The Biodesign® Parastomal Hernia Repair Graft is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Device Description

The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The devices are composed of multiple layers of porcine Small Intestinal Submucosa (SIS), a bioabsorbable, extracellular collagen matrix (ECM) that is non-crosslinked and decellularized; additionally, the device is held together with biodegradable suture to improve device handling characteristics at time of implant and is perforated to assist with fluid transfer. The single-use devices are packaged in a dried state and supplied sterile (EtO) in a sealed double pouch system.

AI/ML Overview

The provided text describes the Biodesign Parastomal Hernia Repair Graft and its substantial equivalence to a predicate device (Permacol® Surgical Implant). The document details performance data through biocompatibility, mechanical testing, and clinical studies.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific device. Instead, it describes performance through various tests and clinical outcomes to demonstrate substantial equivalence to a predicate device.

Biocompatibility:

Acceptance Criteria (Implied): Meet all biocompatibility requirements of the ISO standard for permanent implantable devices.
Reported Device Performance: "Testing results show that the Biodesign® Parastomal Hernia Repair Graft meets all biocompatibility requirements of the ISO standard for permanent implantable devices."

Product Characterization - Mechanical:

Acceptance Criteria (Implied): Adequate mechanical strength for use in abdominal wall defect and hernia repair.
Reported Device Performance: "Product characterization testing shows that the Biodesign® Parastomal Hernia Repair Graft provides adequate mechanical strength for use in the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias."
- Specific mechanical tests performed: Burst strength, Ultimate tensile strength, Device stiffness, Suture retention strength, Tear strength, Delamination. (No specific quantitative results are provided in this summary).

Safety and Performance - Clinical Data (Recurrence Rate for Parastomal Hernias):

Acceptance Criteria (Implied): Safe and effective use for repairing parastomal hernias, comparable to existing treatments or with an acceptable recurrence rate.
Reported Device Performance:
- Short-term (Median 18 months): 10% recurrence (2 out of 20 patients).
- Long-term (Median 53 months): 25% recurrence (5 out of 20 patients).
- Graft-Related Complications: 4 seromas in initial 10 patients (resolved by routine drain placement). No other complications reported long-term.

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

Sample Size for Test Set: 20 patients for the clinical study directly referenced (Ellis A).
Data Provenance: The primary clinical study cited is a published peer-reviewed publication by Ellis CN, titled "Short-term outcomes with the use of bioprosthetics for the management of parastomal hernias" (2010). This indicates retrospective or prospective data collection from a clinical setting, though the exact nature (e.g., country of origin) is not specified in the provided text. The document also mentions "Unpublished long term data on 19/20 patients," which suggests an extension of this initial cohort.

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

The clinical data is derived from a published peer-reviewed study. For clinical studies, the "ground truth" (e.g., diagnosis of recurrence, identification of complications) is typically established by the physicians and medical staff involved in the study. The text does not specify the number of experts, their qualifications, or the specific process they used to establish the ground truth for the clinical data. It just refers to "patients," implying clinical observation and diagnosis by healthcare professionals.

4. Adjudication Method for the Test Set

The text does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's outcomes (recurrence, complications). Clinical study outcomes are generally determined by the treating physicians or study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. The clinical study cited focuses on the outcomes of the SIS-based device itself, not on comparing performance of human readers with and without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a physical medical implant (a surgical graft), not an algorithm or AI. Therefore, the concept of a "standalone study" for an algorithm's performance without a human-in-the-loop is not applicable to this device. The studies performed directly assess the device's physical and biological performance in a clinical setting.

7. The Type of Ground Truth Used

Biocompatibility and Mechanical Testing: The "ground truth" for these tests are the established ISO standards and FDA guidance documents, which define acceptable physical and biological characteristics. The results directly measure these characteristics.
Clinical Data: The "ground truth" for the clinical study outcomes (recurrence, complications) is based on expert clinical diagnosis (e.g., physical examination, radiological (CT) examination) and patient outcomes data collected during follow-up.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a physical graft, not a machine learning model. The biocompatibility and mechanical tests are performed on the device itself, and the clinical study provides evidence of its performance in patients.

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

As noted above, a "training set" is not relevant for this type of medical device. The "ground truth" for the device's safety and performance is established through adherence to regulatory standards (biocompatibility, mechanical testing) and clinical observations/diagnoses in patient studies.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem consisting of a caduceus-like symbol with three human profiles facing right, suggesting health and human services.

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

July 10, 2017

Cook Biotech Incorporated Ms. Daniela Changkuon Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, Indiana 47906

Re: K162934

Trade/Device Name: Biodesign Parastomal Hernia Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXK Dated: June 7, 2017 Received: June 12, 2017

Dear Ms. Changkuon:

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 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.

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

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,

Image /page/1/Picture/7 description: The image shows the text "David Krause -S" in a simple, sans-serif font. The text is arranged horizontally, with "David Krause" appearing first, followed by a hyphen and the letter "S". The text is black against a white background.

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

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

Indications for Use

510(k) Number (if known) K162934

Device Name

Biodesign Parastomal Hernia Repair Graft

Indications for Use (Describe)

The Biodesign Parastomal Hernia Repair Graft is intended for use as a soft tissue patch where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

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."

{3}------------------------------------------------

510(k) Summary

I. SUBMITTER

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906

Phone: (765) 497-3355

Contact Person: Perry W. Guinn Date Prepared: 05 June 2017

DEVICE II.

Name of Device:	Biodesign® Parastomal Hernia Repair Graft
Common or Usual Name:	Surgical graft
Classification Name:	Mesh, Surgical (21 CFR §878.3300)
Regulatory Class:	II
Product Code:	FTM, OXK

III. PREDICATE DEVICE

Permacol® Surgical Implant (K043366; Medtronic)

Reference Device: SIS Hernia Graft (K133306, Cook Biotech Incorporated)

IV. DEVICE DESCRIPTION

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

V. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The Biodesign® Parastomal Hernia Repair Graft is substantially equivalent its predicate in that they are both specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias. The technological principle for both the subject and predicate devices is mechanical reinforcement of soft tissue without leaving behind long-term foreign materials. The two devices are biological scaffolds derived from porcine tissue that are processed and designed to meet the requirements of the intended clinical use. Both devices undergo a remodeling process whereby the scaffold is eventually completely replaced by host tissue.

The predicate device is composed of porcine dermis (predominantly collagen and elastin fibers) which is cross-linked by hexamethylene diisocyanate (HMDI). The subject device is composed of non-crosslinked porcine SIS and biodegradable suture; the Biodesign® Parastomal Hernia Repair Graft is identical in all aspects to the SIS Hernia Graft (K133306; reference device). Table 5-1 below provides a comparison of the subject, predicate and reference devices.

Device	Biodesign® Parastomal Hernia Repair Graft	Permacol® Surgical Implant	SIS Hernia Repair Graft (reference device)
Manufacturer	Cook Biotech Inc.	Medtronic	Cook Biotech Inc.
510 (k) Number	K162934	K043366	K133306
Intended Use	Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.	Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.	Intended for implantation to reinforce soft tissue where weakness exists. Indications for use include repair of a hernia or body wall defect.
Product Code	FTM, OXK	FTL	FTM, OXK

Table 5-1. Substantial Equivalence Information

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

Device	Biodesign® ParastomalHernia Repair Graft	Permacol® SurgicalImplant	SIS Hernia Repair Graft(reference device)
Material	Porcine small intestinalsubmucosa (extracellularmatrix - primarily collagentypes I, III, IV and VI) andpolyglycolic acid (PGA)sutures	Porcine dermis(extracellular matrix -primarily collagen andelastin).	Porcine small intestinalsubmucosa (extracellularmatrix - primarily collagentypes I, III, IV and VI) andpolyglycolic acid (PGA)sutures
Crosslinking	Non-crosslinked	Crosslinked (HMDI)	Non-crosslinked
Dimensions	5 cm x 8 cm to 30 x 30 cm	1 cm x 4 cm to 28 cm x 40cm	5 cm x 8 cm to 30 x 30 cm
Thickness	0.1 mm to 1.5 mm	0.5 mm to 1.5 mm	0.1 mm to 1.5 mm
Sterilization	ethylene oxide	gamma irradiation	ethylene oxide
One-time Use	Yes	Yes	Yes

VII. PERFORMANCE DATA

Biocompatibility:

The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The following biocompatibility tests were performed on finished devices in accordance with the FDA's biocompatibility testing guidance Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (May 1, 1995):

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

Testing results show that the Biodesign® Parastomal Hernia Repair Graft meets all biocompatibility requirements of the ISO standard for permanent implantable devices. Product characterization - Mechanical:

The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). Mechanical testing was performed on finished devices to evaluate the mechanical performance of the device for its intended use. The following mechanical tests were performed in accordance with FDA's 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh' (March 2, 1999):

Burst strength ●
Ultimate tensile strength
Device stiffness ●
Suture retention strength ●
Tear strength
Delamination ●

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

Product characterization testing shows that the Biodesign® Parastomal Hernia Repair Graft provides adequate mechanical strength for use in the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Safety and Performance - Clinical Data:

Clinical data to support the safety and performance of the Biodesign® Parastomal Hernia Repair Graft material for the surgical repair of abdominal wall defects and hernias, including parastomal hernias, is primarily in the form of peer-reviewed publications. The literature describes the safe and effective use of SIS-based devices to treat soft tissue deficiencies in the parastomal anatomy. Table 5-2 summarizes the results of a study published by Ellis using SIS for the repair of parastomal hernias.

Study	NumberofPatients	Follow-up	Recurrence	Graft-RelatedComplications	Comments
EllisA	20	Median:18months;Range:6-38months	Two (2)recurrentparastomalherniasidentified(10%)	There were four(4) seromas in theinitial 10 patients.Drains were thenroutinely placedin the final 12procedures and noadditionalseromas werereported.	Both recurrences were identified inpatients with complicated cases -one with 12 previous repairattempts and removal of infectedmesh, and one, in a patient with a12 cm fascial defect. Although theinitial repair with SIS failed, bothpatients were doing well (at 36 and14 months) following a secondrepair procedure with an SIS graft.

Table 5-2. Surgical outcomes with the use of SIS for parastomal hernias

Unpublished long term data on 19/20 patients (same patient cohort described above four patients died of cancer, unrelated to their procedures) confirms, by physical or radiological (CT) examination, that the SIS-based devices perform as intended at a median follow-up time of 53 months (range 29-69 months). Three additional recurrences were identified, bringing the total recurrence rate to 25% (5/20 patients). Of the three recurrences diagnosed, two were asymptomatic and did not require additional surgical management at 58 and 47 month follow-up. The last recurrence occurred in a patient where an SIS graft was used to bridge the defect. After a second repair procedure with SIS, no recurrence was detected at 63 month follow-up. No other complications were reported.

VIII. CONCLUSIONS

For purposes of determinations of substantial equivalence under section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)), the Biodesign® Parastomal Hernia Repair Graft has the same intended use and functions under the same technological principle as the predicate device. The subject and predicate device are both porcine-derived scaffolds designed to provide mechanical reinforcement of soft tissues where weakness exists, while

A Ellis CN. Short-term outcomes with the use of bioprosthetics for the management of parastomal hernias. Diseases of the Colon and Rectum. 2010;53(3):279-283.

{7}------------------------------------------------

simultaneously being remodeled and replaced with host tissue. The main technological differences between the subject device and the predicate device are that the Biodesign Parastomal Hernia Repair Graft is composed of non-crosslinked SIS and the predicate device is composed of crosslinked dermal collagen.

. The biocompatibility tests, product characterization tests, and clinical data on the Biodesign® Parastomal Hernia Repair Graft demonstrate that the device is substantially equivalent to the predicate device.

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.