(30 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. Each NPseal dressing is intended to be used up to 7 days. The total therapy time across multiple NPseal dressing changes is up to 14 days. NPseal therapy must be discontinued after 14 days. NPSeal dressing wear time may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for dressing change.
- The NPseal 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
- The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
- The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
- The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm.
- The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.
The provided 510(k) clearance letter and summary describe a modification to an existing medical device, the NPseal. The core of this submission is to extend the allowed "Total Therapy Time" from 7 days to 14 days, while the "Single Dressing Wear Time" remains 7 days.
Crucially, the document states that no functional, performance, or clinical testing was conducted for this specific submission (K251156) to support the extended therapy time. Instead, it relies on the safety and effectiveness established for the predicate device (K250708) and asserts that the labeling update itself does not raise new safety or effectiveness concerns.
Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available within this document for the K251156 submission. The document explicitly states: "No functional or performance testing was completed based on the change" and "No clinical testing was applicable to this submission."
However, we can infer some information based on the nature of a 510(k) submission for a device like this and the reliance on a predicate. The original clearance (K250708) for the predicate device would have involved such testing.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
Not Applicable (N/A) for this specific K251156 submission.
The document explicitly states: "No functional or performance testing was completed based on the change." The acceptance criteria and performance data would have been part of the predicate device's (K250708) submission. Since no new testing was performed for K251156, no new performance data or specific acceptance criteria for the change are reported.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
N/A for this specific K251156 submission.
No new test set was used, as no new functional, performance, or clinical testing was conducted. The reliance is on prior V&V data from the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
N/A for this specific K251156 submission.
No new test set was evaluated with expert ground truth, as no new studies were conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A for this specific K251156 submission.
No new test set was adjudicated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device (Negative Pressure Wound Therapy Non-Powered Suction Apparatus) is not an AI/imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device does not incorporate an algorithm in the typical sense (e.g., for automated diagnosis or image analysis). It is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A for this specific K251156 submission.
No new ground truth was established for the purpose of this submission, as no new studies were conducted. For the predicate device, ground truth for performance would likely have been established through physical and mechanical testing (e.g., pressure measurements, exudate absorption capacity, material biocompatibility) rather than clinical "ground truth" as seen in diagnostic device studies.
8. The sample size for the training set
N/A. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
N/A. This device does not involve machine learning or a "training set."
Summary of Device and Rationale for Clearance without New Testing:
The K251156 submission is a Special 510(k) based on the "The Special 510(k) Program" guidance. This program is for modifications to a manufacturer's own legally marketed device where the change does not pose new questions of safety or effectiveness.
- Device Name: NPseal
- Device Type: Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy (NPWT)
- Modification: Extension of the "Total Therapy Time" from 7 days to 14 days. Crucially, the "Single Dressing Wear Time" remains 7 days. This implies that therapy over 14 days would involve at least one dressing change.
- Rationale for No New Testing: The FDA's clearance suggests that changing the total therapy duration from 7 to 14 days, while keeping the single dressing wear time at 7 days, was considered a minor labeling change that does not introduce new risks or alter the fundamental performance of the device that was already proven safe and effective for up to 7 days, presumably including multiple dressing changes within that 7-day period. The assumption is that if a patient can safely use the device for two 7-day periods (with a dressing change) in sequence, then extending the total therapy time to 14 days doesn't inherently change the device's mechanism of action or safety profile. The previous verification and validation data from the predicate (K250708) were deemed sufficient to support this extended timeframe.
§ 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.