Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

K191696 · Cook Biotech Incorporated · OXN · Dec 27, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191696
• Device Name: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
• Applicant: Cook Biotech Incorporated
• Product Code: OXN · General, Plastic Surgery
• Decision Date: Dec 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas. Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. 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 Tissue Graft: For implantation to reinforce soft tissue.

Device Story

Biodesign family devices consist of decellularized, collagen-rich porcine small intestinal submucosa (SIS). Devices are implanted by physicians to reinforce soft tissue in surgical procedures. Modification allows rehydration of the graft with autologous body fluids (e.g., blood, bone marrow aspirate, platelet concentrate) in addition to standard saline. Devices are provided sterile via ethylene oxide. Clinical benefit derived from SIS scaffold supporting tissue repair. No changes to device physical form or fundamental technology compared to predicates.

Clinical Evidence

Bench testing only. Mechanical performance (burst strength, tensile strength, suture retention strength, and delamination testing) was evaluated to ensure that rehydration with autologous body fluids did not adversely affect the mechanical properties of the SIS material compared to saline rehydration.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS) extracellular matrix. Form: Plugs or rectangular sheets (thickness 40-1500 µm). Sterilization: Ethylene oxide. Shelf-life: 18 months. Single-use. Rehydration: Saline or autologous body fluids (blood, bone marrow aspirate, platelet concentrate).

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair, specifically for anal, rectal, enterocutaneous, recto-vaginal, or anorectal fistulas, or general soft tissue weakness in plastic/reconstructive surgery.

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

• Biodesign Anal Fistula Plug (K161221, K050337)
• Biodesign Fistula Plug (K170016)
• Biodesign Plastic Surgery Matrix (K161221, K034039)
• Biodesign Tissue Graft (K160896, K980431)

Reference Devices

• K132025
• K171817

Submission Summary (Full Text)

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

December 27, 2019

Cook Biotech Incorporated Nick Wang Regulatory Science Manager 1425 Innovation Place West Lafayette, Indiana 47906

Re: K191696

Trade/Device Name: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXN, OXH, OXH Dated: November 22, 2019 Received: November 25, 2019

Dear Nick 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. 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.

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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-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 (OS) 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 ([e-mail]) or phone [phone] 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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510(k) Number (if known) K191696

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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Number (if known) K191696

Device Name Biodesign Fistula Plug

Indications for Use (Describe)

For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.

Type of Use (Select one or both, as applicable)

X 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 [e-mail]

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510(k) Number (if known) K191696

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)|X 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 [e-mail]

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510(k) Number (if known) K191696

Device Name Biodesign Tissue Graft

Indications for Use (Describe) For implantation to reinforce soft tissue.

| 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 [e-mail]

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# 510(k) Summary

| Submitted by: | Perry Guinn |
|------------------------|-----------------------------------------------------------|
| | Vice President, Quality Assurance and Regulatory Affairs, |
| | Cook Biotech Inc. |
| | 1425 Innovation Place West Lafayette, IN 47906 |
| | [phone] |
| Date: | December 22, 2019 |
| 510(k) Number: | K191696 |
| Device Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | OXH, OXN, FTM |
| Predicate Devices: | K161221, K050337, K170016, K161221, K034039, K160896 |
| | K980431 |

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

- Biodesign® Anal Fistula Plug 1.
- Biodesign® Fistula Plug 2.
- Biodesign® Plastic Surgery Matrix 3.
- Biodesign® Tissue Graft 4.

This submission is presented as a bundle because the modification under consideration is the same for all four devices.

## Device Descriptions:

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.

The four subject devices of this bundled submission share many of the same technological characteristics:

- All four devices are indicated for applications related to reinforcing soft tissue (with various specific indications)
- All four devices are composed of porcine small intestinal submucosa (SIS) manufactured by CBI
- All four devices are labeled with a shelf-life of 18 months
- o All four devices are sterilized using ethylene oxide

While the four devices are different from each other in device indications and dimensional specifications, each subject device is unchanged from its respective predicate device in physical form (device itself and packaging) and indications for use. The only difference between each subject device and its corresponding predicate device is in the device labeling, with the subject

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devices having additional rehydration fluid options included in their instructions for use (IFUs).

| | Biodesign Anal<br>Fistula Plug<br>(AFP) | Biodesign Fistula Plug<br>(FP) | Biodesign Plastic<br>Surgery Matrix<br>(PSM) | Biodesign Tissue<br>Graft (TG) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------|
| Product<br>Dimensions<br>(nominal) - same<br>as in the cleared<br>predicate 510(k) | 2 mm minor<br>diameter to 7 mm<br>major diameter by<br>100 mm length; | 2 mm minor diameter to 7<br>mm major diameter by 51<br>mm length;<br>Device also contains SIS<br>flange/button | 2 to 70 mm width<br>up to 200 mm<br>length;<br>100 to 1500 µm<br>thick | 2 cm x 4 cm<br>to 20 cm x 40 cm;<br>40 to 700 µm thick |
| Shape | Plug | Plug | Rectangular | Rectangular |

Table 5-2. Dimensional Specifications

# Description of Modifications:

For each subject device, the only modification from the predicate device is in the devicelabeling. The modification that triggered this submission is the inclusion of additional rehydration fluid options in the instructions for use (IFU)4. In addition to saline (which is the rehydration fluid in the predicate devices), autologous body fluid is being added as potential rehydration fluid options for all subject devices of this submission. In addition, example autologous fluids such as blood, bone marrow aspirate, or blood concentrate such as platelet concentrate are also being added to the labeling of the Biodesign Plastic Surgery Matrix and the Biodesign tissue Graft. CBI is making this modification because there is interest in the field to use these fluids to rehydrate the device. There are already several cleared surgical meshes (including the reference devices K132025 and K171817) with this type of rehydration language in their 510(k) summaries.

## 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)].
- Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options that demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties.

## Substantial Equivalence:

Table 5-3 provides a comparison of the subject devices and their respective predicates.

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| | Biodesign Anal Fistula Plug, Biodesign Fistula Plug<br>Biodesign Plastic Surgery Matrix,<br>Biodesign Tissue Graft (Subject Devices) | Predicate Devices all with the<br>Same Name (Predicate<br>Devices) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 510(k) | K191696 | AFP-K161221/K050337 PF-<br>K170016<br>PSM-K161221/K034039 TG-<br>K160896/K980431 |
| Indication for Use<br>(The indications for<br>use of each device in<br>the bundled 510(k) are<br>unchanged from that<br>of its respective<br>predicate device.) | Biodesign Anal Fistula Plug: For implantation to<br>reinforce soft tissue where a rolled configuration is<br>required, for repair of anal, rectal and enterocutaneous<br>fistulas. | Same |
| | Biodesign Fistula Plug: For implantation to reinforce soft<br>tissue for repair of recto-vaginal or anorectal fistulas. | Same |
| | Biodesign Plastic Surgery Matrix: For implantation to<br>reinforce soft tissue where weakness exists in patients<br>requiring soft tissue repair or reinforcement in plastic or<br>reconstructive surgery. | Same |
| | Biodesign Tissue Graft: For implantation to reinforce soft<br>tissue. | Same |
| Material | Porcine small intestinal submucosa; (constituents of the<br>extracellular matrix) | Same |
| Supplied sterile? | Yes | Same |
| Sterilization method | Ethylene Oxide | Same |
| Rehydration Fluid | All devices in the bundle<br>Sterile saline and autologous body fluids<br>Plastic Surgery Matrix and Tissue Graft<br>Sterile saline and autologous body fluids such as blood,<br>bone marrow aspirate, or blood concentrates such as<br>platelet concentrate | Sterile saline |
| | Shelf-Life | 18 months |
| Intended for single<br>use? | Yes | Same |

# Table 5-3. Substantial Equivalence Information

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## Conclusion:

For purposes of determinations of substantial equivalence under section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)), the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, and Biodesign Tissue Graft, the subject devices, have the same intended use and functions under the same mode of action and fundamental scientific technology as the predicate devices with the same name. In addition, the subject devices are composed of the same materials and are manufactured using the same processes as the predicate devices. The only modification is the addition of autologous body fluids as possible rehydration fluids in the devices' IFUs. The absence of changes in the fundamental scientific technology and intended use of the device, as well as the completion of verification and validation activities, provide evidence to support the conclusion that the subject devices perform comparably to the predicate devices that are currently marketed for the same intended use.