(73 days)
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.
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
The provided text describes the 510(k) premarket notification for the Duravess Bovine Pericardial Vascular Patch. It does not contain information about acceptance criteria for a device's performance that would typically be evaluated in a study with metrics like sensitivity, specificity, or reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and successful functional and performance testing.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, and expert involvement are not applicable to the information provided in this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific thresholds for tensile strength, burst pressure, etc.) that the device must meet, nor does it present device performance in a numerical format against such criteria. It states:
- Acceptance Criteria (Implied): The device successfully pass functional and performance testing demonstrating that it satisfies the same performance requirements as the predicate device.
- Reported Device Performance: "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."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "functional and performance testing" but does not detail the sample sizes, data provenance, or study design for these tests.
3. 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)
This information is not provided as the type of "test set" and "ground truth" typically associated with expert review (e.g., for diagnostic AI devices) is not applicable here. The testing referenced is likely material science and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. 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
This type of study is not applicable to a vascular patch device. The document describes a biological implant, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail specific "ground truth" as it relates to clinical outcomes or expert diagnoses. For a vascular patch, "ground truth" for performance would be established through laboratory testing based on predetermined specifications or standards for material properties (e.g., tensile strength, burst pressure, suture retention) and biocompatibility, as well as potentially animal studies. The text states it "successfully passed functional and performance testing."
8. The sample size for the training set
This is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device requiring a training set.
Summary of available information regarding the "study" (functional/performance testing):
- Device Tested: Duravess Bovine Pericardial Vascular Patch
- Purpose of Testing: To demonstrate that the device satisfies the same performance requirements as the predicate device (Edwards bovine pericardial patch; K082139) to establish substantial equivalence.
- Outcome: "successfully passed functional and performance testing."
- Details Not Provided:
- Specific quantitative acceptance criteria or performance results.
- Details of the functional and performance tests performed.
- Sample sizes used for testing.
- Specific methodologies for establishing "ground truth" beyond meeting predefined performance requirements.
- Information related to expert involvement or clinical study design, which are not relevant for this type of device's 510(k) submission focused on substantial equivalence to a predicate.
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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
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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
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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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SECTION 5 - 510(K) SUMMARY
| Duravess Bovine Pericardial Vascular Patch | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLCOne 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 thathas been preserved in a phosphate buffered glutaraldehyde solution. TheDuravess patch comes in three sizes and configurations for vascularreconstruction and repair purposes.Model DP08X8: 0.8 cm x 8 cm, rectangular with round corners and atapered endModel DP1X6: 1 cm x 6 cm, rectangular with round cornersModel 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 surgicalpatch material for: vascular reconstruction and repairs; peripheral vascularreconstruction and repairs; and suture-line buttressing. |
| Comparative Analysis | The Duravess bovine pericardial vascular patch is manufactured fromglutaraldehyde fixed bovine pericardium. It is considered to be substantiallyequivalent 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 passedfunctional and performance testing, demonstrating that the subject devicesatisfies the same performance requirements as the predicate device. |
| Conclusion | The Duravess bovine pericardial vascular patch raises no new questions ofsafety and effectiveness, and is substantially equivalent the predicatedevice for the intended use in hospitals and other appropriate clinicalenvironments. |
§ 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).