← Product Code QSZ · K241660 # SiOxD® Wound Matrix (K241660) _Sioxmed, LLC · QSZ · Jul 5, 2024 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K241660 ## Device Facts - **Applicant:** Sioxmed, LLC - **Product Code:** QSZ - **Decision Date:** Jul 5, 2024 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The SiOxD® Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure 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, first degree and partial thickness burns, skin tears) and draining wounds. ## Device Story SiOxD Wound Matrix is a sterile, non-pyrogenic, single-use, absorbent, non-woven fiber matrix composed of hydrated amorphous silica. It functions as a wound dressing by conforming to the wound bed, providing a moist environment, and acting as a scaffold for cellular infiltration and vascularization. It is applied to the wound bed; it naturally sloughs off during healing and requires no manual removal. It does not require mechanical compression or secondary bandaging, though a non-adherent secondary dressing may be used. The device is intended for use by healthcare professionals in the management of various wound types. It benefits patients by supporting the body's natural healing process. ## Clinical Evidence No clinical data. Substantial equivalence is supported by bench testing of physical and chemical properties and endotoxin levels for devices manufactured with alternate water raw materials. ## Technological Characteristics Material: Hydrated amorphous silica in fibrous form. Form factor: Non-woven, absorbent, porous matrix. Sterilization: Gamma radiation (10^-6 SAL). Connectivity: None. Software: None. ## Regulatory Identification Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application. ## Predicate Devices - SiOxD Wound Matrix ([K222189](/device/K222189.md), [K232847](/device/K232847.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. July 5, 2024 SiOxMed, LLC % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188 Re: K241660 Trade/Device Name: SiOxD® Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: June 10, 2024 Received: June 10, 2024 Dear Justin Gracyalny: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Page 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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, # Mustafa A. Mazher -S For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241660 Device Name SiOxD® Wound Matrix Indications for Use (Describe) The SiOxD® Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure 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, first degree and partial thickness burns, skin tears) and draining wounds. Type of Use (Select one or both, as applicable) ( Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {4}------------------------------------------------ | 510(k) SUMMARY: | |----------------------------| | SiOxMed SiOxD Wound Matrix | | Date Prepared | June 7, 2024 | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor | SiOxMed
2011 Muddy Creek Road
Clemmons, NC 27012
(336) 497-1015 | | 510(k) Contact | Secure BioMed Evaluations
Justin Gracyalny, MSE
Linda Braddon, Ph.D.
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681
Regulatory@SecureBME.com | | Trade Name | SiOxD Wound Matrix | | Common Name | Wound Dressing | | Code – | FRO | | Classification | Unclassified | | Predicate Device | K222189, K232847 SiOxMed LLC SiOxD Wound Matrix | | Device Description | The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device
intended for use in local management of wounds. The SiOxD Wound Matrix
is a soft, white, conformable, non-woven, absorbent, biocompatible fiber
matrix made from synthetic biomaterials. The SiOxD Wound Matrix
conforms in the defect space / wound bed and includes a fibrous, porous
structure that allows for fluid absorption. The SiOxD Wound Matrix is
structurally similar to collagen, a key component of the native extracellular
matrix, and serves as a scaffold for cellular infiltration and vascularization.
SiOxD Wound Matrix promotes a moist environment for the body's natural
healing process.

The SiOxD Wound Matrix is not designed to be held in place with
compression bandages or tapes. Only light pressure without mechanical
compression or secondary bandaging is required for proper device function.
The matrix applied to the wound bed naturally sloughs off during wound
healing and does not require manual removal. | | Indications for Use
Statement | The SiOxD Wound Matrix is intended for use in the management of wounds.
Wound types include: 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,
first degree and partial thickness burns. skin tears) and draining wounds. | {5}------------------------------------------------ | Characteristic | Subject Device
SiOxMed SiOxD Wound Matrix | Primary Predicate
SiOxMed SiOxD Wound Matrix
K222189 / K232847 | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation | Unclassified | Unclassified | | Product Classification | FRO | FRO | | Common Name | Wound Dressing | Wound Dressing | | Indications for Use | The SiOxD Wound Matrix is
intended for use in the management
of wounds. Wound types include:
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, first degree
and partial thickness burns, skin
tears) and draining wounds. | The SiOxD Wound Matrix is
intended for use in the management
of wounds. Wound types include:
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, first degree
and partial thickness burns, skin
tears) and draining wounds. | | Composition of
Material | Hydrated amorphous silica in
fibrous form | Hydrated amorphous silica in
fibrous form | | Primary Function | Wound dressing | Wound dressing | | Available Sizes | 4.91 – 16 in2, 0.1 – 1.0g
• 2.5" Round (0.1g)
• 2.5" Round (0.3g)
• 2.5" Round (0.7g)
• 2.5" Round (1.0g)
• 4" x 4" Square (1.0g) | 4.91 – 16 in2, 0.1 – 1.0g
• 2.5" Round (0.1g)
• 2.5" Round (0.3g)
• 2.5" Round (0.7g)
• 2.5" Round (1.0g)
• 4" x 4" Square (1.0g) | | Packaging | Single and Dual Sterile Barrier
Configurations | Single and Dual Sterile Barrier
Configurations | | Resorbable | No | No | | Absorbent | Yes | Yes | | Requires Mechanical
Pressure / Secondary
Dressing | A non-adherent secondary wound
dressing (e.g., multi-layer
compression bandage system, or
other appropriate dressing) can be
placed over SiOxD Wound Matrix
but is not required. Only light, brief
compression is required. | A non-adherent secondary wound
dressing (e.g., multi-layer
compression bandage system, or
other appropriate dressing) can be
placed over SiOxD Wound Matrix
but is not required. Only light, brief
compression is required. | | Moist Wound
Environment | Maintains a moist wound
environment | Maintains a moist wound
environment | | Reapplication | As needed | As needed | | Characteristic | Subject Device
SiOxMed SiOxD Wound Matrix | Primary Predicate
SiOxMed SiOxD Wound Matrix
K222189 / K232847 | | Single Use | Yes | Yes | | Non-Pyrogenic | Yes | Yes | | Sterility | Gamma, 10-6 SAL | Gamma, 10-6 SAL | | Biocompatibility | Biocompatible | Biocompatible | ## Comparison of Technological Characteristics {6}------------------------------------------------ ## Technological Characteristics There are no significant technological differences between the subject and predicate devices. The subject device is a line extension to the device originally cleared in K222189 / K232847. There are no differences in intended use, device sizes, material of construction, sterilization, or packaging. The subject device allows for use of alternate water raw materials in the manufacture of the subject device fiber matrix. Material testing of key physical and chemical properties demonstrated that devices manufactured with any of qualified water raw material met predetermined release criteria. A worstcase assessment of endotoxin levels showed that devices manufactured with all water raw materials meet the 20 EU/Device acceptance criteria. ### Conclusions Based on the similarities of the intended use / indications for use, technological and functional characteristics, and the results of the sterilization / packaging testing, the subject device is substantially equivalent to the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/device/K241660](https://fda.innolitics.com/device/K241660) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com