(71 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.
The provided text is a 510(k) summary for the SNaP® Wound Care System, a non-powered, negative pressure wound therapy device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria based on a clinical study with performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the questions regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/imaging devices, are not applicable to this type of regulatory submission.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific performance metrics (e.g., accuracy percentages, sensitivity, specificity) are stated in the document. The regulatory pathway is based on substantial equivalence to a predicate device, meaning the new device performs "comparably" and does not raise new safety or effectiveness concerns.
The reported "performance" is primarily a demonstration of its ability to deliver negative pressure wound therapy comparable to the predicate device.
| Acceptance Criteria (Explicitly stated in terms of performance metrics) | Reported Device Performance |
|---|---|
| Not applicable; acceptance is based on demonstrating substantial equivalence to a predicate device and comparable functionality. | The modified SNaP Wound Care System was shown to deliver negative pressure wound therapy comparable to the predicate device (K081406) through bench testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. The "test set" in this context refers to bench testing of the device itself, not a dataset of patient cases. The document does not specify the number of units tested.
- Data provenance: Not applicable. The "data" refers to engineering test results, not patient data. No country of origin for such data is mentioned, nor is it classified as retrospective or prospective.
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)
Not applicable. "Ground truth" in the context of device performance in this 510(k) submission relates to the physical parameters of the device (e.g., negative pressure delivery), not expert interpretation of clinical data. Therefore, no experts were used to establish ground truth in the manner typical for AI/imaging product evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements among human reviewers (experts) when establishing ground truth for clinical data. This regulatory submission relies on bench testing and engineering verification, not human adjudication of clinical cases.
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
No. An MRMC comparative effectiveness study was not done. This device is a mechanical wound therapy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. Its performance is inherent to its mechanical function, not an algorithmic output. The "software validation testing" mentioned is likely for internal control software, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's functionality would be based on engineering specifications and measurements (e.g., verifying that the device consistently generates and maintains the specified negative pressure, or that the alarm functions correctly). This is an objective measurement of physical parameters, not a clinical diagnosis or outcome.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for it.
§ 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.