Who is the manufacturer of NovoGen Wound Matrix?

Novabone Products, LLC filed the 510(k) submission for NovoGen Wound Matrix (K220498).

What is the FDA product code for NovoGen Wound Matrix?

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

What is the regulatory pathway for NovoGen Wound Matrix?

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

What are the predicate devices for NovoGen Wound Matrix?

Mesynthes Ltd Endoform Dermal Template (K092096).

Who can help prepare an FDA 510(k) submission like NovoGen 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.

NovoGen Wound Matrix

K220498 · Novabone Products, LLC · KGN · Jun 9, 2023 · SU

Device Facts

Record ID	K220498
Device Name	NovoGen Wound Matrix
Applicant	Novabone Products, LLC
Product Code	KGN · SU
Decision Date	Jun 9, 2023
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

NovoGen Wound Matrix is indicated for the management of wounds including: · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Diabetic ulcers - · Chronic vascular ulcers - · Tunneled/undermined wounds - · 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) - · Draining wounds

Device Story

Absorbable, sterile, single-use wound matrix; composed of bovine type I collagen and 45S5 bioactive glass. Device functions as scaffold for local management of cutaneous wounds; hydrated with wound exudate or sterile water to form soft, conforming layer; naturally incorporated into wound over time. Used in clinical settings for wound management; applied by healthcare providers. Output is physical wound dressing; provides moist environment to support healing. Benefits include wound coverage and support for tissue management.

Clinical Evidence

No human clinical trials provided. Evidence includes non-clinical bench testing (absorption, compression recovery, degradation, hydration, tensile strength, viral inactivation) and a full-thickness porcine wound healing study showing equivalent performance to predicate. Biocompatibility confirmed per ISO 10993-1 (cytotoxicity, sensitization, systemic toxicity, implantation, genotoxicity, endotoxin). Human Repeat Insult Patch Test (HRIPT) showed no potential for dermal irritation or sensitization.

Technological Characteristics

Composition: Bovine type I collagen and 45S5 bioactive glass. Form factor: Single-layer matrix, trim-to-size. Sterilization: Gamma radiation (10^-6 SAL). Biocompatible per ISO 10993-1. Non-pyrogenic. Maintains moist wound environment.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Moh's/laser/podiatric, dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Predicate Devices

Mesynthes Ltd Endoform Dermal Template (K092096)

Reference Devices

NovaBone Putty - Bioactive Synthetic Bone Graft (K110368)
NovaBone Dental Morsels - Bioactive Synthetic Bone Graft (K112428)
NovaBone Bioactive Strip (K141207)

Related Devices

K171645 — CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle · Strukmyer Medical · Jul 25, 2017
K090894 — COLLAWOUND WOUND DRESSING · Collamatrix Co., Inc. · Jun 25, 2009
K252001 — Collagen Wound Dressing · Winner Medical Co., Ltd. · Oct 10, 2025
K223126 — SurgiAid® Collagen Wound Dressing · Maxigen Biotech, Inc. · Oct 11, 2023
K173223 — ologen Collagen Matrix · Aeon Astron Europe B.V. · Mar 2, 2018

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 09, 2023 Novabone Products, LLC % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K220498 Trade/Device Name: NovoGen Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: May 9, 2023 Received: May 10, 2023 ### Dear Linda Braddon: 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, | Tek N. | Digitally signed by Tek N. Lamichhane | |--------------|------------------------------------------| | Lamichhan -s | | | e-S | Date: 2023.06.09 09:54:23 -04'00' | For Julie A. 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) K220498 Device Name NovoGen Wound Matrix Indications for Use (Describe) NovoGen Wound Matrix is indicated for the management of wounds including: · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Diabetic ulcers - · Chronic vascular ulcers - · Tunneled/undermined wounds - · 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) - · Draining wounds | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| |X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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 K220498 NovoGen Wound Matrix | Date Prepared | June 9, 2023 | Trait | NovaBone Products, LLC NovaGen Wound Matrix (Subject Device) | Primary Predicate Mesynthes Ltd Endoform Dermal Template | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor | NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615 | 510(k) number | K220498 | K092096 | | 510(k) Contact | Secure BioMed Evaluations Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com | Regulation | Unclassified | Unclassified | | Trade Name | NovoGen Wound Matrix | Product | KGN | KGN | | Common Name | Collagen Wound Matrix | Classification | | | | Code - Classification | KGN Unclassified | Common Name | Collagen Wound Dressing | Collagen Wound Dressing | | Primary Predicate | K092096 Mesynthes Endoform Dermal Template | Indications for Use | NovoGen Wound Matrix is indicated for the management of wounds including: • Partial and full-thickness wounds • Pressure ulcers • Venous ulcers • Diabetic ulcers • Chronic vascular ulcers • Tunneled/undermined wounds • 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) • Draining wounds | Endoform is supplied sterile and is intended for single use in the treatment of the following wounds: • Partial and full-thickness wounds • Pressure ulcers • Venous ulcers • Diabetic ulcers • Chronic vascular ulcers • Tunneled/undermined wounds • 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) • Draining wounds | | Reference Devices | K110368 NovaBone Putty - Bioactive Synthetic Bone Graft K112428 NovaBone Dental Morsels - Bioactive Synthetic Bone Graft K141207 NovaBone Bioactive Strip | Composition of Material | Bovine Collagen Bioactive Glass Citric Acid | Ovine collagen | | Device Description | NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time. | Structural Reinforcement Material | Bioactive Glass (Same material as reference device K141207) | Not applicable | | Indications for Use Statement | NovoGen Wound Matrix is indicated for the management of wounds including: ● Partial and full-thickness wounds ● Pressure ulcers ● Venous ulcers ● Diabetic ulcers ● Chronic vascular ulcers ● Tunneled/undermined wounds ● 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) | Primary Function | Wound Dressing | Wound Dressing | | Absorbable | Yes | Not Stated, but websites say it will dissolve into the wound | | | | Size(s) | Range of sizes from 26cm² to 130cm²: • 2" x 2" (5.1cm x 5.1cm) • 2" x 3" (5.1cm x 7.6cm) • 3" x 3" (7.6cm x 7.6cm) • 4" x 5" (10.2cm x 12.7cm) | Range of sizes from 9cm² to 400cm² | | | {4}------------------------------------------------ ## Comparison of Technological Characteristics {5}------------------------------------------------ | Trait | NovaBone Products, LLC NovaGen Wound Matrix (Subject Device) | Primary Predicate Mesynthes Ltd Endoform Dermal Template K092096 | |-------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------| | Fluid Absorbency | Yes | Not stated | | Moist Environment | Maintains a moist wound environment | Not stated | | Perforated | No | Perforated and Non-Perforated | | Layers | One Layer | One or Two Layers | | Customizable | Yes, trim to size | Yes, trim to size | | Sterilization | Gamma, 10-6 SAL | Ethylene Oxide, 10-6 SAL | | Packaging | Single peel packs | Not stated | | Biocompatibility | Biocompatible | Biocompatible | | Single Use | Yes | Yes | | Reapplication | As needed | Every 5 to 7 days as needed | | Non-Pyrogenic | Yes | Not specified | ## Technological Characteristics NovoGen Wound Matrix is supplied terminally sterile barrier packaging configuration. NovoGen Wound Matrix is a scaffold and is similar to other wound matrices with respect to its design. The subject device is composed of bovine collagen with Bioglass® 4555 added as additional structural reinforcement. There are no significant technological differences between the subject and predicate device. The subject device uses similar materials, is of a similar size and thickness, has similar design properties, and has the same intended use as the primary and additional predicates and reference devices. The presentation of the device in single vs dual peel packaging configuration does not create new risks for safety or effectiveness. The subject device uses the same packaging configuration as cleared in reference device K110368 NovaBone Putty - Bioactive Synthetic Bone Graft and uses the same sterilization process as cleared in reference device K112428 NovaBone Dental Morsels - Bioactive Synthetic Bone Graft. ## Non-Clinical Performance Testing Summary Performance testing for the NovaBone NovoGen Wound Matrix includes: - Absorption Capacity - Compression Recovery ● - Degradation Potential via Collagenase ● - Hydration Time - Tensile Strength ● - Viral Inactivation ● {6}------------------------------------------------ A full thickness porcine wound healing study found equivalent wound healing performance for the NovaBone NovoGen Wound Matrix when compared to the primary predicate device and untreated control sites. The NovaBone NovoGen Wound Matrix was found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. Cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, subacute systemic toxicity, implantation, genotoxicity, and endotoxin endpoints were addressed via testing while chronic toxicity and carcinogenicity were addressed via a toxicological risk assessment. A Human Repeat Insult Patch Test (HRIPT) was performed to determine the potential of the test material to elicit dermal irritation and/or induce sensitization following repeated patch applications in human subjects. The Induction Phase of the study is designed to assess the potential of the subject device to elicit an irritation reaction, whereas the Challenge Phase of the study is designed to assess the potential of the subject device to elicit a sensitization response. Based on the test population who completed the study, NovoGen Wound Matrix did not demonstrate a potential for eliciting dermal irritation or inducing sensitization. ### Conclusions Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.