(365 days)
Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride
Not Found
No
The summary describes a wound dressing solution and its intended use, with no mention of AI or ML technology.
No
The device is a wound dressing used for moistening and lubricating absorbent wound dressings, not for active therapeutic treatment of disease or injury beyond basic wound care.
No
The device is a wound dressing intended for moistening and lubricating absorbent wound dressings. Its purpose is to treat wounds, not to diagnose them.
No
The device description clearly states it is a polyethylene bottle containing a wound care dressing, which is a physical 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 lubricating wound dressings for external wounds (traumatic wounds, cuts, abrasions, minor burns). This is a topical application for wound care, not for testing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The device is a bottle containing a wound care dressing. This aligns with a topical wound care product, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for external wound management.
N/A
Intended Use / Indications for Use
For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.
Product codes
FRO
Device Description
The subject device is an 8 ounce polyethylene bottle containing Dermacyn™ Wound Care Dressing intended for multi-use.
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 Dressing as compared to 0.9% sterile saline. Preclinical testing also demonstrated the biocompatibility of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAY - 3 2005
| 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 | Zachary Woodson
QA/RA Manager
Tel: (707) 782-0792
Fax: (707) 782-0705
E-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/v
Sodium Chloride |
| Description | The subject device is an 8 ounce polyethylene bottle containing
Dermacyn™ Wound Care Dressing intended for multi-use. |
| Indications for Use | For use in moistening and lubricating absorbent wound dressings for
traumatic wounds, cuts, abrasions and minor burns. |
| Substantial Equivalence | The product is similar in function and intended use to Saljet Single
Dose Sterile Saline Topical Solution manufactured by Winchester
Laboratories LL and includes among its labeled uses for moistening
and lubricating absorbent wound dressing. |
| Non-clinical
Performance | 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. |
| Conclusion | 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. |
510(k) Summary of the Dermacyn™ Wound Dressing
1
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.
2
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
3
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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