(228 days)
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.
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.
The provided text is a 510(k) summary for the Dermacyn™ Wound Cleanser. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel AI software would.
Therefore, the document does not contain the specific information requested regarding acceptance criteria and performance studies in the context of device performance, test sets, expert adjudication, or AI assistance.
Here's a breakdown of why the requested information is absent based on the provided text:
-
Acceptance Criteria and Reported Device Performance: Not applicable in this context. The 510(k) summary focuses on demonstrating that the device is "substantially equivalent" to existing products, not on meeting specific performance criteria related to accuracy, sensitivity, or other typical metrics for a diagnostic or AI device. It mentions "Non-clinical testing was conducted to confirm the safe and effective performance," but it doesn't quantify or specify acceptance criteria for these tests. The "performance" assessment is comparative, showing it performs similarly to predicate devices.
- Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided. The summary states "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." However, no quantifiable acceptance criteria or reported numerical performance metrics are given.
-
Sample Size and Data Provenance for Test Set: This kind of information is generally not included in a 510(k) summary for a wound cleanser. The "testing" mentioned is likely related to manufacturing quality, sterility, shelf-life, and biocompatibility, not a clinical "test set" in the sense of a medical imaging or AI device.
-
Number of Experts and Qualifications: Not applicable. The "ground truth" concept, as used in the context of expert review for medical devices or AI, does not apply to a physical wound cleanser. The "truth" here would be its chemical and physical properties and its effect on wounds, which are assessed through laboratory and possibly limited preclinical studies, not expert consensus on interpretations.
-
Adjudication Method: Not applicable for the reasons mentioned above. There's no interpretive "ground truth" that needs adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading images) and AI might assist them. A wound cleanser does not involve human interpretation in this manner.
-
Standalone Performance: While the wound cleanser operates "stand-alone" in its intended use, the concept of "standalone performance" in the context of device evaluation usually refers to an algorithm's performance without human intervention, which is not relevant here. The device itself is standalone.
-
Type of Ground Truth Used: The "ground truth" for a wound cleanser would be its physical and chemical properties and its biological effects (e.g., sterilization effectiveness, irritation potential, wound healing mechanisms), established through laboratory assays and possibly animal models, rather than expert consensus, pathology, or outcomes data in humans for substantial equivalence. The document indicates "Pre-clinical testing also demonstrated the biocompatibility of the subject device."
-
Sample Size for Training Set: Not applicable. There is no AI component or machine learning model being "trained."
-
How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided 510(k) document is for a non-AI, non-diagnostic medical device. The regulatory pathway for such devices focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and safety data (e.g., biocompatibility) rather than detailed clinical performance studies with acceptance criteria, test sets, and expert adjudication, which are more typical for novel diagnostic or AI-powered devices.
{0}------------------------------------------------
| 510(k) Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21 C.F.R §807.92. |
|---|---|
| Submitter | Oculus Innovative Sciences1129 North McDowell Blvd.Petaluma, CA 94954 |
| Contact Person | Theresa MitchellQA/RA VicePresidentTel: (707) 559-7234Fax: (707) 283-0551E-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, 1997CarraKlenz Wound Cleanser; Carrington Laboratories, Inc.K022670, Oct. 17th, 2002 |
| Description | The subject device is a wound cleansing solution that is intended forthe cleansing of dermal wounds. The mechanical action of fluidmoving across the wound provides for the mechanism of action andaids in the removal of foreign objects such as dirt and debris. Thesubject device is offered in various bottle sizes. |
| Indications for Use | Dermacyn™ Wound Cleanser is intended for moistening anddebriding acute and chronic dermal lesions, such as Stage I-IVpressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds,first and second degree burns, abrasions and minor irritations of theskin. |
| Substantial Equivalence | The product is similar in function and intended use to Allclenz andCarraKlenz Wound Cleansers manufactured by Healthpoint Medicaland Carrington Laboratories, Inc. and includes among its labeleduses the cleansing of wounds and removal of foreign material fromdermal wounds. |
| Non-clinicalPerformance | Non-clinical testing was conducted to confirm the safe and effectiveperformance of Dermacyn™ Wound Cleanser. Pre-clinical testingalso demonstrated the biocompatibility of the subject device. |
| Conclusion | Dermacyn™ Wound Cleanser is substantially equivalent to thecurrently cleared and marketed Allclenz and CarraKlenz WoundCleansers |
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 __
N/A