(102 days)
The SNaP® Wound Care System is indicated for patients who would benefit from wound 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, single-use, 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 able to generate negative pressure to allow for the removal of wound exudate/fluid from a wound bed or from a closed incision, utilizing dedicated constant-force springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. This 510(k) premarket notification is for design modifications to the 60cc SNaP Cartridge component of the predicate SNaP Wound Care System, in order to introduce a larger capacity 150cc cartridge available with 125mmHg pressure setting.
The provided document is a 510(k) premarket notification for the SNaP® Wound Care System, specifically for a design modification introducing a larger capacity cartridge. This is not typically a document that includes detailed acceptance criteria and a comprehensive study report in the same way a clinical trial or AI device validation would.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K132080). This means the manufacturer is showing that the modified device is as safe and effective as the existing one, not necessarily proving that it meets specific, quantifiable performance criteria against a disease outcome with a new, standalone study.
However, I can extract the relevant information from the document to construct an answer based on its content, acknowledging the limitations of a 510(k) summary.
Acceptance Criteria and Study for SNaP® Wound Care System (K142272)
The SNaP® Wound Care System's acceptance criteria and the study proving it meets these criteria are framed within the context of a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a predicate device. The primary performance criteria revolve around the device's ability to generate and maintain negative pressure and manage exudate, aligning with its intended use in wound therapy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Negative Pressure Generation & Maintenance | Ability to generate and maintain 125mmHg ± 17.5mmHg of negative pressure. | The 150cc capacity SNaP Cartridge demonstrated the ability to generate the specified negative pressure. |
| Durability/Reliability (Resetting) | Functionality maintained after multiple cartridge resets. | "Multiple cartridge resetting test" was conducted, implying successful performance. |
| Pressure Transmission (Dressing) | Effective transmission of negative pressure through the dressing in a simulated wound. | "Dressing pressure transmission test (after 100x resetting)" and "Dressing pressure transmission test (with fluid injection) when used with a representative worst-case SNaP dressing kit (Bridge Dressing) in a simulated wound model" were conducted, implying successful performance. |
| Biocompatibility | Material safety when in contact with tissues and fluids. | "Biocompatibility testing" was conducted, implying successful performance in meeting safety standards. |
| Packaging & Shelf Life | Integrity and prolonged viability of the device and its sterile packaging. | "Packaging and shelf life testing" was conducted, implying successful performance. |
| Exudate Management Capacity | Ability to remove and manage up to 150cc of exudate. | The new SNaP Cartridge is designed and indicated for "removing and managing up to 150cc of exudate." Performance is implied through the design and testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of cartridges tested for pressure, number of dressing kits for pressure transmission). It generically states "All necessary bench testing was conducted."
- Data Provenance: The studies were retrospective in the sense that they were conducted by the manufacturer, Spiracur Inc., in support of their 510(k) application. The data provenance is internal to the manufacturer in sunnyvale CA USA, as it is bench testing to demonstrate equivalance. There is no information about global or specific country of origin for the data beyond the manufacturer's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the studies described are bench tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here is based on engineering specifications and physical measurements.
4. Adjudication Method for the Test Set
- Not applicable. Bench testing involves objective measurements against predefined engineering specifications, not subjective human assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- This device is a physical medical device (Negative Pressure Wound Therapy system), not an AI algorithm for diagnostic or prognostic purposes. Therefore, the concept of human readers and AI assistance is not relevant to this 510(k) submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study
- Not applicable. This document describes a physical medical device, not an AI algorithm. The performance described is the standalone performance of the device itself (its mechanical and material properties).
7. Type of Ground Truth Used
- The ground truth used for the bench testing was based on engineering specifications, regulatory requirements (e.g., biocompatibility standards), and the established performance characteristics of the predicate device. For example, the "ground truth" for negative pressure generation was 125mmHg ± 17.5mmHg.
8. Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning. The design and modification of the device are based on engineering principles and previous product iterations, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in that context. The design process for this medical device relies on established engineering and manufacturing standards.
§ 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.