(78 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 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:
| Performance Test (Analogous to "Acceptance Criteria Review Area") | Reported Device Performance (Implicitly Met) |
|---|---|
| Pressure and Exudate Handling Over Time | Functions in the specified negative pressure range (-75 to -125 mmHg nominal) and effectively handles exudates over its intended 7-day use, similar to the predicate. |
| Pull Testing | The device's adhesion or structural integrity under tension remains adequate for its intended use. |
| Benchtop Usability Testing | The device can be used safely and effectively by its intended users in a lab/simulated environment. |
| Packaging Validation | The packaging effectively protects the device, maintains sterility, and ensures device integrity until use. |
| Sterility | Remains sterile via Gamma irradiation, as per predicate. |
| Biocompatibility | Complies with ISO 10993-1, as per predicate, indicating materials are safe for patient contact. |
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.
§ 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.