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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.

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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 7 days of use. Therapy duration of the system 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 system 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 text is a 510(k) clearance letter for a medical device called NPseal. It is crucial to understand that this document describes a Special 510(k) submission, which is used for minor changes to an already cleared device. In this case, the changes were:

• Adding an MR safety statement to labeling.
• Minor labeling updates regarding wear time and latex content.
• Adding an alternate source for a material (hydrophilic polyurethane foam).

The core of a Special 510(k) is to demonstrate that the minor modifications do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the cleared predicate device. This is different from a de novo submission or a traditional 510(k) for a novel device or significant change, which would typically involve more extensive clinical performance studies.

Therefore, the "studies" mentioned in this document are primarily non-clinical performance testing to ensure the alternative material performs equivalently, and no clinical trials or human-in-the-loop studies (like MRMC studies) were conducted or needed for this specific Special 510(k) submission. The FDA's acceptance is based on the equivalency demonstrated through bench testing and material assessments, not on clinical performance criteria like diagnostic accuracy.

Analysis of the Provided Information against the Request:

Based on the nature of a Special 510(k) for these specific changes, many of the requested elements (especially those related to clinical performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this document. The "device performance" here refers to physical and material performance, not diagnostic accuracy or human-in-the-loop clinical benefit.

Here's an attempt to answer your questions based only on the provided text, highlighting what is applicable and what isn't:

Acceptance Criteria and Device Performance for NPseal (K250708)

The acceptance criteria for this Special 510(k) submission primarily revolved around demonstrating that the modifications (specifically, the alternative foam source) maintained the same performance and safety profile as the predicate device (K241522). This is centered on non-clinical performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of units or patients for performance testing. As this is a Special 510(k) focused on material equivalency, "test sets" would refer to units used in bench testing.
• Data Provenance: Not specified. Performance and shelf-life testing would typically be conducted in a laboratory setting, likely at the manufacturer's or a contract lab's facility. It's non-clinical data, not patient data. This was not a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. No ground truth in the sense of clinical diagnoses or expert consensus was established for a "test set" from patient data, as this was not a clinical study assessing diagnostic performance or clinical outcomes. The "ground truth" here is the technical specification of the predicate device, against which the modified device's bench test results were compared.

4. Adjudication Method for the Test Set

• Not Applicable. There was no expert adjudication process as this was non-clinical performance testing, not a clinical study requiring human interpretation of medical images or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study was not done. This type of study is relevant for AI/imaging devices to show how AI assists human readers. The NPseal is a physical wound therapy device, and this particular submission involved material and labeling changes, not development or modification of an AI component or a diagnostic aid.

• Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. The NPseal is a physical medical device, not a diagnostic algorithm. Therefore, "standalone performance" of an algorithm is not relevant. The closest analogous concept would be the device's physical performance (e.g., maintaining negative pressure), which was assessed via bench testing to be equivalent.

7. The Type of Ground Truth Used

• Technical Specifications / Predicate Device Performance Data: The "ground truth" for affirming substantial equivalence in this context was the established, documented performance specifications and safety profile of the legally marketed predicate NPseal device (K241522). The new material and changes had to meet or exceed these existing, validated specifications through non-clinical testing.

8. The Sample Size for the Training Set

• Not Applicable. There was no "training set" in the context of machine learning or AI, as this submission did not involve an AI/algorithm.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. (See #8)

In summary, this document highlights a Special 510(k) for minor changes to an already cleared physical medical device. The "study" proving acceptance was primarily non-clinical bench testing to demonstrate that the revised device, particularly with an alternate material source, met the same performance specifications as its predicate. Clinical trials, human reader studies, or AI algorithm training/testing were not part of this specific submission.

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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 7 days of use. Therapy duration of the system 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 system change. 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 text is a U.S. FDA 510(k) summary for the NPseal device. It states that the device is a Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy. The document describes modifications to an already cleared device, specifically the introduction of longer versions (NPseal 20 and NPseal 25).

Crucially, the document does not describe the specific acceptance criteria or a study that proves the device meets those acceptance criteria in the context of typical AI/ML medical device performance studies (e.g., sensitivity, specificity, AUC). This is because the device, Guard Medical's NPseal, is a negative pressure wound therapy device, not an AI/ML diagnostic or prognostic device. The 510(k) submission is for a physical medical device with design modifications (longer versions), not a software or AI algorithm.

Therefore, many of the requested information points (like AI performance metrics, sample size for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable to this type of device and submission.

However, I can extract information related to the performance testing that was conducted for this device modification, which served as the "proof" that the modified device is substantially equivalent to its predicate.

Here's the reinterpretation of your request based on the provided document:

Device: Guard Medical NPseal (Negate Pressure Wound Therapy Device)

Nature of the Submission: Special 510(k) for device modification – introducing longer versions (NPseal 20 and NPseal 25) of an already cleared negative pressure wound therapy (NPWT) device.

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

Since this is a physical medical device and not an AI/ML product, the "acceptance criteria" and "performance" relate to its physical and functional characteristics remaining equivalent or safe despite the size change.

The document refers to "Verification and validation data" supporting substantial equivalence. Based on the "Summary of Functional and Performance Testing," the acceptance criteria would be that the modified devices maintain the crucial functionalities of the predicate device.

Table of Performance Testing and Implied Acceptance Criteria:

Study that Proves the Device Meets the Acceptance Criteria:

The studies conducted were benchtop performance and functional tests, not clinical trials in the sense of large patient cohorts, as this was a Special 510(k) for a modification (size increase).

2. Sample Size and Data Provenance:

• Sample Size: Not explicitly stated as a numerical sample size of "patients" or "images" as it's a physical device. For benchtop testing, typically multiple units of the device would be tested to ensure consistency and reliability. The document states testing was performed "exclusively on the NPseal 25 as it represents the most challenging device size," implying tests were sufficient to address the change.
• Data Provenance: Not applicable in terms of country of origin for clinical data or retrospective/prospective collection, as no clinical testing was performed for this submission (as stated in Section 9: "No clinical testing was applicable to this submission."). The data originates from internal engineering and quality validation testing by Guard Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This information is relevant for AI/ML diagnostic devices where human experts establish ground truth for image or data interpretation. For a physical device like NPseal, "ground truth" is typically defined by engineering specifications, material properties, and established medical standards for wound care devices, validated through physical and functional testing.

4. Adjudication Method for Test Set:

• Not applicable. No human interpretation or adjudication of test results in the context of diagnostic agreement was required here. Performance was assessed against engineering specifications and functional requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is for evaluating human reader performance with and without AI assistance for diagnostic tasks. It is not relevant to a negative pressure wound therapy device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The NPseal is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device modification was based on engineering specifications, functional requirements, and performance data from the predicate device. The aim was to demonstrate that the increased sizes (NPseal 20 and NPseal 25) perform equivalently to the predicate devices (NPseal 5, 10, and 15) in terms of established parameters like negative pressure maintenance, exudate handling, and material integrity.

8. Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device. The "training" in a broad sense would be the cumulative design and manufacturing experience for the predicate device.

9. How Ground Truth for Training Set was Established:

• Not applicable. See point 8.

In summary: The provided document is a 510(k) notice for a physical medical device modification, not an AI/ML software device. Therefore, the detailed questions pertaining to AI/ML study methodologies (e.g., AI performance metrics, expert labeling, MRMC studies) are not relevant to this specific FDA submission. The "proof" of meeting acceptance criteria for this device involved benchtop functional and performance testing to demonstrate substantial equivalence to an already cleared predicate device, despite the change in size.

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