(389 days)
Not Found
No
The description focuses on the physical and chemical properties of a wound dressing and its ointment, with no mention of AI or ML capabilities.
Yes.
The device is intended to manage various types of wounds, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a wound dressing for managing various types of wounds, and its function is to keep the wound moist and prevent adherence. It does not perform any diagnostic function to identify or assess a condition.
No
The device description clearly states it is a physical wound dressing made of cellulose acetate mesh impregnated with an ointment, and it undergoes gamma irradiation for sterility. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "wound dressing to manage pressure ulcers... skin irritations, cuts, and abrasions." This describes a device applied externally to the body for therapeutic purposes (wound management).
- Device Description: The description details a physical dressing with an impregnated ointment designed to interact with the wound surface.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (on the body) for wound care.
N/A
Intended Use / 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.
For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K862163, K973507, K942459, K944468
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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1
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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160
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service" in bold, black font. The text is stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image is a black and white seal. The seal is circular and contains an image of a bird in the center. The bird is facing to the right and has three lines that make up its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle and "INSTITUTE OF" is written around the bottom of the circle.
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.
3
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
4
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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