(119 days)
Not Found
No
The summary describes a passive wound dressing made of synthetic biomaterials. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes.
The device is intended for the management of wounds and promotes the body's natural healing process, indicating a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the SiOxD Wound Matrix is for the local management of wounds, acting as a scaffold and promoting healing. It does not mention any diagnostic capabilities or the collection/analysis of data for diagnosis.
No
The device description clearly states it is a physical matrix made from synthetic biomaterials, intended for direct application to wounds. This is a hardware device, not software.
Based on the provided information, the SiOxD Wound Matrix is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of wounds." This involves direct application to the wound bed to promote healing.
- Device Description: The description details a physical matrix that is applied to the wound and interacts with the wound environment. It describes its physical properties and how it functions as a scaffold for healing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) outside of the body to provide diagnostic information about a patient's condition. IVDs are used to diagnose, monitor, or screen for diseases or conditions.
- Performance Studies: The performance studies focus on the device's physical properties (absorption, clotting time, complement activation), biocompatibility, and wound healing performance when applied to a wound. These are not typical performance metrics for an IVD.
In summary, the SiOxD Wound Matrix is a therapeutic device intended for direct application to wounds to aid in the healing process, not a diagnostic device used to analyze samples for medical information.
N/A
Intended Use / Indications for Use
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.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Tests performed:
- Absorption Capacity: The absorption capacity of the device was characterized. Results: 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). Results: 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. Results: 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: Results were consistent with hydrated amorphous silica in fibrous form.
- X-Ray Diffraction (XRD) Spectrometry: XRD spectrometry was used to characterize the material. Results: Results were consistent with hydrated amorphous silica in fibrous form.
- Scanning Electron Microscope (SEM) Imaging: SEM imaging was collected to characterize the matrix structure. Results: The matrix structure was structurally similar to collagen and created a scaffold for cellular infiltration and vascularization.
- Cytotoxicity: ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. Results: 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. Results: Non-sensitizing.
- Irritation: ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation. Also addressed via Human Repeat Insult Patch Testing. Results: Non-irritating.
- Acute Systemic Toxicity: ISO 10993-11 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity. Results: Non-toxic.
- Material Mediated Pyrogenicity: USP Pyrogen Test. Results: Non-pyrogenic.
- Subacute Systemic Toxicity: ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity. Results: 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. Results: No adverse tissue response.
- Endotoxin: USP Bacterial Endotoxins. Results:
N/A
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) |
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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 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 Bacterial Endotoxins |