← Product Code KGN · K191992

# PELNAC Bilayer Wound Matrix (K191992)

_Gunze Limited · KGN · Apr 29, 2020 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K191992

## Device Facts

- **Applicant:** Gunze Limited
- **Product Code:** KGN
- **Decision Date:** Apr 29, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

PELNAC™ Bilayer Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

## Device Story

PELNAC Bilayer Wound Matrix is a collagen-based dressing consisting of a porcine collagen sponge layer, a silicone film layer, and synthetic gauze. Applied by physicians in professional settings to full-thickness skin defects; the collagen sponge acts as a scaffold for cellular invasion and capillary growth. Available in meshed (fenestrated) and non-meshed (non-fenestrated) sheet forms. Terminally sterilized by ethylene oxide. Single-patient use. Provides a physical barrier and biological scaffold to support wound healing; clinical benefit includes tissue regeneration and wound closure.

## Clinical Evidence

Clinical evidence includes a Human Repeat Insult Patch Test (HRIPT) on 56 subjects showing no irritation or sensitization. Additionally, a prospective cohort study of 18 subjects (ages 19-66) with finger degloving injuries treated with the device showed no immune responses (erythema, edema, pain) over 21 days, with 12-month follow-up including biopsy and histological analysis confirming safety.

## Technological Characteristics

Bilayer construction: porcine (Achilles) tendon collagen sponge, silicone film, and synthetic gauze. Sheet form factor. Sterilized via ethylene oxide (ISO 11135). Biocompatibility per ISO 10993-1. No electronic or software components.

## Predicate Devices

- AVAGEN Wound Dressing ([K022127](/device/K022127.md))

## Reference Devices

- Bilayer Matrix Wound Dressing ([K021792](/device/K021792.md))
- INTEGRA™ Meshed Bilayer Wound Matrix ([K081635](/device/K081635.md))
- Wound Matrix TF ([K143426](/device/K143426.md))

## Submission Summary (Full Text)

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April 29, 2020

Gunze Limited % Stuart Goldman Senior Consult Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K191992

Trade/Device Name: PELNAC Bilayer Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: March 24, 2020 Received: March 26, 2020

Dear Stuart Goldman:

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/cfpmp/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.

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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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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## Indications for Use

510(k) Number (if known) K191992

Device Name PELNACTM Bilayer Wound Matrix

#### Indications for Use (Describe) PELNACTM Bilayer Wound Matrix is indicated for the management of wounds including:

- · partial and full-thickness wounds,
- · pressure ulcers,
- · venous ulcers,
- · diabetic ulcers,
- · chronic vascular ulcers,
- · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
- · draining wounds.

The device is intended for one-time use.

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

## PELNAC™ Bilayer Wound Matrix

### 1. Submission Sponsor

GUNZE LIMITED Medical Division 46 Natsumegaichi, Aono Ayabe, Kyoto 623-8513 Japan Contact: Mr. Hidenori Nishioka Title: Regulatory Affairs

### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA

#### 3. Date Prepared

April 29, 2020

#### 4. Device Identification

Trade/Proprietary Name: PELNAC™ Bilayer Wound Matrix Common/Usual Name: Wound Dressing Classification Name: Dressing, Wound, Collagen Regulation Number: Pre-Amendment Device Product Code: KGN Class: Unclassified (Pre-Amendment Device) Review Panel: General & Plastic Surgery

## 5. Legally Marketed Predicate and Reference Devices

- . Predicate Device (AVAGEN):
	- Integra Life Sciences Corp. AVAGEN Wound Dressing (K022127 / KGN) O

The predicate device has not been subject to a design related recall.

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- . Reference Device #1 (BMWD):
	- Integra Life Sciences Corp. Bilayer Matrix Wound Dressing (K021792 / FRO) o
- Reference Device #2 (IMBWM):
	- Integra Life Sciences Corp. INTEGRA™ Meshed Bilayer Wound Matrix (K081635 / FRO) o
- . Reference Device #3 (WMTF):
	- o Miromatrix Medical, Inc. – Wound Matrix TF (K143426 / KGN)

#### 6. Indications for Use

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

- partial and full-thickness wounds,
- pressure ulcers,
- venous ulcers,
- diabetic ulcers,
- chronic vascular ulcers,
- . surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
- draining wounds.

The device is intended for one-time use.

#### 7. Device Description

PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

#### 8. Substantial Equivalence Discussion

PELNAC™ Bilayer Wound Matrix has the same indications for use as the predicate device AVAGEN Wound Dressing (K022127), except for those indications related to tunneled / undermined wounds found in the predicate device which are not included in the indications for the subject and predicate devices employ the same mode of action in that both devices contain a porous sponge-like matrix of animalderived collagen that serves as a scaffold for cellular invasion and capillary growth.

Table 5-1 compares PELNAC™ Bilayer Wound Matrix to the predicate device AVAGEN (K022127) with respect to regulatory information, intended use, indications for use, technological characteristics, and safety and

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#### K191992

performance testing and provides detailed information regarding the basis for the determination of substantial equivalence between the subject and predicate device. Similar and relevant information on the reference devices is also included in Table 5-1.

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| Attributes                                     | Subject Device                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Predicate Device (AVAGEN)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Reference Device #1 (BMWD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Reference Device #2 (IMBWM)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Reference Device #3 (WMTF)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | Similarities / Differences                                                                                                                                                                                                                                 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information                         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                            |
| Device Name                                    | PELNAC™ Bilayer Wound Matrix (Non-Meshed Type and Meshed Type)                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | AVAGEN Wound Dressing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Bilayer Matrix Wound Dressing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Integra Meshed Bilayer Wound Matrix                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Wound Matrix TF                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | -                                                                                                                                                                                                                                                          |
| Manufacturer                                   | GUNZE LIMITED                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Integra Life Sciences                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Integra Life Sciences                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Integra Life Sciences                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Miromatrix Medical                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | -                                                                                                                                                                                                                                                          |
| 510(k) #                                       | Pending                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | K022127                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | K021792                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | K081635                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | K143426                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | -                                                                                                                                                                                                                                                          |
| Product Code                                   | KGN                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | KGN                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | FRO                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | FRO                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | KGN                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Same for the subject and predicate device.                                                                                                                                                                                                                 |
| Regulation                                     | Pre-Amendment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Pre-Amendment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Pre-Amendment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Pre-Amendment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Pre-Amendment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Same for the subject and predicate device.                                                                                                                                                                                                                 |
| Class                                          | Unclassified                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | Unclassified                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Unclassified                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | Unclassified                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Unclassified                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Same for the subject and predicate device.                                                                                                                                                                                                                 |
| Review Panel                                   | General & Plastic Surgery                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | General & Plastic Surgery                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | General & Plastic Surgery                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | General & Plastic Surgery                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | General & Plastic Surgery                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Same for the subject and predicate device.                                                                                                                                                                                                                 |
| Indications for Use                            | PELNAC™ Bilayer<br>Wound Matrix is<br>indicated for the<br>management of<br>wounds including:<br>partial and full-<br>thickness wounds,<br>pressure ulcers,<br>venous ulcers,<br>diabetic ulcers,<br>chronic vascular<br>ulcers, surgical<br>wounds (donor<br>sites/grafts, post-<br>Moh's surgery, post-<br>laser surgery,<br>podiatric, wound<br>dehiscence), trauma<br>wounds (abrasions,<br>lacerations, second-<br>degree burns, and<br>skin tears), and<br>draining wounds.<br>The device is<br>intended for one-<br>time use. | AVAGEN Wound<br>Dressing is indicated<br>for the<br>management of<br>wounds including:<br>partial and full-<br>thickness wounds,<br>pressure ulcers,<br>venous ulcers,<br>diabetic ulcers,<br>chronic vascular<br>ulcers,<br>tunneled/undermin<br>ed wounds, surgical<br>wounds (donor<br>sites/grafts, post-<br>Moh's surgery, post-<br>laser surgery,<br>podiatric, wound<br>dehiscence), trauma<br>wounds (abrasions,<br>lacerations, second-<br>degree burns, and<br>skin tears) and<br>draining wounds.<br>The device is<br>intended for one-<br>time use. | Bilayer Matrix<br>Wound Dressing is<br>indicated for the<br>management of<br>wounds including:<br>partial and full-<br>thickness wounds,<br>pressure ulcers,<br>venous ulcers,<br>diabetic ulcers,<br>chronic vascular<br>ulcers, surgical<br>wounds (donor<br>sites/grafts, post-<br>Moh's surgery, post-<br>laser surgery,<br>podiatric, wound<br>dehiscence), trauma<br>wounds (abrasions,<br>lacerations, second-<br>degree burns, and<br>skin tears) and<br>draining wounds.<br>The device is<br>intended for one-<br>time use. | INTEGRA™ Meshed<br>Bilayer Wound<br>Matrix is indicated<br>for the<br>management of<br>wounds including:<br>partial and full-<br>thickness wounds,<br>pressure ulcers,<br>venous ulcers,<br>diabetic ulcers,<br>chronic vascular<br>ulcers, surgical<br>wounds (donor<br>sites/grafts, post-<br>Moh's surgery, post-<br>laser surgery,<br>podiatric, wound<br>dehiscence), trauma<br>wounds (abrasions,<br>lacerations, second<br>degree burns, and<br>skin tears) and<br>draining wounds.<br>May be used in<br>conjunction with<br>negative pressure<br>wound therapy. The<br>device is intended<br>for one-time use. | Wound Matrix TF is<br>intended for the<br>management of<br>wounds including:<br>Partial and full<br>thickness wounds;<br>Pressure ulcers;<br>Venous ulcers;<br>Diabetic ulcers;<br>Chronic vascular<br>ulcers; Tunneled,<br>undermined<br>wounds; Surgical<br>wounds (donor<br>sites/grafts, post-<br>Mohs' surgery, post-<br>laser surgery,<br>podiatric, wound<br>dehiscence);<br>Trauma wounds<br>(abrasions,<br>lacerations, second-<br>degree burns, and<br>skin tears); Draining<br>wounds.<br>The device is<br>supplied sterile and<br>is intended for one-<br>time use. | Same. Except for<br>those indications<br>related to tunneled<br>/undermined<br>wounds found in the<br>predicate device<br>which are not found<br>in the subject<br>device, the subject<br>and predicate<br>device have the<br>same indications for<br>use. |
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| Attributes                                     | Subject Device                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Predicate Device<br>(AVAGEN)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Reference<br>Device #1<br>(BMWD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Reference<br>Device #2<br>(IMBWM)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | Reference<br>Device #3<br>(WMTF)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Similarities /<br>Differences                                                                                                                                                                                                                              |
| Technological Characteristics                  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                            |
| Construction                                   | Bilayer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Single layer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Bilayer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Bilayer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Single layer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Different.<br>Therefore,<br>Reference Devices<br>1/2 were added to<br>the substantial<br>equivalence<br>discussion.                                                                                                                                        |
| Form                                           | Sheet                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Sheet                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Sheet                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Sheet                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Sheet                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Same                                                                                                                                                                                                                                                       |
| Materials                                      | Silicone film,<br>synthetic gauze, and<br>collagen sponge<br>porous matrix of<br>porcine (Achilles)<br>tendon.                                                                                                                                                                                                                                                                                                                                                                                                                       | Collagen sponge<br>porous matrix of<br>bovine tendon +<br>glycosaminoglyca.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Silicone film and<br>collagen sponge<br>porous matrix of<br>bovine tendon +<br>glycosaminoglyca.                                                                                                                                                                                                                                                                                                                                                                                                                                     | Silicone film and<br>collagen sponge<br>porous matrix of<br>bovine tendon +<br>glycosaminoglyca.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Porous matrix of<br>porcine derived<br>(liver tissue)<br>collagen matrix.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Different.<br>Therefore,<br>Reference Device 3<br>was added to the<br>substantial<br>equivalence<br>discussion.                                                                                                                                            |
| Meshed<br>(fenestrated)<br>Structure           | No / Yes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | No                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | No                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | No                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Different.<br>Therefore,<br>Reference Devices<br>2/3 were added to<br>the substantial<br>equivalence<br>discussion.                                                                                                                                        |
| Mode of Action                                 | Collagen sponge<br>layer is applied to<br>the wound surface<br>and acts as a<br>scaffold for cellular<br>invasion and<br>capillary growth.                                                                                                                                                                                                                                                                                                                                                                                           | Collagen sponge<br>layer is applied to<br>the wound surface<br>and acts as a<br>scaffold for cellular<br>invasion and<br>capillary growth.                                                                                                                                                                                                                                                                                                                                                                                                                      | Collagen sponge<br>layer is applied to<br>the wound surface<br>and acts as a<br>scaffold for cellular<br>invasion and<br>capillary growth.                                                                                                                                                                                                                                                                                                                                                                                           | Collagen sponge<br>layer is applied to<br>the wound surface<br>and acts as a<br>scaffold for cellular<br>invasion and<br>capillary growth.                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Collagen sponge<br>layer is applied to<br>the wound surface<br>and acts as a<br>scaffold for cellular<br>invasion and<br>capillary growth.                                                                                                                                                                                                                                                                                                                                                                                                                                      | Same                                                                                                                                                                                                                                                       |
| Attributes                                     | Subject Device                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Predicate Device<br>(AVAGEN)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Reference<br>Device #1<br>(BMWD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Reference<br>Device #2<br>(IMBWM)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | Reference<br>Devic…

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**Source:** [https://fda.innolitics.com/device/K191992](https://fda.innolitics.com/device/K191992)

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**Cite:** Innolitics at https://innolitics.com