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.

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.

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.

AI/ML Overview

The provided 510(k) summary for the Dermagran Wound Management System (K970660) describes the device and its intended use, but it does not contain the level of detail typically found in modern AI/ML device submissions regarding acceptance criteria, specific performance metrics, or detailed study methodologies that would be required to answer all the questions comprehensively.

This submission predates the widespread use of AI/ML in medical devices and focuses on demonstrating substantial equivalence to predicate devices through comparisons of characteristics and general safety testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Acceptance Criteria and Study for Dermagran Wound Management System (K970660)

The submission for K970660 does not present a formal table of quantitative acceptance criteria with corresponding device performance metrics in the way a modern AI/ML submission would. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to existing predicate devices (Dermagran Wound Cleanser with Zinc and Dermagran-B Hydrophilic Wound Ointment) and demonstrating safety. The "study" mentioned consists of a series of non-clinical and limited clinical evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
Acute Toxicity absent	Components did not produce any toxicity in rabbits.
Sub-chronic Toxicity absent	Components did not produce any toxicity in rabbits.
Delayed Contact Hypersensitivity absent	No signs of delayed hypersensitivity in guinea pigs.
Dermal Sensitivity absent	No significant signs of sensitivity in human volunteers.
Effectiveness (Substantial Equivalence):
Provides wound cleansing	System functions as a wound cleanser, similar to predicate.
Provides primary cover/filler	System functions as primary cover/filler, similar to predicate.
Absorbs exudate	System absorbs exudate, similar to predicate.
Creates moist, mildly acidic environment	System creates moist, mildly acidic environment, similar to predicate.
Conducive to wound healing & autolytic debridement	System is conducive to wound healing & autolytic debridement, similar to predicate.
Usable for indicated wounds (lacerations, abrasions, post-surgical, ulcers, incisions, partial burns)	Clinical studies demonstrated components, when used as a system, provide the same benefit as predicate devices for indicated wounds.

2. Sample Size Used for the Test Set and Data Provenance

Toxicity Studies (Rabbits, Guinea Pigs): The document states "components were tested to determine the acute and sub-chronic toxicity in rabbits" and "Delayed contact hypersensitivity was determined in the guinea pig model." Specific sample sizes for these animal studies are not provided.
Dermal Sensitivity (Human Volunteers): "Human volunteers were tested for dermal sensitivity." The number of human volunteers is not specified.
Clinical Studies: "several clinical studies were performed which demonstrated that the components when used as a system provide the same benefit as the predicate devices." The number of patients/cases in these clinical studies is not specified.
Data Provenance: Not explicitly stated, but the studies were conducted by Derma Sciences, Inc. or their contractors. Given the 1997 submission date, it's highly likely these were retrospective or concurrent studies commissioned for the submission, likely from the USA (where Derma Sciences, Inc. is located).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as the concept of "ground truth" established by experts for performance evaluation (as would be done for an AI/ML device) is not directly applicable to this type of device and submission. The clinical studies likely relied on standard clinical assessments by treating clinicians rather than a panel of independent experts establishing a "ground truth" for an algorithm's output.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers independently interpret images or data, and their disagreements need to be resolved to establish a ground truth for algorithm comparison. This was not the nature of the studies described for the Dermagran Wound Management System.

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

No, an MRMC comparative effectiveness study was not done.
This type of study is relevant for diagnostic devices (especially imaging-based AI) where the aid enhances human reader performance. The Dermagran system is a topical wound management product, not a diagnostic AI device. The comparison was to predicate devices to establish substantial equivalence in function and patient benefit.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

No, standalone performance was not done.
This concept is specific to AI algorithms. The Dermagran system is a physical product (wound cleanser and ointment) designed for direct application, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context would implicitly be clinical observation of wound healing/management outcomes and the absence of adverse events, assessed by clinicians using standard medical practice. For the safety studies, the "ground truth" was derived from direct physiological responses in animal models (toxicity, hypersensitivity) and human volunteers (dermal sensitivity). For effectiveness, it was based on the observed benefits of wound cleansing, creation of a moist environment, and contribution to healing, in comparison to the known effects of the predicate devices.

8. Sample Size for the Training Set

Not applicable/provided. The Dermagran Wound Management System is a physical product, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable/provided. As it is not an AI model, there is no "training set" or ground truth for it.

Summary of Device and Evidence:

The Dermagran Wound Management System is a combination of an existing wound cleanser and an existing hydrophilic wound ointment, marketed together for convenience. The 510(k) submission primarily relies on demonstrating that:

The components are identical to previously cleared predicate devices.
The combined system maintains the safety profiles of its individual components (demonstrated through animal toxicity, hypersensitivity studies, and human dermal sensitivity tests).
The system, when used together, provides the same benefits and characteristics as the individual predicate devices (e.g., cleansing, moist environment, exudate absorption, conducive to healing for various wound types), supported by "several clinical studies."

The FDA's clearance (K970660) indicates that the agency found the device to be substantially equivalent to the predicate devices based on this evidence, with specific labeling limitations added to prevent overstating claims (e.g., no labeling for third-degree burns, no accelerating effect on healing, not a long-term dressing or artificial skin, not a treatment/cure).

Summary

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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

K954743

Dermagran-B Hydrophilic Wound Ointment K944491. K954739 and K963603

Description of the Device:

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K 970660

Intended Use:

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

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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.

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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:

1. This device may not be labeled for use on third degree burns.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. 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).

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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

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INDICATIONS FOR USE

510(k) Number K970660

Device Name Dermagran® Wound Management System

Indications for Use

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

O Over-the Counter Use

TOTAL P.04

Regulation Number and Section

§ 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.