(250 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, venous or pressure), surgically closed incisions, flaps and grafts.
The SNaP® Wound Care System ("SNaP System") is an existing (K081406, K111393, K112341, K 113032) 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 System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The proposed SNaP Wound Care System will have the same indication for use as the predicate device, the SNaP Wound Care System (K113032). In addition, Spiracur has added the SNaP® Bridge Dressing Kit ("SNaP Bridge Dressing") and SNaP® SecurRing" Hydrocolloid ("SNaP SecurRing") to the SNaP Dressing Kit product family.
This document is a 510(k) summary for the SNaP® Wound Care System, focusing on modifications and additions to the existing device and dressing components. It primarily addresses substantial equivalence to predicate devices and does not contain detailed acceptance criteria and study results in the format requested for proving performance.
Based on the provided text, the device in question is the SNaP® Wound Care System, described as a "Non-powered suction apparatus device intended for negative pressure wound therapy." The submission is for modifications and additions (SNaP® Bridge Dressing Kit and SNaP® SecurRing™ Hydrocolloid) to an already cleared device, along with labeling changes.
Therefore, much of the requested information regarding a study that proves the device meets specific acceptance criteria is not present in this 510(k) summary, as the submission focuses on demonstrating substantial equivalence through bench testing rather than a clinical performance study with predefined acceptance criteria for a new device.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics against such criteria in a table format. Instead, it describes various "bench testing" categories performed to ensure "conformance to design specifications" and "substantial equivalence." The performance is generally described qualitatively as being "comparable to the predicate device."
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Verification testing | Conformance to design specifications |
| Simulated wound performance testing | No specific metrics stated; assessed functionality of latent design feature (resetting) and ability to deliver NPWT comparable to predicate. |
| Biocompatibility testing | Conformance to design specifications |
| Packaging and shelf life testing | Conformance to design specifications |
| Oxygen compatibility (Hyperbaric Oxygen Environment) | Characterized probability of self-ignition and potential severity of ignition; evaluated oxygen compatibility of dressing materials. |
| Functionality of resetting feature | Evaluated ability of the SNaP Wound Care System to deliver negative pressure wound therapy comparable to the predicate device. |
2. Sample size 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" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for any of the tests conducted.
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 information is not provided. The text describes bench testing, which typically does not involve human expert ground truth establishment in the way clinical studies with diagnostic devices do.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. As the testing is bench-based, an adjudication method for human readers would not be applicable.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any AI assistance. The device is a non-powered wound care system, not a diagnostic or AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of an algorithm or standalone algorithm performance. The device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing described, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. The document states that testing was done "to ensure conformance to design specifications" and to assess "ability... to deliver negative pressure wound therapy comparable to the predicate device." No clinical ground truth (like pathology or outcomes data) is mentioned for these bench tests.
8. The sample size for the training set
There is no mention of a training set. This document describes the submission for a physical medical device undergoing bench testing for substantial equivalence, not an AI or diagnostic algorithm that would require a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, this information is not applicable and not provided.
§ 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.