(172 days)
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.
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.
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).
§ 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.