(101 days)
The CI-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 small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.
The CI-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 exudate, irrigation fluids and infectious materials. The CI-SNaP Wound Care System is designed to provide active wound treatment to help promote healing in surgical incisions that continue to drain following sutured or stapled closure. The CI-SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The CI-SNaP™ Wound Care System is used in conjunction with the CI-SNaP™ Dressing Kit.
This 510(k) premarket notification for the CI-SNaP™ Wound Care System (K111006) does not contain specific acceptance criteria or an analytical study demonstrating device performance against such criteria in the way a diagnostic AI/ML device submission would.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (SNaP™ Wound Care System, K081406). The testing described is primarily design verification rather than a clinical effectiveness study.
Here's a breakdown based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for Performance (e.g., a specific pressure range with a tolerance) | The device was evaluated under "design verification tests to assure conformance to design specifications" including: |
| Biocompatibility | "Biocompatibility testing" was performed. |
| Functionality (based on changes from predicate) | Minor design modifications (outer housing, receptacle capacity, activation/deactivation, attachment clip) were made, and the "CI-SNaP Cartridge is provided terminally sterile." |
| Substantial Equivalence | The document concludes that "The CI-SNaP Wound Care System is substantially equivalent to the predicate device." |
Explanation: The document states that bench testing was done to "assess the ability to deliver negative pressure wound therapy." However, it does not specify what negative pressure range it must deliver, for how long, or with what accuracy/consistency, which would be typical acceptance criteria for performance. Similarly, while biocompatibility testing was done, the specific acceptance criteria (e.g., passing ISO 10993 cytotoxicity, sensitization, irritation tests) are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The "bench testing" would likely involve a sample of manufactured devices, but the number is not provided.
- Data Provenance: The device is a physical, non-powered suction apparatus. The testing described is non-clinical bench testing rather than testing on patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is a mechanical negative pressure wound therapy system, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The efficacy is based on the physical application of negative pressure.
4. Adjudication Method for the Test Set
- Not applicable. As there's no "ground truth" derived from expert consensus on a test set (e.g., imaging, clinical diagnoses), no adjudication method is relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for diagnostic devices where human readers interpret cases (e.g., radiology images) and compare performance with and without AI assistance. This is a non-powered wound care device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device does not involve an algorithm. It's a mechanical device.
7. The Type of Ground Truth Used
- The "ground truth" for this type of device is its physical performance specifications (e.g., ability to generate and maintain negative pressure, fluid removal capacity, biocompatibility, sterility). The testing described aims to verify these engineering and safety specifications through bench testing and biocompatibility assessments, rather than comparing against a clinical "ground truth" like pathology or patient outcomes for a diagnostic claim. The "intended use" is based on the predicate device's established efficacy.
8. The Sample Size for the Training Set
- Not applicable. This device does not utilize AI/ML and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set.
In summary: The provided 510(k) notification for the CI-SNaP™ Wound Care System focuses on demonstrating substantial equivalence to a predicate device through engineering design verification and biocompatibility testing. It does not involve the types of clinical studies, expert-adjudicated ground truth, or AI/ML specific evaluations that would be described for a diagnostic device. The acceptance criteria are implicitly tied to the device's design specifications and its ability to perform its mechanical function (delivering negative pressure and removing exudate) safely and effectively, as demonstrated by bench testing and biocompatibility.
§ 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.