(358 days)
PICO Single Use Negative Pressure Wound Therapy System 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. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:
- Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
- Post-operative seroma
- Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
PICO 7 Single Use Negative Pressure Wound Therapy System 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. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of:
- Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
- Post-operative seroma
- Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
PICO 7Y Single Use Negative Pressure Wound Therapy System 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. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:
- Superficial incisional surgical site infections for high risk patients in Class I wounds
- Post-operative seroma
- Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
PICO 14 Single Use Negative Pressure Wound Therapy System 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. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:
- Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
- Post-operative seroma
- Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of:
- PICO Pump
- Dressing (s)
- Fixation strips
- Batteries
- Connection tubing
- Instructions for Use
The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.
The PICO family of devices (PICO, PICO 7, PICO 7Y, and PICO 14) are Negative Pressure Wound Therapy Systems intended for use in wound treatment.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it demonstrates the device's effectiveness through a systematic literature review and meta-analyses, aiming to show a "statistically significant reduction" in the incidence of certain wound complications compared to standard care. The reported device performance is presented as Odds Ratios (OR) with 95% Confidence Intervals (CI). A favorable effect is suggested by an OR less than 1.
Here's a summary of the meta-analysis results as reported:
| Outcome | Device Performance (Odds Ratio [95% CI]) | Interpretation (Favorable Effect if OR
§ 878.4783 Negative pressure wound therapy device for reduction of wound complications.
(a)
Identification. A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
(i) Wound complication rates; and
(ii) All adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(5) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use.
(6) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life:
(i) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life;
(ii) Fluid removal rate consistent with the wound types specified in the indications for use; and
(iii) Timely triggering of all alarms.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include the following:
(i) Instructions for use;
(ii) A summary of the device technical specifications, including pressure settings, modes (
e.g., continuous or intermittent), alarms, and safety features;(iii) Compatible components and devices;
(iv) A summary of the clinical evidence for the indications for use;
(v) A shelf life for sterile components; and
(vi) Use life and intended use environments.
(10) For devices intended for use outside of a healthcare facility, patient labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) Information on when to contact a healthcare professional; and
(iii) Use life.