(136 days)
Foundation DRS Solo is indicated for the management of wounds including:
- · Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Diabetic ulcers
- · Partial thickness burns (superficial second-degree burns)
- Donor sites and other bleeding surface wounds
- · Abrasions
- · Trauma wounds (abrasions, lacerations, skin tears)
- Dehisced wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Foundation DRS Solo may be cut to size.
Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.
The provided text is a 510(k) summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo. This document describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document states, "Clinical testing was not required for the labeling update to include moistening of the device by autologous bodily fluids, in addition to saline." This immediately indicates that no clinical study was conducted to prove the device meets acceptance criteria related to its clinical performance for the specific change being submitted (the labeling update).
Therefore, I cannot provide information for all the requested points, as no clinical study was performed for this 510(k) submission. The provided information focuses on non-clinical testing performed to support the substantial equivalence claim.
Here's what can be extracted from the document regarding acceptance criteria and non-clinical testing, as well as the points that cannot be answered due to the absence of a clinical study:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The submission is for a labeling update to an existing device (Foundation DRS Solo, cleared under K210949). The primary focus of the provided document is to demonstrate that this labeling change (allowing moistening with autologous body fluids in addition to saline) does not raise new questions of safety or effectiveness. As such, no new clinical study was required or performed for this specific submission to prove clinical acceptance criteria are met. The document leverages existing data from the predicate device and conducts focused non-clinical tests to address the change.
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed for this submission, there are no clinical acceptance criteria or performance metrics reported in the typical sense for a clinical trial. The acceptance criteria and performance reported are for non-clinical tests and are aimed at demonstrating that the label change does not negatively impact the device's fundamental characteristics or safety.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Hydration | • Test performed (results indicate no new safety/effectiveness concerns due to label change) |
| Dimensional stability | • Test performed (results indicate no new safety/effectiveness concerns due to label change) |
| Handling characteristics | • Test performed (results indicate no new safety/effectiveness concerns due to label change) |
| Biocompatibility | • Leveraged from K210949, conducted per ISO 10993-1:2018 (Cytotoxicity, Intracutaneous Study, Guinea Pig Max Sensitization, Acute Systemic Toxicity, Material-Mediated Rabbit Pyrogen Study, Bacterial Reverse Mutation, Genotoxicity Mouse Lymphoma Assay, Systemic Toxicity Study with Full Thickness Skin Breach, Chemical Characterization) |
| Sterilization | • Leveraged from K210949, conducted per ISO 14937, AAMI ST72, ISO 10993-7 |
| Packaging | • Leveraged from K210949, conducted per ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, ASTM F88 |
| Performance Testing | • Leveraged from K210949 (Wound Healing Study in a Porcine Model, Functionality Testing on Aged Devices, Viral Inactivation) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Tests (Hydration, Dimensional Stability, Handling Characteristics): The document states these tests were performed but does not explicitly mention the sample size or exact provenance. These would be laboratory tests, typically conducted prospectively.
- Leveraged Tests (Biocompatibility, Sterilization, Packaging, Performance): These were leveraged from the primary predicate device (K210949). Specific sample sizes and provenance for these original tests are not detailed in this 510(k) summary. These would also be laboratory or animal studies, conducted prospectively.
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, as no clinical study with human readers/experts establishing ground truth was performed for this submission. The ground truth for non-clinical tests is based on established scientific methods and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study requiring human interpretation and adjudication was performed for this submission.
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. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical product (dermal scaffold), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (hydration, dimensional stability, handling), the ground truth is based on physical and chemical measurements against defined specifications and industry standards.
- For the leveraged biocompatibility, sterilization, and packaging tests, the ground truth is established through adherence to the specified ISO/ASTM standards and methods.
- For the leveraged performance tests (e.g., wound healing in porcine model), the ground truth would be based on physiological observations and measurements in the animal model.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
N/A