(36 days)
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.
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.
This premarket notification (K060113) for Dermacyn™ Wound Care does not contain the detailed information necessary to complete most of the requested sections regarding acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.
However, based on the provided text, I can infer the acceptance criteria relate to the device being substantially equivalent to the predicate devices (Allclenz™ Cleanser and CarraKlenz Wound Cleanser) in terms of function, intended use, and safety, as demonstrated through non-clinical testing.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionally similar to predicate devices | "The product is similar in function and intended use to Allclenz and CarraKlenz/Ultraklenz Wound Cleansers..." |
| Intended use similar to predicate devices | "...and includes among its labeled uses the cleansing of wounds and removal of foreign material from dermal wounds." |
| Safe performance | "Non-clinical testing was conducted to confirm the safe and effective performance of Dermacyn™ Wound Care." |
| Effective performance | "Non-clinical testing was conducted to confirm the safe and effective performance of Dermacyn™ Wound Care." |
| Biocompatible | "Non-clinical testing also demonstrated the biocompatibility of the subject device." |
| Substantially equivalent to predicate devices | "Dermacyn™ Wound Care is substantially equivalent to the currently cleared and marketed Allclenz and CarraKlenz/Ultraklenz Wound Cleansers." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Non-clinical testing was conducted" but gives no details about sample sizes, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. This device is a wound cleanser, and the "testing" mentioned is non-clinical, likely bench testing for safety and performance (e.g., microbial efficacy, chemical composition, biocompatibility). It does not appear to involve human interpretation or a "ground truth" established by clinical experts in the way AI/diagnostic devices would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI or diagnostic device, so an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This product is a physical wound cleanser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For non-clinical testing of a wound cleanser, "ground truth" would relate to accepted standards for biocompatibility (e.g., ISO standards), chemical composition validation, or efficacy against specific microorganisms in a lab setting, rather than clinical outcomes or diagnostic accuracy. The document doesn't detail these specific ground truths.
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided. See point 8.
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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 beingsubmitted in accordance with the requirements of 21 C.F.R 807.92. |
|---|---|
| Submitter | Oculus Innovative Sciences1129 North McDowell Blvd.Petaluma, CA 94954 |
| Contact Person | Tammy Atwood Quality Assurance ManagerTel: (707) 559-7191Fax: (707) 782-0705E-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, 1997CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct.17th, 2002 |
| Description | The subject device is a wound cleansing solution that is intended for themoistening and debriding of dermal wounds. The mechanical action offluid moving across the wound provides for the mechanism of action andaids in the removal of foreign objects such as dirt and debris. The subjectdevice is offered in various bottle sizes with and without a trigger spray. |
| Indications for Use | Dermacyn™ Wound Care is intended for moistening absorbent wounddressings 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 minorirritations of the skin. |
| Substantial Equivalence | The product is similar in function and intended use to Allclenz andCarraKlenz/Ultraklenz Wound Cleansers manufactured by HealthpointMedical and Carrington Laboratories, Inc., respectively, and includesamong its labeled uses the cleansing of wounds and removal of foreignmaterial from dermal wounds. |
| Non-clinical Performance | Non-clinical testing was conducted to confirm the safe and effectiveperformance of Dermacyn™ Wound Care. Non-clinical testing alsodemonstrated the biocompatibility of the subject device. |
| Conclusion | Dermacyn™ Wound Care is substantially equivalent to the currentlycleared and marketed Allclenz and CarraKlenz/Ultraklenz WoundCleansers. |
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
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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.
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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
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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.
N/A