Biodesign Parastomal Hernia Repair Graft

{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) | <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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 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. {4}------------------------------------------------ #### V. INDICATIONS FOR USE 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. #### 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® Parastomal<br>Hernia Repair Graft | Permacol® Surgical<br>Implant | SIS Hernia Repair Graft<br>(reference device) | |---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Porcine small intestinal<br>submucosa (extracellular<br>matrix - primarily collagen<br>types I, III, IV and VI) and<br>polyglycolic acid (PGA)<br>sutures | Porcine dermis<br>(extracellular matrix -<br>primarily collagen and<br>elastin). | Porcine small intestinal<br>submucosa (extracellular<br>matrix - primarily collagen<br>types I, III, IV and VI) and<br>polyglycolic acid (PGA)<br>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 40<br>cm | 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 | Number<br>of<br>Patients | Follow-<br>up | Recurrence | Graft-Related<br>Complications | Comments | |--------|--------------------------|------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EllisA | 20 | Median:<br>18<br>months;<br>Range:<br>6-38<br>months | Two (2)<br>recurrent<br>parastomal<br>hernias<br>identified<br>(10%) | There were four<br>(4) seromas in the<br>initial 10 patients.<br>Drains were then<br>routinely placed<br>in the final 12<br>procedures and no<br>additional<br>seromas were<br>reported. | Both recurrences were identified in<br>patients with complicated cases -<br>one with 12 previous repair<br>attempts and removal of infected<br>mesh, and one, in a patient with a<br>12 cm fascial defect. Although the<br>initial repair with SIS failed, both<br>patients were doing well (at 36 and<br>14 months) following a second<br>repair 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.