Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosolbased emollient foam. 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. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Hylatopic TM Emollient Foam is indicated for use in:

· Atopic Dermatitis
Allergic Contact Dermatitis
Radiation Dermatitis .

Device Description

Hylatopic™ Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called Hylatopic™ Emollient Foam. It focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information elements cannot be fully extracted as they are typical for a study demonstrating analytical or clinical performance of a diagnostic or therapeutic device through specified metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or quantitative measures of clinical effectiveness) and therefore no reported performance against such criteria. The submission is for substantial equivalence to predicates, implying similar intended use and safety profiles.

2. Sample size used for the test set and the data provenance:

Not applicable. The document does not describe a clinical study with a "test set" in the context of device performance evaluation. The submission is based on comparison to predicate devices and functional/performance testing of the product itself.

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

Not applicable. There is no mention of a "test set" requiring expert-established ground truth for device performance evaluation.

4. Adjudication method for the test set:

Not applicable. No "test set" and corresponding adjudication method are described.

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 device is a topical Emollient Foam, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. There is no mention of a "ground truth" as typically defined for performance studies of diagnostic or AI devices. The basis for the 510(k) is substantial equivalence, functional testing, and intended use as an emollient foam.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning model that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning model.

Summary of what the document does state regarding "Tests and Conclusions":

"Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Emollient Foam and all results are satisfactory."

This statement indicates that internal testing was performed to ensure the device met its functional specifications and was safe for its intended use. However, it does not provide details on:

Specific acceptance criteria for this testing (e.g., pH limits, viscosity, stability, microbiological purity, etc.).
The actual results of these tests.
Whether these tests involved human subjects or were solely bench/lab tests.

The 510(k) process for this type of device (a topical emollient foam) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices with the same intended use and similar technological characteristics, rather than extensive clinical efficacy trials against strict performance metrics. The stated "Tests and Conclusions" are sufficient for a 510(k) submission where substantial equivalence is the primary pathway to market.

Summary

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c8/3024 1/3

510 (k) Premarket Notification CONFIDENTIAL

SECTION 2

510(K) Summary

2. 510(k) Summary

Image /page/0/Picture/6 description: The image shows the logo for Collegium Pharmaceutical. The logo consists of the letters "CP" on the left, with the word "COLLEGIUM" in all caps on the top right and the word "Pharmaceutical" on the bottom right. The letters and words are in a simple, sans-serif font.

2.1 510(k) Owner's Name

Collegium Pharmaceutical, Incorporated 400 Highland Corporate Drive Cumberland, RI 02864 Device Establishment Registration Number: Collegium Pharmaceutical intends to register as a manufacturer of medical

devices.

Contact Individual 2.2

Ronald M. Gurge, Ph.D. Associate Director, Product Research & Development Collegium Pharmaceutical, Incorporated 401-762-2000, Extension 41 401-762-2043 (fax) rgurge@collegiumpharma.com

2.3 Date Summary Prepared

October 7, 2008

2.4 510(k) Device Name

Proprietary Name: Common/Usual Name: Classification Name: Panel: CFR Number: Product code:

Hylatopic™ Emollient Foam Dressing, Wound & Burn, Hydrogel w/drug and/or biologic Dressing, Wound & Burn, Hydrogel w/drug and/or biologic General & Plastic Surgery Unclassified MGQ

fax 401 762 2043 400 Highland Corporate Drive · Cumberland, RI · 02864

MAR 2 7 2009

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510 (k) Premarket Notification CONFIDENTIAL

SECTION 2 510(k) SUMMARY (Cont'd)

2.5 Devices to Which New Device is Substantially Equivalent

. Sinclair (Atopiclair™) Wound and Skin Emulsion approved under 510(k) K024367, from Sinclair Pharmaceuticals, Ltd.
MimyX™ Cream cleared approved 510(k) K041342, from Stiefel Laboratories, Inc. .
Locobase® Wound and Skin Emulsion approved under 510(k) K060272, from . Ferndale Laboratories, Inc.

2.6 Device Description

2.7 Intended Use of the Device

Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosol-based emollient foam. 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. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin enviromment, which is beneficial to the healing process.

Hylatopic™ Emollient Foam provides a non-steroidal alternative for the management of symptoms associated with various types of dermatoses.

Summary of Technological Characteristics of the Device Compared to the Predicate 2.8 Devices

All predicate devices referenced are non-sterile, emulsion/gel/cream types that are applied topically to relieve the symptoms of various dermatoses. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The rubbed in product is equivalent to a gel or cream.

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KOY 30-24 3/3

510 (k) Premarket Notification CONFIDENTIAL

SECTION 2 510(k) SUMMARY (Cont'd)

2.9 Tests and Conclusions

Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Emollient Foam and all results are satisfactory.

2.10 Performance Standards

To the best of our knowledge there are no performance standards applicable to these devices that have been adopted under section 514 of the Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle is stylized with three thick lines forming its body and wings. The seal is circular and appears to be in black and white.

Public Health Service

MAR 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Collegium Pharmaceutical, Incorporated % Ronald M. Gurge, Ph.D Associate Director, Product Research & Developoment 400 Highland Corporate Drive Cumberland, Rhode Island

Re: K083024

Trade/Device Name: Hylatopic™ Emollient Foam Regulatory Class: Unclassified Product Code: MGQ Dated: March 24, 2009 Received: March 25, 2009

Dear Dr. Gurgc:

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 - Ronald M. Gurge, Ph.D

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,

L. Aimer. 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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K09 3024 1//

510 (k) Premarket Notification CONFIDENTIAL

SECTION 1 SUBSECTION 1.8

GENERAL INFORMATION

Statement of Indications for Use

1.8 Statement of Indications for Use

510(k) Number (if known): This submission

Device Name: Hylatopic™ Emollient Foam

Indications For Use:

Hylatopic TM Emollient Foam 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 Krone for MXU 3/27/09

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083024

Regulation Number and Section

N/A