(195 days)
The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted
The medical device in question is the Iodofoam® Iodophor Foam Dressing. The study provided focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific performance acceptance criteria for a novel device.
The 510(k) summary provided indicates that the primary approach to establishing substantial equivalence for the Iodofoam® Iodophor Foam Dressing was through comparison to legally marketed predicate devices: Iodoflex® Pads (K940414) and Iodosorb® Gel (K905069).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the traditional sense of a new device having to meet specific performance thresholds. Instead, it demonstrates that the Iodofoam® device's characteristics are "substantially equivalent" to two predicate devices. The study aimed to show that the new device's performance falls within the range or is comparable to existing, legally marketed devices for key characteristics.
The table below presents the comparative data points used to demonstrate substantial equivalence, which effectively serve as the "acceptance criteria" through a bracketing or comparability approach.
| Feature / Characteristic | Acceptance Criteria (Predicate Range/Comparability) | Reported Device Performance (Iodofoam®) |
|---|---|---|
| Cumulative Iodine Release (in vitro at 12 hours) | Bracketed by Iodoflex (377 ppm) and Iodosorb (200 ppm) | 255 ppm |
| Iodine Dose (per cm² wound area) | Comparable to Iodoflex (1.9 mg) and Iodosorb (3.0-6.0 mg) | 1.8 mg (per label) |
| Cytotoxicity (ISO 10993) | Fail (similar to both predicates) | Fail |
| In Vivo Histology (Porcine wound healing model) | No aberration (similar to Iodoflex and PVA controls) | No Aberration |
| Biocompatibility Testing (ISO 10993) | Safe for indications of use (demonstrated by non-reactivity and non-sensitizing) | Non-reactive and non-sensitizing |
| Wound Healing Delay (In vivo porcine model) | No significant delay compared to predicates/controls | Not found to delay wound healing |
2. Sample size used for the test set and the data provenance
Cumulative Iodine Release:
- Sample Size: "three independent lots of each device" (Iodofoam®, Iodosorb®, and Iodoflex®). The exact number of samples per lot is not specified but implies multiple measurements per lot to establish average and lot-specific profiles.
- Data Provenance: In vitro study, conducted in distilled water under agitation at 37°C. The country of origin of the data is not specified but is implied to be from an independent lab commissioned by Progressive WoundCare Technologies. The study is prospective in nature since it was conducted specifically for this 510(k) submission.
Biocompatibility Testing & In Vivo Histology/Wound Healing Model:
- Sample Size:
- Cytotoxicity (ISO): Not specified, typically uses cell cultures.
- Intracutaneous Reactivity (ISO): Not specified, typically involves animal subjects.
- Guinea Pig Maximization Testing (ISO): Not specified, typically involves animal subjects.
- In Vivo Porcine Wound Healing Model: Not specified, but involved comparing Iodofoam®, Iodoflex®, and "PVA controls."
- Data Provenance: The document states "an independent in vitro study" for iodine release and "Biocompatibility testing (per ISO 10993)" and "in vivo porcine wound healing model" for other aspects. The country of origin is not mentioned. These studies were prospective, conducted for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This inquiry is not directly applicable to the type of device and studies presented. The studies involve laboratory measurements (iodine release, cytotoxicity, histology) and animal models, not human interpretation requiring expert consensus on a test set. Therefore, there are no "experts used to establish ground truth" in the context of clinical interpretation, nor are qualifications mentioned. The ground truth is established through standardized laboratory procedures and measurement protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically relevant for studies where subjective human interpretation (e.g., radiology reads) requires reconciliation or consensus, which is not the case for these laboratory and animal model studies.
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. An MRMC study is relevant for evaluating diagnostic systems involving human readers and typically artificial intelligence. The Iodofoam® Iodophor Foam Dressing is a physical wound dressing, and its evaluation does not involve human readers or AI in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept applies to AI algorithms and is irrelevant for a physical wound dressing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the studies presented:
- Cumulative Iodine Release: The ground truth is objective quantitative measurement of iodine concentration (in ppm) over time through chemical analysis.
- Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Guinea Pig Maximization): The ground truth is derived from standardized in vitro and in vivo biological assays according to ISO 10993, which produce measurable endpoints (e.g., cell viability, erythema, edema).
- In Vivo Histology and Wound Healing Model: The ground truth is derived from histological examination of tissue samples and macroscopic observation/measurement of wound healing parameters in an animal model, often assessed by trained histopathologists or researchers.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The studies described are for direct characterization and comparison to predicate devices.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device evaluation.
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