· 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.

AI/ML Overview

The provided text details the 510(k) submission for the Thermedx X-FLO Fluid Management System, which is a medical device intended for fluid distention, warming, and volume/deficit measurements during various endoscopic procedures.

Here's an analysis of the acceptance criteria and study data based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents a comparison table between the subject device (X-FLO Fluid Management System) and its predicate device (FluidSmart), which implicitly defines the performance criteria. The relevant criteria mainly relate to fluid warming, fluid delivery (pressure/flow), and deficit monitoring.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion	Acceptance Criteria (from comparison with predicate/stated capability)	Reported Device Performance (X-FLO Subject Device K210628)
I. Imaging/AI Specifics	(Not Applicable - This is not an AI/imaging device)	(Not Applicable - This is not an AI/imaging device)
II. Device Performance
Fluid Warming
Heating Technology	Infrared lamps	Infrared lamps
Fluid Warming Rate	Increase inlet fluid temp to 40°C.	Capable of increasing inlet fluid temperature from 18 °C ± 1 °C to 40 °C ± 3 °C for flow rates < 800 mL/min; Capable of heating 18 ±1 °C inlet fluid to a 15 ±3 ℃ temperature rise at flow rates of >800 mL/min.
Maximum Setpoint	40°C	40 °C
Temperature Measurement	Measured at exit from cartridge component of tubing set	Irrigation fluid temperature measured at exit from the cartridge component of the tubing set
Temperature Displayed	Displayed at GUI	Irrigation fluid temperature displayed at GUI.
Over-temperature Safety	Disable pumping if fluid temp exceeds set-point + 3°C	The device will disable the lamps if the fluid temperature reaches 41.5 ± 1 °C. The device will disable pumping if the actual fluid temperature reaches 46 ± 1 °C.
Fluid Delivery
Pumping Mechanism	Peristaltic pump	Peristaltic pump with ability to reverse to relieve pressure
Pressure Measurement	(Implied accurate measurement)	Dual transducers measuring fluid pressure
Maximum Flow Rate	1200 mL/min (stated for predicate)	1200 mL/min
Fluid Pressure	30-300 mmHg (predicate)	30-350 mmHg
Max Fluid Vessel Size	(2) 5-Liter (predicate)	(4) 5-Liter (Note: The document states this "does not raise different questions of safety and effectiveness")
Fluid Weight Accuracy	± 10% or 250 mL (whichever is greater) (predicate)	± 5 mL (Note: This is significantly more precise than the predicate's reported accuracy)
Temporary Pressure Increase	User interface (predicate)	Foot pedal or User interface
Over-pressure Safety	Audible/visual notifications, suspend fluid flow if outside ±10% or 12mmHg	Audible and visual notifications and disable pumping if the fluid pressure exceeds the setpoint by the greater of 10% or 12 mmHg. Disable pumping prior to irrigation pressure exceeding the maximum set point by more than the higher of 10% or 12 mmHg.
Deficit Monitoring
Fluid Deficit Monitoring	Yes	Yes
Monitoring Accuracy Spec	The greater of 250ml or 10% of the volume pumped (predicate)	1 – 1000 mL: ± 75 mL; 1000 – 2500 mL: ± 5 %; 2500 – 5000 mL: ± 3 %; ≥ 5000 mL: ± 2.2 % (Note: This is a different and more precise specification than the predicate's reported accuracy)
Measurement Means	Measurement by weight (predicate)	Measurement by flow (Note: This is a different method than the predicate, justified by performance testing)
Fluid Deficit Display	Displayed on GUI (predicate implied)	Displayed on GUI
External Suction Regulation	None (predicate)	0-400 mmHg Suction Setpoint Range (Note: New feature, justified as not raising new questions of safety/effectiveness as it can be evaluated by performance testing)
Over-deficit Safety (Isotonic)	Audible/visible notification, suspend fluid flow if deficit reached	The device will disable pumping when the default setpoint or maximum deficit volume (2,500 mL) is reached
Over-deficit Safety (Hypotonic)	(Not applicable for predicate)	The device will disable pumping and provide audible notification when the deficit level reaches the deficit alarm setpoint inputted by the user. The device will disable pumping and provide audible notification when the maximum allowable deficit level of 2,500 mL is reached if the fluids used are a combination of isotonic and hypotonic. The device will disable pumping when the maximum deficit of 1,000 mL is reached. (Note: New feature due to the new deficit measurement method)
III. Other Performance
Biocompatibility	Compliant with ISO 10993-1, 5, 10, 11	Conducted per 2020 FDA guidance. Tests include: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017)
Electrical Safety & EMC	Compliant with IEC 60601-1, 1-2, 1-6	Complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012), IEC 60601-1-2:2014, and IEC 60601-6:2010 + A1:2013.
Software V&V Testing	Compliant with FDA guidance for "major" level of concern	Conducted as recommended by 2005 FDA guidance document. Software considered "major" level of concern.
Sterility & Shelf-Life	Sterile, compliant with ISO 11135, ASTM F198/F1929/F88	Sterilized via Ethylene Oxide per ISO 11135:2014. Shelf life of 6 months. Shelf-life testing per accelerated aging (ASTM F198-16) with visual inspection (ASTM F1929-15) and seal strength (ASTM F88).
Bench Testing	Specifications met in simulated use for various parameters	Evaluated alarm sound levels, tubing/cartridge leak testing, tubing mechanical strength, fluid sensing, fluid compatibility (sterile water, lactated ringers, mannitol, glycine, saline, sorbitol), irrigation pressure controls (with three hysteroscope models), over-temperature, over-pressure, over-deficit testing, tissue trap capacity, deficit calculation accuracy, empty fluid bag detection, temperature accuracy, and pressure and flowrate accuracy.

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing conducted to support the substantial equivalence determination.

Sample Size Used for Test Set and Data Provenance:
- The document implies that testing was performed on representative units of the device and its accessories (tubing sets, deficit cartridge, etc.).
- Sample Size: Not explicitly stated as a number of devices or data points for each bench test. For example, "Fluid compatibility with sterile water, lactated ringers solution, 5 % mannitol solution, 1.5 % glycine solution, 0.9% saline solution, and sorbitol solution" implies multiple tests, but the quantity of tests, runs, or devices tested for each parameter is not specified. Similarly, "Irrigation pressure controls with three different hysteroscope models" specifies the models but not the number of runs or devices.
- Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, so the testing was presumably conducted in a manner acceptable for US regulatory submission. The studies are bench/laboratory studies focused on device performance, not patient data studies, so "retrospective or prospective" is not an applicable distinction in the sense of patient data collection.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is a technical performance study of a medical device, not a study involving human interpretation of clinical data (like AI for imaging). Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists) is not applicable. The "ground truth" for these tests is the physical measurement of device performance against engineering specifications using calibrated equipment and standard test methods.
Adjudication Method for the Test Set:
- Not Applicable. As this involves objective bench testing, there is no "adjudication" in the sense of reconciling subjective expert opinions. Device performance measurements are compared directly against pre-defined engineering and regulatory specifications.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/imaging device or a device whose performance is dependent on human reader interpretation. Therefore, an MRMC study is not relevant.
If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. While the device has software ("Software controlled"), its performance is measured as an integrated system (hardware and software) in bench testing, not as a standalone algorithm evaluating clinical data. The "stand-alone" performance is implicitly the results of the bench testing.
The Type of Ground Truth Used:
- The "ground truth" for the performance studies is the pre-defined engineering specifications and internationally recognized standards (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) that the device must meet. Performance metrics (e.g., temperature, pressure, flow rate, deficit volume) are objectively measured using calibrated instruments during bench testing.
The Sample Size for the Training Set:
- Not Applicable. This is a hardware medical device with embedded software; it does not involve machine learning or AI models that require "training sets" in the conventional sense of data-driven model training. The software is developed and verified via traditional software engineering principles.
How the Ground Truth for the Training Set Was Established:
- Not Applicable. (As explained above, no traditional training set exists for this type of device.) The "ground truth" for software functionality testing (verification and validation) would be the software requirements specifications derived from the device's intended use and design.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

November 4, 2021

Thermedx, LLC Daniel Marijan Quality and Regulatory Manager 31200 Solon Rd Unit 1 Solon, Ohio 44139

Re: K210628 Trade/Device Name: X-FLO Fluid Management System Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG, LGZ, HRX Dated: October 4, 2021 Received: October 6, 2021

Dear Daniel Marijan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210628

Device Name

X-FLO Fluid Management System

Indications for Use (Describe)

The X-FLO Fluid Management System is intended to:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER INFORMATION

Thermedx, LLC 31200 Solon Rd. Unit#1 Solon, OH 44139

Phone: 440-542-0883 Fax: 440-542-0920

Contact Person: Daniel Marijan; Quality & Regulatory Manager Email: dmarijan@thermedx.com Phone: 440-542-0883 Date Prepared: November 3, 2021

II. DEVICE INFORMATION Name of Device: X-FLO Fluid Management System Common or Usual Name: Hysteroscopic Insufflator Classification Name: Insufflator, Hysteroscopic Regulatory Class: II Regulation Number: 21 CFR 884.1700 Primary Product Code: HIG (Insufflator, Hysteroscopic) Secondary Product Codes: LGZ (Warmer, Thermal, Infusion Fluid), HRX (Arthroscope)

III. PREDICATE DEVICE IDENTIFICATION Name of Device: FluidSmart, K172048

The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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There are several single use tubing sets available as accessories to the X-FLO system including the following:

o Inflow Set - CAT# XT8000 Part# 01790
- o Sterile. Includes inflow tubing and fluid cartridge assembly. This tubing set carries fluid from fluid vessels hung from hooks on the Main Unit, through the fluid cartridge assembly inserted into the Main Unit of the X-Flo system, and to the scope.
Inflow Outflow Set CAT# XT8100 Part# 01800 o
- Sterile. Includes the Inflow Set (01790) and dual outflow tubing (01818, from scope and underbody drape and/or auxiliary floor suction device as applicable).
Uro Inflow Outflow + CBI Set CAT# XT8200 Part# 01805 o
- O Sterile. Includes the Urology Inflow Outflow Set (01990) with continuous bladder irrigation(CBI) tubing (01819).
Urology Inflow Outflow Set CAT# XT8300 Part# 01990 o
- Sterile. Includes the Inflow Set (01790) and dual outflow tubing (01919, from scope O and underbody drape and/or auxiliary floor suction device as applicable). The dual outflow tubing also allows for the addition of an optional tissue or kidney stone trap.
O Urology Morcellator Inflow Outflow Set - CAT# XT8400 Part# 02000
- Sterile. Includes the Inflow Set (01790) and dual outflow tubing (01918, from scope O and morcellator as applicable) with tissue trap.
Deficit Set + CBI CAT# XT8500 Part# 01820 o
- Includes sterile and nonsterile components. Includes the Deficit Set (01810) and o CBI tubing (01819). The only non-sterile component is the deficit cartridge.

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Deficit Set – CAT# XT8600 Part# 01810

O Includes sterile and nonsterile components. Includes the Inflow Set (01790) and 2 outflow tubing sets: 1) dual outflow tubing (01918, from scope and hysteroscopic tissue removal system as applicable) with tissue trap; and 2) dual outflow tubing (01817, from underbody drape and auxiliary floor suction device as applicable) with deficit cartridge (01880). The only non-sterile component is the deficit cartridge.
o 17cc Tissue Trap Kit Part# 02071
- Nonsterile 17 cc Tissue Trap assemblies that can be installed on applicable sets о for procedures that require multiple tissue traps.
50 cc Tissue Trap Kit Part# 02072 o
- Nonsterile 50 cc Tissue Trap assemblies that can be installed on applicable sets o for procedures that require multiple tissue traps.

The tubing sets are made of sterile and non-sterile components, as indicated above, based on their use. The sterile components are indirect tissue contact, while the nonsterile components are non-tissue contact. The sets are made up of a polycarbonate cartridge connected to polyvinyl chloride (PVC) tubing with connectors made of multiple materials including nylon, PVC, polycarbonate, silicone, polytetrafluoroethylene (PTFE), and acrylonitrile butadiene styrene (ABS).

V. INDICATIONS FOR 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.

The Indications for Use of the subject device and predicate device are similar. The Indications for Use of the predicate device is as follows:

Intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

The indications for use of the subject device include details of the procedures and expected functions of the subject device and the subject device is not in laparoscopic procedures. The Indications for use of the predicate device indicate that the predicate device can be used for the laparoscopic procedures. There are no intended use concerns with the subject device indications for use statement.

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Image /page/6/Picture/1 description: The image shows the logo for Thermedx. The logo features the company name in a bold, sans-serif font, with the "x" slightly offset and stylized. Above and below the name, there are curved shapes in a gradient of colors, ranging from orange to blue, creating a circular design element. The overall design is modern and professional.

vi. Comparison of technological characteristics with the predicate device

See the table below for a comparison of the technological characteristics of the X-FLO Fluid Management system to the predicate device.

		X-FLOSubject DeviceK210628	FluidSmartPredicate DeviceK172048	Summary
General Attributes	Manufacturer Name	Thermedx, LLC	Thermedx, LLC	The X-FLO has similar generalattributes to the FluidSmart. Thedifference in device accessories isexplained below in the DeficitMonitoring section. The difference inpower does not raise differentquestions of safety and effectiveness.
	Device Description	A surgical fluid management system using a pump for deliveringpressurized fluid. Monitors fluid deficit and warms fluid	A surgical fluid management system using a pump for deliveringpressurized fluid. Monitors fluid deficit and warms fluid
	Device Accessories	Various tubing sets; Includesoptional deficit module for deficitmonitoring	Various tubing sets; Includescanister ring for deficitmonitoring
	Location of Use	Operating Room or Physician Office	Operating Room or Physician Office
	User Interface	Touch screen with a graphical interface displaying measuredtemperature, pressure, and deficit.	Touch screen with a graphical interface displaying measuredtemperature, pressure, and deficit.
	Software controlled	-	Yes
	Power	120-240±10% VAC, 50/60 Hz	120V±5% VAC, 60Hz
	DisposablesComponentMaterials	EPDM, polycarbonate, PVC, nylon,adhesive, silicone, PTFE, cotton,polypropylene, ABS	Polycarbonate cartridge; PVCtubing; ABS and nylon fittings;and PTFE air vent
	Tubing Sterile?	Yes, for all indirect tissue contacting tubing sets	Yes, for all indirect tissue contacting tubing sets
Irrigation FluidWarming	Irrigation Fluid /Warming	Yes	Yes	The difference in Fluid Warming Ratefor the X-FLO does not raise differentquestions of safety and
	Heating Technology	Infrared lamps	Infrared lamps	effectiveness.
	Fluid Warming Rate	Capable of increasing inlet fluidtemperature from 18 °C ± 1 °Cto 40 °C ± 3 °C for flow rates <800 mL/minCapable of heating 18 ±1 °Cinlet fluid to a 15 ±3 ℃temperature rise at flow rates	Capable of increasing inlet fluidtemperature from 15.5 °C to40 °C for flow rates < 500ml/min
	Maximum Set point	of >800 mL/min.40 °C	40 °C
	TemperatureMeasurement	Irrigation fluid temperature measured at exit from the cartridgecomponent of the tubing set	Irrigation fluid temperature measured at exit from the cartridgecomponent of the tubing set
	TemperatureDisplayed	Irrigation fluid temperature displayed at GUI.	Irrigation fluid temperature displayed at GUI.
	Initial TemperatureSignal	Set point +3 °C (43 °C max)	Set point +3 °C (43 °C max)

Fluid Delivery	Pressure /PumpingMechanism	Peristaltic pump with ability to reverse to relieve pressure		The X-FLO can hold four 5-Liter fluidvessels at a time. This volumeincrease does not raise differentquestions of safety andeffectiveness. The maximumdistention pressure has increased
	PressureMeasurementMechanism	Dual transducers measuring fluid pressure
				from 300 mmHg to 350 mmHg forureteroscopy procedures only. The
	Maximum FlowRate	1200 mL/min		pressure increase does not raisedifferent questions of safety and
	Fluid Pressure	30-350 mmHg	30-300 mmHg	effectiveness.
	Procedure-basedlimits and ranges	Yes, default settings and limits established for pressure, flowrate,temperature, and suction pressure
	Maximum FluidVessel Size (numberof vessels inparentheses)	(4) 5-Liter	(2) 5-Liter
	Max Fluid Capacity	5500 g per hook
	Fluid WeightAccuracy	$\pm$ 5 mL	$\pm$ 10% or 250 mL
	Temporary PressureIncrease Mechanism	Foot pedal or User interface	User interface	The foot pedal has been added as afeature to allow for a physiciancontrolled, configurable, temporarypressure increase within theprocedural limits established by X-FLO. The additional foot pedal doesnot raise different questions of safetyand effectiveness.
Deficit Monitoring	Fluid DeficitMonitoring	Yes		The X-FLO, with the optional deficitmodule, calculates deficit based on
				fluid flow through a deficit cartridge
	MonitoringAccuracySpecification	1 – 1000 mL: $\pm$ 75 mL1000 – 2500 mL: $\pm$ 5 %2500 – 5000 mL: $\pm$ 3 %$\ge$ 5000 mL: $\pm$ 2.2 %	The greater of 250ml or 10% ofthe volume pumped	and, therefore, does not require thatthe fluid returning from the surgical
				site to be collected in canisters and
	MeasurementMeans	Measurement by flow	Measurement by weight	weighed, like the predicate device.The subject device also uses suctionto pass fluid through the deficit
	Fluid Deficit Display	Displayed on GUI		cartridge. The change to deficitmonitoring does not raise different
	External SuctionRegulation	0-400 mmHg Suction SetpointRange	None	questions or safety andeffectiveness. Both methods can beevaluated through performancetesting.
Safety Features	Information Signals	Visual and Audible		The X-FLO offers similar safety
		Audible and visual notifications anddisable pumping if the fluid pressureexceeds the setpoint by the greaterof 10% or 12 mmHg.	Audible and visual notification andfluid flow suspension if the fluidpressure is outside the setpointby the greater of $\pm$ 10% or 12mmHg.	features to the predicate device,with the same types of informationsignals.
	Over-pressure	Disable pumping prior to irrigationpressure exceeding the maximumset point by more than the higher	An automatic reset shall occurwhen values return to theacceptable range.

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Over-temperature	The device will disable the lamps if the fluid temperature reaches $41.5 \pm 1$ °C.The device will disable pumping if the actual fluid temperature reaches $46 \pm 1$ °C	The device flow will be disabled if the outlet fluid temperature exceeds set-point + 3 °C.
Over-deficit(Isotonic Solutions)	The device will disable pumping when the default setpoint or maximum deficit volume (2,500 mL) is reached	If the fluid deficit exceeds the set point, the device shall produce audible and visible notifications and suspend fluid flow. Users may increase the deficit limit to resume fluid flow if the current limit is below the max allowable level.
Over-deficit(Hypotonic Solutions)	The device will disable pumping and provide audible notification when the deficit level reaches the deficit alarm setpoint inputted by the user.The device will disable pumping and provide audible notification when the maximum allowable deficit level of 2,500 mL is reached if the fluids used are a combination of isotonic and hypotonic.The device will disable pumping when the maximum deficit of 1,000 mL is reached.
Fluid Volume	Notify the user when a vessel is $300 \pm 50$ mL from empty.Notify the user when a vessel is empty; defined as ≤ 150 grams.	Indicate that the vessel is empty or low if the measured fluid level is less than 50 mL.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

The following performance data has been provided in support of the substantial equivalence determination. The subject device was evaluated according to the recommendations outlined in the 1995 FDA guidance document "Hysteroscopic and Laparoscopic Insufflators."

Biocompatibility testing

The biocompatibility evaluation for the X-FLO Fluid Management System single use tubing sets was conducted in accordance with 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The following tests were conducted:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010)
. Irritation (ISO 10993-10:2010)
Acute Systemic Toxicity (ISO 10993-11:2017)

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The X-FLO Fluid Management System single use tubing sets have been assessed, based on the tissue contact and contact duration, an externally communicating medical device with tissue/bone/dentin contact for a limited (<24 hours) exposure duration.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the X-FLO Fluid Management System. The system complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012), IEC 60601-1-2:2014, and IEC 60601-6:2010 + A1:2013.

Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by the 2005 FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Sterility and Shelf-Life Testing

The applicable accessories were sterilized via Ethylene Oxide Sterilization per ISO 11135:2014.

The sterile tubing accessories have a shelf life of 6 months. Shelf-life testing was performed using accelerated aging per ASTM F198-16 with visual inspection testing per ASTM F1929-15 and seal strength testing per ASTM F88 completed on aged devices.

Bench testing

Evaluated if the specifications are met as expected in the simulated use, including system functionality testing of the following:
- Alarm sound levels
- . Tubing and cartridge leak testing
- Tubing mechanical strength
- . Fluid sensing
- . Fluid compatibility with sterile water, lactated ringers solution, 5 % mannitol solution, 1.5 % glycine solution, 0.9% saline solution, and sorbitol solution.
- . Irrigation pressure controls with three different hysteroscope models, per the hysteroscopic and laparoscopic insufflator guidance
Over-temperature, over-pressure, and over-deficit testing.
. Tissue trap capacity, deficit calculation accuracy, empty fluid bag detection, temperature accuracy, and pressure and flowrate-accuracy testing.

VIII. CONCLUSIONS

The performance data summarized above demonstrate that the subject device (X-FLO Fluid Management System) is as safe and effective as the predicate device (FluidSmart). The subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1700 Hysteroscopic insufflator.

(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.