(589 days)
Neosalus is indicated for management and relief of irritation associated with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
Neosalus is fragrance-free, water-soluble foam dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. Neosalus is intended for topical application.
This 510(k) summary for Neosalus does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Instead, it's a summary of the device's regulatory submission, focusing on establishing substantial equivalence to predicate devices (Mimyx Cream and Biafine Wound Dressing Emulsion).
Here's a breakdown of why the requested information cannot be provided based on the input:
- Acceptance Criteria and Reported Device Performance (Table): Not mentioned. The document primarily states that the product is a "fragrance-free, water-soluble foam dressing formulated for the management and relief of irritation experienced with various types of dermatoses." It doesn't quantify performance metrics, nor does it set specific thresholds for "relief of irritation."
- Sample Size for Test Set and Data Provenance: Not mentioned. No clinical studies or test sets are described. The "Performance Data" section simply states that predicate devices are "non-sterile formulations that are applied topically to relieve the symptoms of various dermatoses."
- Number of Experts and Qualifications: Not mentioned.
- Adjudication Method: Not applicable as no test set or expert review is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. No human reader studies are described.
- Standalone Performance Study: Not mentioned. The document focuses on the formulation and its intended use, rather than a quantifiable performance study.
- Type of Ground Truth Used: Not mentioned. Since no study is described, no ground truth types are relevant here.
- Sample Size for Training Set: Not applicable as this is not an AI/ML device and no training sets are mentioned.
- Ground Truth for Training Set: Not applicable.
Conclusion from the provided text:
The "Conclusions" section explicitly states: "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 devices under the Food Drug and Cosmetic Act." This indicates that the device was approved based on its similarity to existing, legally marketed devices, rather than a clinical study demonstrating performance against specific acceptance criteria.
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SEP 1 2 2008 510(K) SUMMARY
Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The top line reads "K070309", with each character clearly written. The second line reads "Page 1 of 1", indicating it is the first page of a one-page document. The handwriting is legible, and the text is centered on the image.
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 as well as the substantial equivalence decision making process used for Neosalus.
Sponsor/Applicant Name and Address:
Quinnova Pharmaceuticals, Inc. 411 South State Street 300 Floor Newtown, PA 18940
Sponsor Contact Information:
Jeffrey Day, President and CEO Phone: 215-860-8263 Fax: 215-860-8265 e-mail: JDay@quinnova.com
Date of Preparation of 510(k) Summary:
September 05, 2008
New Device Trade/Proprietary Name:
Neosalus
Device Common/Classification Name:
Dressing. Wound and Burn. Hydrogel with Drug and/or Biologic
Predicate Devices Name and 510(k) Numbers:
Mimyx Cream (K041342) and Biafine Wound Dressing Emulsion (K964240)
Device Description:
Neosalus is fragrance-free, water-soluble foam dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. Neosalus is intended for topical application.
Intended Use:
Neosalus is a non-sterile formulation intended for topical application. It is intended for prescription use for the management and relief of irritation associated with various types of dermatoses including atopic dermatitis and allergic contact dermatitis.
Performance Data: All predicate devices referenced are non-sterile formulations that are applied topically to relieve the symptoms of various dermatoses.
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 devices under the Food Drug and Cosmetic Act.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle emblem, rendered in black, with three overlapping wing-like shapes. Encircling the emblem is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
Quinnova PHarmaceuticals % Mr. Jeffrey Day CEO & President 411 S. State Street, 31d Floor Newtown, Pennsylvania 18940
Re: K070309
Trade/Device Name: Neosalus Regulatory Class: Unclassified Product Code: FRO Dated: September 5, 2008 Received: September 8, 2008
Dear Mr. Day:
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.
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 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.
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Page 2 - Mr. Jeffrey Day
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 Compliance at (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 Postmarket 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.
Mark N Millman
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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Neosalus
Indications for Use:
Neosalus is indicated for management and relief of irritation associated with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
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 IF NEEDED)
Concurrence of CDRH-Office of Device Evaluation [ODE]
(Division Division of General, Restoracive, and Neurological De
510(k) Number 1670307
N/A