(30 days)
MANUKA FILL wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA FILL wound dressings may be used Over-The-Counter for:
- Minor Abrasions
- Lacerations
- Minor Cuts
- Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKA FILL wound dressings may be used for:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns (Superficial and Partial Thickness)
- Diabetic Foot Ulcers
- Surgical Wounds
- Traumatic Wounds
MANUKA FILL wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand that is harvested and processed under controlled conditions. This honey is sealed into low density polyethylene tubes (LDPE) before sterilization using gamma irradiation.
This is a 510(k) premarket notification for the MANUKA FILL wound dressings. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for a novel device. Therefore, many of the requested categories (like MRMC study, sample sizes for test/training sets, number of experts for ground truth, adjudication methods) are not applicable or not provided in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization, Wound Healing) | Adherence to US FDA General Program Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) | Met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested. |
| Sterilization Validation | Acceptance criteria not explicitly detailed but implied by 'All acceptance criteria were met'. | All acceptance criteria were met. |
| Shelf-life (Accelerated and Real-time) | Acceptance criteria not explicitly detailed but implied by 'All acceptance criteria were met'. | All acceptance criteria were met. |
| Packaging Validation | Acceptance criteria not explicitly detailed but implied by 'All acceptance criteria were met'. | All acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
This document primarily describes nonclinical testing for biocompatibility, sterility, shelf-life, and packaging. It does not refer to a "test set" in the context of clinical performance data like a diagnostic algorithm. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not provided. The biocompatibility tests were likely conducted on laboratory animals and/or in vitro, but specific details are not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission focuses on the safety and effectiveness of a wound dressing through nonclinical testing, not on the performance of a diagnostic algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of a clinical performance study for an algorithm.
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 is not an AI-powered device or a diagnostic algorithm, so an MRMC study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
For the nonclinical tests:
- Biocompatibility: The "ground truth" would be the physiological and cellular responses observed in the lab, compared against established biological safety standards (ISO Standard, US FDA General Program Memorandum #G95-1).
- Sterilization, Shelf-life, Packaging: The "ground truth" would be objective measurements and observations confirming sterility, product integrity over time, and packaging effectiveness, compared against defined specifications and regulatory requirements.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
N/A