(381 days)
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
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.
The provided text describes the 510(k) summary for Hylamix Cream, a medical device. It focuses on demonstrating substantial equivalence to a predicate device (Hylatopic Plus™ Cream) rather than establishing performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding a study proving device performance against acceptance criteria, particularly for an AI/algorithm-based device, is not present.
However, I can extract information related to the non-clinical and clinical performance studies conducted to confirm the safety and effectiveness of the Hylamix Cream.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria with corresponding performance metrics in a table format. Instead, it reports the results of safety tests.
| Test Type | Acceptance Standard (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity – Agar Diffusion (ISO 10993-5:2009) | Non-cytotoxic | Hylamix Cream proven to be Non-Cytotoxic. |
| Guinea Pig Sensitization | No sensitization reaction / Acceptable sensitization | The subject device elicited a sensitization reaction in guinea pigs. (Note: This indicates a positive reaction, which might not be an "acceptance," but is a reported finding). |
| Primary Dermal Irritation Tests (ISO 10993-10:2010) | No dermal irritation / Acceptable irritation | The subject device caused a slight dermal irritation response in rabbits. (Note: Similar to sensitization, this indicates a positive reaction). |
| Stability Studies (USP<51> & USP<61>) | Meets chemical and microbiological standards for shelf-life | 12-month expiration date in closed container; 9-month duration of use once opened. |
| 48 hours Patch Test on humans (Dermal Irritation) | Non-indicative of potential for dermal irritation | Hylamix Cream proven to be non-indicative to have a potential for dermal irritation. |
| Repeated Insult Patch Test (RIPT) on humans (Dermal Irritation & Allergic Contact Sensitization) | Non-indicative of potential for dermal irritation or allergic contact sensitization | Hylamix Cream proven to be non-indicative to have a potential for dermal irritation or allergic contact sensitization. |
2. Sample size used for the test set and the data provenance:
- Animal Studies:
- Guinea Pig Sensitization: Sample size not specified.
- Primary Dermal Irritation Tests in rabbits: Sample size not specified.
- Human Studies:
- 48 hours Patch Test on humans: Sample size not specified.
- Repeated Insult Patch Test (RIPT) on humans: Sample size not specified.
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, these studies would have been conducted by or for IGI Laboratories, Inc. The Declaration of Helsinki and 21 CFR parts 50 & 56 (related to human subject protection) are mentioned for the human studies, confirming ethical conduct requirements were followed. Whether these were retrospective or prospective is not specified, but typically pre-market studies are 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 information is not applicable as the studies described are for a topical cream, focusing on safety (cytotoxicity, sensitization, irritation) and stability, not diagnostic performance or image interpretation that would require expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the type of animal and human safety studies 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:
This information is not applicable. The device is a topical cream, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a topical cream, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For cytotoxicity, sensitization, and irritation tests: The "ground truth" would be the observed biological reactions (or lack thereof) in testing models, evaluated against established scientific and regulatory guidelines (e.g., ISO standards).
- For stability studies: The "ground truth" would be the measured chemical and microbiological properties over time, compared to pre-defined specifications.
- For human patch tests: The "ground truth" would be the clinical assessment of skin reactions by qualified personnel, adhering to ethical and scientific standards (Declaration of Helsinki, 21 CFR 50 & 56, ICH guideline E6).
8. The sample size for the training set:
This information is not applicable. The device is a topical cream; there is no "training set" in the context of an AI/algorithm-based device.
9. How the ground truth for the training set was established:
This information is not applicable. As above, there is no training set for this type of device.
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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
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510(k) Summary
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| Submitter | IGI Laboratories, Inc.105 Lincoln AveP.O. Box 687Buena, NJ 08310 |
|---|---|
| Contact Person | Frederick WeissVice President, QualityTel: (856) 697-1441, ext 360Fax: (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 physicalbarrier which maintains a moist wound and skin environment, and will bemarketed 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 indicatedto manage and relieve the burning, itching and pain experienced with varioustypes of dermatoses, including atopic dermatitis, allergic contact dermatitis andradiation dermatitis. Hylamix Cream also helps to relieve dry, waxy skin bymaintaining a moist wound & skin environment, which is beneficial to thehealing process.Hylamix Cream is indicated for use in:Atopic Dermatitis Allergic Contact Dermatitis Radiation Dermatitis |
| Device Descriptionand Comparison | A detailed description of the proposed device and its comparison to thepredicate device can be found in Sections 11 and 12 of this submission. Boththe proposed and referenced predicate device are oil-in-water emulsions,containing humectant and emollient components, which add moisture to theskin, and form a semi-permeable physical barrier which protects the skin fromexternal irritants. Both products are non-sterile creams, and are used topicallyto relieve symptoms of various dermatoses. A comparison of the intended useand labeling of the proposed and predicate device can be found in Section13. |
| SubstantialEquivalence | The product is similar in function and intended use to Hylatopic Plus™ Creammanufactured by PreCision Dermatology Inc., and includes identicalingredients, indicated uses, and operating principles. |
| Non-clinicalPerformance | Non-clinical testing was conducted to confirm the safe and effectiveperformance of Hylamix Cream. Cytotoxicity – Agar Diffusion (ISO109935:2009), 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 slightdermal irritation response in rabbits.For the stability studies, the product has undergone chemical andmicrobiological testing as per USP<51> and USP<61>. The results indicatethat in the closed container the product has a 12 month expiration date. Oncethe 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 PatchTest on humans, and non-indicative to have a potential for dermal irritation orallergic contact sensitization based on Repeated Insult Patch Test (RIPT) onhumans. (Declaration of Helsinki, 21 CFR parts 50 & 56, ICH guideline E6). |
| Conclusion | Sections 11and 12 describe the substantial equivalence of the proposed deviceand 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 werenoted in the animal studies, no negative reactions occurred in the human tests.The identical indicated uses, operating principles and compositions indicate thatHylamix Cream is substantially equivalent to the currently cleared andmarketed Hylatopic Plus™Cream. |
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105 Lincoln Ave.
Buena, NJ 0
Buena, NJ 08310
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Phone: 856.697.1441 Fax: 856.697.2259
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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.
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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
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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
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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
N/A