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.

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.

AI/ML Overview

The provided document K232847, a 510(k) summary for the SiOxD Wound Matrix, does not contain information on an AI/ML-based medical device. Therefore, it does not include details on acceptance criteria, study methodologies for AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document describes a medical device, the SiOxD Wound Matrix, which is a non-pyrogenic, sterile, single-use wound dressing made from hydrated amorphous silica in fibrous form. The submission is for a line extension of an already cleared device (K222189). The new submission adds new intermediate size offerings and single barrier packaging configurations.

Since this is a submission for a physical medical device (wound dressing) and not a software/AI device, the information requested in your prompt regarding AI/ML performance, acceptance criteria, and specific study details (like sample size for test/training sets, expert ground truth) is not applicable to this document. The "study that proves the device meets the acceptance criteria" in this context refers to standard medical device testing (e.g., sterilization, packaging integrity, biocompatibility), not AI model validation.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

Summary

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December 18, 2023

SiOxMed. LLC. % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K232847

Trade/Device Name: SiOxD Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: September 14, 2023 Received: September 14, 2023

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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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.

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,

Yu-chieh Chiu -S

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

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Indications for Use

510(k) Number (if known) K232847

Device Name SiOxD Wound Matrix

Indications for Use (Describe)

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)

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K232847 510(k) SUMMARY: SUMMARY: SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOx

Date Prepared	December 15, 2023
Sponsor	SiOxMed2011 Muddy Creek RoadClemmons, NC 27012(336) 497-1015
510(k) Contact	Secure BioMed EvaluationsJustin Gracyalny, MSELinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com
Trade Name	SiOxD Wound Matrix
Common Name	Wound Dressing
Code –Classification	FROUnclassified
Primary Predicate	K222189 SiOxMed LLC SiOxD Wound Matrix
Reference Device	K153756 Imbed Biosciences, Inc. Microlyte Ag
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 UseStatement	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

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Comparison of Technological Characteristics

Characteristic	Subject DeviceSiOxMed SiOxD Wound Matrix	Primary PredicateSiOxMed SiOxD Wound MatrixK222189
Regulation	Unclassified	Unclassified
Product Classification	FRO	FRO
Common Name	Wound Dressing	Wound Dressing
Indications for Use	The SiOxD Wound Matrix isintended for use in the managementof wounds. Wound types include:Partial and full-thickness wounds,pressure ulcers, venous ulcers,diabetic ulcers, chronic vascularulcers, tunneled/underminedwounds, surgical wounds (donorsites/grafts, post-Moh's surgery,post laser surgery, podiatric, wounddehiscence), trauma wounds(abrasions, lacerations, first degreeand partial thickness burns, skintears) and draining wounds.	The SiOxD Wound Matrix isintended for use in the managementof wounds. Wound types include:Partial and full-thickness wounds,pressure ulcers, venous ulcers,diabetic ulcers, chronic vascularulcers, tunneled/underminedwounds, surgical wounds (donorsites/grafts, post-Moh's surgery,post laser surgery, podiatric, wounddehiscence), trauma wounds(abrasions, lacerations, first degreeand partial thickness burns, skintears) and draining wounds.
Composition ofMaterial	Hydrated amorphous silica infibrous form	Hydrated amorphous silica infibrous form
Primary Function	Wound dressing	Wound dressing
Available Sizes	4.91 – 16 $in^2$ , 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 $in^2$ , 0.1 – 1.0g• 2.5" Round (0.1g)• 4" x 4" Square (1.0g)
Packaging	Single and Dual Sterile BarrierConfigurations	Dual Sterile Barrier Configuration
Resorbable	No	No
Absorbent	Yes	Yes
Requires MechanicalPressure / SecondaryDressing	A non-adherent secondary wounddressing (e.g., multi-layercompression bandage system, orother appropriate dressing) can beplaced over SiOxD Wound Matrixbut is not required. Only light, briefcompression is required.	A non-adherent secondary wounddressing (e.g., multi-layercompression bandage system, orother appropriate dressing) can beplaced over SiOxD Wound Matrixbut is not required. Only light, briefcompression is required.
Moist WoundEnvironment	Maintains a moist woundenvironment	Maintains a moist woundenvironment
Characteristic	Subject DeviceSiOxMed SiOxD Wound Matrix	Primary PredicateSiOxMed SiOxD Wound MatrixK222189
Reapplication	As needed	As needed
Customizable	Yes, trim to size	Yes, trim to size
Single Use	Yes	Yes
Non-Pyrogenic	Yes	Yes
Sterility	Gamma, 10-6 SAL	Gamma, 10-6 SAL
Biocompatibility	Biocompatible	Biocompatible

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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. There are no changes in intended use, device materials, or manufacturing. The subject device adds new intermediate size offerings and single barrier packaging configurations. The use of a single barrier packaging offering is similar to the reference device. Appropriate packaging and sterilization testing was performed to support the new packaging offerings. As all subject device size offerings were within the bookends cleared in K222189, no new biocompatibility or performance testing was required to support substantial equivalence of the subject device.

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.

Regulation Number and Section

N/A