(172 days)
Not Found
No
The summary describes a wound care system consisting of a cleanser and ointment, focusing on their physical and chemical properties for wound healing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is intended for the "management of various skin injuries" and helps in "wound healing and autolytic debridement," which are therapeutic actions.
No
The device is described as a wound management system (cleanser and ointment) used for treatment and healing of various skin injuries, not for diagnosing conditions.
No
The device description explicitly states it contains two physical components: Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Ointment. These are physical substances applied to a wound, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a wound cleanser and primary cover/filler applied directly to the wound on the skin. It focuses on creating a suitable environment for wound healing and debridement.
- Device Description: The description reinforces that the components are applied to the wound and absorb exudate.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a topical wound treatment.
N/A
Intended Use / Indications for Use
Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement. The System is useful in the management of various skin injuries which result in lacerations, abrasions, post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.
Product codes
KMF
Device Description
Dermagran Wound Management System (System) contains two components, Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Ointment. The Systerm, when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement.
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)
The components of the Dermagran Wound Management System were tested to determine the acute and sub-chronic toxicity in rabbits. The results from these studies indicated that the components did not produce any toxicity to the rabbits. Delayed contact hypersensitivity was determined in the guinea pig model. Results from this test did not indicate any signs of delayed hypersensitivity from components of the Dermagran Wound Management System. Human volunteers were tested for dermal sensitivity to the components of the Dermagran Wound Management System. Results from this test did not indicate any significant signs of sensitivity from the components. Finally, several clinical studies were preformed which demonstrated that the components when used as a system provide the same benefit as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K945802, K954743, K944491, K954739, K963603
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
K9.70660
AUG | 2 |997
510(k) PUBLIC SUMMARY
Submitter:
Derma Sciences, Inc. 121 West Grace Street Old Forge, PA 18518
Phone: 717-457-1232 717-457-1793 Fax:
Contact Person: Mary Clark, RN, PA-C Director of Scientific Affairs
Date Summary Prepared: February 4, 1997
Name of the Device: Dermagran Wound Management System
Identification of Predicate Devices: Dermagran Wound Cleanser with Zinc: K945802 and
Dermagran-B Hydrophilic Wound Ointment K944491. K954739 and K963603
Description of the Device:
Dermagran Wound Management System (System) contains two components, Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Ointment. The Systerm, when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement.
The System is useful in the management of various skin injuries which result in lacerations, abrasions. post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.
1
K 970660
Intended Use:
Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conductve to wound healing and autolytic debridement.
The System is useful in the management of various skin injuries which result in lacerations, abrassons. post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.
Comparison of device characteristics to predicate:
Derma Sciences, Inc. presently markets the predicate devices, Dermagran Wound Cleanser with nine and Dermagran-B Hydrophilic Wound Ointment as separate products. The Dermagran Wound Cleanser with zinc is intended to cleanse wound prior to being covered with a dressing and the Dermagran-B Hydrophilic Wound Ointment is used as an occlusive, hydrophilic dressing to cover dermal wounds. Both products are indicated for various wounds such as; dermal ulcers, surgical wounds. abrasions, etc The Systerm, when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment The moist environment created by the System is conducive to wound healing and autolytic debridement These are the same characteristics provided by the predicates.
There is no difference in the design or formulation of the components from that which is described in K945802, K944491, K954739, K954743, K963603.
Labeling of the Dermagran Wound Management System contains the same indications as the predicates
2
Testing for the Dermagran Wound Management System:
The components of the Dermagran Wound Management System were rested to determine the acure and sub-chronic toxicity in rabbits. The results from these studies indicated that the components did not produce any toxicity to the rabbits. Delayed contact hypersensity was determined in the guinea pis model. Results from this test did not indicate any signs of delaved hypersensity.ity from components of the Dermagran Wound Management System.
Human volunteers were tested for dermal sensitivity to the components of the Dermagran Wound Management System. Results from this test did not indicate any significant signs of sensitivity from the components.
Finally, several clinical studies were preformed which demonstrated that the components when used as a system provide the same benefit as the predicate devices.
Conclusion:
Based on the indications for use, the materials used in the device, the performance characteristics it is concluded that the Dermagran Wound Management System is substantially equivalent to Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Wound Ointment.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol inside a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Derma Sciences, Inc. c/o Kenneth Palmer, Ph.D. Senior Technical Advisor Ouintiles-Medical Technology Consultants 15825 Shady Grove Road, Suite 90 Rockville, Maryland 20850
AUG 1 2 1997
Re: K970660
Dermagran® Wound Management System Regulatory Class: Unclassified Product Code: KMF Dated: June 25, 1997 Received: June 27, 1997
Dear Dr. Palmer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
4
Page 2 - Kenneth Palmer, Ph.D.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number K970660
Device Name Dermagran® Wound Management System
Indications for Use
Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System is conducive to wound healing and autolytic debridement.
The System is useful in the management of various skin injuries which result in lacerations, abrasions, post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.
Concurrence of CDRH, Office of Device Evaluation (ODE)
0 Prescription Use (per 21 CFR 801 109)
Division Sign-Off)
Division of General Restorative Devices
K970660
d
O Over-the Counter Use
TOTAL P.04