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

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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (HylatopicPlus™ Cream) that is seeking clearance based on substantial equivalence to a predicate device. This type of submission does not typically include a standalone study proving the device meets specific acceptance criteria in the way a new diagnostic or AI-driven device would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

Therefore, many of the requested items (acceptance criteria, device performance metrics, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context because this is a substantial equivalence submission for a topical cream, not a performance study for a diagnostic or AI-based device.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Not Applicable. This submission is for substantial equivalence. The "acceptance criteria" are demonstrating equivalence to a predicate device, not meeting specific performance metrics in a clinical trial designed to prove efficacy against a predefined standard. The reported performance is the "identical intended uses, operating principles, components, quantities, shelf-lives, and manufacturing procedures."

2. Sample sized used for the test set and the data provenance

Not Applicable. There is no "test set" in the context of validating a diagnostic or AI device's performance. The submission relies on comparing the device's characteristics to a predicate, not on a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No "ground truth" was established in the sense of expert consensus on outcomes for a test set. The "truth" is the characteristics of the predicate device.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process as described would have been used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a topical cream, not an AI or diagnostic device that involves human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a topical cream, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate device, which is inferred from its prior 510(k) clearance based on its intended use, formulation, and manufacturing. No new clinical "ground truth" data was generated for the standalone device.

8. The sample size for the training set

Not Applicable. There is no "training set" for a traditional medical device like a cream.

9. How the ground truth for the training set was established

Not Applicable. See above.

Summary of Applicable Information from the Text:

The "study" in this case is the comparison of the new device (HylatopicPlus™ Cream) to a legally marketed predicate device (Hylatopic™ Plus Emollient Foam). The acceptance criteria are implicit in the concept of "substantial equivalence" as defined by the FDA.

Table of "Acceptance Criteria" (Substantial Equivalence Pillars) and Reported Device Characteristics:

"Acceptance Criteria" (Basis for Substantial Equivalence)	Reported Device Performance (HylatopicPlus™ Cream)
Identical Indicated Uses	Yes (Identical indicated uses)
Identical Operating Principles	Yes (Identical operating principles)
Both Oil-in-Water Emulsions Applied Topically	Yes (Both oil-in-water emulsions that are applied topically)
Identical Device Components at Identical Quantities	Yes (Contain identical device components at identical quantities)
Identical Shelf-Lives	Yes (Have identical shelf-lives)
Manufactured by Identical Procedures	Yes (Are manufactured by identical procedures)

Details of the Equivalence Determination:

Predicate Device: Hylatopic™ Plus Emollient Foam (cleared under K093051). PreCision Dermatology, Inc. acquired legal rights to this predicate.
Key Differences (and rationale for equivalence): The proposed device (Cream) is presented as a cream in packaging and on application. The predicate device (Emollient Foam) forms a foam when dispensed, but "during application, the propellant dissipates and the device returns to a cream form as it is spread on the skin." The submission argues that both are effectively in cream form on application to the skin.
Labeling Changes: Consisted of "removal of aerosol specific text and changes to the name and logo of the company marketing the device."

The FDA's clearance letter (K110727) confirms that based on this comparison, the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Summary

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K110727

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

APR - 1 2011

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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.

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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

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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

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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

Regulation Number and Section

N/A