(29 days)
Not Found
No
The device is a topical cream for dermatoses, and the summary contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML-powered devices.
No
Explanation: The device is described as a cream intended for topical application to manage dermatoses, which typically classifies it as a drug or a topical medical product, not a therapeutic device in the sense of an instrument or machine.
No
The provided text describes NEOSALUS Cream as a topical dressing intended for managing dermatoses. It does not mention any diagnostic capabilities.
No
The device description clearly states it is a "Cream," which is a physical substance and 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 "management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis." This describes a therapeutic or management function applied directly to the patient's skin.
- Device Description: The description states it is a "fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses" and is "intended for topical application." This further reinforces its use as a topical treatment applied to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue, etc., to diagnose or monitor a condition. IVDs are typically used to provide information about a patient's health status based on the analysis of these samples.
Therefore, NEOSALUS Cream is a topical medical device intended for the management of skin conditions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
NEOSALUS Cream is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
Product codes
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The predicate device referenced is non-sterile formulation that is applied topically to relieve the symptoms of various types of dermatoses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NEOSALUS (K070309)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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:
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.
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.
1
K090585
page 2 of 2
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.
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 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
3
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
4
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