episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy).

Device Description

episil® is a medical device constituting an oromucosal liquid in a multidose container and is without active pharmaceutical ingredient. The oromucosal liquid transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid. episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/ Stomatitis (may be caused by chemotherapy or radiotherapy). The oromucosal liquid is made of six ingredients including glycerol dioleate, soy phosphatidyl choline, ethanol, propylene glycol, polysorbate 80, and peppermint oil, which are all GRAS for the intended use.

AI/ML Overview

The provided text describes the 510(k) submission for episil® (K101769) and its substantial equivalence to the predicate device, Gelclair Concentrated Oral Gel (K013056).

However, the provided text does not contain explicit acceptance criteria in a quantitative format (e.g., a specific percentage reduction in pain, or a minimum effect size). Instead, it states that episil® is "as safe and effective as the Gelclair Concentrated Oral Gel" and that "Performance data has been provided which demonstrates the minor differences between episil® and the predicate device raises no new issues of safety or effectiveness."

The study described is a comparative clinical trial.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Safety: No new issues of safety compared to predicate device.	Systemic toxicity testing in Syrian hamsters (including oral irritation) showed no new safety concerns.
Effectiveness (Pain Management): Similar reduction in oral pain compared to predicate device.	"The study showed that patients receiving episil® had less pain and required significantly less pain medication and parenteral nutrition than the control group."
	"The results show a significant reduction of oral pain which is similar to the reduction of pain reported in the literature for the predicate device Gelclair® (Lindsay et al. (2009), Australian Nursing Journal, 16 (9), 30)."
Effectiveness (Reduced Medication/Nutrition Dependence): Implied, as a benefit of reduced pain.	"required significantly less pain medication and parenteral nutrition than the control group."

Note Regarding Acceptance Criteria: The provided text does not state explicit, quantitative acceptance criteria that the device had to meet (e.g., "reduce pain by X%"). Instead, the acceptance is based on demonstrating "substantial equivalence" to the predicate device, K013056, in terms of safety and effectiveness, and showing "no new issues of safety or effectiveness." The clinical study's outcome of "significant reduction of oral pain which is similar to the reduction of pain reported in the literature for the predicate device" served as the primary evidence for effectiveness.

2. Sample Size and Data Provenance for the Test Set

Sample Size: The text states, "A randomized, repeat dose study of episil® in bone marrow transplant patients suffering from oral mucositis, was performed where episil® was given three times daily during 7 days together with cryotherapy compared against cryotherapy alone." The exact number of patients in the study is not specified in the provided document. It refers to "patients receiving episil®" and a "control group" but doesn't give a numerical count.
Data Provenance: The country of origin of the data is not specified. The submitter is Camurus AB (Sweden), and the additional correspondent is Premier Research Group, Ltd. (USA), but this doesn't directly indicate where the clinical trial was conducted.
Retrospective or Prospective: The study is described as "A randomized, repeat dose study," which indicates a prospective clinical trial design.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the text. The study involved "bone marrow transplant patients" suffering from oral mucositis, and outcomes like "less pain," "significantly less pain medication," and "parenteral nutrition" were measured. These are likely patient-reported outcomes or clinical assessments, but the role of experts in establishing a "ground truth" (e.g., for pain scores or mucositis grading if that was part of the assessment) is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial comparing episil® against cryotherapy alone for pain management in oral mucositis. This is a direct patient-outcome study, not a study involving human readers interpreting cases with and without AI assistance.
Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable and not reported.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. episil® is a medical device (an oromucosal liquid/gel), not an AI algorithm. Its performance is directly measured in patients, not as a standalone algorithm.

7. Type of Ground Truth Used

The ground truth used was based on clinical outcomes reported by or observed in patients. This includes patient-reported pain levels, and clinical data on the need for pain medication and parenteral nutrition. It is not expert consensus on images, pathology results, or long-term outcomes data in the sense of a diagnostic device.

8. Sample Size for the Training Set

This information is not applicable/not provided. episil® is a physical medical device (liquid/gel), not a machine learning model or algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided as it's not an AI/ML device requiring a training set.

Summary

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510(k) summary as required by 21 CFR 807.92

Camurus AB, episil® K101769

Submitter's name, address, telephone number, and contact person Camurus AB Ideon Science Park SE-223 70 Lund Sweden Phone: +46 46 286 5730 Facsimile: +46 46 286 5739 Contact person: Fredrik Tiberg, President and CEO

Additional correspondents

Premier Research Group, Ltd. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541 Contact Person: Maureen O'Connell

Date prepared

June 22, 2011

Name of device

Trade name: episil® Common name: Wound dressing Classification name: Unclassified

Predicate device

Gelclair Concentrated Oral Gel (K013056)

Intended use/Indications for use

Device Description

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Substantial Equivalence

episil® is as safe and effective as the Gelclair Concentrated Oral Gel (K013056). episil® has the same intended uses and similar indications for use, characteristics, and modes of action as the predicate device. The mode of action of episil® is achieved in the same manner as the identified predicate device (Gelclair Concentrated Oral Gel (K013056)) which is through the formation of a protective layer over the oral mucosa. episil® and Gelclair Concentrated Oral Gel are used by swirling in the mouth either directly or after mixing with water. Both are provided non-sterile.

The components of episil® have the same function as in the cited predicate device; with a mixture of film-forming excipients, flavors/sweeteners and ingredients required for manufacturing and viscosity.

episil® and the Gelclair Concentrated Oral Gel are both used on the oral mucosa and are both administered by swirling in the mouth. Episil® is recommended for use 2-3 times a day or as needed as is Gelclair Concentrated Oral Gel (K013056).

Performance data has been provided which demonstrates the minor differences between episil® and the predicate device raises no new issues of safety or effectiveness. Thus, episil® is substantially equivalent to the identified predicate device.

Performance Testing

Non-clinical and clinical performance testing was performed to support substantial equivalence claims. episil® conducted systemic toxicity testing in Syrian hamsters including oral irritation testing.

A randomized, repeat dose study of episil® in bone marrow transplant patients suffering from oral mucositis, was performed where episil® was given three times daily during 7 days together with cryotherapy compared against cryotherapy alone. The study showed that patients receiving episil® had less pain and required significantly less pain medication and parenteral nutrition than the control group.

The results show a significant reduction of oral pain which is similar to the reduction of pain reported in the literature for the predicate device Gelclair® (Lindsay et al. (2009), Australian Nursing Journal, 16 (9), 30). Therefore, Camurus has determined that episil® is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows a 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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract figures or waves.

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

Camurus AB C/O Ms. Maureen O'Connell Regulatory Consultant Premier Research Group, Limited 5 Timber Lane North Reading, Massachusetts 01864

1 3 2011

Re: K101769

Trade/Device Name: Episil® Regulation Number: Unclassified Regulation Name: Dressing, Wound and Burn, Hydrogel with Drug and /or Biologic Regulatory Class: Unclassified Product Code: MGQ Dated: August 15, 2011 Received: August 16, 2011

Dear Ms. O'Connell:

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.

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Page 2 -- Ms. O'Connell

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 regencies. 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 to: tegli (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH/CDRH/CDRHOPfices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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), pleasing the 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-fire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "CAMURUS" in all capital letters, with a symbol to the left of the word. The symbol appears to be a stylized caduceus, which is a traditional symbol of medicine. The text is in a simple, sans-serif font, and the overall design is clean and professional. The image is likely a logo or branding element for a company or organization with a connection to medicine.

Date: June 18, 2010

Indications for use statement

510(k) Number (if known): K101769

Device Name: Episil®

Indications for Use:

Episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to Epishing has a mechanical action indicated for the mass etiologies, including Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy).

Prescription Use____X__ AND/OR Over-The-Counter Use_

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runoe

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K161769

CONFIDENTIAL AND PROPRIETARY INFORMATION

Regulation Number and Section

N/A