(318 days)
A highly absorptive pillow dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Osmo/PCA Pillow Wound Dressing:
It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed statistical performance metrics as might be found for novel, higher-risk devices. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and comparative effectiveness studies is not present in this type of document.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Safety (Biocompatibility) | Deemed safe based on "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1" testing for contact with breached or compromised skin. |
| High Absorbency | Absorbs up to 20 times its weight in wound exudate. (Claimed to be comparable to predicate devices.) |
| Containment of Absorbent Material | Inert low-density polyethylene (LDPE) mesh fabric contains absorbent granules, preventing retention in wounds with deep cavities or tunnels. (Claimed to be an advantage over predicate devices in assuring complete removal.) |
| Intended Use | For management of exudating wounds (pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, post-operative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions). |
| No Accelerating Effect on Wound Healing | (Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled as having any accelerating effect on wound healing or epithelization. |
| Not for Third-Degree Burns | (Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled for use on third-degree burns. |
| Not a Long-Term, Permanent, No-Change Dressing, or Artificial Skin | (Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled as such. |
| Not a Treatment or Cure | (Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled as a treatment or a cure for any type of wound. |
Study Details
Given the nature of a 510(k) submission for a wound dressing, the "study" primarily consists of biocompatibility testing and claims of comparable technological characteristics to predicate devices rather than a formal clinical trial with an algorithm. This device is not an AI/algorithm-based device, so questions related to AI performance metrics are not applicable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified for the biocompatibility testing. For claims of performance (e.g., absorbency), no specific test set sample size is provided, nor is the data provenance. The claims rely on the inherent properties of the materials.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. For biocompatibility, testing is typically performed by certified labs according to standards. For performance claims, these are intrinsic material properties or comparative statements to predicate devices, not requiring expert consensus on a test set in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable, as this is not an AI/algorithm-based device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Ground truth is established by adherence to and passing of tests defined by the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1."
- For absorbency and containment: Ground truth would be based on laboratory testing of the material's physical properties.
- For intended use/indications: Ground truth is implicitly established by the demonstrated safety and performance (biocompatibility, absorbency) along with equivalence to predicate devices that already have these indications.
8. The sample size for the training set:
- Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/algorithm-based device.
Summary of Device Performance Study for 510(k):
The "study" for the Osmo/PCA Pillow Wound Dressing to meet its acceptance criteria, as presented in this 510(k) summary, primarily relies on:
- Biocompatibility Testing: Performed according to "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1," supporting its safe use for temporary contact with breached skin.
- Engineering and Material Science Principles: The device's ability to absorb exudate (20 times its weight) and contain its granules within an LDPE mesh is a direct result of its material composition and design. These are inherent physical properties and are likely confirmed through in-house lab testing, not a clinical trial.
- Substantial Equivalence to Predicate Devices: The core of a 510(k) is to demonstrate that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices (OsmoCyte™ Pillow Wound Dressing, Lamin® Hydrating Gel). This comparison effectively "proves" that the device meets acceptance criteria by showing it's "as safe and effective" as something already on the market, rather than through a standalone, comprehensive clinical study for de novo devices. The indications for use are explicitly stated to be "not different from the predicate devices identified above."
§ 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.