(389 days)
For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions.
Epi-Max is a cellulose acetate mesh wound dressing (initially in a 2 x 3 in2 size but later with smaller or larger sizes as per market demand) impregnated with 20mg of a petrolatum (polyethylene glycol-based) ointment. This ointment is a blend of PEG 400, PEG 4000, citric acid, a mild proprietary saline solution, and benzoic acid. The ointment is formulated to melt at skin temperature, helping to keep the wound moist and prevent wound-bandage adherence in order to make removal of the wound dressing less painful. Dressings are gamma irradiated for sterility.
This document describes a 510(k) premarket notification for the Epi-Max® wound dressing. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Epi-Max Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Met |
| Non-dermal irritant | Met | |
| 0% sensitization rating | Met | |
| Functionality | Promote a moist wound environment | Yes, due to ointment melting at skin temperature |
| Easier/less painful dressing removal | Yes, due to ointment melting at skin temperature | |
| Sterility | Gamma irradiated for sterility | Met |
| Indications for Use | Identical to Kendall Xeroform Petrolatum Gauze (Predicate) | Met |
Note: The document explicitly states that the Epi-Max's indications for use are "identical to the indications for use made by Kendall Healthcare Products, inc. for their Kendall Xeroform Petrolatum Gauze dressings." This serves as a key acceptance criterion for equivalence in claimed therapeutic application. The listed predicate devices in the 510(k) summary also indicate that the device is intended to be substantially equivalent in its fundamental properties and performance to these established products.
The Study Proving the Device Meets Acceptance Criteria:
The study described is a non-clinical performance study.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "GLP studies" using guidelines from the "10993 ISO Standard." ISO 10993 standards typically require specific sample sizes for various biocompatibility tests, but the exact numbers used for each test are not provided in this summary.
- Data Provenance: The studies were GLP (Good Laboratory Practice) studies, indicating they were conducted under controlled laboratory conditions to ensure data quality and integrity. The country of origin is not specified, but GLP is an internationally recognized standard. These were prospective studies, as they were conducted specifically to evaluate the Epi-Max device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This was a non-clinical, laboratory-based study for biocompatibility. The "ground truth" here is established by the methods and endpoints defined by the ISO 10993 standard for cytotoxicity, irritation, and sensitization, rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set:
Not applicable. Biocompatibility tests have pre-defined endpoints and acceptance criteria (e.g., cell viability for cytotoxicity, dermal reaction scores for irritation, lack of sensitization reactions). Result interpretation is typically based on objective measurements and comparison to these criteria, not subjective expert adjudication in the same way clinical image interpretation might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, and the assessment presented is primarily for its safety (biocompatibility) and functional equivalence to predicate devices, not for its interpretive performance by human readers.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study was not done. This is a physical wound dressing, not a software algorithm.
7. Type of Ground Truth Used:
The ground truth used for the non-clinical performance data was based on standardized test methods and acceptance criteria defined by the ISO 10993 standard for biocompatibility (cytotoxicity, dermal irritation, and sensitization).
8. Sample Size for the Training Set:
Not applicable. Clinical performance data was not provided ("N/A"). The non-clinical biocompatibility studies do not typically involve a "training set" in the context of machine learning or diagnostic algorithm development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, there was no training set in this context.
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CONFIDENTIAL INFORMATION
Koy/1059
510(k) Summary
Applicant Name Dermagenics, Inc. Steve Monroe, Ph.D. 3251 Poplar Avenue, Suite 150 Memphis. TN 38111 Phone: (901) 452-2395 Fax: (901) 452-3885
Date Prepared April 22, 2004
Trade Name Epi-Max®
Common Name Sterile, non-adhesive wound dressing
Classification Name Dressing (General and Plastic Surgery)
Substantial Equivalence
| Predicate Device Name | 510(k) Number |
|---|---|
| Johnson & Johnson Petrolatum Gauze Non Adhesive Dressings | K862163 |
| Kendall Xeroform Petrolatum Gauze | K973507 |
| CURASALT Hypertonic Saline Dressing | K942459 |
| Kerlix Zinc Saline Dressing | K944468 |
Device Description
Epi-Max is a cellulose acetate mesh wound dressing (initially in a 2 x 3 in2 size but later with smaller or larger sizes as per market demand) impregnated with 20mg of a petrolatum (polyethylene glycol-based) ointment. This ointment is a blend of PEG 400, PEG 4000, citric acid, a mild proprietary saline solution, and benzoic acid. The ointment is formulated to melt at skin temperature, helping to keep the wound moist and prevent wound-bandage adherence in order to make removal of the wound dressing less painful. Dressings are gamma irradiated for sterility.
Indications for Use
Epi-Max is indicated for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudates where mild medication and deoderization are desired.
DERMAGENICS, INC.
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5/17/05
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Predicate Devices
Epi-Max is very similar to numerous other non-adhesive petrolatum gauze dressings and wet saline dressings previously approved by the FDA,
Instead of exclusively using either a petrolatum ointment or saline on the gauze, Epi-Max's ointment is a blend of USP-grade polyethylene glycols (PEGs) and a mild, proprietary saline solution buffered with USP-grade citric acid and with USP-grade benzoic acid added as a preservative. This blended ointment is designed to melt at skin temperature when applied to a wound, thus helping to promote a moist wound environment and making the dressing removal process easier and less painful.
Epi-Max's indications for use are identical to the indications for use made by Kendall Healthcare Products, inc. for their Kendall Xeroform Petrolatum Gauze dressings.
Non-clinical Performance Data
Epi-Max has been found to be non-cytotoxic, not a dermal irritant, and has a 0% sensitization rating using GLP studies based upon guidelines presented in the 10993 ISO Standard.
Clinical Performance Data N/A
Non-clinical and Clinical Conclusions Epi-Max is safe for human use.
DERMAGENICS, INC.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAY 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steve Monroe, Ph.D. Vice President - Technology Greystone Medical Group 3251 Poplar Avenue, Suite 150 Memphis, Tennessee 38111
Re: K041059
Trade/Device Name: Epi-Max Impregnated Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2005 Received: April 22, 2005
Dear Dr. Monroe:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Steve Monroe, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled , "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M
AD
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Évaluation Center for Devices and Radiological Health
Enclosure
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K0$\psi$1059
Indications for Use
510(k) Number (if known): K041059
Device Name:
Epi-Max Impregnated Wound Dressing
Indications For Use:
For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions.
、
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restorative
Logical Devices
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