(421 days)
Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
Xonrid® Gel is a multi-component prescription medical device product. It is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss. Xonrid® Gel contains numerous ingredients that are grouped into several common ingredient classes, including emollients; preservatives; skin conditioning agents; viscosity-increasing agents; emulsifying agents; and binders. Each ingredient is a wellrecognized component of topical cosmetic products that primarily provide the skin conditioning and emollient features of Xonrid® Gel. Xonrid® Gel provides a physical, topical barrier to the skin. The product is packaged in a 75 mL bottle equipped with an airless dispensing system and a cap. The bottle is manually operated, with each pump administering approximately 240 ul of product.
The provided text describes a 510(k) summary for Xonrid® Gel, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through specific acceptance criteria and large-scale clinical trials typically associated with drug approvals or novel high-risk devices.
Therefore, the information you're requesting regarding explicit acceptance criteria and a study dedicated to proving the device meets those criteria (in the way one would for a new drug or high-risk device) isn't present in this document. Instead, the "performance data" sections describe tests conducted to support the substantial equivalence claim.
However, I can extract the available performance data and structure it to best answer your questions based on the provided text.
Here's the breakdown of the information where it is available:
1. A table of acceptance criteria and the reported device performance
As mentioned, explicit, quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy (common for AI/diagnostic devices) are not provided. The performance data focuses on demonstrating safety and functional equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (non-cytotoxic) | Non-cytotoxic (ISO 10993-5:2009) |
| Skin Irritation (low to none) | Slight irritant (Single Application, ISO 10993-10:2010) |
| Skin Irritation (low to none) | Slight irritant (Repeated Application, ISO 10993-10:2010) |
| Delayed Hypersensitivity (non-sensitizing) | Not sensitizing (ISO 10993-10:2010) |
| Bench Performance: | |
| Lenitive Efficacy (expected, or at least not irritant) | Not a skin irritant, no lenitive effect |
| Barrier Effect (demonstrated) | Shows a mechanical barrier effect |
| Washability (complete removal with water) | Completely removed with water |
| Clinical Performance: | |
| Safety (no adverse events) | No adverse events reported |
| Skin hydration, TEWL, elasticity (observed/measured) | Measurements made, but specific "acceptance criteria" values are not stated. The study was "proof-of-concept". |
| Erythema (observed/measured) | Measurements made, but specific "acceptance criteria" values are not stated. The study was "proof-of-concept". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Clinical Study):
- Sample Size: 21 healthy volunteer subjects (11 female, 10 male)
- Data Provenance: Not explicitly stated, but the study was described as a "single-center" study. Country of origin not provided.
- Timing: Prospective (an "early-stage, proof-of-concept" clinical study was conducted).
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 is not applicable as Xonrid® Gel is a topical medical device for skin conditions, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the performance related to biocompatibility and bench tests would be the direct results of the standardized assays and measurements. For the clinical study, the "truth" would be the direct physiological measurements (erythema, hydration, TEWL, elasticity) observed by a blinded evaluator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and study. The clinical study was "evaluator-blind," meaning the assessor of the clinical outcomes was unaware of the treatment assignments, which is a form of blinding to reduce bias.
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. Xonrid® Gel is a topical medical device, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as Xonrid® Gel is a topical medical device, not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Biocompatibility: Standardized assay results (e.g., cell viability for cytotoxicity, skin reaction scores for irritation/sensitization).
- Bench Performance: In vitro measurement results (e.g., microscopic observation of barrier formation, quantitative assessment of washability).
- Clinical Study: Direct physiological measurements (erythema, skin surface hydration, transepidermal water loss, cutaneous elasticity) observed by an evaluator.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning product.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Helsinn Healthcare SA % Ms. Barbara A. Binzak Blumenfeld Buchanan Ingersoll & Rooney PC 1700 K Street Northwest, Suite 300 Washington, District of Columbia 20006
Re: K152533 Trade/Device Name: Xonrid® Gel Regulatory Class: Unclassified Product Code: FRO Dated: September 26, 2016 Received: September 26, 2016
Dear Ms. Blumenfeld:
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 devicerelated 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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) Not assigned
Device Name Xonrid® Gel
Indications for Use (Describe)
Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
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.
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510(K) SUMMARY
I. SUBMITTER
Helsinn Healthcare SA Medical Device Division Via Pian Scairolo 9 6912 Pazzallo - Lugano - Switzerland Phone: +41 91 9852121 Fax: +41 91 9852195
Contact Person: Valentina Tombolini Bossi, Manager, Regulatory Affairs, Medical Device Division Date Prepared: September 3, 2015
II. DEVICE
Name of Device: Xonrid® Gel Product Code: FRO Classification: Unclassified Classification Name: Dressing
PREDICATE DEVICES III.
MimyX® Cream (K041342), Stiefel Laboratories, Inc. [primary predicate] Sinclair Wound and Skin Emulsion™ (K024367), Sinclair Pharmaceuticals, Ltd.
IV. DEVICE DESCRIPTION
Xonrid® Gel is a multi-component prescription medical device product. It is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss.
Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
Xonrid® Gel contains numerous ingredients that are grouped into several common ingredient classes, including emollients; preservatives; skin conditioning agents; viscosity-increasing agents; emulsifying agents; and binders. Each ingredient is a wellrecognized component of topical cosmetic products that primarily provide the skin conditioning and emollient features of Xonrid® Gel. Xonrid® Gel provides a physical, topical barrier to the skin.
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Helsinn Healthcare SA
Xonrid® Gel is applied three times per day (or as needed). The product is packaged in a 75 mL bottle equipped with an airless dispensing system and a cap. The bottle is manually operated, with each pump administering approximately 240 ul of product. The product is intended to be used for less than 30 days, and has a 36-month shelf life when stored at ambient temperature.
V. INDICATIONS FOR USE
Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Topical medical devices such as Xonrid® Gel typically contain ingredients that are different from any other single device. However, these products typically share functional ingredient categories.
MimyX® Cream is selected as the primary predicate because its prescription indication is the most similar to Xonrid® Gel (i.e., neither one is indicated for first and second degree burns, as is Sinclair Wound and Skin Emulsion""). It has several of the same ingredients as Xonrid® Gel, and the functional ingredient classes for each product are largely identical.
Sinclair Wound and Skin Emulsion™ is also selected as a predicate device because it contains sodium hyaluronate, as does Xonrid® Gel. Sinclair Wound and Skin Emulsion" also shares several ingredients with Xonrid® Gel, and the functional ingredient classes for each product are in large part identical.
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination for Xonrid® Gel.
Biocompatibility Testing
Biocompatibility testing meets the criteria of the FDA Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (May 1, 1995). According to that document, Xonrid® Gel is a surface device used on breached or compromised surfaces for prolonged use (24 hours to 30 days). The tests conducted for Xonrid® Gel to support a biocompatibility determination included:
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Helsinn Healthcare SA
- Cytotoxicity Test by Direct Contact (ISO 10993-5:2009) Xonrid® Gel is . non-cytotoxic.
- Skin Irritation Test, Single Application (ISO 10993-10:2010) Xonrid® ● Gel is considered a slight irritant.
- Skin Irritation Test, Repeated Application (ISO 10993-10:2010) Xonrid® ● Gel is considered a slight irritant.
- Delayed Hypersensitivity Test (ISO 10993-10:2010) -- Xonrid® Gel is not . sensitizing.
Performance Testing - Bench
Three performance testing bench studies were completed for Xonrid® Gel, which included the following:
- Comparative in vitro Lenitive Efficacy Evaluation by Reconstructed Human Epidermis ("RHE") – Xonrid® Gel is not a skin irritant, and has no lenitive effect.
- In vitro Barrier Effect Evaluation by RHE Model Xonrid® Gel shows a . mechanical barrier effect.
- Comparative Evaluation of Barrier Effect and Washability -- Xonrid® Gel ● shows a mechanical barrier effect and is completely removed with water.
Performance Testing - Clinical
One early-stage, proof-of-concept, single-center, randomized, evaluator-blind clinical study was conducted on 21 healthy volunteer subjects (11 female, 10 male). Measurements were made under two conditions: (1) product applied before and after UV exposure (UVA + UVB); and (2) product applied after UV exposure (UVA + UVB). Assessments included: (1) erythema; (2) skin surface hydration; (3) transepidermal water loss: and (4) cutaneous elasticity. All subjects completed the study, and no adverse events were reported.
VII. CONCLUSIONS
Based upon the biocompatibility studies, as well as the bench and clinical performance testing, Xonrid® Gel is safe and suitable for the indications for use. The functional ingredient categories are largely identical between Xonrid® Gel and both claimed predicates, MimyX® Cream and Sinclair Wound and Skin Emulsion". Xonride Gel is expected to perform comparably to these predicates under the supervision of a healthcare professional for the management and relief of burning and itching experienced with radiation dermatitis. Xonrid® Gel is also expected to perform comparably to these predicates by helping to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
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