(44 days)
K141012, K1600095
Not Found
No
The device is a wound care solution, and the description focuses on its chemical properties and intended uses for cleansing and debridement. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The "Intended Use / Indications for Use" section states that the product is intended for cleansing, irrigation, moistening, debridement, and removal of foreign material and debris from various types of wounds and skin lesions, which are therapeutic actions aimed at treating or alleviating a condition.
No
The device description and intended use clearly state that it is a solution for cleansing, irrigating, moistening, and debriding wounds, as well as removal of foreign material and debris. These are therapeutic and wound care actions, not diagnostic ones.
No
The device description clearly states it is an "aqueous solution" supplied in "polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Hydrocleanse™ solution is for the cleansing, irrigation, moistening, debridement, and removal of foreign material and debris from wounds and skin lesions. It is applied externally to the body.
- Device Description: The description confirms it's an aqueous solution for external application to wounds and dressings.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. IVDs are used to analyze samples like blood, urine, tissue, etc., to gain insights into a patient's health status.
- Bench Testing: The bench testing described focuses on the properties and effectiveness of the solution itself (package integrity, pH, antimicrobial effectiveness) rather than its ability to diagnose or provide diagnostic information from a biological sample.
In summary, the Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is a topical wound care product, not a diagnostic device.
N/A
# Intended Use / Indications for Use
### Rx Indications for Use:
Under the supervision of a healthcare professional, Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, firstand second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown
toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
### OTC Indications for Use:
OTC Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
# Product codes (comma separated list FDA assigned to the subject device)
FRO
# Device Description
The Hydrocleanse Antimicrobial Skin and Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and device irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
Skin
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Healthcare professional (for Rx indications), OTC (for OTC indications)
# 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)
The following performance data were provided in support of the substantial equivalence determination.
### Biocompatibility Testing
The biocompatibility evaluation for the Hydrocleanse Antimicrobial Skin and Wound Care Solution was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
## Bench Testing
The following tests were performed to support the performance of Hydrocleanse Antimicrobial Skin and Wound Care Solution: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP testing was used to support preservative effectiveness within the solution while on the shelf, used against the following bacteria in solution, Proteus mirabilis (ATCC- 25933), Serratia marcescens (ATCC-8100), antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC-43300), Vancomycin-resistant Enterococcus faecalis (VRE) (ATCC-700221), and Acinetobacter baumannii (ATCC 19606).
# 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.
[K141012](https://510k.innolitics.com/search/K141012), K1600095
# 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2017
Sonoma Pharmaceuticals Brian Martin Director of Regulatory Affairs and Ouality Control 1129 N. McDowell Boulevard Petaluma. California 94954
Re: K171727
Trade/Device Name: Hydrocleanse Antimicrobial Skin and Wound Solution Regulatory Class: Unclassified Product Code: FRO Dated: June 8, 2017 Received: June 12, 2017
Dear Brian Martin:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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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Image /page/3/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a stylized flower-like design on the left, with the word "Sonoma" in a larger, bolder font to the right. Below "Sonoma" is the word "PHARMACEUTICALS" in a smaller font. The flower-like design is made up of teal and gray shapes.
510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
I. SUBMITTER
Sonoma Pharmaceuticals, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551
Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: July 11, 2017
II. DEVICE
Name of Device: Hydrocleanse Antimicrobial Skin and Wound Care Solution Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
III. PREDICATE DEVICE
Hydrocleanse Wound Solution manufactured by Sonoma Pharmaceuticals (K141012) Simple Science Skin and Wound Cleanser manufactured by Simple Science (K1600095)
IV. DEVICE DESCRIPTION
The Hydrocleanse Antimicrobial Skin and Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and device irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.
V. INDICATIONS FOR USE
Rx Indications for Use:
Under the supervision of a healthcare professional, Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, firstand second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown
4
Image /page/4/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a stylized flower-like symbol on the left, with the word "Sonoma" in a gray sans-serif font to the right. Below "Sonoma" is the word "PHARMACEUTICALS" in a smaller, teal-colored sans-serif font. The flower-like symbol is made up of teal and gray shapes arranged in a circular pattern.
toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications for Use:
OTC Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
| Submitter/
Holder | Proposed Device:
Hydrocleanse Antimicrobial
Skin and Wound Care Solution
Sonoma Pharmaceuticals, Inc. | Predicate Device: K141012
Hydrocleanse Skin and Wound
Care Solution
Sonoma Pharmaceuticals, Inc. | Predicate Device:
K1600095
Simple Science Skin and
Wound Cleanser Simple
Science, LLC |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for
Use | Rx Indications:
Under the supervision of a
healthcare professional,
Hydrocleanse™ Antimicrobial Skin
and Wound Care Solution is
intended for the cleansing, irrigation,
moistening, debridement and
removal of foreign material and
debris from exudating wounds, acute
and chronic dermal lesions including
stage I-IV pressure ulcers, stasis
ulcers, diabetic ulcers, post-surgical
wounds, first- and second-degree
burns, abrasions, minor irritations of
the skin, diabetic foot ulcers,
ingrown toe nails, grafted/donor sites
and exit sites. It is also intended for
use to moisten and lubricate wound
dressings and for use with devices
intended to irrigate wounds.
OTC Indications:
OTC Hydrocleanse™ Antimicrobial
Skin and Wound Care Solution is
intended for OTC use in the
management of skin abrasions,
lacerations, minor irritations, cuts,
and intact skin. | Rx Indications:
Under the supervision of a healthcare
professional, Hydrocleanse™ Solution
is intended for the cleansing, irrigation,
moistening, debridement and removal
of foreign material including
microorganisms and debris from
exudating wounds, acute and chronic
dermal lesions including stage I-IV
pressure ulcers, stasis ulcers, diabetic
ulcers, post-surgical wounds, first- and
second-degree burns, abrasions, minor
irritations of the skin, diabetic foot
ulcers, ingrown toe nails, grafted/donor
sites and exit sites. It is also intended
for the irrigation, moistening and
lubricating of wound dressings as well
as device irrigation.
OTC Indications:
Hydrocleanse™ Solution is intended
for OTC use in the management of skin
abrasions, lacerations, minor irritations,
cuts, and intact skin. | Rx Indications:
For management of wounds
such as Stage I-IV pressure
ulcers, partial and full thickness
wounds, diabetic foot and leg
ulcers, post-surgical wounds,
first-and second degree burns,
grafted and donor sites, and
minor irritations of the skin in
addition to moistening and
lubricating absorbent wound
dressings.
OTC Indications:
For management of minor skin
abrasions, minor lacerations,
minor irritations, minor cuts,
minor burns and intact skin. |
| Sterility
Claim | Non-sterile | Same | Same |
| Mechanism
of Action | Dirt debris and foreign material are
mechanically removed by the action
of the fluid moving across the wound
or device. | Same | Same |
| Delivery
System | Aqueous Solution | Same | Same |
| Shelf Life | 24 months | Same | 12 months |
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Image /page/5/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a circular design on the left and the company name on the right. The circular design is made up of several curved shapes in shades of gray and teal, arranged to form a flower-like pattern. The company name "Sonoma" is written in a gray sans-serif font, with the word "PHARMACEUTICALS" written in a smaller teal font underneath.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Hydrocleanse Antimicrobial Skin and Wound Care Solution was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Bench Testing
The following tests were performed to support the performance of Hydrocleanse Antimicrobial Skin and Wound Care Solution: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP testing was used to support preservative effectiveness within the solution while on the shelf, used against the following bacteria in solution, Proteus mirabilis (ATCC- 25933), Serratia marcescens (ATCC-8100), antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC-43300), Vancomycin-resistant Enterococcus faecalis (VRE) (ATCC-700221), and Acinetobacter baumannii (ATCC 19606).
VIII. CONCLUSION
Hydrocleanse Antimicrobial Skin and Wound Care Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Hydrocleanse Wound Solution manufactured by Sonoma Pharmaceuticals, Inc. (K141012) and Simple Science Antimicrobial Skin and Wound Cleanser manufactured by Simple Science (K1600095). Therefore, the Hydrocleanse Antimicrobial Skin and Wound Care Solution is substantially equivalent to the predicate devices.