The Biodesign Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

Device Description

The subject device consists of a thin multi-layer strip of SIS, pre-coated with a ready-to-use contact adhesive that eliminates the need for a separate adhesive (hydrogel), or activation of the adhesive through rehydration to affix the device to surgical stapler jaws. The single-use implant device is provided to the point of use with a protective liner covering the adhesive which has been assembled onto a foam carrier which is suspended in an alignment tray sized for the jaws of a surgical stapler. The completed device, liner, carrier, and alignment tray unit is then sealed in a foil pouch with an integrated humidity control feature and terminally E-beam sterilized. In order to accommodate a variety of commercially available surgical staplers the device is available in configurations measuring from 0.05mm to 0.6mm in thickness, and in nominal (unfolded) device lengths ranging from 76 mm to 176 mm in length and up to 12 mm wide. Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

AI/ML Overview

This document is a 510(k) summary for the Biodesign® Staple Line Reinforcement device. It describes the device, its intended use, and compares it to a legally marketed predicate device (K170945) to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of "Product verification testing" and "Staple line leakage testing" but does not explicitly state numerical acceptance criteria for these tests. Instead, it describes general findings.

Acceptance Criteria (Inferred from Performance Data)	Reported Device Performance
Mechanical performance of the subject device for its intended use.	Product verification testing was performed on SHS (presumably "shelf-stable") conditioned sterilized finished devices to evaluate the mechanical performance of the subject device for its intended use. (Implied: met performance expectations, but no specific metrics provided).
Adequate staple line buttressing for use as a prosthesis for surgical repair of soft tissue deficiencies.	Staple line leakage testing confirms that the Biodesign® Staple Line Reinforcement provides adequate staple line buttressing for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. (Implied: met performance expectations regarding leakage, but no specific leakage rates or thresholds provided).
Adequate packaging system to support a 6-month shelf life claim.	Non-clinical bench testing was performed on representative SHS conditioned packaging system samples to confirm that the packaging system is adequate to support a 6-month shelf life claim. Testing at additional timepoints is ongoing and the product shelf life will be extended as stability and package system integrity data justifies. (Successfully supports 6-month claim, with ongoing testing for longer periods).
Biocompatibility according to ISO 10993 standards for biological evaluation and specific tests (genotoxicity, cytotoxicity, irritation, systemic toxicity, implantation effects).	Biocompatibility test data for the subject device has been submitted in support of the substantial equivalence under the ISO 10993 regime, specifically addressing: Part 1, Part 3, Part 5, Part 6, Part 10, Part 11. (Implied: met biocompatibility requirements for these tests, no specific results are detailed).

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

The document does not provide specific sample sizes for the "Product verification testing" or "Staple line leakage testing". It states "representative SHS conditioned sterilized finished devices" and "representative SHS conditioned packaging system samples" were used.

The data provenance is not explicitly stated in terms of country of origin. The testing appears to be non-clinical bench testing conducted by the manufacturer, Cook Biotech Incorporated, which is a U.S.-based company (West Lafayette, IN). All tests mentioned are retrospective (bench tests performed on the device).

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

This information is not applicable. The device is a physical medical device (surgical mesh), and its performance is evaluated through objective physical and biological tests (mechanical performance, leakage, biocompatibility). There is no "ground truth" derived from expert interpretation of images or clinical data in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above (physical device testing, not expert-based assessment).

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:

This information is not applicable. The device is a surgical mesh for physical reinforcement, not an AI-assisted diagnostic or clinical decision support tool.

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

This information is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance claims of this device is based on objective scientific and engineering measurements in benchtop and laboratory settings:

Mechanical performance: Measured physical properties and behaviors under simulated surgical conditions.
Staple line leakage: Measured leakage rates or other objective indicators of buttressing effectiveness.
Biocompatibility: Results from standardized ISO 10993 in vitro and in vivo biological tests.
Packaging and shelf life: Measured integrity of packaging and stability of the product over time under defined conditions.

8. The Sample Size for the Training Set:

This information is not applicable because the device is a physical medical device and does not involve AI or machine learning that requires training data.

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

This information is not applicable, as there is no training set for this device.

Summary

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

July 13, 2020

Cook Biotech Incorporated Chris Lotzow Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, Indiana 47906

Re: K201000

Trade/Device Name: Biodesign Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: April 16, 2020 Received: April 16, 2020

Dear Chris Lotzow:

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.

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

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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 (QS) 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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Indications for Use

510(k) Number (if known) K201000

Device Name Biodesign® Staple Line Reinforcement

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Biotech. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "BIOTECH" in a smaller, white, sans-serif font on a red background. The word "BIOTECH" is centered below the word "COOK".

510(k) Summary

Submission Date:	04/16/2020
K201000
SUBMITTER INFORMATION:
Company Name:	Cook Biotech Incorporated
Company Address:	1425 Innovation PlaceWest Lafayette, IN 47906
Contact Person:	Chris LotzowRegulatory Affairs SpecialistPhone: 765-497-3355Fax: 765-807-7709Email: chris.lotzow@cookbiotech.com
Device Trade Name:	Biodesign® Staple Line Reinforcement
Device Common Name:	Surgical Mesh
Class:	Class II
Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	FTM

Predicate Devices:

Biodesign® Staple Line Reinforcement (K170945, Cook Biotech Incorporated)

Device Description:

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Image /page/4/Picture/1 description: The image shows the logo for Cook Biotech. The logo is set against a red background. The word "COOK" is written in white, block letters. Below the word "COOK" is a smaller red rectangle with the word "BIOTECH" written in white letters.

The completed device, liner, carrier, and alignment tray unit is then sealed in a foil pouch with an integrated humidity control feature and terminally E-beam sterilized. In order to accommodate a variety of commercially available surgical staplers the device is available in configurations measuring from 0.05mm to 0.6mm in thickness, and in nominal (unfolded) device lengths ranging from 76 mm to 176 mm in length and up to 12 mm wide.

Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

Indications for Use:

The Biodesign® Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staple Line Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung

and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

Comparison of Technological Characteristics with the Predicate Device:

The intended use and mode of action of the Biodesign® Staple Line Reinforcement device is the same as the predicate K170945 device in that they are both intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The porcine Small Intestine Submucosa (SIS) material that functionally buttresses the staple line is identical to that of the predicate. Both devices are single use devices which remodel or are absorbed over time. The technological differences between the subject device and the predicate primarily involve the adhesive which is supplied in a ready-to-use formulation that adheres on contact with the surgical stapler. Other changes include design and packaging improvements made possible by this change.

Device	Biodesign® Staple Line Reinforcement(subject device)	Biodesign® Staple Line Reinforcement(predicate device)
Manufacturer	Cook Biotech, Incorporatedunchanged	Cook Biotech, Incorporated
510 (k) Number	K201000	K170945
Product Code	FTMunchanged	FTM
Materials/Components	SIS buttressing stripIdentical material	SIS buttressing strip

Device Comparison Table

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Image /page/5/Picture/0 description: The image shows the logo for Cook Biotech. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif font. Below "COOK" is a smaller red rectangle with the word "BIOTECH" written in white, sans-serif font.

Device	Biodesign® Staple Line Reinforcement(subject device)	Biodesign® Staple Line Reinforcement(predicate device)
	Pre-coated adhesive	Pre-coated adhesive
	(ready-to-use contact adhesive)	(requires activation with water)
	Center support/carrier(discarded; indirect contact)identical material	Center support(discarded; indirect contact)
	Protective adhesive liner(discarded; indirect contact)	none
	Alignment tray (discarded; non-contact)	Storage tray (discarded; non-contact)
SIS DeviceDimensions(unfolded)	Length: up to 176 mmWidth: up to 12 mmunchanged	Length: up to 176 mmWidth: up to 12 mm
Device Thickness(unfolded)	Overall device thickness: 0.05mm to 0.6mm(depending on layer count)	Overall device thickness: 0.05mm to 0.5mm(depending on layer count)
Shelf-Life	6 months	18 months
Sterile BarrierPackaging	foil pouch	foil pouch
Humidity controlpackaging	Yes(discarded; non-contact)	No
Sterilization	E-beam process	E-beam process
One-time Use	Yesunchanged	Yes

Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the predicate device has been established in accordance with the ISO 10993 Biological Evaluation of Medical Devices series of standards. Biocompatibility test data for the subject device has been submitted in support of the substantial equivalence also under the ISO 10993 regime, specifically addressing:

Evaluation and testing within a risk management process • Part 1:
Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity .
Part 5: Tests for in vitro cytotoxicity .
Tests for local effects after implantation Part 6: ●
Part 10: Tests for irritation and delayed-type hypersensitivity
Part 11: Tests for systemic toxicity ●

Non-Clinical bench testing

Device performance testing:

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Image /page/6/Picture/0 description: The image shows the logo for Cook Biotech. The logo is set against a red background. The word "COOK" is written in white, block letters at the top of the logo. Below "COOK" is a smaller red rectangle with the word "BIOTECH" written in white letters.

Product verification testing was performed on SHS conditioned sterilized finished devices to evaluate the mechanical performance of the subject device for its intended use. Staple line leakage testing confirms that the Biodesign® Staple Line Reinforcement provides adequate staple line buttressing for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers.

Packaging system and shelf life testing:

Non-clinical bench testing was performed on representative SHS conditioned packaging system samples to confirm that the packaging system is adequate to support a 6-month shelf life claim. Testing at additional timepoints is ongoing and the product shelf life will be extended as stability and package system integrity data justifies.

Sterilization

The subject Biodesign® Staple Line Reinforcement device undergoes an E-beam sterilization process, with the sterile barrier established by the primary packaging of each device in a reinforced foil pouch.

Substantial Equivalence:

For purposes of determinations of substantial equivalence under section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)), the Biodesign® Staple Line Reinforcement device has the same intended use and functions under the same mode of action as the predicate device. The only change presented to the patient through implantation of the subject device is from the improved adhesive formulation, while other design and packaging changes are exclusively related to ease-of-use prior to loading the device onto the stapler and do not affect the safety or effectiveness of the implanted device. The physical, functional, biocompatibility, and performance characteristics of the subject device are substantially equivalent to the predicate device and do not indicate any new or increased risks to safety or effectiveness when used according to its labelling.

The supplied verification testing therefore supports the determination that the subject Biodesign® Staple Line Reinforcement device is substantially equivalent to the legally marketed predicate K170945 device.

Conclusion:

The Biodesign® Staple Line Reinforcement device is substantially equivalent to the predicate devices K170945 in indications for use, fundamental scientific technology, and technological characteristics. It is as safe and effective as the predicate. Cook Biotech considers the Biodesign® Staple Line Reinforcement device to be substantially equivalent to the predicate device.

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.