(29 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 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
| Acceptance Criteria Category | Specific Criteria (Implicitly from the changes) | Reported Device Performance (from K250708) |
|---|---|---|
| Material Performance | Equivalent physical and functional performance of the alternative hydrophilic polyurethane foam pad to the original source. | "Testing has shown that the alternative sourced material meets the same performance specifications as the predicate device." |
| Biocompatibility | Compliance with ISO 10993-1 for the alternative material. | "Biocompatibility: Same as predicate (Complies with ISO 10993-1)" (re-executed for alternative source) |
| Shelf-Life | Maintenance of device integrity and performance over its labeled shelf-life with the new material. | "Shelf-life testing was re-executed." (Implied successful, as clearance was granted) |
| Negative Pressure Range | Maintain -75 to -125 mmHg (± 17.5 mmHg) | "Same as predicate" |
| Exudate Management | Maintain management via absorption into foam and evaporation through film. | "Same as predicate" |
| Sterility | Maintain sterility (Gamma irradiation). | "Same as predicate" (Implied validated for new material/source if affected) |
| MR Safety | Demonstrating MR Safe status for the device. | "MR Status: MR Safe" (Previously "Not evaluated") |
| Labeling Accuracy | Accurate reflection of device capabilities and instructions. | Labeling updates made (MR safety, wear time, latex statement). |
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.
§ 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.