(296 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. Examples of 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 a hospital and homecare setting.
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphragm, 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 PICO Single Use Negative Pressure Wound Therapy System's acceptance criteria and studies focused on demonstrating biocompatibility and electrical/software safety rather than a comparative effectiveness study with human readers or standalone algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO 10993 Series) | ||
| Cytotoxicity (Dressing) | ISO 10993-5 (Minimum Essential Medium elution assay) standards for non-cytotoxicity. | N to 1:16, all non-cytotoxic (Grade 0) |
| Cytotoxicity (Fixation Strips) | ISO 10993-5 (elution assay with L-929 mouse fibroblast cells) standards for non-cytotoxicity. | N to 1:16, all non-cytotoxic (Grade 0) |
| Sensitization (Dressing) | ISO 10993-10 (Guinea Pig Maximisation Test) standards for non-sensitizing. | Non-sensitizing |
| Sensitization (Fixation Strips) | ISO 10993-10 (Guinea pig maximisation test) standards for non-sensitizing. | Non-sensitizing |
| Irritation (Dressing) | ISO 10993-10 standards for negligible irritancy. | PII SC = 0.0 (Negligible irritant) |
| Irritation (Fixation Strips) | ISO 10993-10 standards for negligible irritancy (e.g., Primary Irritation Index below a certain threshold). | PII SC = 0.1; 0.9% NaCl extract: Primary Irritation Index: 0.11 (Negligible) |
| Ethylene Oxide Residuals (Dressing & Fixation Strips) | ISO 10993-7 requirements for allowable residual limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) for permanent and tolerable contact. | Permanent contact limits: Ethylene Oxide |
§ 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.