(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 ( |
§ 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.