(118 days)
The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.
The SciVolutions, Doctors Choice slow healing bandage is comprised of three products. The first is a premium gauze bandage with a non-stick net bottom side and a hydropholic breathable, waterproof polyurethane film membrane top side. The second device is a nonstick hydrocolloid bandage with the same polyurethane film membrane top side. Both of these bandage types are packaged for general use or diabetic use, with the only difference being the carton and carton labeling. The third product is the spray on remover, which may be used with both products.
The provided text is a 510(k) summary for a medical device (Doctors Choice slow healing Bandage with Spray on Remover) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven device.
The document states that the device is a Class 1 device, meaning it is considered low risk and falls under general controls. For these types of devices, the regulatory pathway often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical studies with detailed acceptance criteria for performance metrics common to AI/ML systems.
Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to or present in this specific 510(k) submission.
Summary of what is available:
- Intended Use: The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical practitioner.
- Regulatory Clearance Basis: Substantial equivalence to predicate devices (SciVolutions Gentle Care Bandage - K032983, Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348, 3M Tegasorb Thin Hydrocollide Dressing - K982892, DuoDerm Extra Thin CGF Dressing - K973716).
- Product Classification: Class 1, Product Code NAC (Dressing, Wound, Hydrophilic).
What is NOT available in the provided text (and generally not expected for this type of device and submission):
- Table of Acceptance Criteria and Reported Device Performance: Not included, as performance is typically demonstrated by substantial equivalence to predicates for Class I devices like this.
- Sample size used for the test set and data provenance: Not applicable/provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
- Adjudication method for the test set: Not applicable/provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/provided, as this is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used: Not applicable/provided.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
§ 878.4018 Hydrophilic wound dressing.
(a)
Identification. A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.