(228 days)
Not Found
No
The description focuses on the mechanical action of a wound cleansing solution and does not mention any AI/ML components or capabilities.
No.
The device is a wound cleansing solution, which acts mechanically to clean wounds, rather than providing a therapeutic effect on the underlying condition or tissue.
No
The device is a wound cleanser, intended for moistening and debriding dermal lesions and aiding in the removal of foreign objects. It is not described as analyzing or interpreting biological signals or images to diagnose a condition.
No
The device description clearly states it is a "wound cleansing solution" and is offered in "various bottle sizes," indicating it is a liquid 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 is for "moistening and debriding acute and chronic dermal lesions." This describes a topical application and mechanical action on the wound itself, not a test performed on a sample taken from the body.
- Device Description: The device is a "wound cleansing solution" that works through "mechanical action of fluid moving across the wound." This further reinforces its function as a topical wound treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information about a patient's condition.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dermacyn™ Wound Cleanser is intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The subject device is a wound cleansing solution that is intended for the cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The subject device is offered in various bottle sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal lesions, skin
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)
Non-clinical testing was conducted to confirm the safe and effective performance of Dermacyn™ Wound Cleanser. Pre-clinical testing also demonstrated the biocompatibility of the subject device.
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.
Allclenz™ Cleanser; Healthpoint Medical K965120, CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670
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
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 C.F.R §
807.92. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Oculus Innovative Sciences
1129 North McDowell Blvd.
Petaluma, CA 94954 |
| Contact Person | Theresa Mitchell
QA/RA VicePresident
Tel: (707) 559-7234
Fax: (707) 283-0551
E-mail: tmitchell@oculusis.com |
| Date Prepared | September 30th, 2004 |
| Trade Name | Dermacyn™ Wound Cleanser |
| Common Name | Wound Cleanser |
| Classification Name | Solution, saline (wound dressing) |
| Predicate Device | Allclenz™ Cleanser; Healthpoint Medical K965120, Mar. 21st, 1997
CarraKlenz Wound Cleanser; Carrington Laboratories, Inc.
K022670, Oct. 17th, 2002 |
| Description | The subject device is a wound cleansing solution that is intended for
the cleansing of dermal wounds. The mechanical action of fluid
moving across the wound provides for the mechanism of action and
aids in the removal of foreign objects such as dirt and debris. The
subject device is offered in various bottle sizes. |
| Indications for Use | Dermacyn™ Wound Cleanser is intended for moistening and
debriding acute and chronic dermal lesions, such as Stage I-IV
pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds,
first and second degree burns, abrasions and minor irritations of the
skin. |
| Substantial Equivalence | The product is similar in function and intended use to Allclenz and
CarraKlenz Wound Cleansers manufactured by Healthpoint Medical
and Carrington Laboratories, Inc. and includes among its labeled
uses the cleansing of wounds and removal of foreign material from
dermal wounds. |
| Non-clinical
Performance | Non-clinical testing was conducted to confirm the safe and effective
performance of Dermacyn™ Wound Cleanser. Pre-clinical testing
also demonstrated the biocompatibility of the subject device. |
| Conclusion | Dermacyn™ Wound Cleanser is substantially equivalent to the
currently cleared and marketed Allclenz and CarraKlenz Wound
Cleansers |
510(k) Summary of Dermacyn™ Wound Cleanser
Oculus Innovative Sciences, Inc.
Dermacyn™ Wound Cleanser_____________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
MAR 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Zachary J. Woodson OA/RA Consultant Oculus Innovative Sciences, Inc. 1129 North McDowell Boulevard Petaluma, California 94954
Re: K042729 Trade/Device Name: Dermacyn™ Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: February 8, 2005 Received: February 9, 2005
Dear Mr. Woodson:
This letter corrects our substantially equivalent letter of May 17, 2005.
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 -- Mr. Zachary J. Woodson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promance noticated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you a the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general so International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known):
Device Name: Dermacyn™ Wound Cleanser
Dermacyn Wound Cleanser is intended for moistening and Indications for Use: debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
Prescription Use ✗ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
. Vision of Ganetal, RestoreBir .nd Neurological | Durines
Page 1 of __