(95 days)
No
The summary describes a passive wound dressing material and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for the management of various wound types and promotes the body's natural healing process, indicating a therapeutic purpose.
No
The device is described as a wound matrix intended for local management of wounds, promoting healing, rather than identifying or characterizing a medical condition.
No
The device description clearly describes a physical, material-based wound matrix, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 aid in the healing process.
- Device Description: The description details a physical matrix that is applied to the wound, absorbs fluid, and serves as a scaffold for healing.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are designed to provide information about a patient's health status through testing of biological samples.
This device falls under the category of a wound dressing or wound management product, which are typically considered medical devices but not IVDs.
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
Wounds (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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K222189 SiOxMed LLC SiOxD Wound Matrix
Reference Device(s)
K153756 Imbed Biosciences, Inc. Microlyte Ag
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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).
1
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
2
Indications for Use
510(k) Number (if known) K232847
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K232847 510(k) SUMMARY: SUMMARY: SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOxMed SiOx
| Date Prepared | December 15, 2023 |
|---|---|
| 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 – | |
| Classification | FRO |
| Unclassified | |
| 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 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
SiOxMed SiOxD Wound Matrix
K222189 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 $in^2$ , 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 Barrier
Configurations | Dual Sterile Barrier Configuration |
| 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 |
| Characteristic | Subject Device
SiOxMed SiOxD Wound Matrix | Primary Predicate
SiOxMed SiOxD Wound Matrix
K222189 |
| 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 |
5
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.