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510(k) Data Aggregation
(144 days)
PICO 7Y is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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 Systems are suitable for use both in a hospital and homecare setting.
PICO 7Y Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a Yshaped tube known as the "Y-Connector" to two super-absorbent, gentle adhesive dressings. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressings and fixation strips are supplied sterile and for single use. PICO 7Y was designed to deliver negative pressure wound therapy to low and moderate exudate levels of acute and chronic wound types. PICO 7Y Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
The provided text describes the PICO 7Y Single Use Negative Pressure Wound Therapy System, focusing on performance testing and regulatory clearance. It is important to note that this device is a physical medical device (a powered suction pump) and not an AI device or software. Therefore, the typical acceptance criteria and study designs associated with AI/software devices (e.g., MRMC studies, expert consensus on image interpretation, training/test set ground truth establishment for algorithms) are not applicable here.
However, I can extract the acceptance criteria and study details relevant to this physical medical device based on the information provided in the K182323 submission.
Acceptance Criteria and Device Performance for PICO 7Y Single Use Negative Pressure Wound Therapy System
Given that this is a physical medical device (a Negative Pressure Wound Therapy system) and not an AI or software product, the acceptance criteria and study focus on mechanical and performance-based metrics, rather than diagnostic accuracy or human reader improvement with AI assistance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Target/Threshold) | Reported Device Performance (Results) |
|---|---|---|
| Wound Model Testing (Low Exudate) | Dressings must manage fluid at a flow rate modeling a low exuding wound (0.6 g/cm²/24 hours) for a simulated wound of 25% of the dressing absorbent pad area. Maintained negative pressure within test requirements (-60 mmHg to -100 mmHg) for a minimum of 95% of the test time at the simulated wound base. | All dressings managed fluid at 0.6 g/cm²/24 hours (low exudate). Maintained negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base. Concluded that the device and accessories can be used for their intended purposes. |
| Wound Model Testing (Moderate Exudate) | Dressings must manage fluid at a flow rate modeling a moderately exuding wound (1.1 g/cm²/24 hours) for a simulated wound of 25% of the dressing absorbent pad area. Maintained negative pressure within test requirements (-60 mmHg to -100 mmHg) for a minimum of 95% of the test time at the simulated wound base. | All dressings managed fluid at 1.1 g/cm²/24 hours (moderate exudate). Maintained negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base. Concluded that the device and accessories can be used for their intended purposes. |
| Wound Model Testing (No NPWT) | Dressings must manage fluid at a flow rate modeling moderate and low exuding wounds (0.5 g/cm²/24hrs and 0.3g/cm²/24hrs) without negative pressure. | All dressings in vertical position managed fluid at 0.5 g/cm²/24hrs and 0.3g/cm²/24hrs with no NPWT. Concluded that the dressings can handle fluid without the presence of negative pressure. |
| Functionality Testing (Simultaneous Wounds) | Pump pressure limits between -100 to -60mmHg, cycle of ≥10mmHg, time to reach target negative pressure (<100 seconds) for small (50ml total) and large (600ml total) simulated wounds simultaneously. | Pump pressure limits were recorded between -100 to -60mmHg, had a cycle of ≥10mmHg, and the time taken to reach the target negative pressure was less than 100 seconds (using one 50ml canister and two 300ml canisters). Demonstrated the pump can be used for its intended purpose. |
| Battery Low State Performance | Device must continue to deliver negative pressure when in a battery low state. | The device continued to deliver negative pressure when in a battery low state. Demonstrated the pump can be used for its intended purpose. |
| "Check Dressing" Indicator Performance | Indicator successfully activates after 24 hours of use while maintaining negative pressure. After resetting, reactivates after a minimum of 23 hours 45 minutes and a maximum of 24 hours 10 minutes. | The indicator successfully activated after 24 hours of use, while maintaining negative pressure. After resetting, activated after a minimum of 23 hours 45 minutes and a maximum of 24 hours 10 minutes. Concluded that the devices can be used for their intended purposes. |
| Exudate Management (Blocked Port) | System successfully manages exudate during delivery of negative pressure and following loss of negative pressure (due to port blockage) until the 7-day service life is achieved. | The system successfully manages exudate during the delivery of negative pressure and following the loss of negative pressure until the 7-day service life has been achieved. Concluded that the design acts as an effective primary mitigation for the risk of maceration in a blocked port scenario. |
| Blocked Port (One Dressing) | When one dressing soft port is blocked, pressure is maintained within the specified range on the non-blocked dressing. | When one dressing soft port is blocked due to oversaturation, the device still delivers acceptable levels of negative pressure to the non-blocked dressing. |
| Air Leak Testing | Air leak indicators activate at specified time points when high leak rate present, alerting user to inspect and address leak points, ensuring therapeutic negative pressure range (-60mmHg to -100mmHg, target -80mmHg) is achieved and maintained. | Air leak indicator activated at specified time points, consistent with test requirements for initial application to achieve therapeutic range and maintenance of therapeutic range. Concluded the devices can be used for their intended purposes. |
| Shelf Life | Maintain functionality over 24 months, with dressings managing fluid at specified flow rates and maintaining negative pressure (-60 mmHg to -100 mmHg for ≥95% of time, and no readings < -235mmHg). | All dressings managed fluid at 0.6 g/cm²/24 hours (low) and 1.1 g/cm²/24 hours (moderate). Maintained negative pressure within -60 mmHg to -100 mmHg for ≥95% of test time, with no readings < -235mmHg. All specification test results complied. Concluded that a shelf life of 24 months (2 years) can be applied, and the device and accessories can be used for their intended purposes. |
| Electromagnetic Compatibility & Electrical Safety | Compliance with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366. | Found to be in compliance with all listed standards. |
| Human Factors/Usability | Intended users (Lay Users, Healthcare Professionals) can follow IFU, understand safety information, and no unacceptable residual risk due to use errors. | A summative study was carried out in the US. No patterns of use errors resulting in unacceptable residual risk were found. Concluded that the device has appropriate design mitigations and is safe and effective for use by intended users in expected environments. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes in terms of number of devices or number of tests for each "bench test" conducted. The descriptions refer to "all dressings" or "the PICO 7Y device" without quantifying the number of units tested. This is common for this type of K submission where the focus is on demonstrating that the device can meet the specification, rather than statistical significance derived from large sample sizes.
- Sample Size: Not explicitly stated for specific tests (e.g., "Wound model testing was conducted on the PICO 7Y system..." implies multiple dressings/tests, but exact number unknown).
- Data Provenance: The tests are described as "Non-Clinical Tests (Bench)" indicating laboratory-based testing. A "summative study" for Human Factors was "carried out in the US." The origin of the actual materials used in testing (e.g., simulated wounds) is not detailed. All data appears to be prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this device. As a powered suction pump, the "ground truth" is based on objective physical measurements (e.g., pressure, flow rate, volume) and engineering standards, not on expert interpretation of medical images or clinical outcomes that require human consensus. No experts were used to establish ground truth in the typical sense for an AI/software device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used in studies involving human interpretation (e.g., radiology reads) where there might be inter-reader variability. For objective bench tests of a physical device, results are based on defined measurement protocols and pass/fail criteria, not on human judgment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is relevant for evaluating the impact of AI/software assistance on human performance (e.g., how AI improves a radiologist's ability to detect disease). This device is a physical therapy system, not a diagnostic or AI-assisted interpretation tool. Therefore, no MRMC study was performed.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device. There is no "algorithm only" component in the sense of a diagnostic or interpretive AI. Its performance is measured directly through its mechanical and functional operation.
7. Type of Ground Truth Used
The ground truth for the performance of the PICO 7Y system was based on:
- Engineering Specifications and Benchmarking: Pre-defined ranges for pressure (e.g., -60 to -100 mmHg), flow rates (e.g., 0.6 g/cm²/24 hours), and time intervals (e.g., <100 seconds to reach target pressure, 24-hour indicator activation).
- Simulated Clinical Scenarios: Use of simulated wounds (25% of dressing absorbent pad area) and simulated fluid volumes (50ml, 600ml) to mimic real-world conditions in a controlled laboratory environment.
- Industry Standards: Compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601 series).
This is analogous to "bench testing" against defined performance parameters and safety standards.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model. There is no concept of a "training set" in the context of device development described here.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8.
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