NEOSALUS Cream is fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application.

AI/ML Overview

The provided text describes NEOSALUS Cream, which is a non-sterile formulation intended for topical application to manage various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria or a detailed performance study with reported metrics for NEOSALUS Cream. The claim of substantial equivalence is based on the new device being a modified version of an already approved predicate device.

Instead, the submission states:

Criterion/Performance Aspect	Reported Device Performance
Intended Use	NEOSALUS Cream is a non-sterile formulation intended for topical application. It is intended for prescription use for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis.
Substantial Equivalence	"Based on the 510(k) summaries (21CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Food Drug and Cosmetic Act."
Predicate Device Equivalence	"The predicate device referenced is non-sterile formulation that is applied topically to relieve the symptoms of various types of dermatoses."

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

The document does not mention any specific sample sizes for a test set. This type of 510(k) submission for a cream/drug product often relies on chemical formulation comparisons and intended use similarity to a predicate, rather than a clinical performance study with a test set. There is no information on data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as no clinical or performance test set, requiring expert-established ground truth, is described. The approval is based on substantial equivalence to a predicate, not on a novel performance claim that would necessitate such expert evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable as no specific test set requiring adjudication is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices or diagnostic algorithms where human readers' performance is compared with and without AI assistance. This submission is for a topical cream, which does not involve such an evaluation.

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

No, a standalone performance study was not done. This concept is relevant for artificial intelligence algorithms. NEOSALUS Cream is a topical medication and does not involve an algorithm.

7. The Type of Ground Truth Used:

No specific ground truth (expert consensus, pathology, outcomes data, etc.) was explicitly stated as being used for performance evaluation because a clinical performance study with a test set is not detailed. The basis for approval is substantial equivalence to the predicate device in terms of formulation and intended use.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is a pharmaceutical cream, not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. As there is no training set mentioned, there is no ground truth establishment process for it.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria, in this context, is the demonstration of substantial equivalence to an already legally marketed predicate device (NEOSALUS, K070309) under the Food, Drug, and Cosmetic Act. The acceptance criteria essentially revolve around the new device having the same intended use and similar technological characteristics (e.g., being a non-sterile, topically applied formulation for dermatoses) as the predicate device, leading to a conclusion of safety and effectiveness without the need for new, extensive clinical trials. The provided document serves as the "summary" of how this equivalence was established.

Summary

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K090585
page 1 of 2

APR - 2 2009

510(K) SUMMARY N

510(K) Summary

Pursuant to Section 12 Part (a) (i) 3A of the Safe Medical Devices Act of 1990 Quinnova Pharmaceuticals, Inc. is providing a summary of the safety and effectiveness information available for NEOSALUS Cream as well as the substantial equivalence decision making process used for NEOSALUS Cream.

Sponsor/Applicant Name and Address:

Quinnova Pharmaceuticals, Inc. 411 South State Street 3rd Floor Newtown, PA 18940

Sponsor Contact Information:

Shahbaz Khan, M.D. - Associate Director Phone: 215-550-2005 Fax: 215-860-8265 e-mail: skhan@quinnova.com

Date of Preparation of 510(k) Summary:

February 01, 2009

New Device Trade/Proprietary Name:

NEOSALUS Cream

Device Common/Classification Name:

Dressing. Wound and Burn. Hydrogel with Drug and/or Biologic

Predicate Device/s Name and 510(k) Number/s:

NEOSALUS (K070309)

Device Description:

Intended Use:

NEOSALUS Cream is a non-sterile formulation intended for topical application. It is intended for prescription use for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis.

Performance Data:

The predicate device referenced is non-sterile formulation that is applied topically to relieve the symptoms of various types of dermatoses.

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K090585
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Conclusions:

Based on the 510(k) summaries (21CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Food Drug and Cosmetic Act.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized wing shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2009

Quinnova Pharmaceuticals % Shahbaz Khan, M.D. Associate Director 411 S. State Street, 3rd Floor Newton, Pennsylvania 18940

Re: K090585

Trade/Device Name: NEOSALUS Cream Regulatory Class: Unclassified Product Code: FRO Dated: February 26, 2009 Received: March 9, 2009

Dear Dr. Khan:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Shahbaz Khan, M.D.

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pa (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarle, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

For
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

Indications for use

510(k) Number (if known): K090585

Device Name: NEOSALUS Cream

Indications for Use: NEOSALUS Cream is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 if needed)

Concurrence of CDRH-Office of Device Evaluation [ODE]

Daniel Krone for MXM 4/1/2000

(Division S (Division Sign-On)
Division of General, Restorative, Division of or or ogical Devices

510(k) Number K090563

Regulation Number and Section

N/A