← Product Code [FTM](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTM) · K161221 # Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221) _Cook Biotech Incorporated · FTM · May 26, 2016 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTM/K161221 ## Device Facts - **Applicant:** Cook Biotech Incorporated - **Product Code:** [FTM](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTM.md) - **Decision Date:** May 26, 2016 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.3300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use Biodesign Sling: For implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas. ## Device Story Biodesign devices are porcine small intestinal submucosa (SIS) implants used to reinforce soft tissue. Devices are implanted by surgeons in clinical settings to treat conditions like stress urinary incontinence, prolapse, and fistulas. The SIS material acts as a scaffold for tissue repair. Modifications include additional wash steps in the depuration process to remove impurities, plus minor design changes (perforations in sling/matrix, drying method change for sling). Devices are supplied sterile in Tyvek/PE pouches. Clinical benefit is derived from the reinforcement of weakened anatomical structures, facilitating natural tissue repair. ## Clinical Evidence Bench testing only. Evidence includes biocompatibility (ISO 10993), viral inactivation (prEN 12442-3), mechanical testing (burst force and suture retention strength), chemical residuals testing, and endotoxin level measurements. Design controls and risk analysis (ISO 14971) were performed. ## Technological Characteristics Material: Porcine small intestinal submucosa (SIS). Sterilization: Ethylene oxide. Packaging: Tyvek/PE pouch. Shelf-life: 18 months. Form factors: Rectangular sheets (Sling/Matrix) or cone (Plug). Modifications: Additional depuration wash steps; perforations added to Sling and Matrix; modified drying method for Sling. ## Regulatory 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. ## Predicate Devices - Surgisis Sling ([K992159](/device/K992159.md)) - SIS Plastic Surgery Matrix ([K034039](/device/K034039.md)) - SIS Fistula Plug ([K050337](/device/K050337.md)) ## Related Devices - [K160869](/device/K160869.md) — Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft · Cook Biotech Incorporated · Apr 29, 2016 - [K191696](/device/K191696.md) — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft · Cook Biotech Incorporated · Dec 27, 2019 - [K130006](/device/K130006.md) — BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS · Cook Biotech Incorporated · Apr 5, 2013 - [K182259](/device/K182259.md) — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal · Acell, Inc. · Feb 7, 2019 - [K992159](/device/K992159.md) — SURGISIS SLING · Cook Biotech, Inc. · Sep 23, 1999 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by a flowing line that resembles a ribbon or banner. The profiles are arranged in a way that suggests unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 26, 2016 Cook Biotech, Inc. Mr. Perry W. Guinn VP, Regulatory Affairs and Quality Assurance 1425 Innovation Place West Lafayette, IN 47906 Re: K161221 Trade/Device Name: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: April 27, 2016 Received: April 29, 2016 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 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 {1}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. Sincerely yours. # Jennifer R. Stevenson -A 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) K161221, Page 1 of 3 Device Name Biodesign Sling Indications for Use (Describe) For implantation to reinforce soft tissues where weakness exists in the urological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161221, Page 2 of 3 Device Name Biodesign Plastic Surgery Matrix Indications for Use (Describe) For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | <span style="font-size:100%;">☐</span> 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." {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161221, Page 3 of 3 Device Name Biodesign Anal Fistula Plug Indications for Use (Describe) For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas. Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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." {5}------------------------------------------------ # 510(k) Summary Submitted by: Perry Guinn Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 27 April 2016 This 510(k) is a bundled submission pertaining to three devices manufactured by Cook Biotech Incorporated (CBI): - 1. Biodesign Sling - 2. Biodesign Plastic Surgery Matrix - 3. Biodesign Anal Fistula Plug This submission is presented as a bundle because the main technological modification under consideration is the same for all three devices. Table 5-1 below compiles the key regulatory elements for each subject device, which remain unchanged from their respective predicates. | Proprietary Name | Biodesign Sling | Biodesign Plastic<br>Surgery Matrix | Biodesign Anal<br>Fistula Plug | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device | Surgisis Sling<br>(K992159) | SIS Plastic Surgery<br>Matrix (K034039) | SIS Fistula Plug<br>(K050337) | | Intended Use | Intended to be used for<br>implantation to reinforce soft<br>tissues where weakness exists in<br>the urological, gynecological and<br>gasteroenterological anatomy<br>including but not limited to the<br>following procedures: transvaginal<br>repair of stress urinary<br>incontinence, such as pubourethral<br>support and bladder support, and<br>transabdominal repair of apical<br>vaginal prolapse, colon and rectal<br>prolapse, and<br>sacrocolposuspension. By<br>providing pubourethral support,<br>the sling may be used for the<br>treatment of urinary incontinence<br>resulting from urethral<br>hypermobility or intrinsic<br>sphincter deficiency. | Intended for<br>implantation to<br>reinforce soft tissue<br>where weakness<br>exists in patients<br>requiring soft tissue<br>repair or<br>reinforcement in<br>plastic or<br>reconstructive<br>surgery. | Intended for<br>implantation to<br>reinforce soft tissue<br>where a rolled<br>configuration is<br>required, for repair of<br>anal, rectal and<br>enterocutaneous<br>fistulas. | ### Table 5-1. Device names, predicates, intended uses and classifications: {6}------------------------------------------------ | Proprietary Name | Biodesign Sling | Biodesign Plastic<br>Surgery Matrix | Biodesign Anal<br>Fistula Plug | |------------------------------------|-----------------|-------------------------------------|--------------------------------| | Common/Usual<br>Name | Surgical Mesh | Surgical Mesh | Surgical Mesh | | Proposed<br>Classification<br>Name | Mesh, Surgical | Mesh, Surgical | Mesh, Surgical | | Product Code | FTM, PAJ, PAG | FTM | FTM | | Device Class | II | II | II | | Regulation<br>Number | 878.3300 | 878.3300 | 878.3300 | ## Device Descriptions: The three subject devices of this bundled submission share many of the same technological characteristics: - Composed of porcine small intestinal submucosa (SIS) ● - Packaged in a Tyvek/PE pouch - Labeled with a shelf-life of 18 months - Sterilized using ethylene oxide The only differences between the three devices are the indications (and associated labeling) and the dimensional specifications (specific to the indication and anatomic requirement for each device). Both the indications and the dimensional specifications of each subject device, however, are unchanged from the corresponding predicate device. The indications have been described in Table 5-1 and the dimensional specifications are presented in Table 5-2, below: | | Biodesign Sling | Biodesign Plastic<br>Surgery Matrix | Biodesign Anal Fistula<br>Plug | |-------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------| | Product Dimensions<br>(range) – as cleared<br>in predicate 510(k) | $20 cm^2$ to $140 cm^2 lt;br>$70$ to $600 \u03bcm$ thick | 2 to 70 mm width<br>up to 200 mm length<br>$100$ to $1500 \u03bcm$ thick | 2 mm minor diameter to<br>7 mm major diameter by<br>100 mm length | | Shape | Rectangular | Rectangular | Cone | ### Table 5-2. Dimensional Specifications ### Description of Technological Modifications: A series of wash steps was added to the depuration process of the base material for all three subject devices. This process modification serves to further remove impurities from the base material. {7}------------------------------------------------ In addition, two minor technological changes were made to two of the subject devices: - . Addition of perforations to the Biodesign Sling and Biodesign Plastic Surgery Matrix - . Change in drying method for the Biodesign Sling The incorporation of the additional wash steps and the minor technological changes do not result in a change to the fundamental technology of the devices. ## Summary of Supporting Evidence for Substantial Equivalence: The following items are provided to demonstrate substantial equivalence to the predicate devices: - . Analysis of 510(k) Substantial Equivalence Decision-Making Process as outlined in FDA's Guidance Document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - . Biocompatibility analysis performed in accordance with ISO 10993 - Viral Inactivation verification performed in accordance with prEN 12442-3: 2000: . Viral inactivation - Full design control as required by 21CFR 820.30 including review of risk analysis . performed in compliance with ISO 14971. Risk analysis methods used include: - Failure mode, effects and criticality analysis (FMECA) o - Residual risk review o - o Post production review - Mechanical testing for burst force strength and suture retention strength ● - Chemical residuals testing . - Measurement of endotoxin levels ● ## Substantial Equivalence: Table 5-3 below provides a comparison of the subject devices and their respective predicates. ## Conclusion: CBI modified three of its devices by adding a series of wash steps to the depuration process of SIS. The additional wash steps remove impurities from the base material without affecting the fundamental technology of the devices. Any potential new risks associated with the changes to the predicate devices have been identified by appropriate risk analysis techniques. These potential new risks have been addressed with verification and validation activities that meet the pre-determined acceptance criteria to ensure that no change to device safety has occurred. {8}------------------------------------------------ | | Biodesign Sling,<br>Biodesign Plastic Surgery Matrix,<br>Biodesign Anal Fistula Plug<br>(Subject Devices) | Surgisis Sling,<br>SIS Plastic Surgery Matrix,<br>SIS Fistula Plug<br>(Predicate Devices) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | 510(k) | K161221 | K992159 (Surgisis Sling)<br>K034039 (SIS Plastic<br>Surgery Matrix)<br>K050337 (SIS Fistula Plug) | | Indication for Use<br>(The indications for<br>use of each device<br>in the bundled<br>510(k) are<br>unchanged from<br>that of its respective<br>predicate device.) | <i>Biodesign Sling:</i> For implantation to reinforce soft<br>tissues where weakness exists in the urological,<br>gynecological and gasteroenterological anatomy<br>including but not limited to the following<br>procedures: transvaginal repair of stress urinary<br>incontinence, such as pubourethral support and<br>bladder support, and transabdominal repair of<br>apical vaginal prolapse, colon and rectal prolapse,<br>and sacrocolposuspension. By providing<br>pubourethral support, the sling may be used for the<br>treatment of urinary incontinence resulting from<br>urethral hypermobility or intrinsic sphincter<br>deficiency.<br><br><i>Biodesign Plastic Surgery Matrix:</i> For implantation | <i>Surgisis Sling:</i><br>Same | | | to reinforce soft tissue where weakness exists in<br>patients requiring soft tissue repair or<br>reinforcement in plastic or reconstructive surgery. | <i>SIS Plastic Surgery Matrix:</i><br>Same | | | <i>Biodesign Anal Fistula Plug:</i> For implantation to<br>reinforce soft tissue where a rolled configuration is<br>required, for repair of anal, rectal and<br>enterocutaneous fistulas. | <i>SIS Fistula Plug:</i><br>Same | | Material | Porcine small intestinal submucosa; (constituents<br>of the extracellular matrix) | Same | | Technological<br>Characteristics | Additional wash steps included in base material<br>processing | Original base material<br>processing | | Supplied sterile? | Yes | Same | | Sterilization<br>method | Ethylene Oxide | Same | | Packaging | Tyvek/PE Pouch | Same | | Shelf-Life | 18 months | Same | | Intended for single<br>use? | Yes | Same | # Table 5-3. Substantial Equivalence Information --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTM/K161221](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTM/K161221) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTM/K161221