← Product Code QSZ · K222189 # SiOxD Wound Matrix (K222189) _Sioxmed, LLC · QSZ · Nov 18, 2022 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K222189 ## Device Facts - **Applicant:** Sioxmed, LLC - **Product Code:** QSZ - **Decision Date:** Nov 18, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **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, 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. ## Device Story SiOxD Wound Matrix is a sterile, non-pyrogenic, single-use, non-woven, absorbent fiber matrix composed of hydrated amorphous silica. It serves as a scaffold for cellular infiltration and vascularization, mimicking native extracellular matrix to promote a moist wound healing environment. The device is applied directly to the wound bed; it does not require mechanical compression or secondary bandaging, only light pressure. The matrix naturally sloughs off during the healing process, eliminating the need for manual removal. It is intended for use in clinical settings for various wound types. By providing a biocompatible scaffold, it supports the body's natural healing process, potentially improving outcomes for chronic and acute wounds. ## Clinical Evidence No clinical trials on human patients for wound healing efficacy. Evidence includes bench testing (absorption, FTIR, XRD, SEM) and biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, implantation). A Human Repeat Insult Patch Test (HRIPT) with 114 subjects (18-70 years old) demonstrated no dermal irritation or sensitization. A full-thickness porcine wound healing study showed equivalent performance to the predicate. ## Technological Characteristics Material: Hydrated amorphous silica in fibrous form. Form factor: Non-woven, absorbent matrix. Sterilization: Gamma radiation (10^-6 SAL). Biocompatibility: Compliant with ISO 10993-1. Connectivity: None. Energy source: 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 - Mirragen™ Advanced Wound Matrix ([K161067](/device/K161067.md)) - NuStat HemoStatic Dressing ([K142363](/device/K142363.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 shows the logo of the U.S. Food & 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 18, 2022 SiOxMed. LLC. % Linda Braddon Woodstock Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K222189 Trade/Device Name: SiOxD Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: October 18, 2022 Received: October 19, 2022 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 {1}------------------------------------------------ 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 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, # Julie A. Morabito -S 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222189 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 fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, 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." {3}------------------------------------------------ ## 510(k) SUMMARY: SiOxMed SiOxD Wound Matrix | Date Prepared | November 17, 2022 | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor | SiOxMed
2011 Muddy Creek Road
Clemmons, NC 27012
(336) 242-4498 | | 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 | | Trade Name | SiOxD Wound Matrix | | Common Name | Wound Dressing | | Code-Classification | FRO
Unclassified: Class II | | Primary Predicate | K161067 Engineered Tissue Solutions, LLC Mirragen™ Advanced Wound Matrix | | Additional Predicate Device | K142363 Beeken Biomedical NuStat HemoStatic Dressing | | 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 | {4}------------------------------------------------ # Comparison of Technological Characteristics | Characteristic | Subject Device
SiOxMed SiOxD
Wound Matrix | Primary Predicate
Engineered Tissue
Solutions, LLC
Mirragen™ Advanced
Wound Matrix
K161067 | Additional Predicate
Beeken Biomedical
NuStat XR
HemoStatic Dressing
K142363 | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation | Unclassified | Unclassified | Unclassified | | Product
Classification | FRO | FRO | FRO | | Common Name | Wound Dressing | 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 Mirragen™
Advanced 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 and second degree
burns, skin tears) and
draining wounds. | NuStat XR is a single-
use hemostatic wound
dressing applied
externally with
mechanical compression
to temporarily
control bleeding in
lacerations, punctures,
abrasions and incisions. | | Composition of
Material | Hydrated amorphous
silica in fibrous form | Borate glass fibers and
particulate | Knitted cellulose and
continuous filament
silica
Cellulose (rayon, edge
sealant)
Optional Radiopaque
element -
Polypropylene thread
coated with barium
sulfate | | Primary Function | Wound dressing | Wound dressing | Wound dressing | | Characteristic | Subject Device
SiOxMed SiOxD
Wound Matrix | Primary Predicate
Engineered Tissue
Solutions, LLC
Mirragen™ Advanced
Wound Matrix
K161067 | Additional Predicate
Beeken Biomedical
NuStat XR
HemoStatic Dressing
K142363 | | Available Sizes | ● 2.5" Round
● 4" x 4" Square | ● 1" x 6"
● 2" x 2"
● 4" x 4" | Sizes ranges from 2" to
8" in width and 2" to
60" in length | | Resorbable | No | Yes | No | | Absorbent | Yes | 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. | To be used with non-
adherent secondary
bandaging | To be used with
mechanical pressure | | Moist Wound
Environment | Maintains a moist
wound environment | Maintains a moist
wound environment | Not stated | | Reapplication | As needed | Every 3 to 7 days as
needed | As needed | | Customizable | Yes, trim to size | Yes, trim to size | Yes, trim to size | | Single Use | Yes | Yes | Yes | | Non-Pyrogenic | Yes | Yes | Yes | | Sterility | Gamma, 10-6 SAL | Gamma, 10-6 SAL | Gamma, 10-6 SAL | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | {5}------------------------------------------------ ## Technological Characteristics There are no significant technological differences between the subject and predicate devices. The subject device uses similar materials, is of a similar size, has similar design properties, and has the same intended use as the primary and additional predicates. Technological differences include that the subject device does not require mechanical pressure or secondary bandaging for proper function which is required by the predicate devices. The subject device also naturally sloughs off during healing while the primary predicate is resorbed. These differences are adequately addressed through the non-clinical performance and animal testing provided which demonstrate that they do not raise new concerns for safety or effectiveness. {6}------------------------------------------------ ## Subject Device Testing Summary | Test | Test Method Summary | Results | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Absorption Capacity | The absorption capacity of the device was characterized. | Device was characterized as absorbent. | | Partial
Thromboplastin Time | ASTM F2382 Standard Test Method for
Assessment of Circulating Blood-
Contacting Medical Device Materials on
Partial Thromboplastin Time (PTT) | Clotting time was lower than control. | | Complement
Activation | ISO 10993-4 Biological evaluation of
medical devices – Part 4: Selection of tests
for interactions with blood | Device was characterized as a
complement activator. | | Fourier Transform
Infrared Spectroscopy
(FTIR) Analysis | FTIR spectra collected using attenuated
total reflectance (ATR) were used for the
purpose of characterizing the material. | Results were consistent with
hydrated amorphous silica in
fibrous form. | | X-Ray Diffraction
(XRD) Spectrometry | XRD spectrometry was used to
characterize the material. | Results were consistent with
hydrated amorphous silica in
fibrous form. | | Scanning Electron
Microscope (SEM)
Imaging | SEM imaging was collected to
characterize the matrix structure. | The matrix structure was
structurally similar to collagen
and created a scaffold for
cellular infiltration and
vascularization. | Non-clinical performance testing for the SiOxD Wound Matrix include: A full thickness porcine wound healing study found equivalent wound healing performance for the SiOxD Wound Matrix when compared to the additional predicate device and untreated control sites. The SiOxD Wound Matrix was found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. | Test | Test Method Summary | Results | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices –
Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | | Sensitization | ISO 10993-10 Biological evaluation of medical devices –
Part 10: Tests for skin sensitization

Also addressed via Human Repeat Insult Patch Testing | Non-sensitizing | | Irritation | ISO 10993-23 Biological evaluation of medical devices –
Part 23: Tests for irritation

Also addressed via Human Repeat Insult Patch Testing | Non-irritating | | Acute Systemic
Toxicity | ISO 10993-11 Biological evaluation of medical devices –
Part 11: Tests for systemic toxicity | Non-toxic | {7}------------------------------------------------ | Test | Test Method Summary | Results | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Material Mediated
Pyrogenicity | USP <151> Pyrogen Test | Non-pyrogenic | | Subacute Systemic
Toxicity | ISO 10993-11 Biological evaluation of medical devices —
Part 11: Tests for systemic toxicity | Non-toxic | | Implantation | ISO 10993-6 Biological evaluation of medical devices —
Part 6: Tests for local effects after implantation

Testing via full thickness porcine wound model; Endpoints
also addressed as part of subacute toxicity testing results | No adverse
tissue response. | | Endotoxin | USP <85> Bacterial Endotoxins | <20EU/Device;
Non-pyrogenic | 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. 120 male and female subjects ranging from 18 to 70 years old were enrolled in the study. Of the subjects who completed the Induction Phase, 100% were categorized as "No visible skin reaction" at any time point. Of the subjects who completed the Challenge Phase, 100% were categorized as "No visible skin reaction" at any time point. No re-challenge testing was required for any subjects. Based on the test population of 114 subjects who completed the study, SiOxD Wound Matrix did not demonstrate a potential for eliciting dermal irritation or inducing sensitization. All testing passed showing the device to be biocompatible for its intended use. ## 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. --- **Source:** [https://fda.innolitics.com/device/K222189](https://fda.innolitics.com/device/K222189) **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