(235 days)
Not Found
No
The summary describes a wound care solution that operates through mechanical action and contains a preservative. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for use under the supervision of healthcare professionals for cleansing, irrigating, moistening, and debriding various types of wounds, which falls under the scope of therapeutic treatment.
No
The device is a wound care solution that cleanses, irrigates, moistens, and debrides wounds, and its mechanism of action is based on the mechanical flow of the solution to remove debris, not on diagnosing conditions.
No
The device is a liquid solution wound cleanser, which is a physical substance, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Nexodyn AOS Wound Care Solution is for "cleansing, irrigating, moistening and debriding" wounds. These are actions performed on the body (in vivo) to treat a physical condition.
- Mechanism of Action: The mechanism of action is described as "mechanical action of the solution flowing through the lesion and removing biological and inert materials." This is a physical process applied to the wound, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the composition and application of the solution to the wound.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition by examining samples from the body (like blood, urine, tissue, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Nexodyn AOS Wound Care Solution does not fit this definition. It is a wound care product used topically for treatment and management of wounds.
N/A
Intended Use / Indications for Use
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.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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, minor cuts, superficial abrasions and minor skin irritations.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals
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
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 'Antimicrobial Effectiveness Testing', including additional requirements specified by FDA, by an independent laboratory, with a starting inoculum of at least 1 x 10^6 CFU/ml.
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)
- Implantation (ISO 10993-6)
- Sensitization (ISO 10993-10)
- Skin Irritation (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Stability testing to validate a:
- 2 year shelf life
- 30 day in-use life
- Bulk batch analysis and test, including:
- appearance
- colour
- pH
- ORP
- chlorine assay
- chloride assay
- conductivity
- microbiological tests
- Device batch analysis and test, including:
- appearance
- pH
- ORP
- conductivity
- total chlorine assay
- free chlorine assay
- chloride assay
- microbiological tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
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.
1
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
2
Indications for Use
510(k) Number (if known) K151168
Device Name Nexodyn AOS Wound Care Solution
Indications for Use (Describe)
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.
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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Image /page/3/Picture/1 description: The image shows a logo with the letters "APR" in a stylized font. The "A" is represented by a geometric shape with red and orange hues on the left side of the logo. The "P" and "R" are blue and have horizontal lines running through them. The overall design is modern and abstract.
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 SA |
| Via Corti 5 | |
| 6828 Balerna | |
| Switzerland | |
| 510(k) Owner: | APR Applied Pharma Research SA |
| Via Corti 5 | |
| 6828 Balerna | |
| Switzerland | |
| Phone: | |
| Fax: | +41 91 695 7020 |
| +41 91 695 7029 | |
| 510(k) Submitter and Contact: | Mr Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome | |
| Italy | |
| Phone: +39 06 578 2665 | |
| Fax: +30 06 574 3786 | |
| Email: 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 under |
| the supervision of healthcare professionals for cleansing, | |
| irrigating, moistening and debriding, to remove organic and | |
| inorganic debris from partial or full thickness acute and chronic | |
| dermal lesions, such as leg ulcers, stasis 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 cuts, minor burns, superficial | |
| abrasions 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 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.
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 '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 , '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.