(70 days)
Not Found
No
The device description and performance studies focus on the chemical composition and mechanical action of the solution, with no mention of AI or ML.
Yes
The device is intended for the management of minor irritations, abrasions, burns, and lacerations, and is also used for cleansing, irrigating, and debriding wounds, which clearly falls under therapeutic uses.
No
The device is a wound and skin care solution intended for cleansing, irrigating, and debriding wounds, and moistening/lubricating wound dressings. It does not perform any diagnostic function.
No
The device description clearly states it is a "clear liquid solution containing 0.01% hypochlorous acid (HOCI) as preservative in water/saline buffer," which is a physical substance, not software.
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, cleansing, irrigating, and debriding of wounds and intact skin. This is a therapeutic or wound care application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is a liquid solution that aids in the mechanical removal of debris and foreign material. It contains hypochlorous acid as a preservative. This description aligns with a wound cleanser or irrigating solution, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to detect or measure specific substances or markers related to a disease or condition.
- Performance Studies: The performance studies focus on toxicity, biocompatibility, and preservative effectiveness, which are relevant to a wound care product, not an IVD.
In summary, the function of Hychloderm Wound and Skin Care is to physically clean and prepare wounds, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings.
Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor abrasions, minor lacerations, cleansing, irrigating, and debriding to remove wound debris from acute and chronic dermal or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, 1st and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are a single-patient single-use. clear liguid solution containing 0.01% hypochlorous acid (HOCI) as preservative in water/saline buffer, that aids the mechanical removal of debris and foreign material from the application site. Dirt, debris and foreign material is mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). lt can be used in all stages of wound care and it is an ideal foundation for wound bed preparation. In addition to moistening and lubricating adsorbent wound dressings. It is a clear solution with 0.01% of hypochlorous acid that has been demonstrated to act as a preservative that inhibits microbial contamination within the solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dermal or full thickness wound (e.g. skin)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC Indications: over-the-counter use
Rx-only Indications: use by healthcare professionals
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)
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) have been subjected to in vitro and in vivo toxicity/biocompatibility studies to demonstrate that the device is safe for the indications for use. Extensive bench, biocompatibility and animal testing have been performed to support the substantial equivalence of Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC). All of the testing showed that the product functions as intended. Hychloderm® has 0.01% hypochlorous acid that acts as a preservative to help with the inhibition of the bacterial/microbial growth within the solution as supported by preservative effectiveness test USP 51 . The Conclusion of different preservatives effectiveness studies made with Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) shows that the solution is an effective preservative system aqainst bacteria and fungi within the solution according to USP criteria following the 28 day incubation period and following the 56 day re-challenge incubation period.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133542, K123072, K113693, K113820
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2018
Aquilabs US LLC Juan Salcedo Manager 9205 NW 101st St. Medley, Florida 33178
Re: K180305
Trade/Device Name: Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Regulatory Class: Unclassified Product Code: FRO Dated: January 30, 2018 Received: February 2, 2018
Dear Juan Salcedo:
We have reviewed vour 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180305
Device Name
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Indications for Use (Describe)
OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings.
Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor abrasions, minor lacerations, cleansing, irrigating, and debriding to remove wound debris from acute and chronic dermal or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, lst and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.
| 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
This 510(k) Summary is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21CFR 807.92.
The assigned 510(k) Number is: _K180305
Sponsor Information (21 CFR 807.92(a)(1))
Product and Company Information
| Date of Preparation: | April 9, 2018 |
|---|---|
| ---------------------- | --------------- |
| Company: | AQUILABS U.S, LLC. |
|---|---|
| Address: | 9205 NW 101st St Medley FL. 33178 |
| Phone Number: | (+1) 305-885-2255/56 |
| Website: | www.aquilabsus.com |
| contact@aquilabsus.com | |
| Contact Person: | Juan Salcedo & Justo Calderon, |
| Address: | 9205NW 101st ST, Medley, Florida 33178 Telephone: 857-272-1295/ 305-885-2255, juan.salcedo@aquilabsus.com, |
justo.calderon@aquilabsus.com.
Device Name/Classification (21 CFR 807.92(a)(2))
| Device Name: | Hychloderm Wound and Skin Care (Rx) and
Hychloderm Wound and Skin Care (OTC) |
|----------------------|---------------------------------------------------------------------------------|
| Common name: | Wound Cleanser |
| Classification Name: | Dressing, wound, drug |
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| Device Biocompatibility Contact Class: | A ( and ISO 10993. Safety has been established through biocompatibility testing. On the basis of the information presented in this application, Aquilabs concludes that Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are substantially equivalent to the primary and secondary predicate devices as it as has the same intended use as the predicate and the information submitted to FDA which does not raise different questions of safety and effectiveness demonstrating that the device is at least as safe and effective as the legally marketed device. Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) have 0.01% HOCl as preservative.
Device Description (21 CFR 807.92(a)(4))
5
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are a single-patient single-use. clear liguid solution containing 0.01% hypochlorous acid (HOCI) as preservative in water/saline buffer, that aids the mechanical removal of debris and foreign material from the application site. Dirt, debris and foreign material is mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). lt can be used in all stages of wound care and it is an ideal foundation for wound bed preparation. In addition to moistening and lubricating adsorbent wound dressings. It is a clear solution with 0.01% of hypochlorous acid that has been demonstrated to act as a preservative that inhibits microbial contamination within the solution.
OTC Indications:
Hychloderm® Wound and Skin Care (OTC) is intended for over the counter use in the management of minor irritations, minor cuts, minor abrasions, minor burns, minor lacerations and intact skin and lubricating absorbent wound dressings.
Rx Indications:
Hychloderm® Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor cuts, minor abrasions, minor lacerations, cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, leg ulcers, 1st and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.
Device Technological Characteristics (21 CFR 807.92(a)(6))
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC), are clear liquid solutions containing 0.01% of hypochlorous acid (HOCI) that aids the
6
mechanical removal of debris and foreign material from the application site. Dirt, debris and foreign material is mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) products contain of 0.01% Hypochlorous Acid as preservative in Water/saline buffer.
Performance Testing
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) have been subjected to in vitro and in vivo toxicity/biocompatibility studies to demonstrate that the device is safe for the indications for use. Extensive bench, biocompatibility and animal testing have been performed to support the substantial equivalence of Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC). All of the testing showed that the product functions as intended. Hychloderm® has 0.01% hypochlorous acid that acts as a preservative to help with the inhibition of the bacterial/microbial growth within the solution as supported by preservative effectiveness test USP 51 . The Conclusion of different preservatives effectiveness studies made with Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) shows that the solution is an effective preservative system aqainst bacteria and fungi within the solution according to USP criteria following the 28 day incubation period and following the 56 day re-challenge incubation period.
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are similar in function, claims and have the same intended use as the predicate device: K133542 Puracyn Plus, and other cleared devices such as: K123072, Vashe® Wound Therapy Solution. K113693, Nixal ® Wound and Skin K113820, Neutrophase® Skin and Wound Cleanser.
On the basis of the information presented in this application, AquiLabs concludes that Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are substantially equivalent to the predicate device. The product is biocompatible and
7
non-toxic for the intended use. As it as has the same intended use as the predicate and the information submitted to FDA which does not raise different questions of safety and effectiveness; Stability testing supports a shelf life of 12 months for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC). Its characteristics demonstrates that the device is as safe and effective as the legally marketed device.
Substantial Equivalence Discussion/ Conclusion
Hychloderm®
| Active Ingredients: | Hypochlorous Acid: 0.01% |
|---|---|
| Inactive Ingredients: | Saline buffer (NaCl): 0.005% |
| Inactive Ingredients: | Demineralized/purified water: 99.985% |
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are similar in function and has the same intended use as the predicate device, These indications are similar to that of the predicate device K133542, Puracyn plus™, skin and wound care by Innovacyn, Inc. approved by FDA as a wound and skin care product and other cleared devices such as: K123072, Vashe® Wound Therapy Solution. K113693, Nixal ® Wound and Skin K113820. Neutrophase® Skin and Wound Cleanser. The safety evaluation meets the requirements as detailed by USP and ISO. Safety has been established through biocompatibility testing, in-vitro cytotoxicity testing and sensitization testing On the basis of the information presented in this application, Aquilabs concludes that Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are substantially equivalent to the primary and secondary predicate devices as it as has the same intended use as the predicate and the information submitted to FDA which does not raise different questions of safety and effectiveness demonstrating that the device is as safe and effective as the legally marketed device. Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) have 0.01% HOCl as preservative.