Who is the manufacturer of PELNAC Meshed Bilayer Wound Matrix?

Gunze Limited filed the 510(k) submission for PELNAC Meshed Bilayer Wound Matrix (K213498).

What is the FDA product code for PELNAC Meshed Bilayer Wound Matrix?

KGN. as a Class U device in the SU panel.

What is the regulatory pathway for PELNAC Meshed Bilayer Wound Matrix?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PELNAC Meshed Bilayer Wound Matrix?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PELNAC Meshed Bilayer Wound Matrix

K213498 · Gunze Limited · KGN · Jul 14, 2022 · SU

Device Facts

Record ID	K213498
Device Name	PELNAC Meshed Bilayer Wound Matrix
Applicant	Gunze Limited
Product Code	KGN · SU
Decision Date	Jul 14, 2022
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

PELNAC® Meshed 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, partial thickness burns, and skin tears), and draining wounds. The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.

Device Story

Collagen-based wound matrix; consists of porcine-derived collagen sponge layer and silicone film layer. Features slits in both layers to facilitate exudate drainage. Applied by qualified physicians in professional settings to full-thickness skin defects. Acts as scaffold for cellular invasion and capillary growth; remodeled by patient's cells over time. Provided as sterile sheet. Used in conjunction with negative pressure wound therapy (NPWT) to manage complex wounds. Benefits patient by providing structural support for tissue regeneration.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included pore size, cross-linking degree, water vapor transmission, drapeability, heavy metal content, suture retention, and tensile strength. Compatibility with InfoV.A.C. NPWT system validated via simulated wound model testing (pressure stability, fluid removal, alarm function). Biocompatibility and viral inactivation testing performed per ISO 10993-1 and FDA guidance.

Technological Characteristics

Bilayer sheet: top layer silicone film, bottom layer porcine-derived collagen sponge. Meshed/fenestrated structure. Sterilized via ethylene oxide (SAL 10^-6). Shelf life 36 months. Conforms to ISO 10993-1 (biocompatibility), ISO 11135 (sterilization), ISO 11607-1 (packaging), and ASTM F1886 (seal integrity).

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, surgical wounds (donor sites, post-Moh's/laser/podiatric surgery, dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. May be used with negative pressure wound therapy. Single-use.

Predicate Devices

INTEGRA™ Meshed Bilayer Wound Matrix (K081635)

Reference Devices

PELNAC™ Bilayer Wound Matrix (K191992)

Related Devices

K191992 — PELNAC Bilayer Wound Matrix · Gunze Limited · Apr 29, 2020
K090894 — COLLAWOUND WOUND DRESSING · Collamatrix Co., Inc. · Jun 25, 2009
K182838 — Geistlich Derma-Gide · Geistlich Pharma AG · Nov 8, 2018
K081635 — INTEGRA MESHED BILAYER WOUND MATRIX · Integra Lifesciences Corp. · Dec 4, 2008
K250864 — MatriDerm pluS+ Bi-Layer · Medskin Solutions Dr. Suwelack AG · Dec 19, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. July 14, 2022 Gunze Limited % Stuart Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 Re: K213498 Trade/Device Name: PELNAC® Meshed Bilayer Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 1, 2022 Received: June 7, 2022 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/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. 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 {1}------------------------------------------------ 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 (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 mediation-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, Julie Morabito, Ph.D. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213498 Device Name PELNAC® Meshed Bilayer Wound Matrix Indications for Use (Describe) PELNAC® Meshed 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, partial thickness burns, and skin tears), and - · draining wounds. The device may be used in conjunction with negative pressure wound therapy. 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) #### 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 PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary PELNAC® Meshed Bilayer Wound Matrix K213498 #### 1. Submission Sponsor GUNZE LIMITED Medical Division 46 Natsumegaichi, Aono Ayabe, Kyoto Japan 623-8513 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 Contact: Mr. Stuart R. Goldman Title: Sr. Consultant RA/QA #### 3. Date Prepared July 12, 2022 ## 4. Device Identification | Type of 510(k): | Traditional 510(k) | |-------------------------|-------------------------------------| | Trade Name: | PELNAC® Meshed Bilayer Wound Matrix | | Product Code: | KGN | | Classification Name: | Dressing, Wound, Collagen | | Regulation Number: | Pre-Amendment | | Regulation Description: | Pre-Amendment | | Device Class: | Unclassified | | Review Panel: | General & Plastic Surgery | #### 5. Legally Marketed Predicate Device | Trade Name: | INTEGRA™ Meshed Bilayer Wound Matrix | |---------------|--------------------------------------| | 510(k) No.: | K081635 | | Manufacturer: | Integra Life Sciences | The predicate device has not been subject to a design related recall. {4}------------------------------------------------ The following reference device is also included in this submission. | Trade Name: | PELNACTM Bilayer Wound Matrix | |---------------|-------------------------------| | 510(k) No.: | K191992 | | Manufacturer: | GUNZE LIMITED | #### 6. Indications for Use PELNAC® Meshed 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, partial thickness burns, and skin tears), and - draining wounds. PELNAC® Meshed Bilayer Wound Matrix may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use. #### 7. Device Description PELNAC® Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine derived sponge layer and a silicone film layer. Slits are added to the silicone and collagen layers to aid in the drainage of exudate. When applied to full-thickness skin defects, PELNAC® provides a scaffold for cellular invasion and capillary growth. The device 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® Meshed Bilayer Wound Matrix has the same intended use and indications for use as the predicate device INTEGRA™ Meshed Bilayer Wound Matrix (K081635). The subject and predicate device employ the same mode of action in that both devices contain a wound matrix of porous sponge-like material of animal derived collagen that serves as a scaffold for cellular invasion and capillary growth. Table 5-1 compares PELNAC® Meshed Bilayer Wound Matrix to the predicate device with respect to their indications for use and technological characteristics 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 device are also included in Table 5-1. {5}------------------------------------------------ | Attributes | Subject Device | Predicate Device | Similarities / Differences | Reference Device | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | PELNAC® Meshed Bilayer Wound Matrix | INTEGRA™ Meshed Bilayer Wound Matrix | - | PELNAC™ Bilayer Wound Matrix | | Manufacturer | GUNZE LIMITED | Integra Life Sciences | - | GUNZE LIMITED | | 510(k) # | K213498 | K081635 | - | K191992 | | Product Code | KGN | KGN | Same | KGN | | Indications for Use | PELNAC® Meshed 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, partial thickness burns, and skin tears), and draining wounds. PELNAC® Meshed Bilayer Wound Matrix may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use. | INTEGRA™ Meshed 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 bums, and skin tears) and draining wounds. The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use. | Same | 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. | | Attributes | Subject Device | Predicate Device | Similarities / Differences | Reference Device | | Construction | Bilayer | Bilayer | Same | Bilayer | | Form | Sheet | Sheet | Same | Sheet | | Materials | Top layer: silicone film. Bottom layer: porcine derived collagen sponge. | Top layer: polysiloxane (silicone). Bottom layer: porous matrix of cross- linked bovine tendon collagen and glycosaminoglycan. | Different. Therefore, the reference device was added. | Top layer: silicone film. Bottom layer: porcine derived collagen sponge. | | Meshed (fenestrated) Structure | Yes | Yes | Same | Available with or without. | | Mode of Action | Collagen sponge is applied to the wound surface and acts as a scaffold for cellular invasion and capillary growth to occur. The scaffold is eventually remodeled as the patient's cells rebuild the damaged site. | Collagen sponge is applied to the wound surface and acts as a scaffold for cellular invasion and capillary growth to occur. The scaffold is eventually remodeled as the patient's cells rebuild the damaged site. | Same | Collagen sponge layer is applied to the wound surface and acts as a scaffold for cellular invasion and capillary growth to occur. The scaffold is eventually remodeled as the patient's cells rebuild the damaged site. | | Single Use | Yes | Yes | Same | Yes | | Supplied Sterile | Yes (EO) SAL 10-6 | Yes (radiation) SAL 10-6 | Similar | Yes (EO) SAL 10-6 | | Shelf Life | 36 months | 24 months | Similar | 36 months | #### Table 5-1 – Substantial Equivalence Comparison of PELNAC® Meshed Bilayer Wound Matrix to the Predicate Device {6}------------------------------------------------ {7}------------------------------------------------ | Attributes | Subject Device | Predicate Device | Similarities / Differences | Reference Device | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | Sizes | 20 × 30 mm | 50 x 50 mm | Similar. The sizes of the subject device fall within the size range of the predicate device and are the same as the reference device. | 20 × 30 mm | | | 40 × 30 mm | 100 × 125 mm | | 40 × 30 mm | | | 40 × 60 mm | 100 × 250 mm | | 40 × 60 mm | | | 82 × 60 mm | 200 × 250 mm | | 82 × 60 mm | | | 82 × 90 mm | | | 82 × 90 mm | | | 82 × 120 mm | | | 82 × 120 mm | | | 120 × 240 mm | | | 120 × 240 mm | | | 200 × 240 mm | | | 200 × 240 mm | | Biological Evaluation | Conforms with ISO 10993-1 and FDA guidance. | Performed | Similar | Performed. Conforms with ISO 10993-1 and FDA guidance. | | Collagen Viral Inactivation | Conforms with FDA guidance. | Performed | Similar | Performed. Conforms with FDA guidance. | | Physical and Chemical Properties Testing | Conforms with product specification. | Performed | Similar | Performed. Conforms with product specification. | | Non-Clinical Performance Testing | Conforms with product performance requirements including for new use in conjunction with negative pressure wound therapy. | Performed | Similar | Performed. Conforms with product performance requirements. | {8}------------------------------------------------ #### 9. Non-Clinical Performance Data The following non-clinical performance testing was conducted on PELNAC® Meshed Bilayer Wound Matrix. Results confirm that the product specifications for the subject device have been met. - . Animal Tissue Sourcing and Viral Inactivation: - FDA Guidance Document Medical Devices Containing Materials Derived from Animal о Sources (Except for In Vitro Diagnostic Devices) – 2019 (The animal tissue sourcing of the subject device was evaluated following the recommendations of the above referenced FDA guidance document.) - FDA Guidance Document Q5A Viral Safety Evaluation of Biotechnology Products Derived o from Cell Lines of Human or Animal Origin – 1998 (The viral safety evaluation of the subject device was evaluated following the recommendations of the above referenced FDA guidance document.) Except for new viral inactivation studies performed on the subject device, all other animal tissue testing was leveraged from the reference device (K191992). - Biocompatibility: ● - o FDA Guidance Document – Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process - ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within o a Risk Management Process (The biocompatibility of the subject device was evaluated following the recommendations of the above referenced FDA guidance document.) - ■Implantation - ■Cytotoxicity - ■Skin Sensitization - ■Intracutaneous Reactivity - ■Material Mediated Pyrogenicity - ■Chemical Characterization - ■Toxicological Risk Assessment All biocompatibility testing of the subject device was leveraged from the reference device (K191992). - Sterilization, Packaging and Shelf Life: - ISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the O development, validation and routine control of a sterilization process for medical devices - O ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - ASTM F1886, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by O Visual Inspection - USP <85> Bacterial Endotoxin Test O {9}------------------------------------------------ All sterilization, packaging and shelf life testing of the subject device was leveraged from the reference device (K191992). - Performance Testing: ● - Pore Size O - Degree of Cross-Linking o - Water Vapor Transmission o - Drapeability o - o Heavy Metal Content - o Suture Retention - Tensile Strength o PELNAC® Meshed Bilayer Wound Matrix has only been demonstrated for use in conjunction with the InfoV.A.C. NPWT Therapy System in continuous and intermittent mode. Side-by-side testing was conducted between the subject device in conjunction with NPWT, the predicate device in conjunction with NPWT, and NPWT without a wound matrix group. This testing used a simulated wound model in conjunction with a simulated wound fluid. The tests consisted of Pressure Stability, Fluid Removal, Long-Termance and Alarm Function (on the InfoV.A.C. NPWT Therapy System in continuous and intermittent mode). - . Risk Analysis: - o ISO 14971, Medical devices - Application of risk management to medical devices # 10. Clinical Performance Data Not applicable to this submission. ## 11. Substantial Equivalence Conclusion PELNAC® Meshed Bilayer Wound Matrix has the same indications for use as INTEGRA™ Meshed Bilayer Wound Matrix. Any minor differences in the technological features of the subject device when compared to the predicate device have been evaluated through non-clinical performance testing and other verification and validation activities. PELNAC® Meshed Bilayer Wound Matrix is substantially equivalent to the predicate device.