The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

Device Description

The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien.

The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Diaphragmatic Hernia Graft" manufactured by Cook Biotech Incorporated. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Diaphragmatic Hernia Graft are primarily demonstrated through substantial equivalence to predicate devices in terms of intended use, materials, and technological characteristics. The performance is assessed across several categories:

Acceptance Criteria Category	Specific Tests/Assessments	Reported Device Performance
Biocompatibility	- Genotoxicity- Direct contact in vitro hemolysis- Cytotoxicity- Muscle implantation- Acute intracutaneous reactivity- Skin irritation- ISO Sensitization- Acute systemic toxicity- Pyrogenicity- LAL endotoxins- Subchronic systemic toxicity	"The results of these tests provided evidence that the Diaphragmatic Hernia Graft meets biocompatibility requirements of the ISO standard." (ISO 10993-1 compliant)
Mechanical Strength	- Suture retention strength- Burst strength- Tensile strength- Stiffness	"The results of the mechanical testing provide evidence that the Diaphragmatic Hernia Graft possesses adequate mechanical strength for its application."
Safety and Biocompatibility (Animal Studies)	Animal studies for diaphragmatic/hiatal hernia repair using SIS material.	"These animal studies provide evidence that the Diaphragmatic Hernia Graft is biocompatible and safe in its application."
Clinical Performance (Human Studies)	Assessment of Surgisis (same base material) in several clinical studies. Further clinical evidence for rectangular flat sheet and U-shape configurations.	"The clinical outcomes of these studies show that the SIS material, which comprises the Diaphragmatic Hernia Graft, is safe and biocompatible." "Further clinical evidence was submitted showing that the rectangular flat sheet and U-shape configurations of the Diaphragmatic Hernia Graft performed adequately in patients."
Substantial Equivalence	Comparison to predicate devices (SIS Hernia Repair Device, Surgisis Staple Line Reinforcement, Permacol Surgical Implant) in terms of intended use, material, dimensions, and thickness.	The document concludes: "The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Diaphragmatic Hernia Graft show that the device is substantially equivalent to its predicates."

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

The document does not explicitly state the numerical sample sizes for the "test set" in the traditional sense of a randomized controlled trial comparing the new device against a control. Instead, it relies on:

Biocompatibility Testing: Performed on "sterilized SIS devices," which are "identical in base material to the Diaphragmatic Hernia Graft." The specific number of samples for each test is not detailed.
Mechanical Testing: Performed on "The Diaphragmatic Hernia Graft material." The specific number of samples for each test is not detailed.
Animal Testing: The SIS material has been "tested in animal studies for diaphragmatic/hiatal hernia repair." No specific sample size (number of animals) or data provenance (country, retrospective/prospective) is provided.
Clinical Testing: Refers to "several different clinical studies" for Surgisis (same base material) and "further clinical evidence" for the specific configurations of the Diaphragmatic Hernia Graft. No specific sample sizes, patient demographics, or data provenance (country, retrospective/prospective) are provided for these studies.

This submission focuses on demonstrating substantial equivalence by referring to existing data on the constituent material (SIS) and limited, non-comparative clinical data specific to the device's configurations, rather than a single, large-scale comparative test set for the new device.

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

This type of information (number and qualifications of experts for ground truth establishment) is not applicable or provided in this 510(k) submission. Medical device submissions for materials like surgical mesh typically rely on objective measurements (e.g., mechanical strength, biocompatibility assays) and clinical outcomes (e.g., healing, adverse events) rather than expert consensus on subjective interpretations like image analysis.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretations (e.g., radiology reads). This is not relevant to the types of tests (biocompatibility, mechanical, animal studies, general clinical outcomes) described for the Diaphragmatic Hernia Graft.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or appears relevant to this type of medical device (surgical mesh). This study design is typically used for diagnostic or screening devices where human readers interpret medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Not applicable. The Diaphragmatic Hernia Graft is a physical surgical mesh, not an algorithm or AI system. Therefore, an algorithm-only standalone performance study was not conducted or mentioned.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Diaphragmatic Hernia Graft is established through a combination of:

Objective Test Results: Biocompatibility test results (e.g., specific assay outcomes), mechanical strength measurements (e.g., numerical values for suture retention, burst strength).
Histopathological & Biological Observations: Observations from animal studies and clinical studies regarding tissue integration, inflammatory response, and healing, though specific details are not provided.
Clinical Outcomes Data: Safe and biocompatible performance, as evidenced in clinical studies, likely including absence of severe adverse events, successful repair, and tissue reinforcement. This is referenced as "clinical outcomes."

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The data supporting its safety and efficacy comes from prior biocompatibility, mechanical, animal, and clinical studies of the material (SIS) and the device configurations.

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

Not applicable, as there is no "training set" as understood in AI/ML. The "ground truth" for the underlying scientific understanding of SIS material and the performance of surgical meshes is established through standard scientific and regulatory practices, including:

Peer-reviewed scientific literature: Supporting the properties and biological interaction of SIS.
Industry standards: Such as ISO 10993 for biocompatibility.
Pre-clinical research: Animal models for hernia repair.
Prior clinical experience: With predicate devices and the SIS material, often documented in clinical registries or studies.

Summary

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510(k) Summary

June 19, 2014

JUN 2 0 2014

Cook Biotech Incorporated

Diaphragmatic Hernia 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:	Diaphragmatic Hernia Graft
Common Name:	Surgical mesh
Classification Regulations:	Class II, 21 CFR §878.3300 (FTM)

INTENDED USE:

DEVICE DESCRIPTION:

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EQUIVALENCE TO MARKETED DEVICES

The Diaphragmatic Hernia Graft is substantially equivalent to its predicate devices with respect to intended use, materials and technological characteristics, in terms of section 510(k) substantial equivalence, as shown in biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical, pre-clinical and clinical testing.

Biocompatibility Testing

The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material to the Diaphragmatic Hernia Graft (according to the ISO 10993-1 standard):

Genotoxicity .
Direct contact in vitro hemolysis .
Cytotoxicity �
. Muscle implantation
Acute intracutaneous reactivity
Skin irritation .
. ISO Sensitization
Acute systemic toxicity ●
Pyrogenicity ●
. LAL endotoxins
Subchronic systemic toxicity ●

The results of these tests provided evidence that the Diaphragmatic Hernia Graft meets biocompatibility requirements of the ISO standard.

Mechanical Testing

The Diaphragmatic Hernia Graft material was tested for the following:

Suture retention strength .
. Burst strength
Tensile strength �
Stiffness .

The results of the mechanical testing provide evidence that the Diaphragmatic Hernia Graft possesses adequate mechanical strength for its application.

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Animal Testing

The SIS material that comprises the Diaphragmatic Hernia Graft has been tested in animal studies for diaphragmatic/hiatal hernia repair. These animal studies provide evidence that the Diaphragmatic Hernia Graft is biocompatible and safe in its application.

Clinical Testing

The performance of Surgisis (which is made of SIS, the same base material as the Diaphragmatic Hernia Graft) was assessed in several different clinical studies. The clinical outcomes of these studies show that the SIS material, which comprises the Diaphragmatic Hernia Graft, is safe and biocompatible. Further clinical evidence was submitted showing that the rectangular flat sheet and U-shape configurations of the Diaphragmatic Hernia Graft performed adequately in patients. These studies provide evidence that the Diaphragmatic Hernia Graft is substantially equivalent to its predicates in this application.

Substantial Equivalence

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

Device	Diaphragmatic HerniaGraft	SIS Hernia Repair Device	Surgisis Staple LineReinforcement	Permacol SurgicalImplant
Manufacturer	Cook Biotech Incorporated	Cook Biotech Incorporated	Cook Biotech Incorporated	Covidien
510(k) Number	K133011	K974540/K062697	K022044	K120605
Intended Use	For implantation to reinforcesoft tissues where weaknessexists, including the repair ofdiaphragmatic/hiatal hernias.	To be implanted toreinforce soft tissues whereweakness exists.Indications for use includethe repair of a hernia orbody wall defect.	For use as a prosthesis forthe surgical repair of softtissue deficiencies usingsurgical staplers. Thedevice may be used forbuttressing and reinforcingstaple lines during lungresection (e.g., wedgeresection, blebectomy,lobectomy, bullectomy,bronchial resection,segmenteectomy,pneumonectomy/pneumectomy, pneumoreduction)and other incisions andexcisions of the lung andbronchus. The device canbe used for thereinforcement of the gastricstaple line during thebariatric surgical	Intended for use as asoft tissue implant toreinforce soft tissuewhere weakness existsand for the surgicalrepair of damaged orruptured soft tissuemembranes. It isspecifically indicatedfor the repair ofabdominal, inguinal,diaphragmatic, femoral,scrotal, umbilical,incisional, parastomalhernias and abdominalwall defects.

Table 1 - Substantial Equivalence Comparison

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Device	Diaphragmatic HerniaGraft	SIS Hernia Repair Device	Surgisis Staple LineReinforcement	Permacol SurgicalImplant
			bypass and gastric banding.The device can also be usedfor abdominal and thoracicwall repair, muscle flapreinforcement, trans-abdominal rectal andvaginal prolapse repair,trans-abdominalreconstruction of the pelvicfloor, and repair of hernias(e.g., diaphragmatic,femoral, incisional,inguinal, lumbar,paracolostomy, scrotal,umbilical). The SurgisisStaple Line Reinforcementmay be used withanastomotic staplers or withnon-anastomotic staplers.
Material	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IVand VI collagen(constituents of theextracellular matrix)	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IVand VI collagen(constituents of theextracellular matrix)	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IVand VI collagen(constituents of theextracellular matrix)	Porcine dermis(collagen)
Dimensions	Nominally, 7 x 10 cm (arectangular flat sheetconfiguration and a Ushaped configuration). Therectangular sheet hasresorbable stitching acrossthe graft and the U-shapegraft is stitched on the edgesto reduce delaminationduring implantation	5 x 8 cm to 20 x 30 cm	1.0 x 3.8 cm to 1.2 x 8.8 cm	1 cm x 4 cm to 28cm x40 cm
Thickness	0.1 - 1.5 mm	0.1 - 1.5 mm	0.350 mm	0.5-1.5 mm

・、・・・・

CONCLUSION: The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Diaphragmatic Hernia Graft show that the device is substantially equivalent to its predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 20, 2014

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

Re: K133011

Trade/Device Name: Diaphragmatic Hernia Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWV, FTM Dated: May 20, 2014 Received: May 21, 2014

Dear Mr. Guinn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviews 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 that I DI Hos Intellites and regulations administered by other Federal agencies. You must or any I vith 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

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Page 2 - Mr. Perry W. Guinn

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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

David Kranse -S

for 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133011

Device Name

Diaphragmatic Hernia Graft

Indications for Use (Describe)

The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissue where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

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)

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)

Peter L. Hudson -S
2014.06.20 13:12:26 -04'00'

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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.