Professional Use: Wound Cleanser intended for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.

Device Description

The Wound Cleanser is an aqueous solution of sodium hypochlorite, modified with sodium bicarbonate, used as a solution to mechanically cleanse and debride open wounds. The sodium hypochlorite concentration 0.0125% weight / volume.

Sodium hypochlorite is a solution preservative.

AI/ML Overview

Here's the analysis of the acceptance criteria and study information for the given device, based on the provided text:

Device: Wound Cleanser (K090791)

This document describes a 510(k) premarket notification for a Wound Cleanser. The submission aims to demonstrate substantial equivalence to predicate devices (Oculus - Dermacyn - K042729 and Anacapa - Anasept Skin and Wound Cleanser - K073547).

It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria through rigorous clinical trials. Therefore, the "acceptance criteria" here are largely defined by the characteristics and performance of the predicate devices, and the "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to show alignment with these predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Based on Predicate Devices)	Reported Device Performance (Wound Cleanser - K090791)
Indications for Use (OTC)	Mechanical cleansing of dirt and debris from skin, abrasions, minor irritations, cuts, exit sites, and intact skin. (Similar to Anacapa Anasept and Oculus Dermacyn)	Mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. (Identical to predicate Anacapa Anasept and similar to Oculus Dermacyn)
Indications for Use (Professional)	Mechanical cleansing and removal of foreign materials including microorganisms and debris from wounds such as Stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second-degree burns, grafted and donor sites. (Similar to Anacapa Anasept and Oculus Dermacyn)	Mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post-surgical wounds, first and second-degree burns, grafted and donor sites. (Identical to predicate Anacapa Anasept and similar to Oculus Dermacyn)
Formulation/Technology	Similar formulation/technology to Oculus – Dermacyn and Anacapa - Anasept.	Similar formulation/technology to Oculus – Dermacyn and Anacapa - Anasept. (Specifics: Purified Water, Sodium bicarbonate, Sodium Hydroxide, Sodium Hypochlorite)
Sodium Hypochlorite Concentration	Approximately 85 ppm (0.0085%) for Oculus Dermacyn; Isotonic solution for Anacapa Anasept.	0.0125% Weight / volume (This is noted as a difference from the predicate, but stated as not introducing new patient safety issues).
Materials in Patient Contact	Identical to predicate device Oculus – Dermacyn - K042729.	Identical to predicate device Oculus – Dermacyn - K042729. (Implies same materials used in patient contact for the proposed Wound Cleanser as in Oculus Dermacyn).
Biocompatibility	Tested as stated in 510(k) Summary for predicate devices.	Cytotoxicity, Sensitization, Dermal Irritation (Results are not explicitly provided in the summary but it's stated these tests were performed, implying they met acceptable safety profiles for a wound cleanser).
Stability/Shelf-life	Tested as stated in 510(k) Summary for predicate devices.	Shelf-life: 2 years; Time-to-use: 3 months (Once opened/prepared, not explicitly stated how this compares but implies testing was done to support these claims, similar to how predicate devices would have established theirs).
Environment of Use	Hospitals, nursing homes, wound clinics, and pre and post hospitals. (Identical to Anacapa Anasept.)	Hospitals, nursing homes, wound clinics, and pre and post hospitals. (Identical to predicate Anacapa Anasept.)
Contraindications/Warnings	None specified for predicate devices.	Warnings: For external use only, Not for injection, Not for use in or near the eyes, Stop use if redness/irritation/swelling/pain persists, Do not use if sensitive to compounds, Keep out of reach of children. (These are standard for OTC products and wound cleansers, developed to mitigate potential risks.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: This document does not describe a clinical study with a "test set" in the traditional sense of patient data used to evaluate AI performance. Instead, it relies on non-clinical performance testing (biocompatibility, stability) and a comparison of the device's characteristics to its predicate devices. Therefore, the concept of a "test set" from a data provenance perspective (country, retrospective/prospective) is not applicable here.
The tests mentioned (Cytotoxicity, Sensitization, Dermal Irritation) would have used in vitro or in vivo animal models, or potentially human volunteer patch tests for irritation/sensitization, but specific numbers and provenance are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the submission primarily focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing, rather than an expert-adjudicated test set. The "ground truth" for the device's safety and efficacy is implicitly derived from the established safety and efficacy of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the reasons stated above.

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.

This is not an AI-powered device. Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.

This is not an AI-powered device. Therefore, no standalone algorithm performance study was done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests (biocompatibility, stability, shelf-life), the "ground truth" would be established by validated laboratory assays and protocols for assessing endpoints like cell viability (cytotoxicity), inflammatory responses (sensitization, irritation), and chemical degradation over time (stability).
For the overall device, the "ground truth" for its safety and effectiveness is primarily established by the long-standing regulatory approval and clinical use of its predicate devices. The substantial equivalence pathway relies on the understanding that if a new device is sufficiently similar to a legally marketed predicate, it can be presumed safe and effective.

8. The sample size for the training set

This is not an AI-powered device, so there is no concept of a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI-powered device.

Summary of the 510(k) Basis:

The provided document, a 510(k) summary, demonstrates that the Wound Cleanser product achieves substantial equivalence to its predicate devices (Oculus - Dermacyn - K042729 and Anacapa - Anasept Skin and Wound Cleanser - K073547). This is achieved by showing:

Identical/Similar Indications for Use: Both OTC and Professional Use indications are aligned with the predicates.
Similar Formulation/Technology: The core components, while having a slightly different concentration of sodium hypochlorite (0.0125% vs. ~0.0085% for one predicate), are considered similar and the difference is deemed not to introduce new safety issues.
Identical Materials in Patient Contact: Stated as identical to one predicate (Oculus Dermacyn).
Identical Environment of Use: Aligned with one predicate (Anacapa Anasept).
Non-Clinical Performance: Biocompatibility (cytotoxicity, sensitization, dermal irritation) and stability/shelf-life testing were conducted, implicitly meeting acceptable standards as they support the 2-year shelf-life and 3-month use-after-opening claims without raising new safety concerns.

The FDA's review led to a determination of substantial equivalence, meaning the device can be legally marketed based on its similarity to existing cleared devices, rather than requiring a full de novo clinical trial demonstrating independent efficacy and safety.

Summary

{0}------------------------------------------------

510(k) Summary Page 1 of 4 5-Aug-09

AUG
07 2009

Century Pharmaceuticals, Inc. Tel (317) 849-4210 10377 Hague Road Fax (317) 849-4263 Indianapolis, IN 46256 Ross Deardorff - President Official Contact: Wound Cleanser Proprietary or Trade Name: Wound cleanser Common/Usual Name: FRO - Dressing, wound, drug Classification Name/Code: CFR - unclassified - pre-amendment Wound Cleanser Device: Oculus - Dermacyn - K042729 Predicate Devices: Anacapa - Anasept Skin and Wound Cleanser -K073547

Device Description:

Sodium hypochlorite is a solution preservative.

Indications for Use:

OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations.

Professional Use: Wound Cleanser for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.

Patient Population: Patients with acute or chronic wounds.

Environment of Use: Hospitals, nursing homes, wound clinics and pre and post hospitals

4 of 8

{1}------------------------------------------------

510(k) Summary

Summary of substantial equivalenc

	Predicate	Predicate	ProposedWound Cleanser	Features and Performance Characteristics	PredicateOculus - DermacynK042729	PredicateAnacapa - AnaseptK073547	ProposedWound Cleanser
	Oculus – DermacynK042729	Anacapa - AnaseptK073547		Ingredients	Purified Water 99.97%,chloride <200 ppm,chlorate <20ppm,hypochlorous acidhypochlorite < 85 ppm.	Isotonic solutionSodium Hypochlorite	Purified WaterSodium bicarbonateSodium HydroxideSodium Hypochlorite concentration:0.0125% Weight / volume
Indications for Use	Intended for moistening and debridingacute and chronic dermal lesions, suchas pressure ulcers, statis ulcers, diabeticulcers, post-surgical wounds, first andsecond degree burns, abrasions andminor irritations of the skin	OTC: Intended for OTC use formechanical cleansing of dirt and debrisfrom skin abrasions, minor irritations,cuts, exit sites and intact skin	OTC: Wound Cleanser is intended formechanical cleansing of dirt and debrisfrom skin, abrasions, cuts, and minorirritations.	Non-clinical PerformanceBiocompatibilityStabilityShelf-life	Results in very low concentration ofhypochlorous acid and hypochlorite(85 ppm or 0.0085%)Tested as stated in 510(k) Summary	Tested as stated in 510(k) Summary	CytotoxicitySensitizationDermal IrritationShelf-life- 2 yearsTime-to-use- 3 months
		Professional Use: Intended forprofessional use for cleansing andremoval of foreign materials includingmicro-organisms and debris fromwounds such as Stage I-IV pressureulcers, diabetic foot ulcers, port-surgicalwounds, first and second degree burns,grafted and donor sites.	Professional Use: Wound Cleanser formechanical cleansing and debriding acuteand chronic wounds; such as stage I-IVpressure ulcers, diabetic foot ulcers, preand post surgical wounds, first andsecond degree burns, grafted and donorsites.	Contraindications andWarnings	None	None	Warnings:* For external use only* Not for injection* Not for use in or near the eyes* Stop use and ask a doctor ifredness, irritation, swelling orpain persists or increases.* Do not use if sensitive to any ofthe compounds* Keep out of reach of children. Ifswallowed, get medical help orcontact a Poison Control Center
OTC	Prescriptive	OTC	OTC
Prescriptive	Not specified	Prescriptive (Professional use)	Prescriptive (Professional use)
Environments of use		Hospitals, nursing homes, wound clinicsand pre and post hospitals	Hospitals, nursing homes, wound clinicsand pre and post hospitals

5 of 8

{2}------------------------------------------------

510(k) Summary

K090791
3/4

3/4

{3}------------------------------------------------

510(k) Summary Page 4 of 4 5-Aug-09

The Wound Cleanser is viewed as substantially equivalent to the predicate devices because:

Indications -

Identical to predicate Oculus Dermacyn K042729 .
OTC and Professional Use identical to Anacapa Anasept cleanser K073547 .

Formulation / Technology -

Similar formulation / technology used Oculus Dermacyn K042729 and . Anacapa Anasept cleanser - K073547

Materials -

The materials in patient contact are identical to predicate device, Oculus -. Dermacyn - K042729

Environment of Use -

Identical to predicate Anacapa Anasept cleanser K073547 .

Differences -

The differences are:

Concentration 0.0125% weight to volume of sodium hypochlorite .
Any other differences are not significant between the proposed device and the predicate device and do not introduce any new patient safety issues.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Century Pharmaceuticals, Inc.

AUG 0 7 2009

Re: K090791

% ProMedic, Inc. Mr. Paul Dryden

24301 Woodsage Drive

Banita Springs, Florida 34134

Trade/Device Name: Wound Cleanser Product Code: FRO Dated: July 30, 2009 Received: August 4, 2009

Dear Mr. Dryden:

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 application (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{5}------------------------------------------------

Page 2 - Mr. Paul Dryden

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K090791

Indications for Use Statement

Page 1 of 1

510(k) Number:

K090791

Device Name:

Wound Cleanser

Indications for Use:

OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations.

The sodium hypochlorite concentration of 0.0125% weight / volume.

Prescription Use XX	or	Over-the-counter use XX
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K090791

Regulation Number and Section

N/A