ANSWER2SKIN™ SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns.

ANSWER2SKIN™ FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.

Device Description

HYDROPERMEATE™ Topical Emulsion consists of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. HYDROPERMEATE™ is a prescription product.

ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are topical emulsions consisting of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are over-the-counter products.

AI/ML Overview

The provided text describes Dermal Life LLC's HYDROPERMEATE™ Topical Emulsion and ANSWER2SKIN™ SUNBURN RELIEF Cream / FIRST AID Cream. It focuses on demonstrating substantial equivalence to a predicate device (BIAFINE™ Wound Dressing Emulsion K964240) rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, an acceptance criteria table and a detailed study description as requested cannot be fully generated from this document because the submission method relies on substantial equivalence to a predicate device for regulatory clearance, not on meeting specific, de novo performance metrics with a dedicated clinical trial to prove efficacy against acceptance criteria.

The document states:

"The Dermal Life product was tested for performance criteria (physical parameters, biocompatibility, human dermal studies for irritation and dermal sensitization)."
"Performance data support that the Dermal Life wound dressing meets its specified criteria."
"Functional and performance testing has been conducted to assess the safety and efficacy of HYDROPERMEATE™ Topical Emulsion and the results support the substantial equivalence to the predicate device."

This indicates that internal performance testing was done to support the substantial equivalence claim, but the details of the acceptance criteria, the specific study design (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance), and the resulting data are not provided in this 510(k) summary. These types of detailed studies are more common for novel devices or those seeking a De Novo classification, where specific performance targets must be met.

Summary based on available information:

Acceptance Criteria (Inferred from regulatory pathway)	Reported Device Performance (Inferred from submission)
Technological Similarities: Device must be technologically similar to the predicate device (BIAFINE™ Wound Dressing Emulsion K964240) in composition and mechanism.	HYDROPERMEATE™ Topical Emulsion, ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are described as "technologically similar" to the predicate device, consisting of approximately 75% purified water, 20% wax (oily) ingredients, and 5% dissolved ingredients like triethanolamine sodium alginate.
Performance Criteria (Safety & Efficacy): The device must demonstrate equivalent safety and efficacy to the predicate device through performance testing. This includes: - Physical parameters - Biocompatibility - Human dermal studies for irritation - Human dermal studies for dermal sensitization	"The Dermal Life product was tested for performance criteria (physical parameters, biocompatibility, human dermal studies for irritation and dermal sensitization). Performance data support that the Dermal Life wound dressing meets its specified criteria." "Functional and performance testing has been conducted to assess the safety and efficacy... and the results support the substantial equivalence to the predicate device." Specific results are not detailed.
Indications for Use: The device's intended use must align with, or be comparable to, the predicate device.	HYDROPERMEATE™'s indications for use align with those commonly found for wound dressings (full thickness wounds, superficial wounds, burns, donor/graft sites, radiation dermatitis, minor abrasions). ANSWER2SKIN™ products have indications for minor burns/sunburns, and minor superficial wounds/abrasions (cuts/scrapes). This aligns with the predicate's general wound dressing utility.

Missing Information (Not available in the provided document):

Sample size used for the test set and the data provenance: Not specified. The document only generically mentions "performance data" and "human dermal studies."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified for this type of submission. Ground truth, in this context, would likely refer to clinical outcomes in the dermal studies, which are not detailed.
Adjudication method for the test set: Not applicable/not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is more common for diagnostic imaging devices, not topical emulsions.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is not an AI/algorithm-based device.
The type of ground truth used: For the dermal studies, the "ground truth" would be the observed biological response (e.g., presence/absence of irritation or sensitization) as evaluated by dermatological assessment. Details are not provided.
The sample size for the training set: Not applicable. This device is not an AI/machine learning device that requires a "training set."
How the ground truth for the training set was established: Not applicable.

In conclusion, the device's acceptance criteria are framed within the context of substantial equivalence to an existing predicate device. The "study" proving this involves performance testing (physical, biocompatibility, dermal irritation/sensitization) to show that the new device performs comparably to the predicate. However, detailed results, sample sizes, and specific methodologies of these supporting studies are not elaborated in this 510(k) summary.

Summary

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K122595

DERMAL LIFE
Advanced Skin Care Solutions

510(k) Summary of Safety and Effectiveness

MAY 01 2013

HYDROPERMEATE™ Topical Emulsion

Manufacturer and Submitter

Company Name:	Dermal Life LLC
Company Address:	13046 Race Track Rd.Tampa, FL 33636
Telephone:	317.669.2229
Contact Person:	William R. Hitchens
Date Summary Prepared:	August 24, 2012

Device

Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:

Dressing, Wound, Drug Wound Dressing Containing Drug Unclassified Unclassified FRO General & Plastic Surgery Unclassified

Substantial Equivalence

This 510(k) submission demonstrates that HYDROPERMEATE™ Topical Emulsion is substantially equivalent to BIAFINE™ Wound Dressing Emulsion (K964240) in both technology and intended use.

Device Description

Indications for Use

The prescription product requires a physician's diagnosis and is indicated as follows:

HYDROPERMEATE™ Topical Emulsion is indicated for use in:

Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers 트
트 Superficial wounds
트 1st and 2nd degree burns, including sunburns
D Dermal donor and graft site management
D Radiation dermatitis
I Minor abrasions

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Image /page/1/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K122595". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.

Image /page/1/Picture/1 description: The image shows the logo for Dermal Life Advanced Skin Care Solutions. The logo features the text "DERMAL LIFE" in a bold, sans-serif font. Below the main text, there is the tagline "Advanced Skin Care Solutions" in a smaller font. There is a graphic to the left of the text that looks like a stylized sun or star.

Summary of Technological Characteristics of the Device Compared to Predicate Device

HYDROPERMEATE™ Topical Emulsion is technologically similar to the predicate device. The Dermal Life product was tested for performance criteria (physical parameters, biocompatibility, human dermal studies for irritation and dermal sensitization). Performance data support that the Dermal Life wound dressing meets its specified criteria.

Conclusion

Functional and performance testing has been conducted to assess the safety and efficacy of HYDROPERMEATE™ Topical Emulsion and the results support the substantial equivalence to the predicate device.

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K122595

DERMAL LIFE
Advanced Skin Care Solutions

510(k) Summary of Safety and Effectiveness

ANSWER2SKIN™ SUNBURN RELIEF Cream ANSWER2SKIN™ FIRST AID Cream

Manufacturer and Submitter

Company Name:	Dermal Life LLC
Company Address:	13046 Race Track Rd.Tampa, FL 33636
Contact Person:	William R. Hitchens
Date Summary Prepared:	August 24, 2012
	Telephone: 317.669.2229

Device

Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:

Dressing, Wound, Drug Wound Dressing Containing Drug Unclassified Unclassified FRO General & Plastic Surgery Unclassified

Substantial Equivalence

This 510(k) submission demonstrates that ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are substantially equivalent to BIAFINE™ Wound Dressing Emulsion (K964240) in both technology and intended use.

Device Description

Indications for Use

ANSWER2SKIN™ SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns.

ANSWER2SKIN™ FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.

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Image /page/3/Picture/0 description: The image shows the text "K122595" at the top. Below that is the logo for "DERMAL LIFE Advanced Skin Care Solutions". The logo includes a stylized plus sign to the left of the text.

Summary of Technological Characteristics of the Device Compared to Predicate Device

ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are technologically similar to one another and also to the predicate device. The Dermal Life products were tested for performance criteria (physical parameters, biocompatibility, human dermal studies for irritation and dermal sensitization). Performance data support that the Dermal Life wound dressings meet its specified criteria.

Conclusion

Functional and performance testing has been conducted to assess the safety and efficacy of ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream and the results support the substantial cquivalence to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Dermal Life LLC % Diane Horwitz, Ph.D., RAC Mandell Horwitz Consultants LLC 2995 Steven Martin Drive Fairfax, Virginia 22031

Re: K122595

Device Name: Hydropermeate Topical Emulsion, Answer2skin Sunburn Relief Cream and Answer2Skin First Aid Cream Regulation Name: Wound Dressing with Drug Regulatory Class: Unclassified Product Code: FRO Dated: March 14, 2013 Received: March 15, 2013

Dear Dr. Horwitz:

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. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

May 1, 2013

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Page 2 - Diane Horwitz, Ph.D., RAC

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D厚Ruimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K122595

Device Name: HYDROPERMEATE™ Topical Emulsion

Indications For Use:

HYDROPERMEATE™ Topical Emulsion is intended to be used as a wound dressing for the following indications:

트 Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers
트 Superficial wounds
I 1st and 2nd degree burns, including sunburns
트 Dermal donor and graft site management
제 Radiation dermatitis
에 Minor abrasions

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)

Jiyoung Dang -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122595

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Indications for Use

510(k) Number: K122595

ANSWER2SKIN™ SUNBURN RELIEF Cream and Device Name: ANSWER2SKIN™ FIRST AID Cream

Indications For Use:

ANSWER2SKIN™ SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunbums.

ANSWER2SKIN™ FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (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)

Jiyoung Dang -S

(Division Sign-Off). Division of Surgical Devices 510(k) Number: K122595

Regulation Number and Section

N/A