(211 days)
Not Found
No
The document describes a topical wound dressing and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
This device is a wound dressing emulsion intended for topical use in the management of various skin conditions and wounds, including dermal ulcers, burns, and dermatitis, which categorizes it as a therapeutic device.
No.
The document describes a wound dressing that is applied topically to manage wounds; it does not describe any diagnostic function.
No
The device is described as a "preserved emulsion intended to be used as a topically applied preparation" and is provided in a "collapsible tube." This clearly indicates a physical product (a wound dressing in a tube) and not a software-only device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of SONAFINE® Wound Dressing is for topical application to wounds and skin to maintain a moist environment and aid in management. This is a direct application to the body for therapeutic or protective purposes.
- Device Description: The device is described as a "preserved emulsion intended to be used as a topically applied preparation." This further reinforces its external application nature.
- Lack of In Vitro Testing: IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The performance studies mentioned for SONAFINE® are related to cytotoxicity, irritation, sensitization, and stability – all tests related to its safety and properties for topical application, not for analyzing biological samples.
- Anatomical Site: The anatomical site is "Breached and intact skin, full and partial thickness wounds," etc., which are external body surfaces.
- No Mention of Diagnostic Purpose: The indications for use describe managing wounds and skin conditions, not diagnosing them.
In summary, SONAFINE® Wound Dressing is a topical medical device intended for direct application to the skin and wounds, not for testing biological samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
SONAFINE® Wound dressing provides a moist wound environment. SONAFINE® 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.
As a prescription product a physician is needed to diagnose the disease condition and is indicated for the management and relief of the burning and itching associated with various types of dermatosis, including atopic dermatosis, allergic contact dermatitis and radiation dermatitis.
As an OTC product the product is indicated for the management of minor cuts, minor burns, and minor lacerations.
Product codes
MGQ, FRO
Device Description
SONAFINE® 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
Breached and intact skin
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
SONAFINE® 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 (Exhibit II) indicated a grade 0 cytotoxic grade. ISO Intracutaneous reactivity (Irritation) testing indicates a non-irritant (Exhibit III). Repeat Patch Dermal Sensitization Test (Buehler Method) indicates the product is a non-sensitizer (Exhibit IV). Stability has been demonstrated over a three (3) month period at Room Temperature and accelerated conditions and was found to maintain the products attributes and characteristics.
SONAFINE® Wound Dressing has not been studied in a clinical setting.
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
Page 1 of 2
Confidential Phone: 305-254-6793 Stratus Pharmaceutical Inc. FAX: 305-254-0199 12379 SW 130th Street Miami, FL 33186 AUG 1 9 2011 ahoyo@bellsouth.net "510(k)" Premarket Notification: K110172, SONAFINE® Wound Dressing
510(k) Summary
Summary Information:
- . Submitters Name and Address: Stratus Pharmaceutical 12379 SW 130th Street Miami, Florida 33186
- Contact Person: Alberto Hoyo . President Phone: 305-254-6793 E-Mail: ahoyo@bellsouth.net
- User Fee ID Number: MD 6051830-956733 .
- Date of Summary Preparation: September 30, 2010 ●
- Name of Device: .
- Proprietary: SONAFINE® Wound Dressing O
- Common: Dressing Wound and Burn Hydrogel w/Drug or Biologic O
- Classification Name: Dressing Wound and Burn Hydrogel w/Drug or Biologic o
- . Medical Device Classification: Unclassified
- . Product Code: MGQ
- Identification of predicate devices to which substantial equivalence is being claimed: .
| o MimyX™ Cream | Stiefel Laboratories | K041342 |
|---|---|---|
| o BIAFINE® | ||
| Wound Dressing Emulsion | Medix Pharma | K964240 |
| o PruMyx™ Cream | PruGen Inc. | K082089 |
- Description of the Device: SONAFINE® Wound Dressing is a preserved emulsion ● intended to be used as a topically applied preparation to breached and intact skin and
1
K110172
page 2 of 2
Phone: 305-254-6793
Confidential Stratus Pharmaceutical Inc. 12379 SW 130th Street Miami, FL 33186 ahoyo@bellsouth.net
FAX: 305-254-0199
"510(k)" Premarket Notification: K110172, SONAFINE® Wound Dressing
is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
- Intended use of the Device: SONAFINE® Wound dressing provides a moist wound ● environment. SONAFINE® 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.
- As a prescription product a physician is needed to diagnose the disease condition o and is indicated for the management and relief of the burning and itching associated with various types of dermatosis, including atopic dermatosis, allergic contact dermatitis and radiation dermatitis.
- As an OTC product the product is indicated for the management of minor cuts, o 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.
- . Non-Clinical Performance Data: SONAFINE® 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 (Exhibit II) indicated a . grade 0 cytotoxic grade.
- ISO Intracutaneous reactivity (Irritation) testing indicates a non-irritant . (Exhibit III).
- Repeat Patch Dermal Sensitization Test (Buehler Method) indicates the . product is a non-sensitizer (Exhibit IV).
- Stability has been demonstrated over a three (3) month period at Room . Temperature and accelerated conditions and was found to maintain the products attributes and characteristics.
SONAFINE® Wound Dressing has not been studied in a clinical setting.
End of Summary
2
Image /page/2/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 lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stratus Pharmaceutical % Mr. Alberto Hoyo Presiodent 12379 SW 130th Street Miami, Florida 33186
AUG 1 9 2011
Re: K110172
Trade/Device Name: SONAFINE® Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 1, 2011 Received: August 2, 2011
Dear Mr. Hoyo:
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 10 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
3
Page 2 - Mr. Alberto Hoyo
CFR Part 807); labeling (21 CFR Part 801); medical device 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.
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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark A. Millican
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Phone: 305-254-6793
Confidential Stratus Pharmaceutical Inc. FAX: 305-254-0199 12379 SW 130th Street Miami, FL 33186 ahoyo@bellsouth.net "510(k)" Premarket Notification: K110172, SONAFINE® Wound Dressing
Indications for Use
510(k) Number: K110172
Device Name: SONAFINE® Wound Dressing
Indications for Rx Use:
- SONAFINE® Wound Dressing is indicated for topical use in the management of full . and partial thickness wounds including dermal 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 .
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
Indications for OTC use:
SONAFINE® Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations.
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
Contraindications:
- Contraindicated for individuals with a known sensitivity to the components ● contained in the formulation
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Nail Kune ku NXM
(Division Slun-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110172