(127 days)
No
The device description and performance studies focus on the material properties and biological compatibility of a bovine pericardium patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for "repair of pericardial structures" and as "a prosthesis for pericardial closure," which are therapeutic actions.
No
The device is a prosthesis / patch intended for surgical repair of pericardial and intracardiac structures, not for diagnosing conditions.
No
The device description clearly states it is prepared from bovine pericardium and is a physical patch intended for surgical implantation, indicating it is a hardware device, not software.
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 SUPPLE PERI-GUARD and PERI-GUARD are intended for use as prostheses and patches for surgical repair of various anatomical structures (pericardium, intracardiac defects, great vessels, septal defects, annulus). This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a prepared bovine pericardium patch, which is a physical implant used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the physical and biological properties of the patch (suture retention, strength, biocompatibility, etc.) and its performance in animal studies as a surgical implant. There are no studies related to diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural repair.
N/A
Intended Use / Indications for Use
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
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.
Product codes
DXZ
Device Description
SUPPLE PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation.
SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation.
PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardial, intracardiac, great vessel, septal, annulus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 safety and performance of SUPPLE PERI-GUARD Pericardium Patch was evaluated through non-clinical testing.
The bench and pre-clinical testing assessed the following aspects of the device: Suture retention, Thickness, Burst Strength, Ultimate Tensile Strength, Collagenase digestion, Chemical residuals, Pyrogenicity/LAL, Sterilization validation, Packaging and shelf-life, Biocompatibility, Animal studies.
Bench testing results support the performance requirements for SUPPLE PERI-GUARD Pericardium Patch. Biocompatibility testing was performed in accordance to ISO 10993-1: 2009 (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 SUPPLE PERI-GUARD Pericardium Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.
The safety and performance of PERI-GUARD Repair Patch was evaluated through non-clinical testing.
The bench and pre-clinical testing assessed the following aspects of the device: Suture retention, Thickness, Burst Strength, Ultimate Tensile Strength, Collagenase digestion, Chemical residuals, Pyrogenicity/LAL, Sterilization validation, Packaging and shelf-life, Biocompatibility, Animal studies.
Bench testing results support the performance requirements for PERI-GUARD Repair Patch. Biocompatibility testing was performed in accordance to ISO 10993-1: 2009 (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 PERI-GUARD Repair Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synovis Life Technologies, SUPPLE PERI-GUARD Pericardium Patch: K983162
Synovis Life Technologies, PERI-GUARD Pericardium with Apex Processing: K983162, K983602
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
Synovis Life Technologies Inc. % Jodi Jorgenson Manager, Regulatory Affairs 2575 University Ave. W. St. Paul, Minnesota 55129
Re: K142447
Trade/Device Name: PERI-GUARD Repair Patch SUPPLE PERI-GUARD Pericardium 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: DXZ Dated: August 28, 2014 Received: September 2, 2014
Dear Jodi Jorgenson,
This letter corrects our substantially equivalent letter of January 7, 2015.
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.
1
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 devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
Enclosures
2
Indications for Use
510(k) Number (if known) K142447
Device Name
SUPPLE PERI-GUARD Pericardium Patch
Indications for Use (Describe)
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142447
Device Name 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.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K) SUMMARY: SUPPLE PERI-GUARD PERICARDIUM PATCH
Applicant:
Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7300 Fax: 651-642-9018
Contact Person:
Jodi Jorgenson Manager, Regulatory Affairs At address above
Date Prepared:
August 28, 2014
Device Trade Name: SUPPLE PERI-GUARD Pericardium Patch
Common Name:
Intracardiac patch
Classification Name:
Intracardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ
Predicate Devices:
Synovis Life Technologies, SUPPLE PERI-GUARD Pericardium Patch: K983162
Device Description:
SUPPLE PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation.
SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
5
Statement of Intended Use:
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
Summary/Comparison of Technological Characteristics:
SUPPLE PERI-GUARD Pericardium Patch is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the packaging and sterilization method, which are the subject of this premarket notification submission.
The safety and performance of SUPPLE PERI-GUARD Pericardium Patch was evaluated through non-clinical testing.
The bench and pre-clinical testing assessed the following aspects of the device:
- Suture retention .
- Thickness ●
- Burst Strength .
- Ultimate Tensile Strength
- Collagenase digestion
- Chemical residuals ●
- Pyrogenicity/ LAL ●
- Sterilization validation ●
- Packaging and shelf-life ●
- Biocompatibility ●
- Animal studies ●
Bench testing results support the performance requirements for SUPPLE PERI-GUARD Pericardium Patch. Biocompatibility testing was performed in accordance to ISO 10993-1: 2009 (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 SUPPLE PERI-GUARD Pericardium Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.
Conclusions:
The safety and performance of SUPPLE PERI-GUARD Pericardium Patch was evaluated through biocompatibility, bench testing and animal studies. SUPPLE PERI-GUARD Pericardium Patch is substantially equivalent to the predicate device.
6
510(K) SUMMARY: PERI-GUARD REPAIR PATCH
Applicant:
Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7300 Fax: 651-642-9018
Contact Person:
Jodi Jorgenson Manager, Regulatory Affairs At address above
Date Prepared: August 28, 2014
Device Trade Name: PERI-GUARD Repair Patch
Common Name: Intracardiac patch
Classification Name:
Intracardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ
Predicate Devices:
Synovis Life Technologies, PERI-GUARD Pericardium with Apex Processing: K983162 and K983602
Device Description:
PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation.
PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
7
Statement of Intended 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.
Summary/Comparison of Technological Characteristics:
PERI-GUARD Repair Patch is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the packaging and method of sterilization, which is the subject of this premarket notification submission.
The safety and performance of PERI-GUARD Repair Patch was evaluated through non-clinical testing.
The bench and pre-clinical testing assessed the following aspects of the device:
- Suture retention
- Thickness ●
- Burst Strength
- Ultimate Tensile Strength ●
- Collagenase digestion ●
- Chemical residuals
- Pyrogenicity/ LAL ●
- Sterilization validation
- Packaging and shelf-life ●
- Biocompatibility
- Animal studies
Bench testing results support the performance requirements for PERI-GUARD Repair Patch. Biocompatibility testing was performed in accordance to ISO 10993-1: 2009 (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 PERI-GUARD Repair Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.
Conclusions:
The safety and performance of PERI-GUARD Repair Patch was evaluated through biocompatibility, bench testing and animal studies. PERI-GUARD Repair Patch and is substantially equivalent to the predicate device.