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 is a 510(k) summary for the SiOxD Wound Matrix, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for performance as an AI/ML powered device. Therefore, much of the requested information regarding AI/ML specific studies (MRMC study, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods, and sample sizes for training/test sets for AI/ML) is not available in this document.

However, I can extract the acceptance criteria and performance related to the device function and biocompatibility as described in the summary:

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Functional/Material Characterization
Absorption Capacity	Device to be characterized as absorbent.	Device was characterized as absorbent.
Partial Thromboplastin Time (PTT)	Test results to demonstrate material characteristics (no specific threshold stated, but comparison to control is part of the method).	Clotting time was lower than control.
Complement Activation	Test results to demonstrate material characteristics (no specific threshold stated, but characterization is needed).	Device was characterized as a complement activator.
FTIR Analysis	Results to be consistent with hydrated amorphous silica in fibrous form.	Results were consistent with hydrated amorphous silica in fibrous form.
X-Ray Diffraction (XRD) Spectrometry	Results to be consistent with hydrated amorphous silica in fibrous form.	Results were consistent with hydrated amorphous silica in fibrous form.
SEM Imaging	Matrix structure to be structurally similar to collagen and create a scaffold for cellular infiltration and vascularization.	The matrix structure was structurally similar to collagen and created a scaffold for cellular infiltration and vascularization.
Biocompatibility
Cytotoxicity	Non-cytotoxic.	Non-cytotoxic.
Sensitization	Non-sensitizing.	Non-sensitizing (via ISO 10993-10 and Human Repeat Insult Patch Testing, 100% of subjects showed "No visible skin reaction" in Induction and Challenge Phases).
Irritation	Non-irritating.	Non-irritating (via ISO 10993-23 and Human Repeat Insult Patch Testing, 100% of subjects showed "No visible skin reaction" in Induction and Challenge Phases).
Acute Systemic Toxicity	Non-toxic.	Non-toxic.
Material Mediated Pyrogenicity	Non-pyrogenic.	Non-pyrogenic.
Subacute Systemic Toxicity	Non-toxic.	Non-toxic.
Implantation (Local Effects)	No adverse tissue response.	No adverse tissue response (via full thickness porcine wound model and subacute toxicity testing endpoints).
Endotoxin	<20 EU/Device; Non-pyrogenic.	<20 EU/Device; Non-pyrogenic.
Wound Healing (Comparative)	Equivalent wound healing performance to the additional predicate device and untreated control sites.	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.

Study Details (as per available information):

Sample size used for the test set and the data provenance:
- Biocompatibility (Human Repeat Insult Patch Test - HRIPT): 120 male and female subjects (18-70 years old) were enrolled. 114 subjects completed the study.
- Wound Healing Study: "A full thickness porcine wound healing study" was conducted. The specific number of animals or wounds used is not provided, but it's an animal study (porcine model).
- Data Provenance: Not explicitly stated for all tests, but the HRIPT involved human subjects. The wound healing study used porcine data. The other material characterization and biocompatibility tests are laboratory-based. It's assumed these studies were conducted by or for SiOxMed. LLC.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests are objective measurements (e.g., passing/failing biocompatibility standards, instrumental analysis results, wound healing assessment in an animal model). No expert panel for establishing ground truth as understood in AI/ML performance studies is described.
Adjudication method for the test set: Not applicable and not described. The tests conducted are objective laboratory and animal studies, and a human adjudication method is not relevant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a wound matrix, not an AI/ML powered diagnostic or assistive technology for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used:
- Biocompatibility: Established by compliance with international standards (ISO 10993 series) and specific test methodologies, with predefined pass/fail criteria (e.g., non-cytotoxic, non-sensitizing).
- Functional/Material Characterization: Established by instrumental analysis (FTIR, XRD, SEM) and physical property measurements (absorption).
- Wound Healing: Established by comparison to a predicate device and untreated control sites in an animal model, likely involving histological or macroscopic assessment of healing, which is a form of outcome data in a controlled setting.
The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable. This document does not describe an AI/ML device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K222189

Device Name SiOxD Wound Matrix

Indications for Use (Describe)

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)

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510(k) SUMMARY: SiOxMed SiOxD Wound Matrix

Date Prepared	November 17, 2022
Sponsor	SiOxMed2011 Muddy Creek RoadClemmons, NC 27012(336) 242-4498
510(k) Contact	Secure BioMed EvaluationsLinda 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: 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

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Comparison of Technological Characteristics

Characteristic	Subject DeviceSiOxMed SiOxDWound Matrix	Primary PredicateEngineered TissueSolutions, LLCMirragen™ AdvancedWound MatrixK161067	Additional PredicateBeeken BiomedicalNuStat XRHemoStatic DressingK142363
Regulation	Unclassified	Unclassified	Unclassified
ProductClassification	FRO	FRO	FRO
Common Name	Wound Dressing	Wound Dressing	Wound Dressing
Indications for Use	The SiOxD WoundMatrix is intended foruse in the managementof wounds. Woundtypes include: Partialand full-thicknesswounds, pressure ulcers,venous ulcers, diabeticulcers, chronic vascularulcers,tunneled/underminedwounds, surgicalwounds (donorsites/grafts, post-Moh'ssurgery, post lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,first degree and partialthickness burns, skintears) and drainingwounds.	The Mirragen™Advanced WoundMatrix is intended foruse in the managementof wounds. Woundtypes include: Partialand full-thicknesswounds, pressure ulcers,venous ulcers, diabeticulcers, chronic vascularulcers,tunneled/underminedwounds, surgicalwounds (donorsites/grafts, post-Moh'ssurgery, post lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,first and second degreeburns, skin tears) anddraining wounds.	NuStat XR is a single-use hemostatic wounddressing appliedexternally withmechanical compressionto temporarilycontrol bleeding inlacerations, punctures,abrasions and incisions.
Composition ofMaterial	Hydrated amorphoussilica in fibrous form	Borate glass fibers andparticulate	Knitted cellulose andcontinuous filamentsilicaCellulose (rayon, edgesealant)Optional Radiopaqueelement -Polypropylene threadcoated with bariumsulfate
Primary Function	Wound dressing	Wound dressing	Wound dressing
Characteristic	Subject DeviceSiOxMed SiOxDWound Matrix	Primary PredicateEngineered TissueSolutions, LLCMirragen™ AdvancedWound MatrixK161067	Additional PredicateBeeken BiomedicalNuStat XRHemoStatic DressingK142363
Available Sizes	● 2.5" Round● 4" x 4" Square	● 1" x 6"● 2" x 2"● 4" x 4"	Sizes ranges from 2" to8" in width and 2" to60" in length
Resorbable	No	Yes	No
Absorbent	Yes	Yes	Yes
Requires MechanicalPressure / SecondaryDressing	A non-adherentsecondary wounddressing (e.g., multi-layer compressionbandage system, orother appropriatedressing) can be placedover SiOxD WoundMatrix but is notrequired. Only light,brief compression isrequired.	To be used with non-adherent secondarybandaging	To be used withmechanical pressure
Moist WoundEnvironment	Maintains a moistwound environment	Maintains a moistwound environment	Not stated
Reapplication	As needed	Every 3 to 7 days asneeded	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

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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.

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Subject Device Testing Summary

Test	Test Method Summary	Results
Absorption Capacity	The absorption capacity of the device was characterized.	Device was characterized as absorbent.
PartialThromboplastin Time	ASTM F2382 Standard Test Method forAssessment of Circulating Blood-Contacting Medical Device Materials onPartial Thromboplastin Time (PTT)	Clotting time was lower than control.
ComplementActivation	ISO 10993-4 Biological evaluation ofmedical devices – Part 4: Selection of testsfor interactions with blood	Device was characterized as acomplement activator.
Fourier TransformInfrared Spectroscopy(FTIR) Analysis	FTIR spectra collected using attenuatedtotal reflectance (ATR) were used for thepurpose of characterizing the material.	Results were consistent withhydrated amorphous silica infibrous form.
X-Ray Diffraction(XRD) Spectrometry	XRD spectrometry was used tocharacterize the material.	Results were consistent withhydrated amorphous silica infibrous form.
Scanning ElectronMicroscope (SEM)Imaging	SEM imaging was collected tocharacterize the matrix structure.	The matrix structure wasstructurally similar to collagenand created a scaffold forcellular infiltration andvascularization.

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 sensitizationAlso addressed via Human Repeat Insult Patch Testing	Non-sensitizing
Irritation	ISO 10993-23 Biological evaluation of medical devices –Part 23: Tests for irritationAlso addressed via Human Repeat Insult Patch Testing	Non-irritating
Acute SystemicToxicity	ISO 10993-11 Biological evaluation of medical devices –Part 11: Tests for systemic toxicity	Non-toxic

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Test	Test Method Summary	Results
Material MediatedPyrogenicity	USP <151> Pyrogen Test	Non-pyrogenic
Subacute SystemicToxicity	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 implantationTesting via full thickness porcine wound model; Endpointsalso addressed as part of subacute toxicity testing results	No adversetissue 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.

Regulation Number and Section

N/A