(195 days)
No
The device description and performance studies focus on the material properties and biological compatibility of the bovine pericardium patch, with no mention of AI or ML technology.
Yes
The device is intended for the repair of pericardial structures and other cardiac defects, which directly addresses therapeutic intervention in the body.
No
This device is a repair patch made from bovine pericardium, intended for the surgical repair of pericardial structures and other defects. It is a therapeutic device, not a diagnostic one.
No
The device is described as a physical patch derived from bovine pericardium, which is a hardware component. The description details its material, processing, sterilization, and physical properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PERI-GUARD and SUPPLE PERI-GUARD are for the repair of pericardial structures, intracardiac defects, great vessels, septal defects, annulus repair, and suture-line buttressing. These are all surgical procedures performed on the body.
- Device Description: The description details a patch derived from bovine pericardium, crosslinked, treated, and sterilized. This is a physical implantable device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment. This device does not perform any such tests.
The information provided describes a surgical implant used for structural repair within the body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
Product codes (comma separated list FDA assigned to the subject device)
PSQ
Device Description
PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F).
PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.
PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardial structures, intracardiac defects, great vessel, septal defects, annulus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 following performance data were provided in support of the substantial equivalence determination:
- Visual
- Suture retention
- Dimensional
- Burst strength
- Collagenase digestion
- Denaturation Temperature
- Water Permeability
- Pliability
- Chemical and heavy metal residuals
- Bioburden
- Pyrogenicity/Endotoxins
- Temperature Excursion Testing
- Biocompatibility Assessment
The results of performance testing demonstrate the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.
Biocompatibility: The results of new biocompatibility testing, along with applicable historical testing of the primary predicate devices, demonstrate the biocompatibility of the product in accordance with ISO 10993-1:2018 requirements for a long-term implant with tissue/blood contact and equivalence to the predicate devices.
Shelf Life: Synovis has performed aging testing to support a 1 year shelf life claim.
Sterilization and Packaging: Sterilization validation was conducted according to ISO 11137 parts 1 and 2. The modified packaging was designed and evaluated in accordance with ISO 11607-1. The integrity of the sterile barrier is supported by testing conducted in accordance with ASTM F88-15 and ASTM F2096-11.
Validation Studies: Human factors testing was conducted to confirm that the re-designed packaging allows for aseptic transfer of the product to the sterile field without compromising sterility, and that the modified packaging design does not impact the surface of the tissue patch.
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.
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.
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 the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Synovis Life Technologies, Inc. A subsidiary of Baxter International, Inc. Megan Sajjad Sr. Manager, Regulatory Affairs 2575 University Avenue West St. Paul, Minnesota 55114
Re: K221029
Trade/Device Name: PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair 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: PSQ Dated: September 20, 2022 Received: September 20, 2022
Dear Megan Sajjad:
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.
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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Rachel Neubrander, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221029
Device Name
PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch
Indications for Use (Describe)
PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510k SUMMARY: PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch K221029
I. SUBMITTER
Synovis Life Technologies, Inc. (Synovis) (A Subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Phone: 651-796-7410 Fax: 224-270-4119
Contact Person: Megan Sajjad, Sr. Manager, Regulatory Affairs
Date prepared: October 18, 2022
II. DEVICE
Device Trade Names: PERI-GUARD and SUPPLE PERI-GUARD
Common Name: Repair Patch
Classification Name: 21 CFR 870.3470 - Intracardiac Patch Or Pledget, Biologically Derived
Product Code: PSQ
III. PREDICATE DEVICES
Primary: PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Pericardium Patch, K142447
Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.)
Secondary: PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch, K983602
Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.)
Additionally, Synovis PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K192615) serves as a Reference device for this 510k.
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IV. DEVICE DESCRIPTION
PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F).
PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.
PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.
See Table 1 for PERI-GUARD and SUPPLE PERI-GUARD product models and sizes.
| PERI-GUARD Model Number | Size (cm) |
|---|---|
| PG0404 | 4 x 4 |
| PG0608 | 6 x 8 |
| PG0814 | 8 x 14 |
| PG1016 | 10 x 16 |
| PG1225 | 12 x 25 |
| SUPPLE PERI-GUARD Model Number | Size (cm) |
| SPG0404 | 4 x 4 |
| SPG0406 | 4 x 6 |
| SPG0608 | 6 x 8 |
| SPG0814 | 8 x 14 |
Table 1 - PERI-GUARD and SUPPLE PERI-GUARD Product Models and Sizes
V. INTENDED USE/INDICATIONS FOR USE
Statement of Intended Use:
PERI-GUARD and SUPPLE PERI-GUARD are intended to be used as an intracardiac patch.
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Indications for Use
PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
PERI-GUARD and SUPPLE PERI-GUARD are substantially equivalent to the predicate PERI-GUARD and SUPPLE PERI-GUARD devices based on having the same fundamental technology and intended use. The changes between the subject and predicate devices include packaging and sterilization changes. The safety and performance of the subject PERI-GUARD and SUPPLE PERI-GUARD devices have been evaluated through non-clinical testing.
The subject and predicate devices are identical in the following respects:
- Intended Use (both predicates) ●
- Indication for use (both predicates) ●
- Viral inactivation processing steps (both predicates) ●
- Sterilization method (primary predicate) ●
- . Strength specifications (both predicates)
- . Chemical and physical specifications (secondary predicate)
The following technological differences exist between the subject and predicate devices:
- Modified packaging design .
- Same sterilization method but modified sterilization parameters and . packaging for sterilization compared to the primary predicate
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination:
- . Visual
- Suture retention ●
- Dimensional ●
- Burst strength ●
- . Collagenase digestion
- Denaturation Temperature ●
- Water Permeability ●
- Pliability ●
- Chemical and heavy metal residuals ●
- Bioburden
6
- Pyrogenicity/Endotoxins
- Temperature Excursion Testing ●
- Biocompatibility Assessment ●
The results of performance testing demonstrate the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.
Biocompatibility
The results of new biocompatibility testing, along with applicable historical testing of the primary predicate devices, demonstrate the biocompatibility of the product in accordance with ISO 10993-1:2018 requirements for a long-term implant with tissue/blood contact and equivalence to the predicate devices.
Shelf Life
Synovis has performed aging testing to support a 1 year shelf life claim.
Sterilization and Packaging
Sterilization validation was conducted according to ISO 11137 parts 1 and 2.
The the modified packaging was designed and evaluated in accordance with ISO 11607-1. The integrity of the sterile barrier is supported by testing conducted in accordance with ASTM F88-15 and ASTM F2096-11.
Validation Studies
Human factors testing was conducted to confirm that the re-designed packaging allows for aseptic transfer of the product to the sterile field without compromising sterility, and that the modified packaging design does not impact the surface of the tissue patch.
VII. CONCLUSION
The subject PERI-GUARD and SUPPLE PERI-GUARD devices share the same intended use and technological characteristics as the predicate devices. The physical, functional and performance specifications for the devices are substantially equivalent. Testing supports that the subject devices are as safe and effective as the predicate devices when used according to their labeling.