(25 days)
The SiOxD® Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure 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, first degree and partial thickness burns, skin tears) and draining wounds.
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.
The provided document is a 510(k) summary for a medical device called the SiOxD® Wound Matrix. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study with defined endpoints.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: This document focuses on demonstrating equivalence to a predicate device, not on presenting performance metrics against predefined acceptance criteria for the new device.
- Sample sized used for the test set and the data provenance: There is no mention of a clinical test set or data provenance in the context of device performance evaluation. The "material testing" mentioned is likely laboratory-based.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set for ground truth establishment is not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a wound matrix, not an AI or imaging device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding device performance and testing:
The document explains that the subject device (SiOxD Wound Matrix) is a line extension of an already cleared predicate device (SiOxMed LLC SiOxD Wound Matrix K222189 / K232847). The core of the submission is to demonstrate that the new device does not have significant technological differences from the predicate and performs similarly.
The key change described for the subject device is:
- Allowed use of alternate water raw materials in the manufacture of the device fiber matrix.
To address this change, material testing was performed:
- Material testing of key physical and chemical properties: This testing demonstrated that devices manufactured with any of the qualified water raw materials met "predetermined release criteria."
- Worst-case assessment of endotoxin levels: This assessment showed that devices manufactured with all water raw materials meet the "20 EU/Device acceptance criteria."
In summary, while specific performance acceptance criteria for clinical efficacy are not detailed, the report highlights that the manufacturing change (alternate water raw materials) was validated through laboratory material testing to ensure the device met internal "predetermined release criteria" for physical and chemical properties, and an "acceptance criteria" of 20 EU/Device for endotoxin levels. This is a common approach for demonstrating substantial equivalence for minor manufacturing changes in a 510(k) submission, where extensive new clinical studies are often not required if technological characteristics and intended use remain the same as a predicate.
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July 5, 2024
SiOxMed, LLC % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K241660
Trade/Device Name: SiOxD® Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: June 10, 2024 Received: June 10, 2024
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 (QS) 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 OS 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.
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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,
Mustafa A. Mazher -S
For 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
Submission Number (if known)
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 full-thickness wounds, pressure 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, 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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| 510(k) SUMMARY: |
|---|
| SiOxMed SiOxD Wound Matrix |
| Date Prepared | June 7, 2024 |
|---|---|
| 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 – | FRO |
| Classification | Unclassified |
| Predicate Device | K222189, K232847 SiOxMed LLC SiOxD Wound Matrix |
| Device Description | The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use deviceintended for use in local management of wounds. The SiOxD Wound Matrixis a soft, white, conformable, non-woven, absorbent, biocompatible fibermatrix made from synthetic biomaterials. The SiOxD Wound Matrixconforms in the defect space / wound bed and includes a fibrous, porousstructure that allows for fluid absorption. The SiOxD Wound Matrix isstructurally similar to collagen, a key component of the native extracellularmatrix, and serves as a scaffold for cellular infiltration and vascularization.SiOxD Wound Matrix promotes a moist environment for the body's naturalhealing process.The SiOxD Wound Matrix is not designed to be held in place withcompression bandages or tapes. Only light pressure without mechanicalcompression or secondary bandaging is required for proper device function.The matrix applied to the wound bed naturally sloughs off during woundhealing 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/underminedwounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post lasersurgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations,first degree and partial thickness burns. skin tears) and draining wounds. |
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| Characteristic | Subject DeviceSiOxMed SiOxD Wound Matrix | Primary PredicateSiOxMed SiOxD Wound MatrixK222189 / K232847 |
|---|---|---|
| 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 in2, 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 in2, 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) |
| Packaging | Single and Dual Sterile BarrierConfigurations | Single and Dual Sterile BarrierConfigurations |
| 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 |
| Reapplication | As needed | As needed |
| Characteristic | Subject DeviceSiOxMed SiOxD Wound Matrix | Primary PredicateSiOxMed SiOxD Wound MatrixK222189 / K232847 |
| Single Use | Yes | Yes |
| Non-Pyrogenic | Yes | Yes |
| Sterility | Gamma, 10-6 SAL | Gamma, 10-6 SAL |
| Biocompatibility | Biocompatible | Biocompatible |
Comparison of Technological Characteristics
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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 / K232847. There are no differences in intended use, device sizes, material of construction, sterilization, or packaging. The subject device allows for use of alternate water raw materials in the manufacture of the subject device fiber matrix. Material testing of key physical and chemical properties demonstrated that devices manufactured with any of qualified water raw material met predetermined release criteria. A worstcase assessment of endotoxin levels showed that devices manufactured with all water raw materials meet the 20 EU/Device acceptance criteria.
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.
N/A