Nexodyn AOS Wound Care Solution is intended for use under the supervision of healthcare professionals for cleansing, irrigating, moistening and debriding, to remove organic debris from partial or full thickness acute and chronic dermal lesions, such as leg ulcers, diabetic ulcers, stage I-IV pressure ulcers, post-surgical wounds, grafted and donor sites and 1st and 2nd degree burns, together with cleansing and moistening minor burns, superficial abrasions and minor skin irritations.

Device Description

Nexodyn AOS Wound Care Solution is a clear, liquid solution wound cleanser that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the wound cleanser moving across the wound bed. The device contains hypochlorous acid (HClO) acting as a preservative by inhibiting the growth of microorganisms within the solution.

The principle of operation of Nexodyn AOS Wound Care Solution to be irrigated across the wound being treated, by using bottles with a spray cap or by sluicing with larger quantity of solution from an open bottle.

The mechanism of action of Nexodyn AOS Wound Care Solution is based on the mechanical action of the solution flowing through the lesion and removing biological and inert materials such as microorganisms, biological debris and environmental dirt.

Nexodyn AOS Wound Care Solution is obtained by electrolysis, carried out on a saline solution, the starting raw materials being water and sodium chloride.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Nexodyn AOS Wound Care Solution." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a full-fledged clinical study with performance metrics in the way a new, high-risk device might.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance is not directly applicable in the format requested, as this document is a regulatory submission for substantial equivalence.

However, I can extract the relevant performance data and nonclinical testing that supports the claim of safety and effectiveness, which is the basis for substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for a specific performance metric like sensitivity/specificity are not explicitly stated or demonstrated in the provided text. Instead, the performance is demonstrated by nonclinical testing showing that the device is safe and effective compared to a predicate device.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Microbiological Efficacy	Meet requirements of USP <51> 'Antimicrobial Effectiveness Testing', including FDA specified additional requirements, at lowest available chlorine and end of shelf life.	Microbiological efficacy studies conducted at the lowest specification level of available chlorine and on three date-expired batches demonstrated that device specifications and labeling claims are met at the end of the device's shelf life. Tests were in accordance with USP <51> 'Antimicrobial Effectiveness Testing', including additional requirements specified by FDA, performed by an independent laboratory, with a starting inoculum of at least 1 x 10^6^ CFU/ml. The effectiveness has been demonstrated by successful completion of these tests.
Biocompatibility	Meet relevant ISO 10993 standards.	Biocompatibility testing in accordance with ISO 10993 standards was performed, including Cytotoxicity (ISO 10993-5), Implantation (ISO 10993-6), Sensitization (ISO 10993-10), Skin Irritation (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The safety of the device with its free chlorine content and pH has been adequately demonstrated by these results.
Stability	Validate shelf life and in-use life.	Stability testing validated a 2-year shelf life and a 30-day in-use life.
Batch Analysis	Conformity to specified physical and chemical properties.	Bulk batch analysis and test included appearance, color, pH, ORP, chlorine assay, chloride assay, and microbiological tests. Device batch analysis and test included appearance, pH, ORP, conductivity, total chlorine assay, free chlorine assay, chloride assay, and microbiological tests.

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

Test Set Sample Size: For the microbiological efficacy studies, the starting inoculum was "at least 1 x 10^6^ CFU/ml." The number of batches used was "three date expired batches." The number of organisms or specific samples for biocompatibility and other nonclinical tests are not specified in this summary.
Data Provenance: The microbiological efficacy studies were conducted by an "independent laboratory." The location of this lab and the country of origin are not specified. All tests are non-clinical, not human subject data.

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

This information is not applicable. The studies described are nonclinical (in vitro/laboratory and animal testing for biocompatibility) and do not involve human subjects or expert assessment for establishing ground truth in the context of clinical performance.

4. Adjudication method for the test set:

Not applicable, as this is nonclinical testing and does not involve adjudication by experts.

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 a wound care solution, not an AI-powered diagnostic device, and therefore, no MRMC studies or AI assistance for human readers are relevant.

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

Not applicable. This device is a wound care solution, not an algorithm.

7. The type of ground truth used:

Microbiological Efficacy: The "ground truth" was established by comparing the results against the requirements of USP <51> 'Antimicrobial Effectiveness Testing' and FDA specified additional requirements. This typically involves measuring microbial reduction compared to controls.
Biocompatibility: The "ground truth" was conformity to the relevant ISO 10993 standards. This involves observing biological responses (e.g., cytotoxicity, irritation) against established criteria in those standards.
Stability and Batch Analysis: The "ground truth" was the predefined specifications and analytical methods for the physical, chemical, and microbiological properties of the solution.

8. The sample size for the training set:

Not applicable. This is a physical wound care solution, not an AI model requiring a training set.

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

Not applicable.

Summary

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

December 22, 2015

APR Applied Pharma Research SA c/o Roger Gray Donawa Lifescience Consulting SRL Piazza Albania 10 00153 Rome Italy

Re: K151168

Trade/Device Name: Nexodyn AOS Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: November 25, 2015 Received: November 27, 2015

Dear Mr. Gray:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 mav 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151168

Device Name Nexodyn AOS Wound Care Solution

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary in accordance with 21 CFR 807.92(c)

Device Name:	Nexodyn AOS Wound Care Solution
Type of 510(k) submission:	Traditional
Date of Submission:	29 April 2015
Manufacturer:	APR Applied Pharma Research SAVia Corti 56828 BalernaSwitzerland
510(k) Owner:	APR Applied Pharma Research SAVia Corti 56828 BalernaSwitzerland
Phone:Fax:	+41 91 695 7020+41 91 695 7029
510(k) Submitter and Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItalyPhone: +39 06 578 2665Fax: +30 06 574 3786Email: rgray@donawa.com
FDA Product Code:	FRO
FDA Regulation Number:	N/A - Pre-amendment device
FDA Classification Name:	Dressing, Wound, Drug
Classification Panel:	General and Plastic Surgery
Common Name:	Wound Cleansing Solution
FDA Classification:	Unclassified
Indications for Use/Intended Use:	Nexodyn AOS Wound Care Solution is intended for use underthe supervision of healthcare professionals for cleansing,irrigating, moistening and debriding, to remove organic andinorganic debris from partial or full thickness acute and chronicdermal lesions, such as leg ulcers, stasis ulcers, diabetic ulcersstage I-IV pressure ulcers, post-surgical wounds, grafted anddonor sites and 1st and 2nd degree burns, together withcleansing and moistening minor cuts, minor burns, superficialabrasions and minor skin irritations.

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Image /page/4/Picture/1 description: The image shows a logo with a geometric design. On the left, there is a three-dimensional shape with red and orange hues. To the right of the shape, there are the letters 'APR' in blue. The 'A' has horizontal lines within it, the 'P' has horizontal lines within it, and the 'R' has diagonal lines within it.

Device Description:

Nexodyn AOS Wound Care Solution is obtained by electrolysis, carried out on a saline solution, the starting raw materials being water and sodium chloride.

Performance data:

Microbiological efficacy studies carried out with Nexodyn AOS Wound Care Solution have been conducted at the lowest specification level of available chlorine and on three date expired batches to demonstrate that the device specification and labeling claims are met at the end of the device shelf life. The tests were conducted in accordance with USP<51> 'Antimicrobial Effectiveness Testing', including additional requirements specified by FDA, by an independent laboratory, with a starting inoculum of at least 1 x 106 CFU/ml.

Nonclinical testing:

The following nonclinical tests have been performed on the subject device:

Biocompatibility testing in accordance with the relevant ISO 10993 standards, including: .
- Cytoxicity (ISO 10993-5): o
- Implantation (ISO 10993-6) o
- Sensitization (ISO 10993-10); O
- Skin Irritation (ISO 10993-10); O
- Acute Systemic Toxicity (ISO 10993-11); O
Stability testing to validate a: ●
- 2 year shelf life: o
- 30 day in-use life O
. Bulk batch analysis and test, including:
- appearance; O
- O colour;
- рН; o
- ORP: o
- O chlorine assay:
- chloride assay; O
- conductivity; O
- microbiological tests O
Device batch analysis and test, including: ●
- appearance; O
- pH: O
- ORP: O
- conductivity: O
- total chlorine assay; O
- free chlorine assay; O
- O chloride assay;
- O microbiological tests.

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Image /page/5/Picture/1 description: The image shows a logo with the letters "APR" in a stylized font. The "A" is a geometric shape with a gradient of red and orange on the left side and blue on the right. The "P" and "R" are blue and have horizontal lines running through them. The logo appears to be for a company or organization with the initials "APR".

Substantial equivalence:

The predicate devices selected for comparison with the Nexodyn AOS Wound Care Solution are:

Predicate Device 2:	Vashe Wound Therapy Solution
Sponsor:	PuriCore, Inc.
510(k) Number:	K123072
Clearance Date:	14 February 2013
FDA Product Code:	FRO
Classification Name:	Dressing, Wound, Drug
Regulation No:	Unclassified

The subject device and the predicate devices have many identical or similar properties or features. The only differences that exist are with respect to preservative concentration (i.e. free chlorine content), and solution pH.

The free chlorine content of the predicate devices is higher than Nexodyn AOS Wound Care Solution, being in the range of 100 to 330 ppm versus 40 to 70 ppm.

The pHs of the predicate devices are mildly acidic, being in the range of 3.5 to 6.7. The pH of Nexodyn AOS Wound Care Solution is slightly more acidic, being in the range 2.5 to 3.0.

The safety of Nexodyn AOS Wound Care Solution with this free chlorine content and at this pH has been adequately demonstrated by the results of biocompatibility testing.

The effectiveness of Nexodyn AOS Wound Care Solution has also been demonstrated by successful completion of the tests required by USP <51>, 'Antimicrobial Effectiveness Testing'.

These differences therefore have no significant effect on the safety or effectiveness of the subject device.

Substantial Equivalence Conclusion:

Based on the information contained in this submission, it is concluded that Nexodyn AOS Wound Care Solution is substantially equivalent to the identified predicate devices which are already in interstate commerce within the USA.

Regulation Number and Section

N/A