The Hybrid Graft is for implantation to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The graft is supplied sterile and is intended for one-time use.

Device Description

The Hybrid Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAPRO in that all are made of a composite of a bioabsorbable or collagen-based and synthetic (polypropylene) component. The polypropylene mesh in the Hybrid Graft is layered between six (6) layers of SIS on the side facing the viscera and two (2) layers of SIS on the side facing the body wall. The device is packaged in a vacuum pressed (dried), laminated state and supplied sterile in a sealed double pouch system.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Hybrid Graft." It's important to note that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies as one might find for novel AI/software devices.

Instead, the "acceptance criteria" here refer to meeting standards for mechanical performance and biocompatibility to demonstrate that the new device is as safe and effective as existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" refers to bench testing and biocompatibility testing.

Here's the information broken down as requested, with the caveat that the prompt's structure is more aligned with AI/software performance studies, which is not the primary focus of this type of medical device submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit from equivalence)	Reported Device Performance
Mechanical Performance	Suture retention	Adequate for the application (similar to predicates)	"Finished devices were tested for mechanical performance... The mechanical performance of the Hybrid Graft is adequate for the application." (Specific numerical values for suture retention, tensile strength, and burst strength are not provided in this summary but were presumably part of the submission.)
	Ultimate tensile strength	Adequate for the application (similar to predicates)	"Finished devices were tested for mechanical performance... The mechanical performance of the Hybrid Graft is adequate for the application."
	Diaphragmatic burst strength	Adequate for the application (similar to predicates)	"Finished devices were tested for mechanical performance... The mechanical performance of the Hybrid Graft is adequate for the application."
Biocompatibility	Genotoxicity	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." (Specific test results would be in the full submission, referred to here by NAMSA™ assessment)
	Direct contact in vitro hemolysis	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	Cytotoxicity	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	Muscle implantation	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	Acute intracutaneous reactivity	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	ISO sensitization	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	Acute systemic toxicity	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	Pyrogenicity	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	LAL endotoxins	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."
	Subchronic toxicity	Meets ISO 10993 standards	"The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates."

Note on Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence. The device must perform comparably to predicate devices in mechanical tests and meet established biocompatibility safety standards (ISO 10993). Specific numerical thresholds for mechanical properties are not explicitly stated in this summary but are implied by the statement "adequate for the application" and "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact number of devices or material samples used for the bench and biocompatibility testing. It only states "Finished devices were tested" and "The SIS material comprising the Hybrid Graft was tested."
Data Provenance: Not specified, but generally, such bench and biocompatibility testing would be conducted in a controlled laboratory environment, often by the manufacturer or a contract research organization (like NAMSA, mentioned for biocompatibility). The nature of these tests (mechanical and in vitro/in vivo biocompatibility) is prospective for the specific purpose of this submission. Country of origin for data is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. The "ground truth" here is established by standardized testing protocols (e.g., ISO 10993 for biocompatibility) and engineering principles for mechanical testing, not by expert interpretation of medical images or clinical outcomes. The "experts" would be testing technicians and engineers qualified in these specific laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies requiring consensus on subjective interpretations (e.g., image reading). The tests performed are objective laboratory measurements.

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 is not applicable. The Hybrid Graft is a physical surgical mesh, not an AI or imaging device that would involve human readers or MRMC studies.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this submission consists of:

Performance Standards: Established mechanical properties required for surgical meshes (implicitly benchmarked against predicate devices).
Biocompatibility Standards: Established international standards (ISO 10993) for assessing biological responses to medical devices.
Predicate Device Performance: The characteristics and performance of the legally marketed predicate devices (SIS Hernia Repair Device, PROCEED™ Ventral Patch, ULTRAPRO® Mesh) serve as a de facto "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

This is not applicable as there is no training set.

Summary

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111695

510(k) Summary

APR - 2 2012

Cook Biotech Incorporated

Hybrid Graft

Manufacturer Name:

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709

Official Contact:

Perry W. Guinn

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Hybrid Graft
Common Name:	Surgical Mesh
Classification Regulations:	Class II, 21 CFR §878.3300 (79FTL)

INTENDED USE:

DEVICE DESCRIPTION:

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EQUIVALENCE TO MARKETED DEVICES

The Hybrid Graft is similar with respect to intended use and with respect to materials and technological characteristics to the predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing:

Bench Testing

Finished devices were tested for mechanical performance as follows:

Suture retention ●
Ultimate tensile strength ●
Diaphragmatic burst strength .

The mechanical performance of the Hybrid Graft is adequate for the application.

Biocompatibility testing

The SIS material comprising the Hybrid Graft was tested under ISO 10993 standards as follows:

. Genototicity
Direct contact in vitro hemolysis ●
Cytotoxicity ●
. Muscle implantation
Acute intracutaneous reactivity ●
ISO sensitization
Acute systemic toxicity ●
. Pyrogenicity
LAL endotoxins ●
Subchronic toxicity .

The Hybrid Graft was tested under ISO 10993 standard under the following:

· Cytotoxicity
A Biocompatibility Assessment from NAMSA™ attesting to the biocompatibility of the Hybrid Graft was provided for this submission.

The results of the biocompatibility testing show that the Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates.

Substantial Equivalence

See Table 1 below for a comparison of the subject device and its predicates.

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Device	Hybrid Graft	SIS Hernia RepairDevice	SurgiSIS Mesh	PROCEED™ VentralPatch	ULTRAPRO® Mesh
Manufacturer	Cook BiotechIncorporated	Cook BiotechIncorporated	Cook BiotechIncorporated	Ethicon, Incorporated	Ethicon, Incorporated
510(k)Number	K111695	K974540, K062697	K980431	K061533	K033337
Intended Use	To be implanted toreinforce soft tissueswhere weaknessexists. Indicationsfor use include therepair of a hernia orbody wall defectrequiring theaddition of areinforcing orbridging material toobtain the desiredsurgical result.	To be implanted toreinforce soft tissueswhere weakness exists.Indications for useinclude the repair of ahernia or body walldefect.	For implantation toreinforce soft tissue.	For the repair ofhernias or otherabdominal fascialdefects that require theaddition of areinforcing or bridgingmaterial to obtain thedesired surgicalresults.	For the repair ofhernias and otherabdominal fascialdeficiencies thatrequire the additionof a reinforcing orbridging material toobtain the desiredsurgical result.
Material	Small intestinalsubmucosaPrimarily Types I,III, IV and VIcollagenand polypropylene	Small intestinalsubmucosaPrimarily Types I, III,IV and VI collagen	Small intestinalsubmucosaPrimarily Types I,III, IV and VIcollagen	Oxidized regeneratedcellulose (ORC),polypropylene	Poliglecaprone-25and polypropylene
Dimensions	15 cm x 22 cm to30 cm x 30 cm, 15cm diameter	5 cm x 8 cm to 20 cm x30 cm	0.6 cm x 5 cm to 7cm x 20 cm	5 cm x 10 cm to 30.5cm x 30.5 cm	7.6 cm x 15 cm to 30cm x 30 cm
Thickness	0.1 to 2.0 mm	0.1 to 1.5 mm	0.1 to 2.0 mm	N/A	N/A

Table 1 - Substantial Equivalence Table

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Cook Biotech, Incorporated % Mr. Perry W. Guinn Vice President, Regulatory Affairs and Quality Assurance 1425 Innovation Place West Lafayette, Indiana 47906-4224

APR - 2 2012

· Re: K111695

Trade/Device Name: Hybrid Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 14, 2012 Received: March 15, 2012

Dear Mr. Guinn:

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

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Page 2 - Mr. Perry W. Guinn

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 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,

For Arthur
Dep. C.C.s D.n

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KIIIBqr

Indications for Use

510(k) Number (if known):

Device Name: Hybrid Graft

Indications For Use:

The Hybrid Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. This graft is supplied sterile and is intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Daniel Kune fei McKay

(Division Sign-Off) Division of Surgical, Orthopedic and Restorative Devices

510(k) Number K11695

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.