(29 days)
Not Found
No
The device description focuses on the biological material and chemical processing, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on material properties and biological response, not algorithmic performance.
Yes
This device is intended for the repair and replacement of soft tissues, which falls under the definition of a therapeutic device as it directly treats a medical condition.
No
This device, Peri-Guard, is described as a biologic tissue repair patch for surgical repair of various soft tissue deficiencies. Its intended use is for repair and prosthesis, not for diagnosing conditions.
No
The device description clearly states that Peri-Guard is a biologic tissue prepared from bovine pericardium, which is a physical material used for surgical repair. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a surgical prosthesis for repairing various soft tissue deficiencies and pericardial structures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a biologic tissue patch made from bovine pericardium, intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as an implant.
N/A
Intended Use / Indications for Use
Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
Product codes (comma separated list FDA assigned to the subject device)
FTM , OXB
Device Description
Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.
Supple Peri-Guard® is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardial structures, abdominal and thoracic wall, gastric, soft tissue, hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical)
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)
Cross-linked pericardium was treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOHtreated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical residuals testing. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium. Product subjected to 1 M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.
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.
Peri-Guard K961811 and K842066, Supple Peri-Guard K961810 and K921895
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
§ 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.
0
PAGE 1/4
,
510(K) SUMMARY
| Submitted by: | Synovis Surgical Innovations
2575 University Avenue West
St. Paul, MN 55114-1024
Tel: 651-796-7300
Fax: 651-642-9018 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fonda Burley
At address above |
| Device Trade Name: | Peri-Guard Repair Patch |
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical
21 CFR 878.3300 |
| Product Code: | FTM , OXB |
| Predicate devices: | Peri-Guard K961811 and K842066
(Device acting as its own predicate) |
| Device Description: | Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared
from bovine pericardium cross-linked with glutaraldehyde. The
pericardium is procured from cattle originating in the United States.
Peri-Guard is chemically sterilized using ethanol and propylene oxide.
Peri-Guard is treated with 1 molar sodium hydroxide for 60-75
minutes at 20-25°C. |
| Statement of Intended use: | Peri-Guard is intended for repair of pericardial structures and for use
as a prosthesis for the surgical repair of soft tissue deficiencies which
include: defects of the abdominal and thoracic wall, gastric binding,
muscle flap reinforcement, and hernias (including diaphragmatic,
femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and
umbilical hernias). |
| Technological Comparisons: | The subject device is technologically identical to the predicate device.
The only difference between these devices is that the subject device
is treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75
minutes at 20-25 °C. |
1
Technology/Device Testing:
Cross-linked pericardium was treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodlum hydroxide treated and control (non-NaOHtreated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical residuals testing. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium. Product subjected to 1 M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.
2
K983162
Page 3/4
510(K) SUMMARY
| Submitted by: | Synovis Surgical Innovations
2575 University Avenue West
St. Paul, MN 55114-1024
Tel: 651-796-7300
Fax: 651-642-9018 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fonda Burley
At address above |
| Device Trade Name: | Supple Peri-Guard Pericardium |
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical
21 CFR 878.3300 |
| Product Code: | FTM |
| Predicate devices: | Supple Peri-Guard K961810 and K921895
(Device acting as its own predicate) |
| Device Description: | Supple Peri-Guard® is prepared from bovine pericardium which is
cross-linked with glutaraldehyde. The pericardium is procured from
cattle originating in the United States. Supple Peri-Guard is chemically
sterilized using ethanol and propylene oxide. Supple Peri-Guard has
been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-
25°C.
Supple Peri-Guard is packaged in a container filled with sterile, non-
pyrogenic water containing propylene oxide. The contents of the
unopened, undamaged container are sterile. |
| Statement of Intended use: | For use as a prosthesis for pericardial closure and soft tissue
deficiencies which include: defects of the abdominal and thoracic
wall, gastric banding, muscle flap reinforcement, and hernias
(diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy,
scrotal and umbilical). |
| Technological Comparisons: | The subject device is technologically identical to the predicate device.
The only difference between these devices is that the subject device
is treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75
minutes at 20 -25 C. |
.
3
K983162
page 4/4
Technology/Device Testing:
Cross-linked pericardium was treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOHtreated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical residuals testing. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium. Product subjected to 1 M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.
4
Image /page/4/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle with three lines forming its body and wings. The eagle is oriented towards the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bio-Vascular, Incorporated % Ms. Dianna L. Geck Regulatory Affairs Associate 2575 University Avenue St. Paul, Minnesota 55114-1024
AUG 2 7 2012
Re: K983162 Trade/Device Name: Peri-Guard® Repair Patch Supple Peri-Guard® Pericardium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM OxB Dated: September 9, 1998 Received: September 10, 1998
Dear Ms. Geck:
This letter corrects our substantially equivalent letter of October 9, 1998.
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 (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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 -Ms. Dianna L. Geck
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.
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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K983162
Device Name:
Peri-Guard Repair Patch
Indications For Use:
Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of _
510(k) Number K983162
7
Indications for Use
510(k) Number (if known): K983162
Device Name:
Supple Peri-Guard® Pericardium
Indications For Use:
For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kracfer MM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K983162