The Biodesign® Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device 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 device can be used for the reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers.

Device Description

The Biodesign® Staple Line Reinforcement device is part of a family of implant devices manufactured from porcine small intestine that are disinfected and processed to remove the tunica mucosa from the inner intestinal surface and tunica muscularis from the outer intestinal surface. The resulting membrane is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Biodesign® Staple Line Reinforcement consists of a thin multi-layer strip of SIS, pre-coated with an adhesive that eliminates the need for a separate adhesive (e.g. hydrogel) to affix the device to surgical stapler jaws. The single-use device is provided on a foam applicator and suspended in a form-fitting tray before being sealed in a foil pouch and sterilized (E-beam). The material composition, general manufacturing processes, packaging configuration and sterilization method of the subject device are identical to the predicate, SURGISIS® SLRTM Staple Line Reinforcement (K070405).

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) premarket notification decision letter and summary for a medical device called "Biodesign® Staple Line Reinforcement." It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report with specific performance metrics for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, performance data with specific metrics (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

The document discusses:

Device: Biodesign® Staple Line Reinforcement (a surgical mesh).
Purpose: Buttressing and reinforcing staple lines during various surgical procedures (lung, gastric, small bowel, colon/colorectal).
Comparison to Predicate: The core of the submission is to show the device is substantially equivalent to the SURGISIS® SLRTM Staple Line Reinforcement (K070405). The key point is that the subject device is identical to the predicate in materials, manufacturing, intended use, and mode of action, with the only modification being the addition of thinner configurations.
Performance Data Mentioned:
- Biocompatibility testing: Leveraged from the predicate device as materials and manufacturing are identical.
- Non-Clinical testing: "Product verification testing was performed on 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..."

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study details for an AI-driven medical device, as it describes a traditional surgical mesh device seeking 510(k) clearance based on substantial equivalence to an existing product, primarily through material and mechanical performance validation rather than clinical or AI algorithm performance.

Summary

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

April 28, 2017

Cook Biotech Incorporated Mr. Perry Guinn Vice President, Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906

Re: K170945

Trade/Device Name: Biodesign Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXE, FTM Dated: March 28, 2017 Received: March 30, 2017

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 of medical device

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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/ResourcesforYou/Industry/default.htm. 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

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,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Biodesign Staple Line Reinforcement

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906

Phone: (765) 497-3355

Contact Person: Perry W. Guinn Date Prepared: 28 March 2017

DEVICE II.

Name of Device:	Biodesign® Staple Line Reinforcement
Common or Usual Name:	Surgical Mesh
Classification Name:	Surgical Mesh
Product Code:	FTM (21 CFR §878.3300)
Regulatory Class:	Class II

III. PREDICATE DEVICE

SURGISIS® SLRTM Staple Line Reinforcement (K070405, Cook Biotech Incorporated)

IV. DEVICE DESCRIPTION

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INDICATIONS FOR USE v.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Biodesign® Staple Line Reinforcement device is identical to its predicate in that they are both intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Moreover, the subject device's component materials, general manufacturing processes, fundamental scientific technology, and mode of action remain unchanged from the predicate.

The only modification to the Biodesign® Staple Line Reinforcement devices is the addition of thinner configurations (dimensional change) to the already existing line of staple line reinforcement devices. Table 5-1 provides a comparison of the subject and predicate devices.

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	Biodesign® Staple Line Reinforcement(subject device)	SURGISIS® SLRTM Staple LineReinforcement(predicate device)
Device
Manufacturer	Cook Biotech, Inc.	Cook Biotech, Inc.
510 (k) Number	Not assigned	K070405
Product Code	FTM	FTM
Intended Use	Intended for use as a prosthesis for thesurgical repair of soft tissue deficienciesusing surgical staplers. The device maybe used for buttressing and reinforcingstaple lines during lung resection (e.g.wedge resection, blebectomy,lobectomy, bullectomy, bronchialresection, segmentectomy,pneumonectomy/pneumectomy,pneumoreduction) and other incisionsand excisions of the lung and bronchus.The device can be used for thereinforcement of the gastric staple lineduring bariatric surgical procedures ofgastric bypass and gastric banding, andfor reinforcement of staple lines duringsmall bowel, mesentery, colon andcolorectal procedures. The device maybe used with anastomotic staplers orwith non-anastomotic staplers.	Intended for use as a prosthesis for thesurgical repair of soft tissue deficienciesusing surgical staplers. The device maybe used for buttressing and reinforcingstaple lines during lung resection (e.g.wedge resection, blebectomy,lobectomy, bullectomy, bronchialresection, segmentectomy,pneumonectomy/pneumectomy,pneumoreduction) and other incisionsand excisions of the lung and bronchus.The device can be used for thereinforcement of the gastric staple lineduring bariatric surgical procedures ofgastric bypass and gastric banding, andfor reinforcement of staple lines duringsmall bowel, mesentery, colon andcolorectal procedures. The device maybe used with anastomotic staplers orwith non-anastomotic staplers.
Materials andComponents	SIS buttressing stripPre-coated adhesivePolystyrene foam applicator	SIS buttressing stripPre-coated adhesivePolystyrene foam applicator
SIS DeviceDimensions(unfolded)	Length: 76 mm to 176 mmWidth: 10 mm to 12 mmThickness: 4-layer SIS(100 μm to 500 μm)2-layer SIS(50 μm to 300 μm)	Length: 76 mm to 176 mmWidth: 10 mm to 12 mmThickness: 4-layer SIS(100 μm to 500 μm)
Shelf-Life	18 months	18 months
Packaging	foil pouch	foil pouch
Sterilization	E-beam	E-beam
One-time Use	Yes	Yes

Table 5-1. Substantial Equivalence Information

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VII. 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 ISO 10993-1:2009 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process to demonstrate that the device is safe for permanent contact (>30 days) implantation. The predicate test data was leveraged to support the substantial equivalence of the subject device as the device materials and general manufacturing processes are identical for the subject and predicate devices.

Non-Clinical testing

Product verification testing was performed on 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.

VIII. CONCLUSIONS

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 and fundamental scientific technology as the predicate device. In addition, the subject device is composed of the same materials and manufactured using the same processes as the predicate. The only design modification is with regard to device dimensions, where the subject device includes thinner configurations to supplement the existing line of SIS staple line reinforcement devices. The absence of changes in the fundamental scientific technology and intended use of the device, as well as a risk analysis and completion of verification and validation activities, provide evidence to support the conclusion that the thickness modification does not introduce new risks and that the subject device performs comparably to the predicate device that is 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.