(190 days)
No
The summary describes a biological tissue-based surgical patch and its performance testing. There is no mention of any computational or algorithmic components, let alone AI or ML.
Yes
The device is intended for the surgical repair of soft tissue deficiencies as a prosthesis, which directly addresses medical conditions and restores function, classifying it as a therapeutic device.
No
Explanation: The device, PERI-GUARD, is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies. This indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device is a physical implant derived from bovine pericardium, not software. The description details its material, processing, sterilization, and physical performance testing.
Based on the provided information, 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 surgical repair of soft tissue deficiencies. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details the material (bovine pericardium), processing, sterilization, and packaging. This aligns with a surgical implant or prosthesis.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. The device is implanted into the body for repair.
- Performance Studies: The performance studies focus on the physical properties of the patch (suture retention, burst strength, etc.), biocompatibility, and performance in animal models for surgical repair. These are relevant to a surgical device, not a diagnostic one.
In vitro diagnostics are devices used to perform tests on samples taken from the human body to detect diseases, conditions, or infections. This device is a surgical implant used for structural support and repair within the body.
N/A
Intended Use / Indications for Use
PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).
SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral. incisional, inguinal, lumbar, scrotal, and umbilical hernias).
Product codes (comma separated list FDA assigned to the subject device)
FTM, OWV, OXB
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 cross linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (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
abdominal and thoracic wall, gastric banding, muscle flap reinforcement, diaphgramatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias.
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 bench testing 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 demonstrated that the modified devices are substantially equivalent to the predicate devices.
Two animal studies were performed:
-
Implantation: Porcine incisional hernia repair model for 6 months per ISO 10993-6
- Results: No test material-related changes among clinical observations, bodyweights, veterinary physicals, clinical pathology parameters, mortality, significant macroscopic or microscopic differences, tensile or burst strength, or clinical performance between the subject and predicate devices at Day 113+/-3 or Day 203+/-3.
- Conclusions: The subject and predicate devices performed equivalently and had an equivalent safety profile in the in vivo porcine model for incisional hernia repair.
-
3-week Rat Calcification Potential Study
- Results: No significant mineralization was noted microscopically for either the subject or predicate device.
- Conclusions: No significant difference in calcification potential.
Biocompatibility testing against ISO 10993-1:2018 for a permanent implant (tissue, bone or non-direct blood contact) included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.
Shelf life testing found a 1 year shelf life.
Sterilization validation was conducted according to ISO 11137 parts 1 and 2.
Packaging validation was conducted according to ISO 11607-1, ASTM F88-15 and ASTM F2096-11.
Human factors testing was conducted to confirm aseptic transfer and no impact on tissue patch surface.
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
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Synovis Life Technologies, Inc. Megan Sajjad Sr. Manager Regulatory Affairs A Subsidiary of Baxter International Inc.) 2575 University Ave. W. St. Paul, Minnesota 55114
Re: K223052
Trade/Device Name: Peri-Guard and Supple Peri-Guard Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: March 27, 2023 Received: March 28, 2023
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Deborah A. Fellhauer -S
Deborah Fellhauer, RN, BSN Assistant Director DHT4B:Division of Infection Control and Plastic Surgery Devices OHT4:Office of Surgical And Infection Control 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) K223052
Device Name PERI-GUARD Repair Patch SUPPLE PERI-GUARD Repair Patch
Indications for Use (Describe)
PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).
SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral. incisional, inguinal, lumbar, scrotal, and umbilical hernias).
| 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
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: March 27, 2023
II. DEVICE
Device Trade Names: PERI-GUARD and SUPPLE PERI-GUARD
Common Name: Repair Patch
Regulation: 21 CFR 878.3300 - Surgical Mesh
Product Codes: FTM (Mesh, Surgical), OWV (mesh, surgical, collagen, diaphragmatic hernia), OXB (mesh, surgical, collagen, thoracic, chest wall reconstruction);
III. PREDICATE DEVICE
PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch, K983162
Manufacturer: Synovis Life Technologies, Inc., (A Subsidiary of Baxter International Inc.)
Additionally, Synovis PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Pericardium Patch (K142447) and PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K192615) serve as Reference devices for this 510k.
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 cross
4
linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (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 a surgical mesh.
Indications for Use:
PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).
SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric
5
banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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 device include a change in sterilization method and redesigned packaging. The safety and performance of the subject devices has been evaluated through non-clinical testing.
The subject and predicate devices are identical in the following respects:
- Intended Use
- Patch material ●
- Viral inactivation processing steps ●
- Strength, chemical and physical specifications ●
The following technological differences exist between the subject and predicate devices:
- Modified sterilization method from chemical sterilization to gamma . irradiation
- Modified packaging from a jar to a double foil pouch ●
PERFORMANCE DATA VII.
The following bench testing 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 ●
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The results of performance testing demonstrate that the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.
Animal Studies
Two animal studies were performed to support the substantial equivalence of the chemically sterilized and gamma irradiated PERI-GUARD and SUPPLE PERI-GUARD devices.
| Test | Results | Conclusions |
|---|---|---|
| Implantation: | ||
| Porcine incisional | ||
| hernia repair model | ||
| for 6 months per | ||
| ISO 10993-6 | No test material-related | |
| changes among clinical | ||
| observations, bodyweights, | ||
| veterinary physicals, clinical | ||
| pathology parameters, | ||
| mortality, significant | ||
| macroscopic or microscopic | ||
| differences, tensile or burst | ||
| strength, or clinical | ||
| performance between the | ||
| subject and predicate devices at | ||
| Day $113\pm3$ or Day $203\pm3$ . | The subject and predicate | |
| devices performed | ||
| equivalently and had an | ||
| equivalent safety profile in the | ||
| in vivo porcine model for | ||
| incisional hernia repair. | ||
| 3-week Rat | ||
| Calcification | ||
| Potential Study | No significant mineralization | |
| was noted microscopically for | ||
| either the subject or predicate | ||
| device. | No significant difference in | |
| calcification potential. |
Biocompatibility
The results of biocompatibility testing demonstrate the biocompatibility of the product in accordance with ISO 10993-1:2018 requirements for a permanent (long term) implant with tissue, bone or (non-direct) blood contact. As per FDA Guidance, testing included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.
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.
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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.