(16 days)
Not Found
No
The 510(k) summary describes a topical cream and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated to manage and relieve symptoms of various dermatoses, maintaining a moist environment beneficial to healing, which demonstrates a therapeutic purpose.
No
The provided text for HylatopicPlus™ Cream describes a topical product used to manage and relieve symptoms of skin conditions and maintain a moist skin environment. It is not used to identify or diagnose a disease.
No
The device description clearly states it is a "topical product" and a "cream," indicating it is a physical substance applied to the skin, not software.
Based on the provided information, HylatopicPlus™ Cream is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the product as a topical cream applied to the skin to manage and relieve symptoms of various dermatoses. This is a direct application to the body for therapeutic purposes.
- Device Description: The description reinforces that it's a topical product forming a physical barrier on the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, not applied directly to the body for treatment or symptom relief.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional. HylatopicPlus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process.
HylatopicPlus Cream is indicated for use in:
- Atopic Dermatitis
- Allergic Contact Dermatitis
- Radiation Dermatitis
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
Device Description
HylatopicPlus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. The HylatopicPlus forms a physical barrier that helps to maintain a moist wound and skin environment. This is a prescription device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Page 1/2
510(k) Summary
510(k) Owner's Name
PreCision Dermatology, Incorporated 400 Highland Corporate Drive Cumberland, RI 02864 Device Establishment Registration Number: Registration active but number not yet assigned
Contact Individual
Ronald M. Gurge, Ph.D. Associate Director, Product Research & Development PreCision Dermatology, Incorporated 401-762-2000, Extension 41 401-658-2167 (fax) rgurge(@precisionderm.com
Date Summary Prepared
March 14, 2011
510(k) Device Name
| Proprietary Name: | HylatopicPlus™ Cream |
|---|---|
| Common/Usual Name: | Dressing, Wound & Burn, Hydrogel w/drug and/or biologic |
| Classification Name: | Dressing, Wound & Burn, Hydrogel w/drug and/or biologic |
| Panel: | General & Plastic Surgery |
| CFR Number: | Unclassified |
| Product code: | MGQ |
Devices to Which New Device is Substantially Equivalent
Hylatopic™ Plus Emollient Foam cleared December 7th, 2009 under 510(k) K093051, from Collegium Pharmaceutical, Inc. PreCision Dermatology acquired the legal rights to 510(k) K093051 and thus PreCision has full ownership for the Hylatopic Plus Emollient Foam predicate device.
Device Description
HylatopicPlus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. The HylatopicPlus forms a physical barrier that helps to maintain a moist wound and skin environment. This is a prescription device.
APR - 1 2011
1
K110727 page 2/2
Intended Use of the Device
Under the supervision of a healthcare professional. HylatopicPlus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process.
Device Description and Comparison
A detailed description of the proposed device and its comparison to the predicate device is located in Section 3 of this submission. Both the proposed and referenced predicate devices are oil-in-water emulsions containing humectant and emollient components which donate moisture to the skin and form a semi-permeable physical barrier protecting the skin from exogenous irritants. In the packaging, both the predicate and proposed devices are in the form of a cream. When dispensed. the predicate device forms a foam; during application, the propellant dissipates and the device returns to a cream form as it is spread on the skin. The predicate device is thus a cream form in the packaging and on application to the skin, as is the proposed device. Both the proposed and predicate devices are non-sterile and are applied topically to relieve the symptoms of various dermatoses. A comparison of the intended use and labeling of the proposed and predicate device is located in Section 4 and Appendix 6. All labeling changes consisted of the removal of aerosol specific text and changes to the name and logo of the company marketing the device. PreCision intends to market both the predicate and proposed devices.
Substantial Equivalence
Section 4 of this submission describes the substantial equivalence of the proposed and predicate devices in detail. In summary both devices:
- · Have identical indicated uses
- · Have identical operating principles
- · Are both oil-in-water emulsions that are applied topically
- · Contain identical device components at identical quantities
- · Have identical shelf-lives
- · Are manufactured by identical procedures
Therefore HylatopicPlus Cream is substantially equivalent to the previously cleared Hylatopic™ Plus Emollient Foam.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
PreCision Dermatology, Inc. % Ronald M. Gurge, Ph.D. Associate Director, Product Research and Development 400 Highland Corporate Drive Cumberland, Rhode Island 02864
APR - 1 201
Re: K110727
Trade/Device Name: HylatopicPlus™ Cream Regulatory Class: Unclassified Product Code: FRO, MGQ Dated: March 14, 2011 Received: March 16, 2011
Dear Dr. Gurge:
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 Ameridments, 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. 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
3
Page 2 - Ronald M. Gurge, Ph.D.
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/ReportaProblem/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Aling B. R. ta
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known): K 110727
Device Name: HylatopicPlus™ Cream
Indications For Use:
Under the supervision of a healthcare professional, HylatopicPlus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
HylatopicPlus Cream is indicated for use in:
- · Atopic Dermatitis
- · Allergic Contact Dermatitis
- · Radiation Dermatitis
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kramer for MXM
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110727