(245 days)
PICO 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 Single Use Negative Pressure Wound Therapy System is suitable for use in both hospital and homecare setting.
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of an electric motor driven, twin-diaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.
The document provided is a 510(k) premarket notification clearance letter for the PICO Single Use Negative Pressure Wound Therapy System. It describes the device, its indications for use, and the modifications compared to a predicate device. The document also details the non-clinical (bench) tests performed to demonstrate substantial equivalence for the modified device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details specific performance as part of the "Non-Clinical Tests (Bench)". Since these are bench tests and not clinical studies comparing performance against specific acceptance criteria for a new clinical endpoint, the 'acceptance criteria' are primarily related to maintaining the performance of the predicate device and ensuring the modifications (like the microfuse) do not negatively impact its functionality.
| Acceptance Criteria (Inferred from Test Goals) | Reported Device Performance (with microfuse) |
|---|---|
| Temperature within allowable tolerance limits as per IEC 60601-1, fuses intact after drop tests. | Temperature within allowable tolerance. Fuses did not break, soldering intact after drop tests. Microfuse fit for purpose. |
| Current consumption attributed to fuses comparable over accelerated life; no unacceptable power draw limiting device life. | Current consumption comparable. No unacceptable power draw. |
| Fuse intervention occurs within nominal fuse failure time (0.21 seconds) throughout a 3-year shelf life. | Fuse interventions occurred well within nominal fuse failure time at all time points, throughout a 3-year shelf life. |
| No battery replacement required over 7 days service life, end-of-life countdown not reached before 7 days, microfuse assembled and functional, no pump leak. | No batteries replacement required over 7 days. End of Life countdown not reached. All microfuses assembled and functional. No pump leak observed. |
| Dressings manage fluid at moderate flow rate (1.1 g/cm²/24 hours) for 25% of dressing absorbent pad area. | All dressings managed fluid at 1.1 g/cm²/24 hours for 25% of the dressing absorbent pad area. |
| Maintain negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of test time at simulated wound base. | Maintained negative pressure within test requirements (-60 mmHg to -100 mmHg) for a minimum of 95% of test time. |
| Dressings manage fluid at low flow rate (0.6 g/cm²/24 hours) for 25% of dressing area. | All dressings managed fluid at 0.6 g/cm²/24 hours for 25% of the dressing area. |
| Maintain negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of test time at simulated wound base. | Maintained negative pressure within test requirements (-60 mmHg to -100 mmHg) for a minimum of 95% of test time. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily describes bench testing. It does not specify sample sizes in terms of human patients or clinical data. Instead, it refers to tests on the device components (microfuse, pumps, dressings) in simulated environments. For example, "all of the dressings" in wound model testing implies a sample of dressings, but the exact number isn't quantified. The data provenance is laboratory/bench testing. No country of origin for clinical data is applicable as no clinical data is presented. The tests are prospective in the sense that they were conducted specifically for the 510(k) submission to evaluate the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The document describes bench testing of mechanical and electrical performance, not a study requiring expert clinical assessment to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set or need for adjudication in the context of the bench tests described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a non-clinical evaluation of a modified Negative Pressure Wound Therapy System, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for wound therapy, not an algorithm. The performance described is for the device operating as intended.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" is based on established engineering and medical device standards (e.g., IEC 60601-1, ISO 10993-1, ISO 10993-7) and the pre-defined performance characteristics of the predicate device. The tests aim to demonstrate that the modified device's performance meets these objective criteria in simulated environments.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.