Biodesign Enterocutaneous Fistula Plug

K150668 · Cook Biotech Incorprated · FTM · Dec 9, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150668
• Device Name: Biodesign Enterocutaneous Fistula Plug
• Applicant: Cook Biotech Incorprated
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Dec 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Bioabsorbable, collagen-derived device for enterocutaneous fistula repair. Consists of implanted SIS (small intestinal submucosa) plug, flange/gasket assembly, suture tether, and Molnar Disc; includes delivery system (pusher, dilator, sheath, transfer tube). SIS plug fills fistula tract, remodeling into patient tissue; flange/gasket assembly seals internal opening to prevent fluid ingress; suture connects internal assembly to external Molnar Disc to maintain tension. Used by clinicians in surgical settings. Device provides mechanical reinforcement and biological scaffold for tissue healing; temporary components pass naturally or fall off skin.

Clinical Evidence

Bench testing included leak resistance, pushability, deployment, gasket expansion, and tensile strength. GLP animal study in domestic swine model demonstrated fistula closure and complete plug incorporation at five weeks with no negative clinical sequelae.

Technological Characteristics

Materials: Porcine SIS (plug), Nitinol (flange), 316 stainless steel (pin/marker), Polyurethane (flange), Polydioxanone (tether), Crosslinked SIS (gasket). Sterilization: Ethylene Oxide. Form factor: Rolled, freeze-dried plug with delivery system. Biocompatibility per ISO-10993.

Indications for Use

Indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

Regulatory Classification

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.

Predicate Devices

• Surgisis® Biodesign® Enterocutaneous Fistula Plug (K082682)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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 Incorporated<br>1425 Innovation Place<br>West Lafayette, Indiana 47906<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Perry W. Guinn, VP of Quality Assurance and<br>Regulatory Affairs |
| Device Name and Classification: | |

# e Name and Classification:

| Trade Name: | Biodesign® Enterocutaneous Fistula Plug |
|-------------------------------|----------------------------------------------------|
| Common/Usual Name: | Surgical Mesh |
| Proposed classification name: | Surgical Mesh<br>21 CFR 878.3300 (FTM)<br>Class II |

# Indications for Use:

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.

### Predicate Device:

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

# 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

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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/gasket<br>assembly | Surface device | Mucosal membrane<br>contacting | Prolonged contact (24<br>hrs - 30 days) |
| Delivery<br>device | Externally<br>communicating device | Tissue contacting | Limited (<24 hrs) |
| Molnar Disc | Surface device | Skin contacting | Prolonged contact (24<br>hrs - 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® Enterocutaneous<br>Fistula Plug<br>(subject device) | Surgisis® Biodesign®<br>Enterocutaneous Fistula Plug<br>(predicate device) |
|---------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Incorporated | Cook Biotech Incorporated |
| 510(k) number | Unassigned | K082682 |
| Indication | Implantation to reinforce soft<br>tissue for repair of<br>enterocutaneous fistulas | Implantation to reinforce soft<br>tissue for repair of<br>enterocutaneous 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<br>- Plug<br>- Suture<br>- Molnar Disc<br>- Temporary flange<br>- Expandable gasket<br>Delivery System<br>- Pusher<br>- Dilator<br>- Sheath with Captor valve<br>- Transfer tube | Implanted Device<br>- Plug<br>- Suture<br>- Molnar Disc<br>- Temporary flange<br>Delivery System<br>- Pusher<br>- Dilator<br>- Sheath with Captor valve<br>- Transfer tube |
| Plug<br>dimensions | Length: 180 mm<br>Diameter: 4 mm | Length: 180 mm<br>Diameter: 4 and 7 mm |
| Implant<br>materials | - SIS lyophilized, acellular, collagenous, porcine small intestinal mucosa (plug)<br>- Nitinol (flange)<br>- 316 stainless steel (pin and radio-opaque marker)<br>- Polyurethane (flange)<br>- Polydioxanone (PDO) (tether)<br>- Crosslinked SIS (gasket) | - SIS lyophilized, acellular, collagenous, porcine small intestinal mucosa (plug)<br>- Nitinol (flange)<br>- 316 stainless steel (radio-opaque marker)<br>- Polyurethane (flange)<br>- Polydioxanone (PDO) (tether)<br>- Poly (lactic-co-glycolic acid) (PLGA) (pin) |
| Supplied sterile | Yes | Yes |
| Sterilization<br>method | Ethylene Oxide | Ethylene Oxide |
| Intended for | Yes | Yes |