Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
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 Tissue Graft: For implantation to reinforce soft tissue.

Device Description

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated (CBI) consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.

AI/ML Overview

This document does not contain an acceptance criteria table or a study proving the device meets specific performance criteria. Instead, it is a 510(k) premarket notification of intent to market for several Biodesign devices. The submission aims to demonstrate substantial equivalence to already marketed predicate devices, not to prove performance against specific acceptance criteria.

The core of the submission, as per the snippets provided, is that the subject devices are largely identical to their predicate devices, with the only change being the inclusion of additional rehydration fluid options in the instructions for use (IFUs).

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance:
* Absent. This document does not present specific acceptance criteria with corresponding performance data. The submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be similar or equal to that of the predicates. The closest information is a comparison of characteristics between the subject devices and predicate devices (Table 5-3 on page 8).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Absent. The document mentions "Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options" to demonstrate no negative effects on mechanical properties. However, it does not specify the sample size used for these tests, the data provenance, or whether the study was retrospective or prospective.

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):
* Not applicable / Absent. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic imaging). This submission describes mechanical testing of a medical device (surgical mesh), not expert-based assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable / Absent. Similar to point 3, adjudication methods are usually for expert consensus on results, which is not described here for mechanical testing.

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:
* Not applicable. This submission pertains to a surgical mesh, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis is presented.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the mechanical testing would be the measured mechanical properties (burst strength, tensile strength, suture retention strength, delamination) of the device. The aim was to show that these properties, when rehydrated with new fluid options, were comparable to those rehydrated with saline. The text states: "...demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties."

8. The sample size for the training set:
* Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
* Not applicable. As there is no training set, this information is not relevant.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence for modifications to existing surgical mesh devices, primarily concerning rehydration fluid options. It describes mechanical testing performed to ensure the modified devices retain expected properties but does not detail acceptance criteria or study specifics in the format requested, which is typical for performance studies of AI/diagnostic devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 27, 2019

Cook Biotech Incorporated Nick Wang Regulatory Science Manager 1425 Innovation Place West Lafayette, Indiana 47906

Re: K191696

Trade/Device Name: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXN, OXH, OXH Dated: November 22, 2019 Received: November 25, 2019

Dear Nick Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K191696

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)
-------------------------------------------------

X 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

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510(k) Number (if known) K191696

Device Name Biodesign Fistula Plug

Indications for Use (Describe)

For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.

Type of Use (Select one or both, as applicable)

X 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K191696

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)|X 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K191696

Device Name Biodesign Tissue Graft

Indications for Use (Describe) For implantation to reinforce soft tissue.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary

Submitted by:	Perry Guinn
	Vice President, Quality Assurance and Regulatory Affairs,
	Cook Biotech Inc.
	1425 Innovation Place West Lafayette, IN 47906
	(765) 497-3355
Date:	December 22, 2019
510(k) Number:	K191696
Device Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	OXH, OXN, FTM
Predicate Devices:	K161221, K050337, K170016, K161221, K034039, K160896
	K980431

This 510(k) is a bundled submission pertaining to four devices manufactured by Cook Biotech Incorporated (CBI):

Biodesign® Anal Fistula Plug 1.
Biodesign® Fistula Plug 2.
Biodesign® Plastic Surgery Matrix 3.
Biodesign® Tissue Graft 4.

This submission is presented as a bundle because the modification under consideration is the same for all four devices.

Device Descriptions:

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.

The four subject devices of this bundled submission share many of the same technological characteristics:

All four devices are indicated for applications related to reinforcing soft tissue (with various specific indications)
All four devices are composed of porcine small intestinal submucosa (SIS) manufactured by CBI
All four devices are labeled with a shelf-life of 18 months
o All four devices are sterilized using ethylene oxide

While the four devices are different from each other in device indications and dimensional specifications, each subject device is unchanged from its respective predicate device in physical form (device itself and packaging) and indications for use. The only difference between each subject device and its corresponding predicate device is in the device labeling, with the subject

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devices having additional rehydration fluid options included in their instructions for use (IFUs).

	Biodesign AnalFistula Plug(AFP)	Biodesign Fistula Plug(FP)	Biodesign PlasticSurgery Matrix(PSM)	Biodesign TissueGraft (TG)
ProductDimensions(nominal) - sameas in the clearedpredicate 510(k)	2 mm minordiameter to 7 mmmajor diameter by100 mm length;	2 mm minor diameter to 7mm major diameter by 51mm length;Device also contains SISflange/button	2 to 70 mm widthup to 200 mmlength;100 to 1500 µmthick	2 cm x 4 cmto 20 cm x 40 cm;40 to 700 µm thick
Shape	Plug	Plug	Rectangular	Rectangular

Table 5-2. Dimensional Specifications

Description of Modifications:

For each subject device, the only modification from the predicate device is in the devicelabeling. The modification that triggered this submission is the inclusion of additional rehydration fluid options in the instructions for use (IFU)4. In addition to saline (which is the rehydration fluid in the predicate devices), autologous body fluid is being added as potential rehydration fluid options for all subject devices of this submission. In addition, example autologous fluids such as blood, bone marrow aspirate, or blood concentrate such as platelet concentrate are also being added to the labeling of the Biodesign Plastic Surgery Matrix and the Biodesign tissue Graft. CBI is making this modification because there is interest in the field to use these fluids to rehydrate the device. There are already several cleared surgical meshes (including the reference devices K132025 and K171817) with this type of rehydration language in their 510(k) summaries.

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)].
Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options that demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties.

Substantial Equivalence:

Table 5-3 provides a comparison of the subject devices and their respective predicates.

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	Biodesign Anal Fistula Plug, Biodesign Fistula PlugBiodesign Plastic Surgery Matrix,Biodesign Tissue Graft (Subject Devices)	Predicate Devices all with theSame Name (PredicateDevices)
510(k)	K191696	AFP-K161221/K050337 PF-K170016PSM-K161221/K034039 TG-K160896/K980431
Indication for Use(The indications foruse of each device inthe bundled 510(k) areunchanged from thatof its respectivepredicate device.)	Biodesign Anal Fistula Plug: For implantation toreinforce soft tissue where a rolled configuration isrequired, for repair of anal, rectal and enterocutaneousfistulas.	Same
	Biodesign Fistula Plug: For implantation to reinforce softtissue for repair of recto-vaginal or anorectal fistulas.	Same
	Biodesign Plastic Surgery Matrix: For implantation toreinforce soft tissue where weakness exists in patientsrequiring soft tissue repair or reinforcement in plastic orreconstructive surgery.	Same
	Biodesign Tissue Graft: For implantation to reinforce softtissue.	Same
Material	Porcine small intestinal submucosa; (constituents of theextracellular matrix)	Same
Supplied sterile?	Yes	Same
Sterilization method	Ethylene Oxide	Same
Rehydration Fluid	All devices in the bundleSterile saline and autologous body fluidsPlastic Surgery Matrix and Tissue GraftSterile saline and autologous body fluids such as blood,bone marrow aspirate, or blood concentrates such asplatelet concentrate	Sterile saline
	Shelf-Life	18 months
Intended for singleuse?	Yes	Same

Table 5-3. Substantial Equivalence Information

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Conclusion:

For purposes of determinations of substantial equivalence under section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)), the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, and Biodesign Tissue Graft, the subject devices, have the same intended use and functions under the same mode of action and fundamental scientific technology as the predicate devices with the same name. In addition, the subject devices are composed of the same materials and are manufactured using the same processes as the predicate devices. The only modification is the addition of autologous body fluids as possible rehydration fluids in the devices' IFUs. The absence of changes in the fundamental scientific technology and intended use of the device, as well as the completion of verification and validation activities, provide evidence to support the conclusion that the subject devices perform comparably to the predicate devices that are currently marketed for the same intended use.

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.