← Product Code KGN · K140820

# XENOMEM WOUND MATRIX (K140820)

_Viscus Biologics, LLC · KGN · Jun 26, 2015 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K140820

## Device Facts

- **Applicant:** Viscus Biologics, LLC
- **Product Code:** KGN
- **Decision Date:** Jun 26, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

XenoMem™ Wound Matrix is indicated for the management of wounds including: - Partial and full-thickness wounds; - Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers; - Tunnelled/undermined wounds - Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence), - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears); - Draining wounds.

## Device Story

Acellular porcine peritoneal matrix; functions as biological wound dressing to support wound management. Derived from porcine peritoneum; processed via decellularization, viral inactivation, and freeze-drying to remove donor genetic material while maintaining tissue structure. Supplied sterile via gamma irradiation for prescription use. Applied by clinicians to wound site; provides robust biological matrix for easier handling and conformability. Benefits patient by providing scaffold for wound healing. No active components or software.

## Clinical Evidence

Bench testing only. Testing included tensile strength, thickness, residual DNA analysis, packaging validation, shelf-life performance, sterility (SAL 10^-6), biocompatibility (ISO 10993-1), residual chemical risk assessment, viral inactivation, and differential scanning calorimetry (DSC). All tests met requirements.

## Technological Characteristics

Acellular porcine peritoneal membrane; non-crosslinked extracellular matrix. Supplied in various sizes; can be fenestrated for conformability. Sterilized via gamma irradiation. Biocompatibility per ISO 10993-1.

## Predicate Devices

- Oasis® Wound Matrix ([K061711](/device/K061711.md))
- SS Matrix ([K020732](/device/K020732.md))

## Reference Devices

- Kensey-Nash Meso Wound Matrix ([K112888](/device/K112888.md))
- Kensey-Nash ECM Surgical Patch ([K094061](/device/K094061.md))

## 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

June 26, 2015

Viscus Biologies LLC Ms. Elaine Duncan Paladian Medical Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K140820

Trade/Device Name: XenoMem™ Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 24, 2015 Received: June 25, 2015

Dear Ms. Duncan:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21CFR 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

### Indications for Use

510(k) Number (if known) Pending

Device Name

XenoMem(tm) Wound Matrix

Indications for Use (Describe)

XenoMem™ Wound Matrix is indicated for the management of wounds including:

- · Partial and full-thickness wounds;
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
- · Tunnelled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence),
- · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- Draining wounds.

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)

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# 510(K) SUMMARY

# TRADITIONAL 510(k)

Submitter- Manufacturer: Viscus Biologics LLC, Peter Gingras, CEO Viscus Biologics LLC, Dayton, OH 45402, USA.

Tel: +1 216 658 4111

#### Submitted by and Contact Person

|                      | Elaine Duncan                                  |
|----------------------|------------------------------------------------|
|                      | Paladin Medical, Inc.                          |
|                      | P.O. Box 560                                   |
|                      | Stillwater, MN 55082                           |
|                      | 715-549-6035                                   |
|                      | 715-549-5380                                   |
| CONTACT PERSON:      | Elaine Duncan                                  |
| DATE PREPARED:       | June 26, 2015                                  |
| TRADE NAME:          | XenoMem™ Wound Matrix                          |
| COMMON NAME:         | Topical Wound Dressing                         |
| CLASSIFICATION NAME: | Dressing, Wound, Collagen                      |
| REGULATION           | Unclassified                                   |
| PROCODE and CLASS    | General and Plastic Surgery, KGN: Unclassified |

#### INDICATIONS FOR USE:

XenoMem™ Wound Matrix is indicated for the management of wounds including:

- . Partial and full-thickness wounds;
- Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
- Tunnelled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence),
- Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- . Draining wounds.

#### DESCRIPTION of the DEVICE:

XenoMem™ Wound Matrix is an acellular, porcine peritoneal matrix, supplied sterile to maintain and support an environment for wound management. It consists of an extracellular tissue matrix, derived from porcine peritoneum. XenoMem™ Wound Matrix porcine peritoneal membrane provides a robust biological matrix that allows for easier handling during preparation and application of the wound dressing. The membrane has undergone a decellularisation, viral inactivation and a freeze-drying process in order to remove donor genetic material, in a non-destructive manner, so as

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to maintain the structure and function of the tissue. XenoMem is sterilized via gamma irradiation and sold for prescription only.

### SUBSTANTIALLY EQUIVALENT TO:

XenoMem™ Wound Matrix is substantially equivalent to Oasis® Wound Matrix, cleared with Special 510(k) K061711, which is in turn based on SS Matrix cleared via Traditional 510(k) K020732. Oasis Ultra, a line extension, is a triple layer version of Oasis Wound Matrix. Cook Biotech, Inc. manufactures these predicate devices. XenoMem™ Wound Matrix has the same indications, intended use, and the same or similar technological characteristics, principles of operation and performance properties to the Oasispredicates. K112888 (Kensey-Nash Meso Wound Matrix) and K094061 (Kensey-Nash ECM Surgical Patch) are included as Reference Predicates because these devices are also manufactured from porcine peritoneum.

| Oasis® Wound Matrix                                                                                          | XenoMem™ Wound Matrix                                                        |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| K061711/K020732                                                                                              | Pending                                                                      |
| Cook Biotech, Inc.                                                                                           | Viscus Biologics, LLC                                                        |
| Indication:                                                                                                  | Indication:                                                                  |
| The Oasis Wound Matrix is intended for the                                                                   | XenoMem™ Wound Matrix is indicated for the                                   |
| management of wounds including:                                                                              | management of wounds including:                                              |
| • Partial and full thickness wounds;                                                                         | • Partial and full thickness wounds:                                         |
| • Pressure ulcers;                                                                                           | • Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;  |
| • Venous ulcers                                                                                              | • Tunneled/ undermined wounds                                                |
| • Diabetic ulcers                                                                                            | • Surgical wounds (donor sites/grafts, post-                                 |
| • Chronic vascular ulcers;                                                                                   | Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)              |
| • Tunneled, undermined wounds;                                                                               | • Trauma wounds (abrasions, laceration, second-degree burns, and skin tears) |
| • Surgical wounds (donar sites/grafts, post Moh's surgery, post-laser surgery, podiatric, wound dehiscence); | • Draining wounds.                                                           |
| • Trauma wounds (abrasions, laceration, second-degree burns, and skin tears)                                 |                                                                              |
| • Draining wounds.                                                                                           |                                                                              |
| The device is intended for one-time use.                                                                     |                                                                              |
| Material and Origin                                                                                          | Material and Origin                                                          |
| Non Cross Linked Extra Cellular Matrix<br>Porcine Small Intestinal Submucosa                                 | Non Cross Linked Extra Cellular Matrix<br>Porcine Peritoneal Membrane        |
| Nominal Size                                                                                                 | Nominal Size                                                                 |
| 3 cm X 3.5 cm<br>3 cm X 7 cm                                                                                 | 3 cm X 3.5 cm 3 cm X 7 cm                                                    |
|                                                                                                              | 7 X 10 cm 10 cm X 15 cm                                                      |
| Fenestrated                                                                                                  | Sold non-fenestrated;                                                        |
|                                                                                                              | Can be fenestrated for conformability; see IFU                               |
| Sterilization method ETO                                                                                     | Sterilization method Gamma                                                   |

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#### 510(k) Summary-Continued

## SUMMARY OF TESTING and RESULTS SUPPORTING SUBSTANTIAL

### EQUIVALENCE:

| Evaluation to Demonstrate Substantial<br>Equivalence               | Conclusion                   |
|--------------------------------------------------------------------|------------------------------|
| 1) tensile strength (with and without<br>fenestration),            | Met requirements             |
| 2) thickness                                                       | Met requirements             |
| 3) residual DNA analysis                                           | Met requirements             |
| 4) packaging validation and post shelf-life<br>product performance | Met requirements             |
| 5) sterility validation to SAL 10-6                                | Met requirements             |
| 6) biocompatibility per ISO 10993-1 & FDA<br>guidance              | Met requirements             |
| 7) residual chemical risk assessment                               | Risks deemed acceptable      |
| 8) viral inactivation studies.                                     | Reduced to acceptable levels |
| 9) differential scanning calorimetry (DSC)                         | Met requirements             |

Therefore, it is concluded that results of testing and comparative analysis have shown that any technological differences between the XenoMem™ and Oasis® wound dressing do not change the intended therapeutic use and do not introduce any new issues of safety and effectiveness.

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**Source:** [https://fda.innolitics.com/device/K140820](https://fda.innolitics.com/device/K140820)

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