Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue
Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater.
Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease.

Device Description

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

Composed of multilayered sheets of processed porcine small intestinal submucosa (SIS).
Packaged in a Tyvek/PE double pouch.
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 (analogous 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.

AI/ML Overview

The provided text describes a 510(k) submission for three medical devices: Biodesign Tissue Graft, Biodesign Dural Graft, and Biodesign Peyronie's Repair Graft. The submission focuses on a technological modification to these devices, specifically the removal of a "sidedness indicator" (a small hole) that was present in the predicate devices. The document does not contain information about acceptance criteria for device performance, nor does it detail a study that proves the device meets such criteria in the way typically associated with diagnostic or AI-driven devices.

Instead, the submission aims to demonstrate substantial equivalence to predicate devices after a minor design change. The "evidence" presented is to show that the removal of the sidedness indicator does not alter the fundamental safety or effectiveness of the devices compared to their previously cleared versions.

Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission as the device is not an AI/ML or diagnostic device and the submission is focused on a minor design change for substantial equivalence.

Here's an analysis based on the information provided, highlighting the differences in the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not present in the document. The submission is not about demonstrating performance against specific numerical benchmarks for a new device's function (e.g., sensitivity, specificity for a diagnostic tool). Instead, it argues that removing a mechanical indicator does not impact the device's original, established performance.

Criterion Type	Acceptance Criterion	Reported Device Performance
Not Applicable to this 510(k) submission	This document concerns substantial equivalence after a minor design modification (removal of a sidedness indicator) for already cleared devices. It does not establish new performance criteria or report performance data in the typical sense of a diagnostic or AI device study.

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

Not applicable. There is no "test set" in the context of performance metrics for a new claim or an AI algorithm. The evidence relies on:

Clinical feedback: Stated as confirming "functional differences between the sides were minimal and additionally reported that the presence of the sidedness indicator was confusing." (Page 7)
Published peer-reviewed literature: Stated as confirming "that devices without the sidedness indicator performed as expected, giving evidence of substantial equivalence." (Page 7)

The document does not provide details on the sample size or provenance of this clinical feedback or the specific publications cited.

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

Not applicable. There is no concept of "ground truth" establishment in the context of this specific design modification. The "clinical feedback" mentioned is anecdotal or summarized, and no specific number or qualification of experts is provided.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process described for performance evaluation.

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 device is a surgical mesh/graft, not an AI-driven diagnostic tool, so an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not have an algorithm or standalone performance in the sense of AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. For this type of submission, the "ground truth" of the device's functionality and safety is broadly accepted from its predicate devices. The modification (removal of a sidedness indicator) is supported by:

Cell culture data (suggesting minimal functional differences).
Clinician feedback (confirming minimal functional differences and reporting confusion with the indicator).
Risk analysis (ISO 14971, which "did not identify sidedness of the material as a potential risk").
Peer-reviewed literature (confirming performance of devices without the indicator).

These are not "ground truth" in the diagnostic sense but rather supporting evidence for substantial equivalence of a design change.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

Summary of the Study/Evidence Provided:

The "study" in this context is a collection of evidence supporting substantial equivalence for a minor design change, rather than a performance study for a new device or AI algorithm.

Nature of the Change: Removal of a "sidedness indicator" (a small hole) from the Biodesign Tissue Graft, Biodesign Dural Graft, and Biodesign Peyronie's Repair Graft.
Rationale for Removal:
- Cell culture data suggested minimal functional differences between sides.
- Clinician feedback confirmed minimal functional differences and indicated the indicator caused confusion.
- Risk management activities (ISO 14971) did not identify sidedness as a potential risk.
Supporting Evidence for Substantial Equivalence (as described in the document):
- Review of FDA's 510(k) Guidance Document.
- Risk analysis performed in compliance with ISO 14971 (FMEA, residual risk review, post-production review).
- Summary of publications showing SIS (porcine small intestinal submucosa) performed as expected in versions of the device without the sidedness indicator.

This submission is a demonstration that the modified devices remain substantially equivalent to their predicate devices, and therefore do not require a new PMA. It is not a performance study as typically understood for diagnostic or AI devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 29, 2016

Cook Biotech, Inc. Nick Wang, Ph.D., RAC Regulatory Affairs Scientist 1425 Innovation Place West Lafayette, Indiana 47906

Re: K 160869

Trade/Device Name: Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, GXQ Dated: March 28, 2016 Received: March 30, 2016

Dear Dr. 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. 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 and 809); medical device reporting

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(reporting of medical device-related 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.

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/Resourcesfor You/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.

for

Sincerely yours,

David Krause -S

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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Indications for Use

510(k) Number (if known)

K160869 Page 1 of 3

Device Name Biodesign Tissue Graft

Indications for Use (Describe) Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue

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

"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."

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Indications for Use

510(k) Number (if known) K160869 Page 2 of 3

Device Name Biodesign Dural Graft

Indications for Use (Describe) Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater.

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

"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."

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Indications for Use

510(k) Number (if known) K160869 Page 3 of 3

Device Name Biodesign Peyronie's Repair Graft

Indications for Use (Describe)

Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease.

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

"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."

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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 28 March 2016

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

1. Biodesign Tissue Graft
1. Biodesign Dural Graft
1. Biodesign Peyronie's Repair Graft

This submission is presented as a bundle because the technological modification under consideration is the same for all three devices. Table 5-1 below compiles the main regulatory elements of each subject device, which remain unchanged from their respective predicates.

Proprietary Name1	Biodesign Tissue Graft	Biodesign Dural Graft	Biodesign Peyronie's Repair Graft
Predicate Device	Surgisis (K980431)	Durasis Dural Substitute (K031850)	Surgisis Peyronie's Repair Graft (K062320)
Intended Use	intended to be used for implantation to reinforce soft tissue	intended for use as a dura substitute for the repair of dura mater	intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease
Common/Usual Name	Surgical Mesh	Dura Substitute	Surgical Mesh

Table 5-1. Device names, predicates, intended uses and classifications:

1 The current proprietary names for the devices are Biodesign Tissue Graft, Biodesign Dural Graft and Biodesign Peyronie's Repair Graft. In the past, Surgisis and Durasis Dural Substitute were the proprietary names for the Biodesign Tissue Graft and the Biodesign Dural Graft respectively.

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ProprietaryName1	Biodesign TissueGraft	Biodesign DuralGraft	Biodesign Peyronie'sRepair Graft
ProposedClassificationName	Mesh, Surgical	Dura Substitute	Mesh, Surgical
Product Code	FTM	GXQ	FTM
Device Class	II	II	II
RegulationNumber	878.3300	882.5910	878.3300

Device Descriptions:

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

Composed of multilayered sheets of processed porcine small intestinal submucosa (SIS).
Packaged in a Tyvek/PE double pouch. ●
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 (analogous 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 TissueGraft	Biodesign DuralGraft	BiodesignPeyronie's RepairGraft
ProductDimensions(range)	2 cm x 4 cmto 20 cm x 40 cm	2 cm x 2 cmto 10 cm x 20 cm	1 cm x 4 cmto 7cm x 12 cm
Shape	Rectangular	Rectangular	Oval

Table 5-2. Dimensional Specifications

Description of Technological Modifications:

A technological feature that was present in all three predicate devices was a small hole at the top right corner of the devices, which functioned as a sidedness indicator. Device labeling for predicate devices noted that the functional differences between the sides were

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minimal, but cell culture data suggested that the growth of epithelial cells moderately favored one of the sides. Subsequent clinician feedback on the use of the predicate devices confirmed that the functional differences between the sides were minimal and additionally reported that the presence of the sidedness indicator was confusing. Therefore, based on the lack of necessity for a sidedness indicator, all three devices have been modified to no longer include this technologic feature.

Summary of Supporting Evidence for Substantial Equivalence:

The following items are provided to demonstrate substantial equivalence to the predicate devices:

. 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)]
Review of risk analysis performed in compliance with ISO 14971. Risk analysis ● methods used include:
- Failure mode and effects analysis (FMEA) o
- Residual risk review o
- o Post production review
Summary of publications showing SIS performed as expected in versions of the . device without the sidedness indicator.

Substantial Equivalence:

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

Conclusion:

CBI modified three of its devices by removing the sidedness indicator, a small hole at the top right corner of each device. The indicator was initially included in the design of the device based on cell culture data, and not on the functional differences between the sides or reducing specific clinical risk(s). Clinical feedback confirmed functional differences between the sides were minimal and reported that the presence of the sidedness indicator led to confusion. Risk management activities performed in accordance with ISO 14971 on the subject devices did not identify sidedness of the material as a potential risk. Published peer-reviewed literature also confirmed that devices without the sidedness indicator performed as expected, giving evidence of substantial equivalence.

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	Biodesign Tissue GraftBiodesign Dural GraftBiodesign Peyronie's RepairGraft(Subject Devices)	Surgisis,Durasis Dural Substitute,Surgisis Peyronie's RepairGraft(Predicate Device)
510(k)	Unassigned	K980431 (Surgisis)K031850 (Durasis)K062320 (Surgisis Peyronie'sRepair Graft)
Indication forUse(The indicationsfor use of eachdevice in thebundled 510(k)are unchangedfrom that ofeach respectivepredicatedevice.)	Biodesign Tissue Graft: intendedto be used for implantation toreinforce soft tissue.	Surgisis: intended to be used forimplantation to reinforce softtissue.
	Biodesign Dural Graft: intendedfor use as a dura substitute for therepair of dura mater.	Durasis Dural Substitute:intended for use as a durasubstitute for the repair of duramater.
	Biodesign Peyronie's RepairGraft: intended for implantationto reinforce soft tissue whereweakness exists in the urologicalanatomy, including but notlimited to the repair of tunicaalbuginea defects, andreinforcement in the repair ofPeyronie's disease.	Surgisis Peyronie's Repair Graft:intended for implantation toreinforce soft tissue whereweakness exists in the urologicalanatomy, including but notlimited to the repair of tunicaalbuginea defects, andreinforcement in the repair ofPeyronie's disease.
Material	Processed Porcine smallintestinal submucosa;(constituents of the extracellularmatrix)	Processed Porcine smallintestinal submucosa;(constituents of the extracellularmatrix)
TechnologicalCharacteristics	Does not include a sidednessindicator	Includes a sidedness indicator(small hole at the top rightcorner)
Suppliedsterile?	Yes	Yes
Sterilizationmethod	Ethylene Oxide	Ethylene Oxide
Packaging	Double pouchedTyvek/PE	Double pouchedTyvek/PE
Shelf-Life	18 months	18 months
Intended forsingle use?	Yes	Yes

Table 5-3. Substantial Equivalence Information

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.