(28 days)
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 6 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing result in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.
This document describes a Special 510(k) submission for the NPseal device, focusing on a labeling modification to extend the wear time from 3 days to 6 days. Due to this being a Special 510(k) and the nature of the device (non-powered suction apparatus for negative pressure wound therapy), the study performed is primarily performance and functional testing rather than a complex clinical or AI-based study.
Here's the breakdown of the acceptance criteria and the study, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Device Performance (Result) |
|---|---|
| Pressure and Exudate Handling Over Time | The document states that this testing was performed to assess the impact of extending the wear time from 3 to 6 days. While specific numerical results (e.g., precise pressure maintenance values, exudate absorption rates) are not provided in this summary, the conclusion drawn from this testing is that the modified NPseal is "as safe as the predicate device" and that the labeling changes "do not raise any different questions of safety or effectiveness." This implies that the device successfully maintained its intended pressure range (-75 mmHg to -125 mmHg nominal range, ± 17.5 mmHg) and adequately handled exudate over the extended 6-day period, meeting the implicit functional acceptance criteria of the predicate device. |
| Shelf-Life Testing | Shelf-life was extended from 6 to 24 months. The testing used "identical test methods and acceptance criteria to the predicate device." While specific test methods (e.g., accelerated aging, real-time aging data) and acceptance criteria (e.g., maximum allowable change in material properties, sustained negative pressure over time after aging) are not detailed here, the successful extension of the shelf-life to 24 months indicates that the device met these criteria, maintaining its integrity and functionality over the extended storage period. |
| Biocompatibility | "Complies with ISO 10993-1." This signifies that the materials used in the device are considered biocompatible and suitable for direct or indirect patient contact for the intended duration of use (up to 6 days), as per international standards. |
| Sterility | "Sterile - Gamma irradiation." This indicates the device achieved and maintained sterility as validated by appropriate methods (e.g., bioburden testing, sterility assurance level (SAL) validation) following gamma irradiation, in line with regulatory requirements. |
| Negative Pressure Range | The device maintains Negative Pressure Wound Therapy (NPWT) in the "-75 mmHg to -125 mmHg nominal range (± 17.5 mmHg)." This is a key functional requirement, and the comparative table states this is "Same as predicate," implying the modified device continues to meet this defined pressure range. |
| Management of Exudates (Mechanism) | "Managed by the dressing itself - via combination of absorption into the foam pad and evaporation through the breathable upper film." This describes the mechanism, which is indicated as "Same as predicate," suggesting the effectiveness of this mechanism was sustained with the extended wear time. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes (e.g., number of devices or test units) used for the pressure and exudate handling over time, or for the shelf-life testing. These would typically be determined based on statistical justification for engineering bench testing, but are not disclosed in this summary.
The data provenance is from bench testing (laboratory-based performance and functional testing). The country of origin for the data is implicitly the United States, given Guard Medical Inc.'s location in Miami, FL, and the FDA submission. The testing would be considered prospective in the sense that it was conducted specifically to support this 510(k) submission for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of submission (Special 510(k) for a non-AI/imaging device with a labeling change based on performance testing) does not involve medical experts establishing ground truth in the way an AI diagnostic tool would. The "ground truth" here is based on engineering specifications, validated test methods, and performance against established benchmarks (i.e., the predicate device's performance over its shorter wear time). The experts involved would be engineers, materials scientists, and quality/regulatory personnel who designed and executed the tests and interpreted the results against defined acceptance criteria. Their qualifications would be in their respective technical fields.
4. Adjudication Method for the Test Set
No adjudication method as typically understood in human-reader studies (e.g., 2+1, 3+1 consensus) was performed. The data generated is from objective, quantitative bench testing, assessed against predefined engineering specifications and performance targets from the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic devices where the performance of human readers with and without AI assistance is compared. The NPseal is a physical medical device, and the changes relate to its wear time and shelf-life, not its diagnostic capability or a human-in-the-loop diagnostic process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this question is not applicable. The NPseal is a physical device, not an algorithm. Its "standalone" performance refers to its ability to maintain negative pressure and manage exudate, which was evaluated through the "Pressure and Exudate Handling Over Time" and "Shelf-Life Testing" mentioned.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications and Performance Benchmarks: The device must maintain specific negative pressure ranges and manage exudate effectively over the specified wear time.
- Predicate Device Performance: The modified device's performance must be substantially equivalent to, or better than, the predicate device's performance regarding safety and effectiveness, even with the extended wear time.
- International Standards: Compliance with standards like ISO 10993-1 for biocompatibility is also a form of established "ground truth" for material safety.
It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy, as this is not a diagnostic device.
8. The Sample Size for the Training Set
This question is not applicable. The NPseal is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
§ 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.