(147 days)
Indicated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis
NEOCERA Advanced Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. NEOCERA Cream is intended for topical application. This product is to be sold by prescription only.
The provided text describes a 510(k) premarket notification for a medical device called NEOCERA Advanced Barrier Cream. It focuses on establishing substantial equivalence to a predicate device, Neosalus cream. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate device and specific non-clinical and clinical tests. It is essential to note that this document does not describe a study comparing the device against specific, quantitative performance acceptance criteria in the way one might expect for a diagnostic or therapeutic device with measurable outcomes. Instead, it demonstrates safety and biocompatibility to support substantial equivalence.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a topical cream, the "acceptance criteria" are implied by the performance of the predicate device and the regulatory requirements for similar products, particularly for safety and biocompatibility. The "reported device performance" refers to how NEOCERA cream met these implied criteria through specific tests.
| Acceptance Criteria (Implied) | Reported Device Performance (NEOCERA Cream) |
|---|---|
| Safety and Biocompatibility: | |
| - Non-cytotoxic | - Met requirements of ISO 10993-5 (Test for In Vitro Cytotoxicity); not cytotoxic. |
| - Non-irritating (dermal) | - Primary Dermal Irritation Index of 0.67 (on a scale of 0-8), categorized as "slightly irritant" (lower end of 0.5-1.9 range). |
| - Non-sensitizing (allergic contact) | - Did not elicit sensitization reactions in guinea pigs (ISO 10993-10). |
| - Non-irritating/non-sensitizing in humans (dermal) | - No potential for dermal irritation or allergic contact sensitization in humans based on Repeated Insult Patch Test. |
| - Antimicrobial Efficacy | - Met requirements. |
| Functional Equivalence: | |
| - Similar Intended Use and Indications for Use as predicate | - "Management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis." Identical to predicate. |
| - Prescription Use Only | - Yes. Identical to predicate. |
| - Topical Dressing | - Similar to predicate. |
| - Similar Composition (with justifiable differences) | - Similar composition to predicate, with additional ingredients (Ceramide PC-104, Palmitamide MEA, Glycyrrhetinic Acid, Grape seed extract, Petrolatum, higher Dimethicone) previously used in cleared devices for enhanced application. |
| - Non-Sterile | - Non-Sterile. |
| Shelf Life: | |
| - Adequate stability (predicate has 36 months) | - 24 months (on-going stability). This is shorter than the predicate's 36 months but presumably deemed acceptable for initial marketing, with stability testing continuing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cytotoxicity Agar Diffusion: Not specified, but generally involves a standard number of cell cultures.
- Primary Dermal Irritation in Rabbits: Not specified, but rabbit irritation tests typically involve 3-6 rabbits.
- Guinea Pig Closed Patch Sensitization Test: Not specified, but standard guinea pig sensitization studies typically use 10-20 animals per group.
- Repeated Insult Patch Test in Humans: Not specified. These studies can range from 50 to over 200 subjects.
The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though biocompatibility and human patch tests are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes biocompatibility and safety testing for a topical cream, not a diagnostic device requiring expert interpretation of images or clinical findings to establish a "ground truth." The results of the tests (e.g., cytotoxicity, irritation index) are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reported non-clinical and clinical (safety) tests. Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers interpret data (e.g., medical images) and a consensus or tie-breaking mechanism is needed to establish ground truth. The tests performed are objective, laboratory-based, or involve direct observation (like irritation scores) by trained personnel according to standardized protocols.
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
This is not applicable. An MRMC study is designed for evaluating diagnostic devices, particularly those involving human interpretation, and comparing performance with and without AI assistance. This document pertains to a topical cream, not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a topical cream, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given the nature of the device and tests, the "ground truth" is defined by:
- For Biocompatibility (cytotoxicity, irritation, sensitization): Standardized ISO (International Organization for Standardization) protocols and GLP (Good Laboratory Practice) standards are used to generate objective quantitative and qualitative results (e.g., cytotoxicity score, irritation index, presence/absence of sensitization).
- For Human Repeated Insult Patch Test: Direct observation and scoring of skin reactions by trained clinicians or dermatologists against a predefined scale, following Good Clinical Practice (GCP) principles as indicated by adherence to the Declaration of Helsinki, ICH E6, and 21 CFR Parts 50 and 56.
8. The sample size for the training set
This is not applicable. This document describes the testing of a cream, not an algorithm that requires a training set. The term "training set" is relevant for machine learning models.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2017
EXELTIS USA Dermatology, LLC Babu Lad Vice President of Regulatory Affair 180 Park Avenue. Suite 101 Florham Park, New Jersey 07932
Re: K170911
Trade/Device Name: NEOCERA Advanced Barrier Cream Regulatory Class: Unclassified Product Code: FRO Dated: March 23, 2017 Received: July 19, 2017
Dear Babu Lad:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170911
Device Name Neocera Advanced Cream
Indications for Use (Describe)
Indicated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
July 2017 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
5 510(k) K170911 Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR 807.87(h) and (21 CFR 807.92a), the following summary is provided.
Submitter Information 5.1
| Owner's Name: | EXELTIS USA Dermatology, LLC |
|---|---|
| Address: | 180 Park Avenue, Suite 101Florham Park, NJ 07932 |
| Phone: | (973) 324-0200 |
| Fax: | (973) 324-0795 |
Contact Person: Babu Lad, Vice President, Regulatory Affairs
Date of Summary Updated: August 22, 2017
{4}------------------------------------------------
5.2 Product Information
Product Trade Name: NEOCERA™ Advanced Cream
| Common Name: | Wound Dressing |
|---|---|
| Device Classification: | Unclassified |
| Product Code: | FRO |
Device Description
NEOCERA Advanced Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
NEOCERA Cream is intended for topical application. This product is to be sold by prescription only.
Intended Use and Indications for Use
NEOCERA Cream is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
Predicate Device
The chosen predicate device is Neosalus cream (K090585).
| NEOCERA | Predicate Neosalus | |
|---|---|---|
| Intended Use and Indicationfor Use | Management of varioustypes of dermatoses,including atopic dermatitisand allergic contactdermatitis. | Management of varioustypes of dermatoses,including atopic dermatitisand allergic contactdermatitis. |
| Rx Only | Yes | Yes |
Technological Characteristics
NEOCERA Cream is a topical dressing. The chosen predicate device is Neosalus cream (K090585). The two product are very similar in terms of formulation and indication for use. Both device are non-sterile formulations intended for topical application and for prescription use only.
The formulation of NEOCERA Cream helps the product form a semi-occlusive dressing to cover the affected area of the body. The only difference in the formulations of the
Confidential and Proprietary EXELTIS USA Dermatology, LLC
{5}------------------------------------------------
NeoCera Advanced Cream 510(K) K170911
NEOCERA Cream and the predicate is the use of additional ingredients in the NEOCERA Cream formulation. These ingredients although new in the formulation, have been previously used in various cleared devices in the same category as NEOCERA Cream and the Predicate. The ingredients were added to enhance the ease of application. More information has been provided on the additional ingredients in section 10 of this 510 (k) submission (Executive Summary)
Comparison of technological Characteristics between NEOCERA Cream and the Predicate
| TechnologicalCharacteristics | NEOCERA | Neosalus |
|---|---|---|
| Topical Dressing | Same | Same |
| Composition | Similar to predicate | Similar |
| Skin conditioning agents toenhance appearance of dryskin | Present | None |
| Film Former | Present* | Present |
| Preservatives | Present | Present |
| Emulsifier | Present | Present |
- In higher quantity than in predicate (see Table 10.2, Page 32 of original submission)
{6}------------------------------------------------
| Comparison of NEOCERA Cream and Predicate Device Composition | |
|---|---|
| -------------------------------------------------------------- | -- |
| Ingredient | Function | NEOCERA | Neosalus | Medicaldevices Use |
|---|---|---|---|---|
| Purified Water | Solvent | QS | QS | Predicate |
| Carbomer 980 | Thickeningagent | 0.7 | 0.7 | Predicate |
| Stearic Acid | Emulsifyingagent | 6.25 | 6.25 | Predicate |
| Glycerin | Humectant | 1.7 | 1.7 | Predicate |
| Propylene Glycol | Humectant | 5.8 | 5.8 | Predicate |
| Polysorbate 20 | Emulsifyingagent | 1.4 | 1.4 | Predicate |
| Plasdone | Film former | -- | 1.9 | Predicate |
| Triethanolamine | Emulsifyingagent and pHbuffer | 1 | 1.3 | Predicate |
| Phenonip XB | Preservative | 0.5 | 0.5 | Predicate |
| Sodium Hydroxide | pH adjuster | 0.008 | 0.2 | Predicate |
| Dimethicone@ | Film former | 5 | 0.95 | Predicate |
| Petrolatum | Film former | 5 | -- | HylatopicPlus Cream(K110727) |
| Ceramide PC-104 * | Skinconditioningagent | 0.5 | -- | HylatopicPlus Cream(K110727) |
| Palmitamide MEA | Viscositybuilder; Skinconditioningagent | 0.01 | -- | MimyxCream(K041342) |
| Glycerrhetinic Acid | Skinconditioningagent | 0.4 | -- | PruclairCream(K09156)PromisebCream(K050158) |
| Grape seedextract** | Antioxidant | 0.1 | -- | PruclairCream(K09156)PromisebCream(K050158) |
@ Dimethicone is accepted for human use in OTC monograph from 1% to 30% [21 CFR 347.10 (g)] Petroleum and Ceramide
{7}------------------------------------------------
NeoCera Advanced Cream 510(K) K170911
Performance Data
The predicate device is a non-sterile formulation that is applied topically for the management and relief of irritation associated with various types of dermatoses. Non-clinical testing as well as clinical testing were conducted to establish that NEOCERA has a safety and biocompatibility profile similar to the predicate device.
Non-Clinical testing
-
Cytotoxicity Agar Diffusion Report No. V15-2677 (see section 15. Biocompatibility -Page 312)
Cytotoxicity testing was performed under Good Laboratory Practice (GLP) Standards and per ISO 10993-5, part 5: Test for In Vitro Cytotoxicity. The testing demonstrated that NEOCERA cream meets the requirement of the test per ISO 10993-5, and therefore is not cytotoxic. -
Primary Dermal Irritation in Rabbits Report No. T15-1205-01 (see section 15. -Biocompatibility Page 312)
Irritation testing was performed under GLP standards and also according to ISO 10993-10. Biological Evaluation of Medical devices- Part 10: Test for Irritation and Sensitization. The test article, NEOCERA Cream Elicited a primary dermal irritation index of 0.67 on a scale of 0-8. A primary dermal irritation index of 0.67 is categorized as being slightly irritant. We would like to point out that slightly irritant category ranges from 0.5-1.9, and clearly the test article NEOCARA Cream is at the lower end of the range. -
Guinea Pig Closed Patch Sensitization Test Report No. T15-1205-2 (see section 15. Biocompatibility Page 313)
Sensitization testing was also performed under GLP standards and per ISO 10993-10. Biological Evaluation of Medical devices- Part 10: Test for Irritation and Sensitization. Under the conditions of the testing, the test article did not elicit a sensitization reactions in the guinea pigs.
Clinical testing
- Repeated Insult Patch Test in Humans Report No. C15-1204.01 (see section 15. -Biocompatibility Page 313)
This test was perform in accordance with the Declaration of Helsinki. ICH E6. and 21 CFR Parts 50 and 56. The test article NEOCERA Cream did not demonstrate any potential for dermal irritation or allergic contact sensitization in humans.
{8}------------------------------------------------
Biocompatibility Sterilization and Shelf Life
| NEOCERA | Neosalus | |
|---|---|---|
| Biocompatibility (Non –clinical and Clinical testing) | Similar | Similar |
| Sterilization | Non- Sterile | Non-Sterile |
| Antimicrobial EfficacyTesting | Meet requirement | Meet requirement |
| Shelf Life | 24 months ( on goingStability) | 36 months |
Conclusion
Based on its formulation, indication for use, as well as the non-clinical and clinical testing results showing a similar safety profile, we conclude that NEOCERA Cream is substantially equivalent to its predicate device Neosalus cream.
N/A