(394 days)
Not Found
No
The 510(k) summary describes a topical wound dressing emulsion and its performance in standard biocompatibility tests. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
Yes
The device is intended for topical use in the management of full and partial thickness wounds, including dermal ulcers, leg ulcers, superficial wounds, first and second-degree burns, and various dermatoses, all of which are conditions that require a therapeutic effect.
No
The device is a wound dressing indicated for the management of wounds and skin conditions by maintaining a moist environment, not for diagnosing medical conditions.
No
The device description clearly states it is a "preserved emulsion intended to be used as a topically applied preparation," indicating a physical substance, 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 topical management of various types of wounds and skin conditions. This involves applying the product directly to the skin to create a moist environment for healing.
- Device Description: The device is described as a "preserved emulsion intended to be used as a topically applied preparation to breached and intact skin."
- Mechanism of Action: The description focuses on maintaining a moist wound and skin environment, which is a physical effect on the tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a topical wound dressing, which falls under a different regulatory category.
N/A
Intended Use / Indications for Use
- Rx Indications for Use: DermaFINE Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include: Radiation Dermatitis, Various types of dermatoses, Atopic dermatitis, Allergic contact dermatitis, Dry waxy skin by maintaining a moist wound and skin environment.
- OTC Indications for Use: DermaFINE Wound Dressing Emulsion is indicated for the management of minor cuts, minor burns, and minor lacerations by maintaining a moist wound and skin environment.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
DermaFINE Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (breached and intact)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: DermaFINE Wound Dressing has been evaluated in accordance with Part 10-993 of the International Standard Organization (ISO). Standard tests which include:
- Agar Overlay (direct contact) Cytotoxicity testing indicated a grade 0 cytotoxic grade.
- Primary Skin Irritation ISO Direct Contact indicated no erythema, no edema.
- Kligman Maximization Test ISO Direct Contact indicated Grade 1, weak allergenic potential.
- Antimicrobial Preservatives Effectiveness Test.
DermaFINE Wound Dressing has not been studied in a clinical setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a representation of a human figure embracing another, conveying a sense of care and support. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Invado Pharmaceuticals LLC Mr. Edward Kobus President 25 Ravenna Drive Pomona, New York 10970
Re: K140905
Trade/Device Name: DermaFINE Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 24, 2015 Received: April 29, 2015
Dear Mr. Kobus:
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 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
1
Page 2 - Mr. Edward Kobus
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.
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.
David Krause -S
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K140905 |
|---|---|
| Device Name | DermaFINE Wound Dressing |
| Indications for Use ( Describe ) | |
| Rx Indications for Use: | DermaFINE Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include: |
| Radiation Dermatitis | |
| Various types of dermatoses | |
| Atopic dermatitis | |
| Allergic contact dermatitis | |
| Dry waxy skin | |
| by maintaining a moist wound and skin environment. | |
| OTC Indications for Use: | DermaFINE Wound Dressing Emulsion is indicated for the management of minor cuts, minor burns, and minor lacerations by maintaining a moist wound and skin environment. |
| Type of Use ( Select one or both, as applicable ) | |
| [X] Prescription Use (Part 21 CFR 801 Subpart D) [X] Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740
3
Invado Pharmaceuticals LLC 25 Ravenna Drive Pomona, New York 10970 K140905
510(k) Summary
Summary Information:
Submitters Name and Address: Invado Pharmaceuticals LLC 25 Ravenna Drive Pomona, New York 10970
Contact Person:
Edward Kobus President Phone: 866-963-8881 E-Mail: ekobus@invadopharma.com
Date of Summary Preparation: May 8, 2015
Name of Device:
Proprietary: DermaFine Wound Dressing Emulsion for Topical Application Common: Dressing, Wound, Drug Classification Name: Dressing Wound Drug
Medical Device Classification: Unclassified
Product Code: FRO
Identification of predicate devices to which substantial equivalence is being claimed:
| SonaFine Wound Dressing | Stratus Pharmaceutical | K110172 (Principal Predicate) |
|---|---|---|
| MimyX Cream | Stiefel Laboratories | K041342 |
| PruMyx Cream | PruGen Pharmaceutical | K082089 |
Description of the Device: DermaFINE Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
4
Invado Pharmaceuticals LLC 25 Ravenna Drive Pomona, New York 10970 K140905
Intended use of the Device: DermaFINE Wound dressing provides a moist wound environment. The dressing contains methyl paraben, potassium sorbate and propyl paraben which act as preservatives to inhibit microbial colonization within the dressing.
Rx - DermaFINE Wound Dressing is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include:
Radiation Dermatitis Various types of dermatoses Atopic dermatitis Allergic contact dermatitis Dry waxy skin
by maintaining a moist wound and skin environment.
OTC - DermaFINE Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations.
Technology Characteristics: This particular, preserved, formulation does not affect the intended use or alter the fundamental scientific technology of the device. DermaFine Wound Dressing contains the same chemical components as the designated predicate as provided in the Device Comparison Table provided below.
| Parameters | DermaFINE Wound Dressing
K140905 | SonaFINE
K110172 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Rx - DermaFINE Wound Dressing
is indicated for topical use in the
management of full and partial
thickness wounds including dermal
ulcers, leg ulcers, superficial
wounds, first and second degree
burns and donor sites to include:
Radiation Dermatitis
Various types of dermatoses
Atopic dermatitis
Allergic contact dermatitis
Dry waxy skin
OTC - DermaFINE Wound
Dressing is indicated for the
management of minor cuts, minor
burns, and minor lacerations | Rx - SonaFINE Wound Dressing
is indicated for topical use in the
management of full and partial
thickness wounds including dermal
ulcers, leg ulcers, superficial
wounds, first and second degree
burns and donor sites to include:
Radiation Dermatitis
Various types of dermatoses
Atopic dermatitis
Allergic contact dermatitis
Dry waxy skin
OTC - SonaFINE Wound Dressing
is indicated for the management of
minor cuts, minor burns, and minor
lacerations. |
Device Comparison Table
5
Invado Pharmaceuticals LLC 25 Ravenna Drive Pomona, New York 10970 K140905
| Product Code | FRO | FRO |
|---|---|---|
| Rx | Yes | Yes |
| OTC | Yes | Yes |
| Product Description | Emulsion | Emulsion |
| Preserved | Yes | Yes |
| Formulation | purified water, | |
| light mineral oil, | ||
| ethylene glycol monostearate, | ||
| stearic acid, | ||
| propylene glycol, | ||
| paraffin wax, | ||
| squalane, | ||
| avocado oil, | ||
| triethanolamine alginate, | ||
| cetyl palmitate, | ||
| methylparaben (sodium salt), | ||
| propylparaben (sodium salt), | ||
| fragrance | purified water, | |
| light mineral oil, | ||
| ethylene glycol monostearate, | ||
| stearic acid, | ||
| propylene glycol, | ||
| paraffin wax, | ||
| squalane, | ||
| avocado oil, | ||
| triethanolamine alginate, | ||
| cetyl palmitate, | ||
| methylparaben (sodium salt), | ||
| propylparaben (sodium salt) | ||
| Dermal Irritant | No | No |
| Cytotoxic | No | No |
| Dermal Sensitizer | No | No |
| Product Classification | Unclassified | Unclassified |
Non-Clinical Performance Data: DermaFINE Wound Dressing has been evaluated in accordance with Part 10-993 of the International Standard Organization (ISO). Standard tests which include:
- Agar Overlay (direct contact) Cytotoxicity testing indicated a grade 0 cytotoxic grade. .
- Primary Skin Irritation ISO Direct Contact indicated no erythema, no edema .
- . Kligman Maximization Test ISO Direct Contact indicated Grade 1, weak allergenic potential.
- Antimicrobial Preservatives Effectiveness Test .
DermaFINE Wound Dressing has not been studied in a clinical setting.
End of Summary