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510(k) Data Aggregation
(463 days)
The Kendall NPWT Incision Management Dressing Kit, when used with a Cardinal Health NPWT CATALYST, ALLY or ALLY TO GO Devices, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. The Cardinal Health NPWT CATALYST, ALLY TO GO System is intended for use in acute, extended and home care settings.
The Kendall Negative Pressure Wound Therapy Incision Management Dressing Kit is a wound dressing kit to be used with cleared Cardinal Health Negative Pressure Wound Therapy (NPWT) CATALYST, ALLY, and ALLY to GO systems (K171499).
The disposable single-use sterile Kendall NPWT Incision Management Dressing Kit consists of five dressing configurations, tubing, and drape strips. The dressing covers the closed surgical site and forms a seal over the sutured or stapled surgical site. The proximal end of the tubing is attached to the dressing while the distal end of the tubing attaches to an exudate canister. The powered suction pump delivers negative pressure to the dressing to aid in the removal of exudate from the wound into the exudate canister. The drape strips are used to patch any air leaks if necessary.
Here's an analysis of the provided text, focusing on acceptance criteria, study details, and how the device meets those criteria:
Device: Kendall NPWT Incision Management Dressing Kit
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Prevena Plus Incision Management System) through various non-clinical tests. The reported device performance is presented as successfully meeting the objectives of these tests, implying they are comparable to or within acceptable limits for the predicate.
| Acceptance Criteria (Implied by Testing Objectives) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 for limited contact exposure (>24 hrs to <30 days) on breached/compromised surface (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subacute/Subchronic Toxicity, 4 Week Full Thickness Wound Healing in Rats) | Met: Testing demonstrated biocompatibility per ISO 10993-1 standards. |
| Absorbency: Demonstrate absorption of wound exudate in the absence of negative pressure | Met: Demonstrated the dressing can absorb wound exudate. |
| Alert Testing: Not inhibit NPWT CATALYST/ALLY Systems from detecting leaks, occlusion, or full canister | Met: Dressing Kit does not inhibit the NPWT systems' alert capabilities. |
| Useful Life Testing: Maintain target pressure and transport simulated exudate over the useful life (7 days maximum) | Met: Confirmed the dressing can maintain target pressure and transport simulated exudate over its useful life (stated as 7 days maximum). |
Missing Information Regarding AI/Machine Learning Studies:
The provided text does not contain any information about an AI/Machine Learning device or study. The device described is a medical dressing kit for Negative Pressure Wound Therapy (NPWT), a physical medical device. Therefore, the following sections pertinent to AI/ML device studies cannot be addressed based on the given text:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
Conclusion Regarding Device Acceptance and Study:
The Kendall NPWT Incision Management Dressing Kit gained FDA clearance (K191101) based on a demonstration of substantial equivalence to a predicate device, the Prevena Plus Incision Management System (K180855). This was achieved through a series of non-clinical tests, including biocompatibility and bench testing:
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1 standards to support limited contact exposure.
- Bench Testing: Included absorbency tests, alert system compatibility tests, and useful life tests. These tests confirmed the dressing's ability to absorb exudate, not interfere with the compatible NPWT pump's alert functions, and maintain performance (target pressure and exudate transport) over its intended 7-day use life.
The document explicitly states: "There were no Human Clinical or Animal Performance Studies required for substantial equivalence determination." This means the clearance was based entirely on the non-clinical and bench testing, demonstrating that the device functions as intended and is comparable to the predicate regarding safety and effectiveness, despite some technological differences (e.g., presence of silver in predicate dressing, different compatible NPWT devices, varying pressure settings, and a shorter maximum use life for the proposed device). The conclusion is that these differences "are not critical to the intended use of the device" and "do not affect the safety and effectiveness."
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