(36 days)
Not Found
No
The device description and intended use clearly define it as a wound cleansing solution with a mechanical action, and there is no mention of AI, ML, or any related technologies.
Yes
The device is intended for the debridement and cleaning of acute and chronic dermal lesions, including pressure ulcers, statis ulcers, diabetic ulcers, and burns, which are therapeutic actions aimed at treating wounds.
No
Explanation: The device is a wound cleansing solution intended for moistening, debriding, and cleaning wounds. Its mechanism of action is mechanical (fluid movement) to remove foreign objects. It does not perform any diagnostic function such as identifying, assessing, or monitoring a disease or condition.
No
The device description clearly states it is a "wound cleansing solution" offered in "various bottle sizes with and without a trigger spray," indicating it is a physical product (liquid and container) and 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 Dermacyn™ Wound Care is for cleaning and debriding dermal lesions and moistening wound dressings. This is a topical application for wound management, not for testing samples taken from the body to diagnose a condition.
- Device Description: The description reinforces that it's a wound cleansing solution with a mechanical action to remove foreign objects. This is consistent with wound care, not in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Dermacyn™ Wound Care does not fit this definition.
N/A
Intended Use / Indications for Use
Dermacyn™ Wound Care is intended for moistening absorbent wound dressings and for debriding and cleaning 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.
Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial 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 moistening and debriding 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 with and without a trigger spray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Care. Non-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.
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
Premarket Notification for Dermacyn Wound Care Traditional 510(k) January 13, 2006
Koco113
Appendix 6
2/22/06
510(k) Summary of Dermacyn™ Wound Care
| 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 | Tammy Atwood Quality Assurance Manager
Tel: (707) 559-7191
Fax: (707) 782-0705
E-mail: tatwood@oculusis.com |
| Date Prepared | January 13, 2006 |
| Trade Name | Dermacyn™ Wound Care |
| Common Name | Wound Cleanser |
| Classification Name | Liquid Bandage |
| 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
moistening and debriding 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 with and without a trigger spray. |
| Indications for Use | Dermacyn™ Wound Care is intended for moistening absorbent wound
dressings and for debriding and cleaning 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/Ultraklenz Wound Cleansers manufactured by Healthpoint
Medical and Carrington Laboratories, Inc., respectively, 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 Care. Non-clinical testing also
demonstrated the biocompatibility of the subject device. |
| Conclusion | Dermacyn™ Wound Care is substantially equivalent to the currently
cleared and marketed Allclenz and CarraKlenz/Ultraklenz Wound
Cleansers. |
Page 42
Oculus Innovative Sciences, Inc. considers this application to be confidential and not subject to disclosure without the express written consent of the applicant.
80
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with curved lines forming the faces and necks. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Oculus Innovative Sciences, Inc. c/o Ms. Tammy Atwood Manager, Quality Assurance 1129 N. McDowell Blvd. Petaluma, California 94954
Re: K060113
Trade/Device Name: Dermacyn™ Wound Care Regulatory Class: Unclassified Product Code: FRO Dated: January 13, 2006 Received: January 17, 2006
Dear Ms. Atwood:
This letter corrects our substantially equivalent letter of February 22, 2006.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rotty premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regarly manatised provice American of the Federal Food. Drug commerce prof to May 20, 1970, the enastinone with the provisions of the Federal Food, Drug, devices that have been reclassified in accessaries approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a president of the Act. The and Cosment Act (Act) that do not require approvine the general controls provisions of the Act. The You may, merelore, market the device, sucject to increases for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the receinentals requirements.
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 If your device is classified (see above) mho child cases in personations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis: Existing increase of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may
1 be louid in the Code of Peacharters)
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 Please be advised that FDA s issualice of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies with one must that FDA nas made a determination that your are rose overpress. You must or any Peteral statures and regulations daministers or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, monation readies requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sectroni CFR Part 807); labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the electroni forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Atwood
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 marketed predicate 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 contact 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 Manufacturers, 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,
Sincerely yours,
Mark H Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
KO60113 f. 1.42
Premarket Notification for Dermacyn Wound Care Traditional 510(k) February 17, 2006
Appendix 5 - Revised
Statement of Indication for Use
510(k) Number: K060113
Device Name: Dermacyn™ Wound Care
Indications for Use:
Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use X
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
EQMDE
Division Sign-Division of General. Rastorative, and Neurological Devices
KO60113 519(k) Number_
Oculus Innovative Sciences, Inc. considers this application to be confidential and not subject to disclosure without the express written consent of the applicant.