(158 days)
PICO 7 is indicated for patients who would benefit from a suction device (NPWT) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.
Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed Surgical incisions
PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
PICO 7 Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO 7 was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
The PICO 7 Single Use Negative Pressure Wound Therapy System is intended to promote wound healing by removing low-to-moderate levels of exudate and infectious materials. The device was evaluated against specific acceptance criteria for its performance indicators and safety. The study that proves the device meets the acceptance criteria is detailed in the "Non-Clinical Tests (Bench)" section of the 510(k) summary (pages 6-10).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Wound Model Testing | Dressings manage fluid at low (0.6 g/cm²/24 hours) and moderate (1.1 g/cm²/24 hours) exudate flow rates for a simulated wound of 25% of the dressing absorbent pad area. Dressings maintain negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of test time. | All dressings managed fluid at low and moderate flow rates. Dressings maintained negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base throughout the test. |
| Dressing Full Indicator | Device detects blockages and activates the "dressing full" indicator no later than 2 hours after occlusion. | All test results showed that when dressings reached maximum capacity, the device detected blockages and activated the "dressing full" indicator no later than 2 hours after the occlusion occurred. |
| Air Leak Indicator | Air leak indicators activate at specified time points when a high leak rate is introduced, in line with requirements for initial application (to achieve -60mmHg to -100mmHg) and maintenance of therapeutic pressure. | Air leak indicator was activated at specified time points in line with test requirements, representing initial application to achieve the therapeutic negative pressure range of -60mmHg to -100mmHg (target -80mmHg), and maintenance of the therapeutic pressure range. |
| Low Battery Indicator | "Battery low" indicator activates and flashes for a minimum of 12 hours prior to "critical low battery" state. Once in "critical low battery" state, pressing play/pause button enables "battery low" indicator to flash 3 times. | "Battery low" indicator activated and flashed for a minimum of 12 hours prior to the device entering "critical low battery" state. Once in "critical low battery" state, pressing the play/pause button enabled the "battery low" indicator to flash 3 times. |
| Acoustic Testing | Average noise level emitted during normal operation does not exceed recommended levels (e.g., in line with ANSI/AAMI HE75:2009/(R)/2013 for frequent peaks at night in a convalescent area). Maximum noise (LAFmax) does not exceed 35dB. | Average noise level during normal operation was 27.6dB. Maximum noise (LAFmax) did not exceed 35dB, in accordance with ANSI/AAMI HE75:2009/(R)/2013. |
| Electromagnetic Compatibility & Electrical Safety | Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, and IEC 62366 standards. | The device was tested and found to be in compliance with all listed standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, and IEC 62366. |
| Shelf Life | Maintain functionality and original performance criteria (fluid management, negative pressure maintenance) over the specified shelf life (initially 6, extended to 18 months). | All dressings managed fluid at low and moderate flow rates. Dressings maintained negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of the test time. All specification test results complied with acceptance criteria. Functionality maintained over extended duration, allowing for an 18-month shelf life. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical (bench) tests. Specific numerical sample sizes for each test are not consistently provided in this summary. For example, "Wound model testing was conducted on PICO 7 Kits (10x20cm and 25x25cm dressings) at low and moderate flow rate..." implies testing was done on multiple kits/dressings but doesn't state the exact number. Similarly for "Dressing Full Indicator" and "Low Battery Indicator" tests, it states "All test results showed...", suggesting multiple tests were carried out, but without giving a precise count.
Data provenance: These are bench tests, meaning they are conducted in a controlled laboratory environment rather than on human subjects. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. These were non-clinical, bench testing experiments conducted against engineering and performance specifications, not based on expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set:
Not applicable. This pertains to clinical studies often involving expert interpretation of medical images or patient outcomes, not bench testing against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This 510(k) summary only describes non-clinical bench testing. MRMC studies are typically for evaluating diagnostic or predictive AI systems in a clinical context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The tests described are for the device's standalone performance, albeit within a simulated or controlled bench environment rather than a clinical human-in-the-loop setting. The device's indicators (dressing full, air leak, low battery) and its physical performance (fluid management, pressure maintenance, noise) are tested "algorithm only" in the sense that their automated function is evaluated.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests was based on pre-defined engineering specifications, performance metrics, and compliance standards. For example:
- Wound model testing: Based on specified fluid flow rates (0.6 and 1.1 g/cm²/24 hours) and negative pressure ranges (-60 mmHg to -100 mmHg).
- Indicator testing: Based on the device correctly activating indicators within specified timeframes or conditions (e.g., "dressing full" within 2 hours, "low battery" for 12 hours).
- Acoustic testing: Based on noise level limits defined by ANSI/AAMI HE75:2009/(R)/2013 (e.g., maximum 35dB LAFmax).
- EMC/Electrical Safety: Compliance with specific IEC and AAMI/ANSI standards.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical/electronic negative pressure wound therapy system, not an AI/machine learning algorithm requiring a "training set" in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.