Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy / pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

Device Description

The Bovine Pericardium Patch is intended for use as an implant to reinforce soft tissue where weakness exists. The Boyine Pericardium Patch is derived from bovine pericardium tissue. The tissue is subjected to decontamination and decellularization processing using non-toxic reagents. The resulting mesh is intended for use as a resorbable implant for soft tissue repair which subsequently remodels and is integrated in the host connective tissue. The Bovine Pericardium Patch is terminally sterilized and is available in sizes ranging from 2cm x10cm to 8cm x16cm.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The document is a 510(k) summary for the Bovine Pericardium Patch, aiming to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" here are implicitly linked to the substantial equivalence requirements, meaning the Bovine Pericardium Patch must perform comparably to the predicate device across various aspects.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for specific performance metrics. Instead, the document demonstrates substantial equivalence by comparing the Bovine Pericardium Patch to a predicate device (Veritas® Collagen Matrix, K062915). The implicit acceptance criteria are that the Bovine Pericardium Patch's performance and characteristics are "comparable" or "substantially equivalent" to the predicate device.

Category	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Bovine Pericardium Patch)	Predicate Device Performance (Veritas® Collagen Matrix)
Biocompatibility	Comparable safety profile	Showed comparable safety profile	(Implied safe based on predicate's clearance)
In Vitro Cytotoxicity	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Skin Sensitization	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Intracutaneous Reactivity	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Acute Systemic Toxicity	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Genotoxicity	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Muscle Implantation	Comparable	Tested	(Not specified for predicate, but assumed comparable)
In Vitro Hemolysis	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Pyrogenicity	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Subchronic Systemic Toxicity	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Bench/Laboratory Testing	Comparable mechanical properties	Demonstrated substantially equivalent	(Implied appropriate for reinforcing soft tissue)
Tensile Strength	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Suture Retention Strength	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Burst Force	Comparable	Tested	(Not specified for predicate, but assumed comparable)
Tear Resistance	Comparable	Tested	(Not specified for predicate, but assumed comparable)
DNA Residuals	Tested and comparable to predicate	Tested	(Not specified for predicate, but assumed comparable)
Collagen Analysis	Tested and comparable to predicate	Tested	(Not specified for predicate, but assumed comparable)
Viral Inactivation	Tested and comparable to predicate	Tested	(Not specified for predicate, but assumed comparable)
Stability	Tested and comparable to predicate	Tested	(Not specified for predicate, but assumed comparable)
Device Characteristics	Identical or comparable	As listed in table	As listed in table
Classification Regulation	21 CFR 878.3300, Class II	21 CFR 878.3300, Class II	21 CFR 878.3300, Class II
Product Code	FTM, OXE, OXB, PAJ	FTM, OXE, OXB, PAJ	FTM, OXE, OXB, PAJ
Indication	Identical (with predicate's additional feature noted)	Listed	Listed
Rx/OTC	Rx	Rx	Rx
Physical Shape	Rectangular Patch	Rectangular Patch	Rectangular Patch
Available Sizes	Various (2x8cm to 12x25cm)	Various (2x8cm to 12x25cm)	Various (2x8cm to 12x25cm)
Product Description	Type I Bovine Collagen	Type I Bovine Collagen	Type I Bovine Collagen
Animal Tissue	Bovine Pericardium	Bovine Pericardium	Bovine Pericardium
Sterile	Yes (E-Beam)	Yes (E-Beam)	Yes (E-Beam)
Pore Size (SEM)	Comparable (1-3 μm vs 1-4 μm)	1-3 μm	1-4 μm
Average Device Thickness	Comparable (0.55mm vs 0.67mm)	0.55mm	0.67mm
Storage	20-25°C	20-25°C	20-25°C
Handling characteristics	Flexible	Flexible	Flexible

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical trials or AI model validation. The studies described are primarily bench testing and biocompatibility testing.

Bench/Laboratory Testing: No specific sample sizes (e.g., number of patches tested for tensile strength) are provided for each mechanical test. Data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted lab.
Biocompatibility Testing: The specific sample sizes for animal tests (e.g., muscle implantation, subchronic systemic toxicity) are not provided. These are standard pre-clinical tests; the provenance would be from laboratory studies, likely animal models.

The data is retrospective in the sense that it's pre-market data collected to support the 510(k) submission, not an ongoing prospective clinical trial. The country of origin of the data is not explicitly stated but assumed to be from the US or a compliant lab, given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device submission. There is no mention of "ground truth" established by human experts in the context of image interpretation or diagnostic accuracy for this device, which is a surgical mesh. The "truth" for this device's performance is derived from standardized physical and biological tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. There is no expert review or adjudication process described for the bench and biocompatibility tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is a physical medical device (surgical mesh), not an AI-powered diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the bench/laboratory testing, the "ground truth" is established by standardized measurement techniques and accepted engineering principles for material properties. For biocompatibility, the "ground truth" is based on biological responses observed in validated in vitro and in vivo (animal) models, interpreted against established safety standards (e.g., ISO 10993 series). There is no "expert consensus" or "pathology" in the sense of diagnosing human conditions within this context.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2014

CollaFirm, LLC Dr. Surendra P. Batra Founder and Chief Executive Officer 7 Deer Park Drive, Suite M-7 Monmouth Junction, New Jersey 08852

Re: K141721

Trade/Device Name: Bovine Pericardium Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXE, OXB, PAJ Dated: November 24, 2014 Received: November 25, 2014

Dear Dr. Batra:

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

{1}------------------------------------------------

device-related 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/Resourcesfor You/Industry/default.htm. 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 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,

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name Bovine Pericardium Patch

Indications for Use (Describe)

Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy/pneumectomy/pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair of hemias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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}------------------------------------------------

510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Bovine Pericardium Mesh is provided below.

Device Common Name:	Surgical Mesh
Device Proprietary Name:	Bovine Pericardium Patch
Submitter:	CollaFirm, LLC7 Deer Park drive, Suite M-7Monmouth Junction, NJ 08852
Contact:	Surendra P. Batra, Ph. DFounder & CEO, CollaFirm LLCPhone: (732) 823-1051surendra@collafirm.com
Prepared By:	Stephen P. RhodesBiologics Consulting Group, Inc.
Date Prepared:	June 25, 2014
Classification Regulation:	21 CFR 878.3300, Class II
Panel:	79 General & Plastic Surgery
Product Code:	FTM, OXE, OXB, PAJ
Predicate Device:	Veritas® Collagen Matrix, Synovis Surgical InnovationsK062915

Indication for Use:

Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

{4}------------------------------------------------

Device Description:

Performance Data:

Mechanical testing, biocompatibility testing and animal testing were conducted per the recommendations in: Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance – Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, " dated March 2, 1999." The following tests were conducted:

Biocompatibility

In Vitro Cytotoxicity ●
Skin Sensitization ●
Intracutaneous Reactivity
Acute Systemic Toxicity ●
Genotoxicity
Muscle Implantation ●
In Vitro Hemolysis ●
Pyrogenicity ●
Subchronic Systemic Toxicity ●

Bench/Laboratory Testing

Tensile Strength ●
Suture Retention Strength
Burst Force
Tear Resistance
DNA Residuals
Collagen Analysis
Viral Inactivation
Stability

The biocompatibility testing showed the comparable safety profile of the Bovine Pericardium Patch and the predicate. Bench testing demonstrated that the mechanical properties of the mesh are substantially equivalent for reinforcing soft tissue.

{5}------------------------------------------------

Substantial Equivalence:

As summarized in Table 1 below, the Bovine Pericardium Patch is substantially equivalent to the predicate device with respect to design, physical shape, characteristics, basic principles of operation and intended use.

	Bovine Pericardium Patch	Veritas® Collagen Matrix
510(k) Number	TBD	K062915
Submitter	CollaFirm	Synovis Surgical Innovations
Classification Regulation	21 CFR 878.3300, Class II	21 CFR 878.3300, Class II
Product Code	FTM, OXE, OXB, PAJ	FTM, OXE, OXB, PAJ
Indication	Bovine Pericardium Patch isintended for use as an implant forthe surgical repair of soft tissuedeficiencies, this includes but isnot limited to the following:Buttressing and reinforcing staplelines during lung resection (e.g.,wedge resection, blebectomy,lobectomy, bullectomy, bronchialresection, segmentectomy,pneumonectomy / pneumectomy,pneumoreduction) and otherincisions and excision of the lungand bronchus.Reinforcement of the gastricstaple line during the bariatricsurgical procedures of gastricbypass and gastric banding.Abdominal and thoracic wallrepair, muscle flap reinforcement,rectal prolapse excludingrectocele, reconstruction of thepelvic floor excludingtransvaginal organ prolapserepair, and repair of hernias (e.g.,diaphragmatic, femoral,incisional, inguinal, lumbar,paracolostomy, scrotal,umbilical).	Veritas® Collagen Matrix isintended for use as an implant forthe surgical repair of soft tissuedeficiencies, this includes but isnot limited to the following:Buttressing and reinforcing staplelines during lung resection (e.g.,wedge resection, blebectomy,lobectomy, bullectomy, bronchialresection, segmentectomy,pneumonectomy / pneumectomy,pneumoreduction) and otherincisions and excision of the lungand bronchus.Reinforcement of the gastricstaple line during the bariatricsurgical procedures of gastricbypass and gastric banding.Abdominal and thoracic wallrepair, muscle flap reinforcement,rectal prolapse excludingrectocele, reconstruction of thepelvic floor excludingtransvaginal organ prolapserepair, and repair of hernias (e.g.,diaphragmatic, femoral,incisional, inguinal, lumbar,paracolostomy, scrotal,umbilical).Veritas® Collagen Matrixminimizes tissue attachment to thedevice in case of direct contact
	Bovine Pericardium Patch	Veritas® Collagen Matrix
		with viscera.
Rx/OTC	Rx	Rx
Physical Shape	Rectangular Patch	Rectangular Patch
Available Sizes	Various sizes ranging from2x8cm to 12x25cm	Various sizes ranging from2x8cm to 12x25cm
Product Description	Type I Bovine Collagen	Type I Bovine Collagen
Animal Tissue	Bovine Pericardium	Bovine Pericardium
Sterile	Yes (E-Beam)	Yes (E-Beam)
Pore Size (SEM)	1-3 μm	1-4 μm
Average Device Thickness	0.55mm	0.67mm
Storage	20-25°C	20-25°C
Handling characteristics	Flexible	Flexible

Table 1: Device Comparison Table

{6}------------------------------------------------

Conclusion

Based on the indications for use, technological characteristics and performance
test results, the Bovine Pericardium Patch is substantially equivalent to the predicate.

Regulation Number and Section

§ 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.