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510(k) Data Aggregation
K Number
K112458Device Name
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Manufacturer
MEDICA-RENTS CO., LTD.
Date Cleared
2012-01-05
(132 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
MEDICA-RENTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prospera Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The Prospera Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside and is indicated for home use.
Device Description
The Prospera PRO Series of Powered Suction Pump is a portable, AC-powered device to be used to remove fluids, including wound exudate, irrigation fluids, and infectious materials from a wound. The pump is operated through computer software, having help and alarm functions. The software settings permit continuous or intermittent negative pressure to be applied for proscribed time periods. The device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The pumps may be used at a patient's bedside. Some models are portable. The Prospera series of pumps are sutiable for use in either a hospital or home, with proper training and supervision.
The Prospera Negative Pressure Wound Therapy Powered Suction Pump is available in three models. The PRO-I was previously cleared in K062456 and is again included here because a relief valve was added. The PRO-II is a smaller, more portable unit having an integrated disposable canister. Both the PRO-II and PRO-III have a lithium ion battery while the PRO-I has a Nickel-metal Hydride (NiMh) battery. All three models are rechargeable and include a port for an external power supply and/or a battery charger. The pump can also be externally powered from a 12V automotive battery source.
All models provide suction at the rate of 9 liters per minute; have a maximum vacuum of -200 mmHg (negative pressure); weigh between 1.8 and 2.8 kg; and operate in continuous or intermittent modes. Maximum dimensions of the unit are 290mmX359mmX130mm (PRO-1).
Consumable accessory components include collection canisters (rigid or collapsible), hoses, connectors and drains (tubing), and foam or gauze dressings.
The device provides negative pressure wound therapy at a range of pressure settings and removes exudates from the wound site through tubing and microbial filters to a disposable canister. The pumps are compatible with a variety of wound dressing kits, using either gauze or foam dressings.
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