← Product Code FRO · K123678 # HYALMIX CREAM (K123678) _Igi Laboratories, Inc. · FRO · Dec 16, 2013 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K123678 ## Device Facts - **Applicant:** Igi Laboratories, Inc. - **Product Code:** FRO - **Decision Date:** Dec 16, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Under the supervision of a healthcare professional, Hylamix 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. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist would & skin environment, which is beneficial to the healing process. Hylamix Cream in indicated for use in: Atopic Dermatitis . Allergic Contact Dermatitis . Radiation Dermatitis ● ## Device Story Hylamix Cream is a non-sterile, topical oil-in-water emulsion; functions as a physical barrier to maintain a moist wound and skin environment; protects skin from external irritants; contains humectant and emollient components. Marketed in 100g tubes and 450g jars for prescription use under healthcare professional supervision. Applied topically to manage symptoms of dermatoses; provides relief from burning, itching, and pain; supports healing process. No complex electronics or software involved. ## Clinical Evidence Clinical safety confirmed via human testing. Conducted 48-hour patch test and Repeated Insult Patch Test (RIPT) on human subjects. Results showed no potential for dermal irritation or allergic contact sensitization. Compliant with Declaration of Helsinki, 21 CFR parts 50 & 56, and ICH guideline E6. ## Technological Characteristics Oil-in-water emulsion; contains humectants and emollients. Non-sterile topical cream. Stability tested per USP <51> and USP <61>. Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation). ## Predicate Devices - Hylatopic Plus™ Cream ([K110727](/device/K110727.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for IGI Laboratories. The logo is black and white and features the letters "IGI" in a stylized font. Below the letters is the word "LABORATORIES" in a smaller font. The logo has a sleek and modern design. DEC 16 2013 . ## 510(k) Summary . | Submitter | IGI Laboratories, Inc.
105 Lincoln Ave
P.O. Box 687
Buena, NJ 08310 | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Frederick Weiss
Vice President, Quality
Tel: (856) 697-1441, ext 360
Fax: (856) 697-2259 | | Date Prepared | November 7, 2013 | | Trade Name | Hylamix Cream | | Common Name | Dressing, Wound, Drug | | Classification Name | Dressing, Wound, Drug | | Classification Code | FRO | | Panel | General & Plastic Surgery | | Device Class | Unclassified | | Predicate Device | Hylatopic Plus™ Cream; PreCision Dermatology, Inc. 510(k) K110727 | | Description | Non-sterile, white, fragrance free, topical cream. Hylamix forms a physical
barrier which maintains a moist wound and skin environment, and will be
marketed in a 100 g tube, and 450 g jar as a prescription device. | | Indications for Use | Under the supervision of a healthcare professional, Hylamix 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. Hylamix Cream also helps to relieve dry, waxy skin by
maintaining a moist wound & skin environment, which is beneficial to the
healing process.
Hylamix Cream is indicated for use in:
Atopic Dermatitis Allergic Contact Dermatitis Radiation Dermatitis | | Device Description
and Comparison | A detailed description of the proposed device and its comparison to the
predicate device can be found in Sections 11 and 12 of this submission. Both
the proposed and referenced predicate device are oil-in-water emulsions,
containing humectant and emollient components, which add moisture to the
skin, and form a semi-permeable physical barrier which protects the skin from
external irritants. Both products are non-sterile creams, and are used topically
to relieve symptoms of various dermatoses. A comparison of the intended use
and labeling of the proposed and predicate device can be found in Section13. | | Substantial
Equivalence | The product is similar in function and intended use to Hylatopic Plus™ Cream
manufactured by PreCision Dermatology Inc., and includes identical
ingredients, indicated uses, and operating principles. | | Non-clinical
Performance | Non-clinical testing was conducted to confirm the safe and effective
performance of Hylamix Cream. Cytotoxicity – Agar Diffusion (ISO
109935:2009), Guinea Pig Sensitization, and Primary Dermal Irritation Tests | | | (ISO 10993-10:2010) were performed on the proposed device.
Hylamix Cream has been proven to be:
Non-Cytotoxic based on Agar Diffusion Test (ISO 10993-5).
The subject device elicited a sensitization reaction in guinea pigs and a slight
dermal irritation response in rabbits.
For the stability studies, the product has undergone chemical and
microbiological testing as per USP<51> and USP<61>. The results indicate
that in the closed container the product has a 12 month expiration date. Once
the tube has been opened the duration of use (expiration date) is 9 months. | | Clinical Performance | Several clinical tests were conducted to confirm the safety of Hylamix Cream.
Hylamix Cream has been proven to be:
Non-indicative to have a potential for dermal irritation based on 48 hours Patch
Test on humans, and non-indicative to have a potential for dermal irritation or
allergic contact sensitization based on Repeated Insult Patch Test (RIPT) on
humans. (Declaration of Helsinki, 21 CFR parts 50 & 56, ICH guideline E6). | | Conclusion | Sections 11and 12 describe the substantial equivalence of the proposed device
and the predicate device. The non-clinical and clinical data found in sections 5,
6, 7 confirm the safety of the proposed product. Although slight reactions were
noted in the animal studies, no negative reactions occurred in the human tests.
The identical indicated uses, operating principles and compositions indicate that
Hylamix Cream is substantially equivalent to the currently cleared and
marketed Hylatopic Plus™Cream. | . 105 Lincoln Ave. Buena, NJ 0 Buena, NJ 08310 . Phone: 856.697.1441 Fax: 856.697.2259 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for IGI Laboratories. The logo is black and white and features the letters "IGI" in a stylized font. Below the letters is the word "LABORATORIES" in a smaller, sans-serif font. The logo is simple and modern. : · . . . . {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 IGI Laboratories, Incorporated Mr. Frederick Weiss Vice President, Quality 105 Lincoln Avenue P.O. Box 687 Buena, New Jersey 08310 December 16, 2013 Re: K123678 · Trade/Device Name: Hylamix Cream Regulatory Class: Unclassified Product Code: FRO Dated: November 8, 2013 Received: November 12, 2013 Dear Mr. Weiss: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Mr. Frederick Weiss 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" (2) 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 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, ## Joshua C. Nipper -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Statement of Indications for Use 510(k) Number (if known): K123678 Device Name: Hylamix Cream Indications for Use: Under the supervision of a healthcare professional, Hylamix 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. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist would & skin environment, which is beneficial to the healing process. Hylamix Cream in 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 801 Subpart C) K123678 page 1 of 1 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jiyoung Dang -S --- **Source:** [https://fda.innolitics.com/device/K123678](https://fda.innolitics.com/device/K123678) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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