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, Tr
| Device Type ID | 5814 |
| Device Name | Negative Pressure Wound Therapy Powered Suction Pump |
| 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 Dri |
| 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 Description | Powered Suction Pump. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5814 |
| Device | Negative Pressure Wound Therapy Powered Suction Pump |
| Product Code | OMP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Suction Pump. |
| CFR Regulation Number | 878.4780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED TISSUE TECHNOLOGIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARGENTUM MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAYMAX RESEARCH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLUE OCEAN MEDICAL PRODUCT, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDINAL HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
CARDINAL HEALTH 200, LLC | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
CARILEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CONVATEC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONVATEC LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORK MEDICAL PRODUCTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CREO QUALITY, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEVON MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DEVON MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEVON MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENADYNE BIOTECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
KCI USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
KCI USA, INC. (KINETIC CONCEPTS, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
KINETIC CONCEPTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
LC MEDICAL CONCEPTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDELA | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MEDELA HOLDING AG | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MOLNLYCKE HEALTH CARE US LLC | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MOLNLYCKE HEALTH CARE US, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POLYNOVO BIOMATERIALS PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIMEX MEDIZINTECHNIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
SMITH AND NEPHEW MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STORTFORD MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TALLEY GROUP LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Insufficient Information | 394 |
Adverse Event Without Identified Device Or Use Problem | 213 |
Appropriate Term/Code Not Available | 125 |
Failure To Charge | 81 |
Device Alarm System | 56 |
Defective Alarm | 53 |
Electrical /Electronic Property Problem | 37 |
Pumping Stopped | 32 |
Mechanical Problem | 21 |
Suction Problem | 16 |
Leak / Splash | 14 |
Pressure Problem | 12 |
Device Operates Differently Than Expected | 12 |
Overheating Of Device | 11 |
Thermal Decomposition Of Device | 9 |
Air Leak | 9 |
Power Problem | 9 |
No Audible Alarm | 8 |
Pumping Problem | 8 |
Battery Problem | 7 |
Smoking | 6 |
Use Of Device Problem | 6 |
No Apparent Adverse Event | 5 |
Electronic Property Issue | 5 |
Difficult To Remove | 5 |
Partial Blockage | 5 |
Alarm Not Visible | 4 |
Unexpected Shutdown | 4 |
Charging Problem | 4 |
Electrical Power Problem | 4 |
Component Misassembled | 3 |
Device Displays Incorrect Message | 3 |
Failure To Pump | 3 |
Device Inoperable | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Sparking | 3 |
Complete Blockage | 3 |
Device Emits Odor | 3 |
Excessive Heating | 3 |
No Pressure | 3 |
Alarm | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Moisture Or Humidity Problem | 2 |
Low Battery | 2 |
Entrapment Of Device | 2 |
Noise, Audible | 2 |
Fluid Leak | 2 |
Power Cord | 2 |
Decrease In Pressure | 2 |
Electrical Shorting | 2 |
Loss Of Power | 2 |
Failure To Power Up | 2 |
Device Handling Problem | 2 |
Tube | 2 |
Fire | 2 |
Contamination During Use | 2 |
Device Contamination With Body Fluid | 2 |
Suction Failure | 2 |
Circuit Failure | 2 |
Connection Problem | 1 |
Occlusion Within Device | 1 |
Melted | 1 |
Seal | 1 |
Power Supply | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Port | 1 |
Material Discolored | 1 |
Power Conditioning Problem | 1 |
Electro-Static Discharge | 1 |
Defective Component | 1 |
Cable | 1 |
Patient-Device Incompatibility | 1 |
Surgical Graft | 1 |
Hole In Material | 1 |
Material Too Rigid Or Stiff | 1 |
Device Issue | 1 |
Environmental Particulates | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Detachment Of Device Component | 1 |
Power Switch | 1 |
Charred | 1 |
Crack | 1 |
Defective Device | 1 |
Blocked Connection | 1 |
Calibration Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Temperature Problem | 1 |
Torn Material | 1 |
Loose Or Intermittent Connection | 1 |
Premature End-of-Life Indicator | 1 |
No Audible Prompt / Feedback | 1 |
Decrease In Suction | 1 |
Alarm, Audible | 1 |
Connector | 1 |
| Total Device Problems | 1282 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | KCI USA, INC. | II | May-30-2017 |
| 2 | KCI USA, INC. | II | Jan-06-2016 |
| 3 | KCI USA, INC. | II | Mar-05-2014 |
| 4 | KCI USA, Inc. | II | Oct-15-2014 |
| 5 | Medela Inc | II | Jul-23-2018 |
| 6 | Smith & Nephew Inc. | II | Mar-10-2014 |
| 7 | Smith & Nephew Inc. | II | Feb-21-2014 |
| 8 | Smith & Nephew, Inc. | II | Jan-18-2017 |
| 9 | Smith & Nephew, Inc. | II | Sep-20-2016 |
| 10 | Smith & Nephew, Inc. | II | Oct-08-2014 |
| 11 | Smith & Nephew, Inc. | II | Sep-23-2014 |