Biodesign Sling: 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.

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 Description

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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device modification, specifically the Biodesign Sling, Biodesign Plastic Surgery Matrix, and Biodesign Anal Fistula Plug. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing clinical efficacy through a comparative effectiveness study involving human readers or AI assistance.

Therefore, the information regarding acceptance criteria and performance is related to the equivalence of the modified device to existing predicate devices, primarily through non-clinical performance testing and risk analysis, rather than a study proving new clinical effectiveness or an AI's diagnostic performance.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of a numerical threshold for clinical performance metrics (like sensitivity, specificity, etc.) for a new device's efficacy. Instead, the acceptance criteria are implicitly met by demonstrating that the modified devices are substantially equivalent to their predicate devices and that the modifications do not introduce new risks or affect fundamental performance.

The "reported device performance" is demonstrated through various non-clinical tests and analyses to ensure the modified devices remain safe and effective for their intended use, comparable to the predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence Determination)	Reported Device Performance (Summary of Evidence)
Biocompatibility: No adverse biological reactions.	Biocompatibility analysis performed in accordance with ISO 10993.
Viral Inactivation: Effective inactivation of viruses.	Viral Inactivation verification performed in accordance with prEN 12442-3: 2000.
Risk Mitigation: All identified risks from modification are addressed.	Full design control (21 CFR 820.30) including risk analysis (ISO 14971) such as FMECA, residual risk review, post-production review. No change to device safety determined.
Mechanical Strength: Maintained burst force strength and suture retention strength.	Mechanical testing for burst force strength and suture retention strength.
Chemical Residuals: Acceptable levels of chemical residuals.	Chemical residuals testing.
Endotoxin Levels: Acceptable endotoxin levels.	Measurement of endotoxin levels.
Equivalence in Indications & Dimensions: Indications for use and dimensional specifications remain unchanged from predicates.	Confirmed in Table 5-1 and Table 5-2 that indications, common name, product code, device class, regulation number, and dimensions are unchanged or within acceptable ranges compared to predicates.
Fundamental Technology Equivalence: Modifications do not change the fundamental technology.	The document states, "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."

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

This document describes a premarket notification for device modification and focuses on non-clinical testing and risk assessment for substantial equivalence. It does not describe a clinical study with a "test set" in the context of data provenance (e.g., country of origin, retrospective/prospective). The "testing" refers to laboratory-based evaluations of the device's physical, chemical, and biological properties.

Therefore, sample size and data provenance in the context of a clinical test set are not applicable here.

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

Since this is a submission for substantial equivalence based on non-clinical testing and risk analysis, there is no "ground truth for a test set" established by clinical experts (like radiologists). The "truth" is established by adherence to engineering standards, biocompatibility standards, and manufacturing quality controls.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human adjudication of clinical outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This document concerns the substantial equivalence of a physical medical device (surgical mesh/plug) based on changes to its manufacturing process, not an AI or diagnostic imaging device requiring evaluation of human reader performance.

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

No, a standalone algorithm performance study was not done. This document is not about an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Adherence to recognized standards for biocompatibility (ISO 10993), viral inactivation (prEN 12442-3: 2000), and risk management (ISO 14971).
Engineering and material science principles for mechanical properties (burst strength, suture retention), chemical residuals, and endotoxin levels.
Regulatory definitions of "substantial equivalence" based on device characteristics, intended use, and safety/effectiveness profiles compared to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI context, so there is no "training set."

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

Not applicable, as there is no training set described.

Summary

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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

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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

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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)
☑ 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)

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)

☒ 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)

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)

☑ 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 27 April 2016

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

1. Biodesign Sling
1. Biodesign Plastic Surgery Matrix
1. 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 PlasticSurgery Matrix	Biodesign AnalFistula Plug
Predicate Device	Surgisis Sling(K992159)	SIS Plastic SurgeryMatrix (K034039)	SIS Fistula Plug(K050337)
Intended Use	Intended to be used forimplantation to reinforce softtissues where weakness exists inthe urological, gynecological andgasteroenterological anatomyincluding but not limited to thefollowing procedures: transvaginalrepair of stress urinaryincontinence, such as pubourethralsupport and bladder support, andtransabdominal repair of apicalvaginal prolapse, colon and rectalprolapse, andsacrocolposuspension. Byproviding pubourethral support,the sling may be used for thetreatment of urinary incontinenceresulting from urethralhypermobility or intrinsicsphincter deficiency.	Intended forimplantation toreinforce soft tissuewhere weaknessexists in patientsrequiring soft tissuerepair orreinforcement inplastic orreconstructivesurgery.	Intended forimplantation toreinforce soft tissuewhere a rolledconfiguration isrequired, for repair ofanal, rectal andenterocutaneousfistulas.

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

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Proprietary Name	Biodesign Sling	Biodesign PlasticSurgery Matrix	Biodesign AnalFistula Plug
Common/UsualName	Surgical Mesh	Surgical Mesh	Surgical Mesh
ProposedClassificationName	Mesh, Surgical	Mesh, Surgical	Mesh, Surgical
Product Code	FTM, PAJ, PAG	FTM	FTM
Device Class	II	II	II
RegulationNumber	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

	Biodesign Sling	Biodesign PlasticSurgery Matrix	Biodesign Anal FistulaPlug
Product Dimensions(range) – as clearedin predicate 510(k)	$20 cm^2$ to $140 cm^2$$70$ to $600 \u03bcm$ thick	2 to 70 mm widthup to 200 mm length$100$ to $1500 \u03bcm$ thick	2 mm minor diameter to7 mm major diameter by100 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.

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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.

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	Biodesign Sling,Biodesign Plastic Surgery Matrix,Biodesign Anal Fistula Plug(Subject Devices)	Surgisis Sling,SIS Plastic Surgery Matrix,SIS Fistula Plug(Predicate Devices)
510(k)	K161221	K992159 (Surgisis Sling)K034039 (SIS PlasticSurgery Matrix)K050337 (SIS Fistula Plug)
Indication for Use(The indications foruse of each devicein the bundled510(k) areunchanged fromthat of its respectivepredicate device.)	Biodesign Sling: For implantation to reinforce softtissues where weakness exists in the urological,gynecological and gasteroenterological anatomyincluding but not limited to the followingprocedures: transvaginal repair of stress urinaryincontinence, such as pubourethral support andbladder support, and transabdominal repair ofapical vaginal prolapse, colon and rectal prolapse,and sacrocolposuspension. By providingpubourethral support, the sling may be used for thetreatment of urinary incontinence resulting fromurethral hypermobility or intrinsic sphincterdeficiency.Biodesign Plastic Surgery Matrix: For implantation	Surgisis Sling:Same
	to reinforce soft tissue where weakness exists inpatients requiring soft tissue repair orreinforcement in plastic or reconstructive surgery.	SIS Plastic Surgery Matrix:Same
	Biodesign Anal Fistula Plug: For implantation toreinforce soft tissue where a rolled configuration isrequired, for repair of anal, rectal andenterocutaneous fistulas.	SIS Fistula Plug:Same
Material	Porcine small intestinal submucosa; (constituentsof the extracellular matrix)	Same
TechnologicalCharacteristics	Additional wash steps included in base materialprocessing	Original base materialprocessing
Supplied sterile?	Yes	Same
Sterilizationmethod	Ethylene Oxide	Same
Packaging	Tyvek/PE Pouch	Same
Shelf-Life	18 months	Same
Intended for singleuse?	Yes	Same

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.