(52 days)
The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
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.
The provided text is a 510(k) summary for the Restore Wound Cleanser. This type of regulatory submission historically did not typically include detailed performance studies with acceptance criteria in the same way modern AI/ML device submissions do. My analysis will explain why most of the requested information cannot be found in this document, and what limited information can be extracted.
Based on the provided document, the following information can be extracted or deduced:
The Restore Wound Cleanser is a legally marketed device that gained clearance based on substantial equivalence to predicate devices (Carrington Carra Klenz Wound Cleanser K022670, Allclenz Wound Cleanser K965120, Derma Sciences Dermagran Wound Cleanser with Zinc K945802). Substantial equivalence means that the device has the same intended use, and the same technological characteristics as the legally marketed predicate device, or if there are differences in technological characteristics, these differences do not raise different questions of safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Explanation: This document does not describe specific numerical acceptance criteria or performance metrics for the Restore Wound Cleanser in terms of efficacy or performance compared to a standard. The 510(k) pathway relies on establishing substantial equivalence to a predicate device, not on meeting specific, pre-defined performance thresholds for device functionality in clinical use.
2. Sample size used for the test set and the data provenance
Sample Size for Test Set: Not applicable.
Data Provenance: Not applicable.
Explanation: This 510(k) clearance relied on a comparison of technological characteristics and safety data (biocompatibility) with predicate devices, rather than a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.
Explanation: As no clinical performance study on a test set (with ground truth) was conducted or presented, there were no experts involved in establishing ground truth for such a test set.
4. Adjudication method for the test set
Adjudication Method: Not applicable.
Explanation: No test set requiring expert adjudication was utilized for this 510(k) submission.
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
MRMC Study: No.
Effect Size: Not applicable.
Explanation: This device is a wound cleanser, not an AI/ML diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Standalone Performance Study: No.
Explanation: This device is not an algorithm, so a standalone algorithmic performance study is not applicable.
7. The type of ground truth used
Type of Ground Truth: Not applicable.
Explanation: As there was no clinical performance study requiring a "ground truth" for classification or measurement outcomes, this concept is not applicable. The primary "truth" established in a 510(k) is the safety and effectiveness on par with a predicate device, often supported by bench testing and biocompatibility data.
8. The sample size for the training set
Sample Size for Training Set: Not applicable.
Explanation: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Ground Truth Establishment for Training Set: Not applicable.
Explanation: No training set was used for this device.
Summary of what the document focuses on regarding "proof":
The "study" or evidence provided to prove the device meets acceptance criteria (specifically, being substantially equivalent to predicates) primarily consists of:
- Comparison of Intended Use: The Restore Wound Cleanser has the same intended use (removal of foreign material like dirt and debris from dermal wounds) as the identified predicate devices.
- Comparison of Technological Characteristics: It is a buffered isotonic water-based surfactant solution, similar to the predicates. All are intended for use on low, medium, or high exudating wounds.
- Biocompatibility Testing: The document states that "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 followed principles and guidelines from ISO 10993, FDA G95-1, USP, FHSA, and FDA GLP regulations. This testing demonstrates that the device is "appropriate for its intended use" from a biological safety perspective.
In essence, for this 510(k), the "acceptance criteria" were that the device's intended use and technological characteristics were sufficiently similar to legally marketed predicate devices, and that any differences (including materials) did not raise new questions of safety or effectiveness, supported by biocompatibility testing. No specific performance study in a clinical setting with numerical acceptance criteria, as one might see for an AI/ML diagnostic, was required or performed.
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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
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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 Incorporated2000 Hollister DriveLibertyville IL. 60048 | Joseph S. TokarzDirector, Regulatory AffairsHollister Incorporated2000 Hollister DriveLibertyville, IL 60048Ph: (847) 680-2849Fax: (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.
§ 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.