The Biodesign® Enterocutaneous Fistula Plug is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.

Device Description

The Biodesign® Enterocutaneous Fistula Plug is a bioabsorbable, collagen-derived, minimally invasive treatment option for the repair of enterocutaneous fistulas. The device consists of two parts - an implanted device and a delivery system. The implanted device has four components - the small intestinal submucosa (SIS) plug, the flange/gasket assembly, the suture tether and the Molnar Disc. The SIS plug is manufactured from porcine small intestine that has been stripped of its serosal, mucosal, and muscle layers and virally inactivated. The resulting acellular collagenous layer, termed Small Intestinal Submucosa, is manufactured into a rolled, freeze dried plug. The function of the SIS plug is to fill and aid in the healing of the tract. The plug fully remodels into patient tissue over time. The other three components, the flange/gasket assembly, the suture tether and the Molnar Disc are all temporary implants designed to either naturally pass out of the body or fall off the skin. The function of the flange/gasket assembly is to seal the internal opening of the fistula tract and prevent the ingress of any gastric/intestinal fluid from entering the fistula tract. The suture connects the flange assembly at the internal opening of the fistula to the Molnar Disc at the external opening. Tethering the suture to the Molnar Disc provides tension to keep the flange/gasket assembly securely in place. In addition to the implanted device, a delivery system is provided to ensure proper device delivery and deployment.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Biodesign® Enterocutaneous Fistula Plug and does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria from an AI/algorithm perspective. Instead, it focuses on demonstrating substantial equivalence to a predicate device through biocompatibility, mechanical testing, and animal testing.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract information related to the device performance and the studies conducted to support its substantial equivalence.

Here's the breakdown of the information that can be extracted or deduced from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format for each test, nor does it provide detailed raw performance data. It generally states that the device "meets the biocompatibility requirements" and that mechanical tests "ensure the device design is appropriate and the device is able to function as intended."

| Acceptance Criteria Category | Reported Device Performance |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Biocompatibility | The Biodesign® Enterocutaneous Fistula Plug meets the biocompatibility requirements of the ISO-10993 standard. Tests performed on permanent tissue implant components (SIS material) included Genotoxicity, Cytotoxicity, Muscle implantation, Acute intracutaneous reactivity, Skin irritation, ISO sensitization, Acute systemic toxicity, and Subchronic systemic toxicity. |
| Mechanical Testing | Mechanical tests were conducted to ensure the device design is appropriate and able to function as intended. These tests included Leak resistance, Pushability, Deployment, Gasket expansion, and Tensile strength, and Two-plug deployment. All tests were performed on terminally sterilized devices. The same types of testing were used for the predicate device. |
| Animal Testing (Safety & Biological Response) | A GLP animal study in a domestic swine model showed closure of surgically created fistulas, complete incorporation of enterocutaneous fistula plugs at five weeks, with no negative clinical sequelae. The study also evaluated local/regional responses of the intestine and adjacent organs, and the time the flange remained in the luminal surface. |
| Substantial Equivalence | All differences between the subject device (Biodesign® Enterocutaneous Fistula Plug) and the predicate device (Surgisis® Biodesign® Enterocutaneous Fistula Plug, K082682) were analyzed. The conclusion was that these differences did not change the intended use, fundamental mode of action, or introduce new types of questions in risks or effectiveness, thus supporting a determination of substantial equivalence. The subject device is a "design improvement of the predicate device" based on user feedback and clinical experience. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Biocompatibility: Not specified beyond "portions classified to be permanent tissue implant (e.g. the SIS material)" and implied samples for the other components.
- Mechanical Testing: Not specified for individual tests. The document states "All testing were performed on terminally sterilized devices," implying multiple samples.
- Animal Testing: "A GLP animal study was performed using the Biodesign® Enterocutaneous Fistula Plug (subject device) in a domestic swine model." The exact number of swine is not specified, but "a domestic swine model" suggests a controlled, prospective study.
Data Provenance:
- Biocompatibility & Mechanical Testing: Conducted by the manufacturer (Cook Biotech Incorporated, based in West Lafayette, Indiana, USA), likely in a controlled laboratory setting.
- Animal Testing: Described as a "GLP animal study," indicating a Good Laboratory Practice compliant prospective study. Location is not explicitly stated but assumed to be in a controlled environment, likely in the US given the manufacturer's location.

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. The studies described are preclinical (biocompatibility, mechanical, animal) and do not involve human expert interpretation for establishing ground truth in the context of clinical performance or diagnostic accuracy. The animal study outcomes (closure of fistulas, incorporation of plugs, no negative clinical sequelae) would be evaluated by veterinary pathologists or researchers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no mention of expert adjudication for clinical or diagnostic performance.

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 physical surgical implant, not an AI or diagnostic algorithm, so MRMC studies are not relevant. This document is a 510(k) submission for a medical device, not an AI product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical implant, not an AI or diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Biocompatibility: Based on established international standards (ISO-10993) using biological assays (e.g., cytotoxicity, genotoxicity, systemic toxicity) and tissue reactions observed in animal models (e.g., muscle implantation, acute intracutaneous reactivity).
Mechanical Testing: Based on engineering specifications and physical measurements (e.g., leak resistance, tensile strength).
Animal Testing: Based on observed biological outcomes in a live animal model (e.g., fistula closure, tissue incorporation, clinical sequelae, pathological examination of tissues). This would involve macroscopic and microscopic pathology.

8. The sample size for the training set

Not applicable. There is no AI component or training set involved with this physical device.

9. How the ground truth for the training set was established

Not applicable. There is no AI component or training set involved with this physical device.

Summary

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

December 9, 2015

Cook Biotech Incorprated Mr. Nick Wang Regulatory Affairs Scientist 1425 Innovation Place West Lafayette, Indiana 47906

Re: K150668

Trade/Device Name: Biodesign Enterocutaneous Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: March 13, 2015 Received: November 10, 2015

Dear Mr. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours,

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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Indications for Use

510(k) Number (if known) K150688

Device Name Biodesign® Enterocutaneous Fistula Plug

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

13 March 2015

Cook Biotech Incorporated

Biodesign® Enterocutaneous Fistula Plug

Manufacturer Name:	Cook Biotech Incorporated1425 Innovation PlaceWest Lafayette, Indiana 47906Telephone: +1 (765) 497-3355Fax: +1 (765) 807-7709
Official Contact:	Perry W. Guinn, VP of Quality Assurance andRegulatory Affairs
Device Name and Classification:

e Name and Classification:

Trade Name:	Biodesign® Enterocutaneous Fistula Plug
Common/Usual Name:	Surgical Mesh
Proposed classification name:	Surgical Mesh21 CFR 878.3300 (FTM)Class II

Indications for Use:

Predicate Device:

The predicate device is the Surgisis® Biodesign® Enterocutaneous Fistula Plug (K082682), also manufactured by Cook Biotech Incorporated.

Device Description:

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has four components - the small intestinal submucosa (SIS) plug, the flange/gasket assembly, the suture tether and the Molnar Disc. The SIS plug is manufactured from porcine small intestine that has been stripped of its serosal, mucosal, and muscle layers and virally inactivated. The resulting acellular collagenous layer, termed Small Intestinal Submucosa, is manufactured into a rolled, freeze dried plug. The function of the SIS plug is to fill and aid in the healing of the tract. The plug fully remodels into patient tissue over time. The other three components, the flange/gasket assembly, the suture tether and the Molnar Disc are all temporary implants designed to either naturally pass out of the body or fall off the skin. The function of the flange/gasket assembly is to seal the internal opening of the fistula tract and prevent the ingress of any gastric/intestinal fluid from entering the fistula tract. The suture connects the flange assembly at the internal opening of the fistula to the Molnar Disc at the external opening. Tethering the suture to the Molnar Disc provides tension to keep the flange/gasket assembly securely in place. In addition to the implanted device, a delivery system is provided to ensure proper device delivery and deployment.

Equivalence of Market Device:

The Biodesign® Enterocutaneous Fistula Plug, the subject device, is a design improvement of the predicate device, Surgisis® Biodesign® Enterocutaneous Fistula Plug (K082682). The modifications described in this 510(k) are made based on user feedback and clinical experience resulting from use of the predicate device. Analysis and comparison of the intended use, and material and technological characteristics, in conjunction with relevant testing, support the determination that the subject and predicate devices are substantially equivalent. A brief summary of the relevant testing and the substantial equivalence comparison are provided below in this 510(k) summary.

Biocompatibility

The biocompatibility assessment of the Biodesign® Enterocutaneous Fistula Plug was conducted in accordance with FDA's biocompatibility testing guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (May 1, 1995). Based on the standard, the plug, the flange/gasket assembly, the delivery system and the Molnar Disc each have different classifications. The classifications are summarized in Table 5-1.

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Device	Biocompatibility Classification
Component	Device Type	Contact	Duration
SIS Plug	Implant device	Tissue contacting	Permanent (>30 days)
Flange/gasketassembly	Surface device	Mucosal membranecontacting	Prolonged contact (24hrs - 30 days)
Deliverydevice	Externallycommunicating device	Tissue contacting	Limited (<24 hrs)
Molnar Disc	Surface device	Skin contacting	Prolonged contact (24hrs - 30 days)

Table 5-1. Biocompatibility Classification

Relevant biocompatibility testing was performed based the biocompatibility classification of each of the components.

For example, the following biocompatibility tests were performed on portions classified to be permanent tissue implant (e.g. the SIS material):

Genotoxicity
Cytotoxicity ●
Muscle implantation ●
Acute intracutaneous reactivity ●
Skin irritation ●
. ISO sensitization
Acute systemic toxicity ●
. Subchronic systemic toxicity

The results of the biocompatibility assessment provided evidence that the Biodesign® Enterocutaneous Fistula Plug meets the biocompatibility requirements of the ISO-10993 standard.

Mechanical Testing

Mechanical testing was conducted to ensure the device design is appropriate and the device is able to function as intended. Tests performed include:

. Leak resistance
Pushability
Deployment ●
Gasket expansion ●
Leak resistance .

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Tensile strength
Two-plug deployment ●

The same types of testing were used to support the clearance of the predicate device (K082682). All testing were performed on terminally sterilized devices.

Animal Testing

A GLP animal study was performed using the Biodesign® Enterocutaneous Fistula Plug (subject device) in a domestic swine model. The purpose of the animal study was to characterize the safety and biological response of the Biodesign® Enterocutaneous Fistula Plug under a simulated use animal model. Endpoints of the study included evaluation of local, regional responses of the intestine and adjacent organs, as well as the time over which the flange portion of the device remained in the luminal surface of the intestine. The study showed closure of the surgically created fistulas, complete incorporation of enterocutaneous fistula plugs at five weeks, with no negative clinical sequelae.

Conclusions drawn from tests

Evaluation of the subject device, Biodesign® Enterocutaneous Fistula Plug, provides evidence of its suitability for use in soft tissue repair of enterocutaneous fistulas and substantial equivalency to the predicate device in terms of intended use, material, and technological characteristics.

Substantial Equivalence

All differences between the predicate and the subject device were analyzed; the differences did not change the intended use, fundamental mode of action, or introduce new types of questions in risks or effectiveness, thus supporting a determination that the subject and predicate devices are substantially equivalent. See Table 5-2 below for a comparison of the subject and predicate devices.

	Biodesign® EnterocutaneousFistula Plug(subject device)	Surgisis® Biodesign®Enterocutaneous Fistula Plug(predicate device)
Manufacturer	Cook Biotech Incorporated	Cook Biotech Incorporated
510(k) number	Unassigned	K082682
Indication	Implantation to reinforce softtissue for repair ofenterocutaneous fistulas	Implantation to reinforce softtissue for repair ofenterocutaneous fistulas

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Mode of action	Enterocutaneous fistulas are repaired by sealing the internal opening of the fistula and filling the fistula tract by using cylindrical SIS plugs	Enterocutaneous fistulas are repaired by sealing the internal opening of the fistula and filling the fistula tract by using cylindrical SIS plugs
Components	Implanted Device- Plug- Suture- Molnar Disc- Temporary flange- Expandable gasketDelivery System- Pusher- Dilator- Sheath with Captor valve- Transfer tube	Implanted Device- Plug- Suture- Molnar Disc- Temporary flangeDelivery System- Pusher- Dilator- Sheath with Captor valve- Transfer tube
Plugdimensions	Length: 180 mmDiameter: 4 mm	Length: 180 mmDiameter: 4 and 7 mm
Implantmaterials	- SIS lyophilized, acellular, collagenous, porcine small intestinal mucosa (plug)- Nitinol (flange)- 316 stainless steel (pin and radio-opaque marker)- Polyurethane (flange)- Polydioxanone (PDO) (tether)- Crosslinked SIS (gasket)	- SIS lyophilized, acellular, collagenous, porcine small intestinal mucosa (plug)- Nitinol (flange)- 316 stainless steel (radio-opaque marker)- Polyurethane (flange)- Polydioxanone (PDO) (tether)- Poly (lactic-co-glycolic acid) (PLGA) (pin)
Supplied sterile	Yes	Yes
Sterilizationmethod	Ethylene Oxide	Ethylene Oxide
Intended for	Yes	Yes

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.