(148 days)
SNaP System with SNaP Cartridge (60cc):
The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, 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.
SNaP System with SNaP Plus Cartridge (150cc):
The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal 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 a non-powered, portable, singleuse, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is based on the concept of forced expansion of volume to produce negative pressure at the wound bed or at the closed incision, utilizing dedicated constantforce springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. It is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician.
This document is a 510(k) premarket notification for a medical device called the "SNaP® Wound Care System." It describes modifications to an already cleared device, not a new device requiring a full efficacy study. As such, the information typically found in a study proving a device meets acceptance criteria, such as detailed clinical study results with specific sample sizes, ground truth establishment, adjudication methods, or multi-reader multi-case studies, is not present here.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical, bench testing. The acceptance criteria are essentially met by showing the modified device performs similarly to the predicate devices and existing specifications, and that the changes do not raise new questions of safety or effectiveness.
Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not applicable in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device design verification: Conformance to design specifications at baseline and after 2-years accelerated aging | Testing ensured conformance to design specifications at baseline and after 2-years accelerated aging. |
| Device user requirements verification: For the SNaP Plus Strap | Testing confirmed user requirements for the SNaP Plus Strap. |
| 7-day use verification: For SNaP cartridges | Verification testing supported 7-day use of the SNaP cartridges. |
| Sterilization validation: For the additional dressing kit | Sterilization validation was performed for the additional dressing kit. |
| Biocompatibility: Of device materials | Biocompatibility testing was conducted. |
| Packaging and shelf life: Integrity and stability | Packaging and shelf life testing was performed. |
| Safety and Effectiveness: No new questions of safety or effectiveness compared to predicate devices | The collective nonclinical testing demonstrates that the SNaP Wound Care System does not raise new questions of safety or effectiveness. |
| Intended Use: Identical to predicate devices | The proposed Indications for Use statements are identical to the FDA-cleared Indications for Use of the predicate devices. |
| Performance: Consistent performance during intended use | The collective results demonstrate the materials and design meet established specifications for consistent performance during intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The testing was nonclinical (bench testing), not a clinical trial with a "test set" of patients. The sample sizes would refer to the number of devices or components tested.
- Data Provenance: Not applicable in the context of clinical trial data. This refers to in-house laboratory testing of the device components and system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This was a nonclinical submission. "Ground truth" in this context would refer to the established performance requirements and specifications for the device, likely determined by engineering and regulatory standards, and internal quality control. No external experts or medical professionals were involved in establishing "ground truth" for nonclinical bench testing results presented here.
4. Adjudication Method for the Test Set
- Not applicable. This was a nonclinical submission. Adjudication methods are typically relevant for clinical studies where expert consensus or review is needed to classify findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. An MRMC study was not done. This is a nonclinical submission for a wound care system, not an imaging device requiring human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic tool.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: For nonclinical bench testing, the "ground truth" is defined by established engineering design specifications, internationally recognized standards for medical devices (e.g., for materials, sterilization, pressure levels, and biocompatibility), and internal test protocols. The device's performance is compared against these predetermined specifications.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI algorithm or training set, this question is irrelevant to this submission.
Summary of the Study (Bench Testing):
The "study" described in the 510(k) notification is a series of nonclinical, bench tests designed to demonstrate that minor design changes and additions to the SNaP Wound Care System do not alter its safety or effectiveness compared to its predicate devices. The modifications included a simplified reset feature, minor material/design changes for commercial scale production, and the addition of a Long Dressing Kit and a SNaP Plus Strap.
The testing covered:
- Device design verification at baseline and after 2-year accelerated aging.
- User requirements verification for the SNaP Plus Strap.
- Verification of 7-day use for the SNaP cartridges.
- Sterilization validation for the new dressing kit.
- Biocompatibility testing.
- Packaging and shelf life testing.
No clinical testing was performed. The collective results of these nonclinical tests formed the basis for concluding that the device meets established specifications and is substantially equivalent to the predicate devices, not raising new questions concerning safety or effectiveness. The removal of a contraindication for use on actively infected wounds was supported by comparison to other NPWT products and published clinical evidence (though not clinical evidence specifically generated for this submission).
§ 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.