(52 days)
Not Found
No
The summary describes a simple wound cleanser solution and its application method, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics associated with algorithmic analysis.
No.
The device is a wound cleanser intended for the removal of foreign material, not for treating or curing a medical condition.
No
The device is a wound cleanser, intended for the removal of dirt and debris from dermal wounds. It does not perform any diagnostic function.
No
The device description clearly states it is a liquid solution in a spray bottle, indicating it 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 the removal of foreign material from dermal wounds. This is a topical application and a physical cleaning process, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a cleaning solution applied externally to a wound. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Lack of Diagnostic Elements: There is no mention of analyzing biomarkers, detecting pathogens, or providing any kind of diagnostic information based on the wound or a sample from it.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This wound cleanser does not fit that definition.
N/A
Intended Use / Indications for Use
The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
Product codes
KMF
Device Description
The Restore Wound Cleanser is a buffered isotonic water based surfactant solution that is a clear colorless slightly viscous liquid that is intended to remove foreign material such as dirt is a debris from dermal wounds. The device can be used on low, medium or high exudating and wounds. The product is available in an 80z. spray bottle. The Restore Wound Cleanser is applied to the dermal wound area using a trigger spray closure that helps facilitate the removal of foreign material such as dirt and debris.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal wounds
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other. The figures are facing to the right and appear to be in motion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 - 2004
Mr. Joseph S. Tokarz Director, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048
Re: K040779
Trade/Device Name: Restore Wound Cleanser Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: March 24, 2004 Received: March 26, 2004
Dear Mr. Tokarz:
This letter corrects our substantially equivalent letter of May 17, 2004 regarding the identification of the Restore Wound Cleanser as a prescription device. The device will be marketed as an over-the-counter (OTC) product.
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.
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.
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Page 2 - Mr. Joseph S. Tokarz
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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milherson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ___ K040779
Device Name:____ Restore Wound Cleanser
Indications For Use:
The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Offic Device Evaluation (ODE)
Mark A. Millerson
Division Division of General, Restorative, and Neurological Devices
510(k) Number K040779
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K040 779
page 1 of 2
MAY 1 7 2004
Hollister Incorporated Restore Wound Cleanser Pre-market notification -510(k)
510(k) Summary
1. Sponsor's name, Address and Contact Person
| Sponsor | Contact Person |
|---|---|
| Hollister Incorporated | |
| 2000 Hollister Drive | |
| Libertyville IL. 60048 | Joseph S. Tokarz |
| Director, Regulatory Affairs | |
| Hollister Incorporated | |
| 2000 Hollister Drive | |
| Libertyville, IL 60048 | |
| Ph: (847) 680-2849 | |
| Fax: (847) 918-3860 |
Date Summary Prepared - March 23, 2004
2. Name of Device:
Restore Wound Cleanser
3. Name of Predicate Device(s)
- · Carrington Carra Klenz Wound Cleanser K022670
- · Allclenz Wound Cleanser K965120
- · Derma Sciences Dermagran Wound Cleanser with Zinc K945802
4. Description of Device
The Restore Wound Cleanser is a buffered isotonic water based surfactant solution that is a clear colorless slightly viscous liquid that is intended to remove foreign material such as dirt is a debris from dermal wounds. The device can be used on low, medium or high exudating and wounds. The product is available in an 80z. spray bottle. The Restore Wound Cleanser is applied to the dermal wound area using a trigger spray closure that helps facilitate the removal of foreign material such as dirt and debris.
5. Statement of Intended Use
The Restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
6. Statement of Technological Characteristics and Substantial Equivalence
The Restore wound cleanser is substantially equivalent to the predicate devices identified in item 3 above in its intended use. All of the wound cleansers are intended for use on dermal wounds and abrasions. The R and the predicate devices are all indicated for high, medium, and low exudating dermal wounds.estore Wound Cleanser
Issues of biomaterial safety or biocompatibility have been addressed based upon biomaterial history or in separate in-vitro or in-vivo laboratory evaluations using licensed commercial reference laboratories. This assessment has been conducted based on the principles
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KOYO779
page 2 of 2
and guidelines established by various governmental regulatory agencies and standard setting organizations.
Among these are the following:
- ISO 10993, International Standard Organization (ISO) Standard --
- General Program Memorandum #G95-1, U.S. FDA Office of Device Evaluation --
- United Stated Pharmacopoeia (USP) --
- Federal Hazardous Substances Act Regulations (FHSA), 16CFR Part 1500 --
- FDA Good Laboratory Practice (GLP) Regulations, 21CFR Part 58
The biocompatibility tests that have been performed demonstrate that the Restore Wound Cleanser is considered appropriate for its intended use.
7. Conclusion
--
Based on the information presented above it is concluded that the proposed Restore Wound Cleanser is safe and effective for its intended use and is substantially equivalent to the identified predicate devices.