairs; and suture-line buttressing. | |
| Comparative Analysis | The Duravess bovine pericardial vascular patch is manufactured from |
| glutaraldehyde fixed bovine pericardium. It is considered to be substantially | |
| equivalent to the predicate device because they share: | |
| • Same intended use pertaining to vascular applications | |
| • Same patient population pertaining to vascular applications | |
| • Same technological characteristics | |
| • Same material | |
| • Same processing method | |
| • Same sterilization method | |
| Functional/ Safety Testing | The Duravess bovine pericardial vascular patch has successfully passed |
| functional and performance testing, demonstrating that the subject device | |
| satisfies the same performance requirements as the predicate device. | |
| Conclusion | The Duravess bovine pericardial vascular patch raises no new questions of |
| safety and effectiveness, and is substantially equivalent the predicate | |
| device for the intended use in hospitals and other appropriate clinical | |
| environments. |