(365 days)
Dermacyn™ Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.
The subject device is an 8 ounce polyethylene bottle containing Dermacyn™ Wound Care Dressing intended for multi-use.
This document describes the 510(k) summary for the Dermacyn™ Wound Dressing (K041161). It is a medical device application that establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.
Here's an analysis based on the provided text, addressing the requested points where applicable:
1. A table of acceptance criteria and the reported device performance
This 510(k) summary does not present specific quantitative acceptance criteria or performance metrics in the way a clinical study for a novel device would. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Intended Use Equivalence: The device should have the same intended use as the predicate device. | Dermacyn™ Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions, and minor burns, which is similar to the predicate device. |
| Technological Characteristics Equivalence: The device should have similar technological characteristics or demonstrate that different characteristics do not raise new questions of safety and effectiveness. | The summary states "The product is similar in function and intended use to Saljet Single Dose Sterile Saline Topical Solution...". The non-clinical testing further aimed to confirm "safe and effective performance... as compared to 0.9% sterile saline" and "demonstrated the biocompatibility of the subject device." The core formulation (hypochlorous acid) and its safety and efficacy profile in wound care are not explicitly detailed here, but the equivalence is asserted based on "similar in function." |
| Safety and Effectiveness Equivalence: The device should be as safe and effective as the predicate device. | Non-clinical testing was conducted to confirm the safe and effective performance of Dermacyn™ Wound Care Dressing as compared to 0.9% sterile saline. Preclinical testing also demonstrated the biocompatibility of the subject device. The conclusion states "The Dermacyn™ Wound Care Dressing is substantially equivalent to the currently cleared and marketed Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This document refers to "non-clinical testing" and "preclinical testing" but does not detail the sample sizes for these tests. There's no mention of a human "test set" in the context of a clinical performance study.
- Data Provenance: Not specified, but given the nature of non-clinical and preclinical testing, it would typically be laboratory-based rather than patient data.
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. This is not a study that involves expert review or ground truth establishment in the context of diagnostic accuracy or equivalent performance. The evaluation is based on scientific testing related to the product's formulation and biocompatibility, as compared to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human "test set" or adjudication process described.
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
Not applicable. This device is not an AI-powered diagnostic or assistive tool, nor does the document describe a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a topical solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the traditional sterile saline wound dressing, to which the new device is compared in terms of its properties and intended use. The non-clinical and preclinical tests would have generated data on properties like sterility, pH, antimicrobial activity (if applicable, though not explicitly stated as a primary function here), and biocompatibility, using established laboratory methods.
8. The sample size for the training set
Not applicable. There is no machine learning or AI component that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
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MAY - 3 2005
| 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 | Zachary WoodsonQA/RA ManagerTel: (707) 782-0792Fax: (707) 782-0705E-mail: zwoodson@oculusis.com |
| Date Prepared | February 1st, 2005 |
| Trade Name | Dermacyn™ Wound Dressing |
| Common Name | Topical Solution |
| Classification Name | Solution, Wound Dressing |
| Predicate Device | Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/vSodium Chloride |
| Description | The subject device is an 8 ounce polyethylene bottle containingDermacyn™ Wound Care Dressing intended for multi-use. |
| Indications for Use | For use in moistening and lubricating absorbent wound dressings fortraumatic wounds, cuts, abrasions and minor burns. |
| Substantial Equivalence | The product is similar in function and intended use to Saljet SingleDose Sterile Saline Topical Solution manufactured by WinchesterLaboratories LL and includes among its labeled uses for moisteningand lubricating absorbent wound dressing. |
| Non-clinicalPerformance | Non-clinical testing was conducted to confirm the safe and effectiveperformance of Dermacyn™ Wound Care Dressing as compared to0.9% sterile saline. Preclinical testing also demonstrated thebiocompatibility of the subject device. |
| Conclusion | The Dermacyn™ Wound Care Dressing is substantially equivalentto the currently cleared and marketed Saljet Single Dose SterileSaline Topical Solution, 0.9% w/v Sodium Chloride. |
510(k) Summary of the Dermacyn™ Wound Dressing
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles facing to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2007
Mr. Zachary J. Woodson QA/RA Manager Oculus Innovative Science, Inc. 1129 North McDowell Boulevard Petaluma, CA 94954
Re: K041161
Trade Name: Dermacyn™ Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 1, 2005 Received: February 2, 2005
Dear Mr. Woodson:
This letter corrects our substantially equivalent letter of May 3, 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 (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 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.
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Page 2 – Mr. Zachary J. Woodson
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.
This letter will allow you to continue 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/dsma/dsmamain.html
Sincerely yours,
pol Dolo R Del Ansitol
Mark N Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K041161
Device Name: Dermacyn™ Wound Dressing
Dermacyn™ Wound Dressing is intended for use in moistening and Indications for Use: Delinacyn - Wound Dressings for traumatic wounds, cuts, abrasions and minor burns.
X Prescription Use _ (Part 21 CFR 801 Subpart D)
: "
AND/OR
Over-The-Counter Use _ (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)
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