Last synced on 25 November 2022 at 11:04 pm

Negative Pressure Wound Therapy Powered Suction Pump

Page Type
Product Code
Definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. 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.
Physical State
Powered suction pump and wound dressing kit
Technical Method
The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions). The suction apparatus is engaged to create a vacuum (negative pressure) within the wound bed drives the wound exudate to be pumped from the wound bed into a collection canister. The device is designed to provide a pre-set level of negative pressure to the wound bed.
Target Area
For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4780
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4780 Powered suction pump

§ 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.

Negative Pressure Wound Therapy Powered Suction Pump

Page Type
Product Code
Definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. 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.
Physical State
Powered suction pump and wound dressing kit
Technical Method
The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions). The suction apparatus is engaged to create a vacuum (negative pressure) within the wound bed drives the wound exudate to be pumped from the wound bed into a collection canister. The device is designed to provide a pre-set level of negative pressure to the wound bed.
Target Area
For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4780
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4780 Powered suction pump

§ 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.