(85 days)
For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional, HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.
HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.
HA Absorbent Wound Dressing is an absorbent fibrous fleece (F) or rope (R), entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid.
Here's a breakdown of the acceptance criteria and study information for the HA Absorbent Wound Dressing, based on the provided text:
HA Absorbent Wound Dressing
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the HA Absorbent Wound Dressing and its substantial equivalence to predicate devices, but does not explicitly state quantitative acceptance criteria or provide specific device performance metrics in numerical form (e.g., absorption rate in mL/cm², healing time in days, etc.).
Instead, the "performance" is demonstrated through:
- Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) based on composition, function, and intended use.
- Biocompatibility Testing: The device passed standard toxicity tests.
Therefore, a direct table of "Acceptance Criteria" and "Reported Device Performance" as typically expected for diagnostic AI/ML devices is not present in this type of submission for a wound dressing. The "acceptance criteria" for clearance in this context are primarily demonstrating substantial equivalence and safety.
| Feature/Criterion | Description of "Acceptance" | "Reported Device Performance" / Evidence from Study |
|---|---|---|
| Material Composition | Equivalent biopolymer composition to predicate device. | HA Absorbent Wound Dressing (HYAFF 11p757M, a benzyl ester of hyaluronic acid) is "entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid," similar to FIBRACOL Collagen-Alginate Wound Dressing. |
| Function - Absorbency | Absorb wound exudate and create a moist wound environment. | HA Absorbent Wound Dressing is an "absorbent fibrous fleece (F) or rope (R)." HA Absorbent Wound Dressing-F is equivalent to FIBRACOL Collagen-Alginate Wound Dressing, which also "absorb wound exudate, and create a moist wound environment." |
| Intended Use (Fleece) | Management of abrasions, lacerations, minor cuts, first-degree burns, leg ulcers, pressure ulcers (I-IV), diabetic ulcers, surgical wounds, second-degree burns, and bleeding-prone wounds. | Indications for Use statement matches predicate device and deemed acceptable by FDA. |
| Intended Use (Rope) | Management of deep exuding wounds, sinuses, and fistulae. | Indications for Use statement matches predicate device and deemed acceptable by FDA. |
| Biocompatibility | Non-toxic, non-hemolytic, negligible irritant, non-cytotoxic, 0% sensitization potential. | "The results of this testing show that Hyalofill Absorbent Wound Dressing has passed toxicity tests and is considered to be non-toxic, non-hemolytic, a negligible irritant, non-cytotoxic, and has shown to have 0% sensitization potential." |
| Contraindications | No known sensitivity to the dressing or its components. | Standard contraindication listed, consistent with similar medical devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not describe a "test set" in the context of an algorithm or AI system evaluation. This submission is for a physical medical device (wound dressing), and its clearance is based on substantial equivalence to predicate devices and biocompatibility testing, not on clinical performance data in a "test set" as understood for AI/ML devices. Therefore, these categories are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. As above, there is no "test set" or "ground truth" establishment for an algorithm in this submission.
4. Adjudication Method for the Test Set:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is not an AI/ML device.
7. Type of Ground Truth Used:
Not applicable in the context of an algorithm. For the physical device, the "ground truth" or basis for acceptance relies on:
- Predicate Device Equivalence: The established safety and effectiveness of the legally marketed predicate devices.
- Biocompatibility Standards: Pre-defined standards for biological safety testing of medical devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device.
Summary for the HA Absorbent Wound Dressing (K984388):
This submission is for a physical medical device (a wound dressing), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and "study" as typically applied to AI performance (e.g., sensitivity, specificity, F1-score on a test set) is not directly applicable.
The "study" in this context refers to biocompatibility testing and the comparison to predicate devices to demonstrate substantial equivalence and safety. The acceptance criteria for clearance were primarily based on:
- Demonstrating the HA Absorbent Wound Dressing is substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) in terms of materials, intended use, and fundamental function.
- Passing a series of biocompatibility tests to ensure the material is safe for its intended use (non-toxic, non-hemolytic, negligible irritant, non-cytotoxic, 0% sensitization potential).
The FDA's decision letter (K984388) confirms the device's substantial equivalence and outlines specific labeling limitations, which effectively become part of the modified acceptance criteria for its marketing.
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