(14 days)
The SNaP® Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.
This document describes a Special 510(k) premarket notification for the SNaP® Wound Care System, focusing on a minor design modification. Due to the nature of a Special 510(k) and the specific information provided, a detailed performance study with acceptance criteria in the typical sense for a new diagnostic device is not presented. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device through bench testing.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Preamble: The special 510(k) is for a modified version of the SNaP® Wound Care System (K111393). The modification involves a change to the SNaP Dressing Kit to incorporate a hydrophobic polyurethane foam. The core argument is that this modification does not change the intended use or alter the fundamental scientific technology. | |
| Ability to deliver negative pressure wound therapy comparable to the predicate device (K111393) | Bench testing was conducted on the modified SNaP Wound Care System to assess this ability. The summary statement is that the SNaP Wound Care System is "substantially equivalent to the predicate device." While specific performance metrics (e.g., precise pressure levels, consistency over time) are not detailed, the implication is that the bench testing confirmed comparable negative pressure delivery. |
| Biocompatibility | Biocompatibility testing was performed. The overall conclusion of "substantial equivalence" implies that the new material (hydrophobic polyurethane foam) met biocompatibility requirements. |
| No new issues of safety or effectiveness | The document explicitly states: "Any differences between the devices do not raise any new issues of safety or effectiveness." This is a key acceptance criterion for a Special 510(k). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" and "Biocompatibility testing." For bench testing, typical sample sizes would involve a certain number of manufactured units or material samples. However, specific sample sizes for the bench tests are not provided in the supplied text. Similarly, data provenance (country of origin, retrospective/prospective) is not specified. Biocompatibility testing usually follows ISO standards, which dictate the types and number of samples.
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)
This is not applicable in the context of this Special 510(k). The evaluation is based on bench testing and biocompatibility assessments related to the physical performance and material properties of the device, not on diagnostic accuracy requiring expert interpretation of results. Therefore, there are no "experts to establish ground truth" in the clinical diagnostic sense. The "ground truth" here is adherence to design specifications and comparable performance to the predicate device, assessed through engineering and material science testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this submission focuses on bench testing and biocompatibility, not clinical diagnostic performance requiring adjudication of interpretations.
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 a non-powered suction apparatus for negative pressure wound therapy, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device for wound therapy, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is related to the engineering specifications and performance characteristics of the device, as well as biocompatibility standards. This is established through:
- Design specifications: The device is evaluated to ensure conformance to its own design specifications.
- Predicate device performance: The modified device's ability to deliver negative pressure is compared to that of the already cleared predicate device (K111393). The established performance profile of the predicate serves as a benchmark for "ground truth" comparability.
- Biocompatibility standards: The materials used are tested against established biocompatibility standards.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.