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510(k) Data Aggregation
K Number
K210628Device Name
X-FLO Fluid Management System
Manufacturer
Thermedx, LLC
Date Cleared
2021-11-04
(247 days)
Product Code
HIG, HRX, LGZ
Regulation Number
884.1700Why did this record match?
Applicant Name (Manufacturer) :
Thermedx, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-FLO Fluid Management System is intended to:
· Warm and pump fluid, via intravenous (IV) bags or fluid bottles, to provide fluid distention and flushing of the uterus for gynecology procedures. The device can also measure fluid deficit of the surgical procedure.
· Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the bladder and kidneys, or general distention and flushing, for urological procedures. The device can also measure fluid deficit of the surgical procedure.
· Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the shoulder, knee, or other small joints for orthopedic procedures. The device can also measure fluid deficit of the surgical procedure.
Device Description
The X-FLO Fluid Management System ("X-FLO") (P/N 01910), with an optional deficit module (P/N 01601) is intended for fluid distention, fluid warming, and fluid volume/deficit measurements, as well as external suction regulation pertaining to deficit measurements for diagnostic and/or operative endoscopic procedures within gynecology, urology, and orthopedic disciplines.
The X-FLO utilizes a touchscreen user interface and performs fluid pressurization, warming, and volume/deficit monitoring functions. More specifically, the device employs a peristaltic pump to pressurize and deliver fluid to the surgical site for distending and continually flushing the surgical site for visualization purposes, utilizes infrared lamps to optionally warm the fluid to body temperature, and uses fluid bag weight to monitor fluid inflow.
Regarding the optional deficit monitoring function, the device utilizes external suction to return fluid from the surgical site. The X-FLO monitors and adjusts the vacuum level to the operator selected setpoint by opening the suction line to atmosphere if necessary. Once the fluid is returned from the surgical site, the single-use deficit cartridge measures the fluid volume collected, prior to transfer to fluid collection equipment and/or the hospital's waste disposal system.
The X-FLO is controlled via a Graphical User Interface (GUI), wherein the user is guided to select a surgical discipline and a procedure type. Once selected, the user can input the desired setpoint within the established minimum and maximum parameters for that procedure type. As set forth below, the X-FLO can operate in Pressure Control (the default control, or X-Control. Each control view has defaults and adjustment ranges for fluid pressure, flow, temperature, deficit alarm, and external suction regulation.
In addition to adjusting the fluid pressure setpoint via the GUI, the user may optionally utilize a foot pedal included with the X-FLO to temporarily increase the fluid pressure. By pressing the foot pedal, the user initiates an increase in fluid pressure. The increase is user configurable but can never exceed the maximum allowable fluid pressure for the procedure. When the user desires to have the fluid pressure return to the setpoint, the foot pedal is released.
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K Number
K172048Device Name
FluidSmart
Manufacturer
THERMEDX, LLC
Date Cleared
2017-09-05
(61 days)
Product Code
HIG, HRX, LGZ
Regulation Number
884.1700Why did this record match?
Applicant Name (Manufacturer) :
THERMEDX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, and orthopedic disciplines.
Device Description
FluidSmart® is intended for irrigation, distention, fluid warming, and fluid volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines. Fluids commonly used include 0.9% saline, lactated ringer's solution, 5% mannitol, 1.5% glycine, and sterile water.
The main unit is mounted on a rolling stand which houses the technology used to warm the fluids and the peristaltic pump used to pressurize the fluids. A touch-screen operated processor provides closed loop controls for fluid warming and pumping. The processor monitors temperature and pressure sensors to adjust warming power and pump speed as required. Load cells attached to the fluid bag hooks and suction canister ring allow the processor to monitor fluid levels pumped to and suctioned from the surgical site.
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K Number
K102275Device Name
THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
Manufacturer
THERMEDX, LLC
Date Cleared
2011-03-25
(226 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
THERMEDX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermedx 37~5 electrocautery probes are indicated for electrosurgical cutting and coagulation during a variety of urological, gynecological, laparoscopic and general surgical procedures.
Device Description
The Thermedx 37~5 electrode probes are electrosurgical devices which enable the user to have the functions of cutting and coagulation along with suction and irrigation in a single hand held device. These probes are intended to be used in conjunction with the Trumpet valve disposable assembly (model number TV0002), The probes come in a variety of tip configurations. Monopolar electrodes include a J Hook. L Hook. Spatula and Needle tip. . All electrodes have working dimensions of 33 cm in length and 5 mm diameter. Electrodes are manufactured of biocompatible materials per ISO 10993 and are safe, effective and durable for their intended use. All electrodes have an ABS coupling to connect to the trumpet valve disposable assembly and are connected to an electrosurgical unit with a cable of PVC insulation and copper wires.
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K Number
K091939Device Name
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
Manufacturer
THERMEDX, LLC
Date Cleared
2010-07-23
(388 days)
Product Code
HIG, HRX, LGZ
Regulation Number
884.1700Why did this record match?
Applicant Name (Manufacturer) :
THERMEDX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 37-5 is a multi-purpose fluid management system indicated for the following:
- Laparoscopy: warming fluids for irrigation and aspiration .
- Hysteroscopy: uterine distention during diagnostic and operative procedures .
- Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional . fluid warming)
- Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic . and operative procedures
During hysteroscopic, cystoscopic and arthroscopic procedures, the 37~5 can be used to monitor fluid deficit.
Device Description
The Thermedx 37-5 is a general purpose fluid management system intended for standard surgical fluid management applications. The device consists of a Base Unit and Disposable Tubing Sets. A rolling standmounted device houses infrared fluid heating technology and a peristaltic fluid pump with closed-loop controls. The unit operates in 2 primary modes with fluid heating; flow control and pressure control. The Disposable Tubing Sets include IV bag spike, heating cartridge, and trumpet valve or luck connectors for endoscopes or other devices.
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