SONAFINE WOUND DRESSING

• K Number: K110172
• Device Name: SONAFINE WOUND DRESSING
• Manufacturer: STRATUS PHARMACEUTICAL
• Date Cleared: 2011-08-19 ( 211 days)
• Product Code: FRO , MGQ
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K041342 , K964240 , K082089
• Predicate For: K140905 , K233151

Intended 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.

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.

AI/ML Overview

The provided document, K110172 for SONAFINE® Wound Dressing, does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, a study proving device performance in that context, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML.

Instead, the document details a traditional medical device (wound dressing) and outlines its non-clinical performance data based on established ISO standards.

Here's a breakdown of the available performance data, framed to address the spirit of your request where possible, but highlighting the absence of AI/ML specific information:

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Non-Clinical Performance Data for SONAFINE® Wound Dressing

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria (ISO Standard Tests)	Reported Device Performance
Agar Overlay (direct contact) Cytotoxicity testing (Grade ≤ 1)	Grade 0 cytotoxic grade
ISO Intracutaneous reactivity (Irritation) testing (Non-irritant)	Non-irritant
Repeat Patch Dermal Sensitization Test (Buehler Method) (Non-sensitizer)	Non-sensitizer
Stability over 3 months at Room Temperature & accelerated conditions (Maintain product attributes & characteristics)	Maintained product attributes and characteristics

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The non-clinical tests are standard in vitro and animal models, but the specific number of samples or subjects used for each test (e.g., how many cells for cytotoxicity, how many animals for irritation/sensitization) is not detailed. The provenance is implied to be laboratory testing in accordance with ISO standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. These are laboratory tests with objective endpoints (e.g., cell viability, visual skin reactions). No human expert "ground truth" establishment in the sense of clinical interpretation is described for these non-clinical tests.

4. Adjudication Method

Not applicable. The non-clinical tests have defined protocols for evaluation rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a non-clinical evaluation of a pharmaceutical wound dressing, not an AI/ML diagnostic or assistive device.

6. Standalone Performance (Algorithm Only)

No. This device does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for these non-clinical tests refers to the objective outcomes determined by the standardized test methods themselves (e.g., cell viability measurements for cytotoxicity, observation of skin reactions for irritation/sensitization, analytical measurements for stability).

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned as this is not an AI/ML device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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Crucially, the document explicitly states:

"SONAFINE® Wound Dressing has not been studied in a clinical setting."

This further confirms that no clinical studies, which would be essential for evaluating an AI/ML device's performance, were conducted for this product at the time of this submission.

Summary

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Confidential Phone: [phone] Stratus Pharmaceutical Inc. FAX: [phone] SW 130th Street Miami, FL 33186 AUG 1 9 2011 [e-mail] "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: [phone] E-Mail: [e-mail]
• 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

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K110172
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Phone: [phone]

Confidential Stratus Pharmaceutical Inc. 12379 SW 130th Street Miami, FL 33186 [e-mail]

FAX: [phone]

"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

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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

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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 [phone] or [phone] 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

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Phone: [phone]

Confidential Stratus Pharmaceutical Inc. FAX: [phone] SW 130th Street Miami, FL 33186 [e-mail] "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

Regulation Number and Section

N/A