(219 days)
Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.
Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.
The Synovis Collagen Matrix is an implantable biologic patch made from non-crosslinked bovine pericardium, intended for the reconstruction and repair of the pericardium. This device received 510(k) clearance (K122306) based on substantial equivalence to predicate devices, primarily Veritas® Collagen Matrix.
The device's safety and performance were evaluated through non-clinical testing, including bench testing and animal studies.
Acceptance Criteria and Device Performance:
| Acceptance Criteria Category | Specific Test | Reported Device Performance | Study Type |
|---|---|---|---|
| Mechanical Properties | Suture retention | Bench testing results support performance requirements | Bench Testing |
| Thickness | Bench testing results support performance requirements | Bench Testing | |
| Amine index | Bench testing results support performance requirements | Bench Testing | |
| Tensile | Bench testing results support performance requirements | Bench Testing | |
| Burst | Bench testing results support performance requirements | Bench Testing | |
| Sterility & Packaging | Sterilization validation | Bench testing results support performance requirements | Bench Testing |
| Packaging and shelf-life | Bench testing results support performance requirements | Bench Testing | |
| Biocompatibility | Biocompatibility | Performed in accordance with ISO 10993-1. | Bench Testing |
| Systemic Toxicity | Systemic toxicology | No detectable systemic or site-specific toxicity at all time points. | Swine Animal Model |
| Tissue Integration/Remodeling | Histological examination (Swine) | Device was readily remodeled and integrated into the adjacent host connective tissue. | Swine Animal Model |
| Healing & Mechanical Integrity | Pneumonectomy stump repair, chest wall defect repair | No systemic or implant site specific toxicity; minimal inflammation, minimal foreign body response or fibrosis; complete healing of bronchial stump with no air leaks; repaired chest wall defects had sufficient mechanical integrity and remained hernia-free for 90 days. | Canine Animal Model |
| Remodeling (Canine) | Histological analysis (Canine) | Undergoes extensive remodeling through host tissue integration, leading to connective tissue indistinguishable from adjacent host tissue. | Canine Animal Model |
| Adhesion Formation | Adhesion formation | Demonstrates minimal tissue attachment to the device in case of direct contact with viscera. | Rat Animal Model |
Details of the Studies:
-
Sample size used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify the exact sample sizes for each bench test (suture retention, thickness, amine index, tensile, burst, sterilization validation, packaging, shelf-life, biocompatibility). These tests are typically conducted in a laboratory setting. Data provenance is implied to be from the manufacturer's internal testing.
- Animal Studies:
- Swine Model: Used for systemic toxicology and histological examination. The exact number of swine is not specified.
- Canine Model: Used for pneumonectomy stump repair and chest wall defect repair. The exact number of canines is not specified.
- Rat Model: Used for adhesion formation evaluation. The exact number of rats is not specified.
- All animal studies were conducted prospectively as part of the device evaluation process. The country of origin for the data is not specified but is assumed to be part of the manufacturer's regulatory submission process.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- The studies described are non-clinical (bench and animal studies). Ground truth for these studies is established through objective measurements (e.g., mechanical properties, chemical analysis) and histopathological examination by qualified veterinarians and pathologists, typically employed by contract research organizations or the device manufacturer. The specific number and qualifications of these experts are not provided in the summary.
-
Adjudication Method for the Test Set:
- Not applicable as these were non-clinical bench and animal studies, not human clinical trials involving expert review and adjudication of patient data for diagnostic accuracy.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Synovis Collagen Matrix is an implantable surgical patch, not an imaging device.
-
Standalone Algorithm Performance:
- Not applicable. This device is a biocompatible surgical implant, not a standalone algorithm.
-
Type of Ground Truth Used:
- For bench testing: Objective measurements of physical and chemical properties.
- For animal studies: Histopathology (histological examination), clinical observation (e.g., absence of air leaks, hernia-free), and systemic toxicology (laboratory analysis).
-
Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is used for machine learning models, not for traditional medical devices like surgical implants. The animal studies served as preclinical evaluation, not "training."
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
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510(K) SUMMARY
Applicant:
MAR 8 2013
Synovis Surgical Innovations 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7300 Fax: 651-642-9018
Contact Person:
Jodi Jorgenson Regulatory Affairs Manager At address above
Date Prepared:
July 31, 2012
Device Trade Name: ·
Synovis Collagen Matrix (TBD)
Common Name:
Pericardial Patch
Classification Name:
21 CFR 870.3470: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate or polytetrafluoroethylene Product Code: DXZ
Predicate Devices:
- Synovis Surgical Innovations, Veritas® Collagen Matrix: . K002233, K030879, K062915
- . Synovis Surgical Innovations, Supple Pericard® Pericardium with APEX Processing: K921895, K923657, K961810, K983162
- . Synovis Surgical Innovations, Peri-Guard® Pericardium with APEX Processing: K821532, K833021, K842066, K961811, K971726, K983162
- . CorMatrix Cardiovascular Inc, CorMatrix® ECM™ for Pericardial Closure: K051405
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Device Description:
Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.
Statement of Intended Use:
Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.
Substantial Equivalence:
The indications for use for Synovis Collagen Matrix for reconstruction and repair of the pericardium are substantially equivalent to the indications for use of the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Therefore, Synovis Collagen Matrix for reconstruction and repair of the pericardium is substantially equivalent to the predicate devices.
Summary/Comparison of Technological Characteristics:
The safety and performance of Synovis Collagen Matrix was evaluated through nonclinical testing.
The non-clinical testing assessed the following aspects of the device:
- Suture retention .
- Thickness .
- Amine index �
- Tensile �
- Burst ●
- . Sterilization validation
- . Packaging and shelf-life
- . Biocompatibility
- . Animal studies
Bench testing results support the performance requirements for Synovis Collagen Matrix. Biocompatibility testing was performed in accordance to ISO 10993-1 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).
Various animal studies were conducted to support the safety and efficacy of Synovis Collagen Matrix. Systemic toxicology was evaluated in a swine model, and the results indicated that at all time points, there was no detectable systemic or site-specific toxicity. Histological examination revealed the device was readily remodeled and integrated into the adjacent host connective tissue.
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Synovis Collagen Matrix was also used to repair the tissue "stump" remaining after pneumonectomy and defects in the chest wall in a canine model. Results indicated no systemic or implant site specific toxicity, elicits minimal inflammation, minimal foreign body response or fibrosis, complete healing of the bronchial stump with no air leaks and repaired chest wall defects with sufficient mechanical integrity that remained hernia free throughout the 90 day post-implant period. Histological analysis demonstrated that Synovis Collagen Matrix undergoes extensive remodeling through host tissue integration of the implant and leads to formation of connective tissue that is indistinguishable from adjacent host tissue.
Adhesion formation was evaluated in a rat model, and the results confirmed that Synovis Collagen Matrix demonstrates minimal tissue attachment to the device in case of direct contact with viscera. These animal studies indicate that the device is safe and confirms product functionality.
Conclusions:
Synovis Collagen Matrix for reconstruction and repair of the pericardium is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2013
Synovis Surgical Innovations C/O Jodi Jorgenson, Regulatory Affairs Manager 2575 University Avenue West St. Paul, MN 55114-1024
Re: K122306
Trade/Device Name: Synovis Collagen Matrix 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: DXZ Dated: February 20, 2013 Received: February 22, 2013
Dear Ms. Jorgenson:
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 801); medical device reporting (reporting of medical
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Page 2 - Ms. Jodi Jorgenson
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
OwenPFaris-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):_ K122306
Device Name: Synovis Collagen Matrix
Indications For Use:
Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.03.08
15:17:13 -05'00'
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§ 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).