(211 days)
No
The device is a topical cream and the summary does not mention any AI/ML components or functions.
No.
The device description states it is a topical cream for management of dry skin, and the intended use specifies it maintains a moist skin environment for dry intact skin, which indicates a supportive rather than a direct therapeutic function.
No
The device, SiOxC Cream, is an emulsion for managing dry skin by maintaining a moist environment, not for diagnosing conditions.
No
The device description clearly states it is a "topical cream," which is a physical substance and not software. The performance studies also focus on the physical and biological properties of the cream.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of dry intact skin by maintaining a moist skin environment." This is a topical application for a skin condition, not a diagnostic test performed on samples taken from the body.
- Device Description: It is described as a "topical cream."
- Lack of Diagnostic Activity: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition by examining samples from the body (like blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the physical properties of the cream (pH, viscosity), preservative effectiveness, biocompatibility, and skin irritation/sensitization. These are relevant to a topical skin product, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This cream does not fit that description.
N/A
Intended Use / Indications for Use
SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.
Product codes
FRO
Device Description
SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
The summary of performance testing mentions "120 male and female subjects ranging from 18 to 70 years old were enrolled in the subjects".
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)
Non-clinical performance testing for the SiOxC Cream included characterization of pH, viscosity, and macroscopic and microscopic appearance. Preservative effectiveness testing per USP was also conducted to support the subject device shelf-life.
The SiOxC Cream was found to be biocompatible in accordance with ISO 10993-1 for its intended use when tested in compliance with ISO 10993-5, ISO 10993-10, and ISO 10993-23.
A Human Repeat Insult Patch Test (HRIPT) was also 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 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 106 subjects who completed the study, SiOxC Cream did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Based on the test population of 106 subjects who completed the study, SiOxC Cream did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.
Predicate Device(s)
K052643 Ceragenix Corporation EPICERAM® Skin Barrier Emulsion
Reference Device(s)
K241660 SiOxMed LLC SiOxD Wound Matrix
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
March 13, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
SiOxMed, LLC % Justin Gracyalny Regulatory Affairs Program Manager Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock. Georgia 30188
Re: K242406
Trade/Device Name: SiOxC Cream Regulatory Class: Unclassified Product Code: FRO Dated: August 14, 2024 Received: August 14, 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"
1
(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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 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
3
Indications for Use
Submission Number (if known)
Device Name
SiOxC Cream
Indications for Use (Describe)
SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.
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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4
| Date Prepared | March 13, 2025 |
|---|---|
| Sponsor | SiOxMed |
| 2452 Salem Park Dr. | |
| Winston-Salem, NC 27127 | |
| (336) 551-2209 | |
| 510(k) Contact | SiOxMed |
| Adam Jorgensen, MD, PhD | |
| 2452 Salem Park Dr. | |
| Winston Salem, NC, 27127 | |
| (336) 551-2209 | |
| Regulatory@SiOxMed.com | |
| Trade Name | SiOxC Cream |
| Common Name | Cream |
| Code - Classification | FRO |
| Unclassified | |
| Predicate Device | K052643 Ceragenix Corporation EPICERAM® Skin Barrier Emulsion |
| Reference Device | K241660 SiOxMed LLC SiOxD Wound Matrix |
| Device Description | SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use. |
| Indications for Use Statement | SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores. |
510(k) SUMMARY: SiOxMed SiOxC Cream
Comparison of Technological Characteristics
The subject device is intended for use for management of dry intact skin. As such, this difference does not represent a new intended use.
There are no significant technological differences between the subject and predicate devices are intended for similar uses and have similar technological characteristics including promoting a moist environment as the principle of operation, application frequency, and sterility. Both the subject and predicate device utilize the same preservative. Any minor differences such as specific cream formulation and size offerings are addressed via biocompatibility and non-clinical performance testing.
5
| Characteristic | Subject Device
SiOxMed LLC
SiOxC Cream K242406 | Primary Predicate
Oculus Innovative Sciences, Inc.
EPICERAM® Skin Barrier
Emulsion
K052643 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | Unclassified | Unclassified |
| Product Classification | FRO | FRO |
| Common Name | Cream | Cream |
| Principle of Operation | Promotes a moist environment | Promotes a moist environment |
| Composition | A water-based formulation containing
emollients, humectants, structural and
stabilizing agents, pH adjusters,
surfactants/emulsifiers, antioxidants,
and preservatives. The formulation
includes a proprietary
amorphous
hydrated silica. | A water-based formulation with
emollients, humectants, lipid-
replenishing agents, stabilizers, pH adjusters,
surfactants/emulsifiers,
antioxidants, and preservatives. The
formulation includes a proprietary lipid
delivery system. |
| Preservative | Phenoxyethanol (0.5% ± 1%) | Phenoxyethanol |
| Available Offerings | 1 or 8 fl oz jar | 90g tube or 225g airless pump |
| Reapplication | Twice daily, as needed | Twice daily, as needed |
| Sterility | Non-Sterile | Non-Sterile |
| Biocompatibility | Biocompatible | Biocompatible |
Summary of Performance Testing
Non-clinical performance testing for the SiOxC Cream included characterization of pH, viscosity, and macroscopic and microscopic appearance. Preservative effectiveness testing per USP was also conducted to support the subject device shelf-life.
The SiOxC Cream was found to be biocompatible in accordance with ISO 10993-1 for its intended use when tested in compliance with ISO 10993-5, ISO 10993-10, and ISO 10993-23.
A Human Repeat Insult Patch Test (HRIPT) was also 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 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.
6
Based on the test population of 106 subjects who completed the study, SiOxC Cream did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.
Conclusions
Based on the similarities of the intended use / indications for use, technological and functional characteristics, and the results of the biocompatibility / non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.