(146 days)
The NPseal is indicated for patients who would management via application of a negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
The NPseal Neqative 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 time to wound closure and rate of exudate, 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 Small is intended for surgically closed incisions up to 5cm x 0.5 cm
The NPseal Medium is intended for surgically closed incisions up to 10 cm x 0.5 cm.
The NPseal Large is intended for surgically closed incisions up to 15 cm x 0.5 cm.
The provided text is a 510(k) Summary for the NPseal device, specifically for the Medium and Large versions. It outlines the device description, indications for use, comparison to a predicate device, and functional/performance testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (NPseal Large) |
|---|---|---|
| Pressure and Exudate Handling | Maintain negative pressure within the specified range (-75 mmHg to -125 mmHg). | Demonstrated that negative pressure could be maintained within the specified range. |
| Capable of absorbing simulated exudate. | Demonstrated that the device was capable of absorbing simulated exudate. | |
| Volume of simulated exudate absorbed covers less than 50% of the foam pad. | Demonstrated that the volume of simulated exudate absorbed covered less than 50% of the foam pad. | |
| Benchtop Usability Testing | Usability requirements for pump actuation met. | Demonstrated that usability requirements including pump actuation met acceptance criteria. |
| Usability requirements for device removal from packaging met. | Demonstrated that usability requirements including device removal from packaging met acceptance criteria. | |
| Usability requirements for device application met. | Demonstrated that usability requirements including device application met acceptance criteria. | |
| Usability requirements for ability to generate negative pressure met. | Demonstrated that usability requirements including ability to generate negative pressure met acceptance criteria. | |
| Packaging Validation | Sterile packaging seal maintained after environmental conditioning. | Demonstrated that sterile packaging seal was maintained after undergoing environmental conditioning. |
| Sterile packaging seal maintained after simulated distribution. | Demonstrated that sterile packaging seal was maintained after undergoing simulated distribution. | |
| Biocompatibility | Compliance with ISO 10993-1. | The predicate device (NPseal Small) complies with ISO 10993-1, and the subject devices use the same materials, implying continued compliance. |
| Negative Pressure Range Maintenance | Maintain negative pressure within -75 mmHg to -125 mmHg (± 17.5 mmHg). | The "Pressure and Exudate Handling Over Time" test demonstrated negative pressure could be maintained, aligning with this criterion. |
| Maximum Therapy Time | 6 days. | The device is intended for 6 days of use. (This is a design specification, confirmed by comparison to predicate). |
| Maximum Number of Dressing Changes | 1 dressing change. | The device can be replaced only one time. (This is a design specification, confirmed by comparison to predicate). |
| Wear Time per Dressing | Up to 6 days. | Up to 6 days. (This is a design specification, confirmed by comparison to predicate). |
| Sterility | Sterile - Gamma irradiation. | Sterile - Gamma irradiation. (This is a design specification, confirmed by comparison to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (e.g., number of devices/units) for each of the performance tests. It mentions that testing was performed "exclusively on the NPseal Large as it represents the worst-case device size," indicating that the tests were conducted using physical samples of the NPseal Large.
- Sample Size: Not explicitly stated for each test (e.g., how many NPseal Large devices were tested for pressure, usability, or packaging).
- Data Provenance: The studies described appear to be prospective benchtop and in-house laboratory testing conducted by Guard Medical (or their designated testing facilities) as part of their design control and 510(k) submission process. There is no indication of external or retrospective data from patients. The country of origin of this testing data is not specified, but the applicant and consultant are based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
There is no mention of experts being used to establish ground truth for the test set. The tests described (Pressure and Exudate Handling, Benchtop Usability, Packaging Validation) are objective functional and performance tests with predefined acceptance criteria that do not typically require expert consensus for ground truth establishment. For usability, a group of users might be involved, but they would be testers, not "experts" establishing ground truth in the sense of a diagnostic interpretation.
4. Adjudication Method for the Test Set
Since the described studies are objective functional and performance tests (e.g., measuring pressure, observing exudate absorption, confirming sterilization seal integrity), an "adjudication method" as typically understood in studies involving subjective interpretations (like medical imaging) is not applicable and therefore not mentioned. The results are based on direct measurements and observations against pre-defined engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was applicable to this submission." The submission focuses on demonstrating substantial equivalence through bench testing, comparing the larger NPseal sizes to the already cleared smaller NPseal predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to this device. The NPseal is a physical medical device (a non-powered negative pressure wound therapy device), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" for an algorithm is irrelevant. The focus is on the device's mechanical and material performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims are based on pre-defined engineering specifications, regulatory standards (e.g., ISO 10993-1), and the performance characteristics of the predicate device.
- For pressure maintenance, the ground truth is the specified pressure range (-75 to -125 mmHg).
- For exudate handling, the ground truth includes criteria like "capable of absorbing simulated exudate" and "less than 50% foam pad coverage."
- For usability, the ground truth is the successful completion of specific tasks (pump actuation, removal from packaging, application, generation of negative pressure).
- For packaging, the ground truth is maintaining seal integrity.
- For biocompatibility, the ground truth is compliance with ISO 10993-1.
These are objective, measurable standards rather than subjective expert consensus, pathology, or outcomes data typically used for diagnostic or treatment effectiveness claims.
8. The Sample Size for the Training Set
This question is not applicable. The NPseal is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The design and development process for a physical device involves engineering principles, material science, and iterative testing, not data-driven training of a model.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8. There is no training set for a physical 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.