X-FLO Fluid Management System

K210628 · Thermedx, LLC · HIG · Nov 4, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K210628
• Device Name: X-FLO Fluid Management System
• Applicant: Thermedx, LLC
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1700
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

X-FLO Fluid Management System provides fluid distention, warming, and volume/deficit monitoring for endoscopic procedures. Input: IV bags/bottles of fluid. Operation: Peristaltic pump pressurizes/delivers fluid; infrared lamps warm fluid to body temperature; fluid bag weight monitored for inflow. Optional deficit module uses external suction to return fluid; single-use deficit cartridge measures volume. Controlled via touchscreen GUI; user selects discipline/procedure and sets parameters (pressure, flow, temperature). Foot pedal allows temporary, configurable pressure increase within safety limits. Output: Pressurized, warmed fluid to surgical site; real-time display of temperature, pressure, and deficit on GUI. Used in OR or physician office by clinicians. Safety features include audible/visual alarms and automatic pump disablement for over-pressure, over-temperature, or over-deficit conditions. Benefits: Maintains surgical site visualization and monitors fluid balance to prevent complications.

Clinical Evidence

Bench testing only. Evaluated system functionality, alarm levels, leak testing, mechanical strength, fluid sensing, and compatibility with various irrigation fluids. Verified irrigation pressure controls with multiple hysteroscope models per FDA guidance. Confirmed accuracy of tissue trap capacity, deficit calculation, empty bag detection, temperature, pressure, and flow rate. Biocompatibility, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and sterility (ISO 11135) testing performed.

Technological Characteristics

Peristaltic pump; infrared lamp heating; dual pressure transducers. Materials: EPDM, polycarbonate, PVC, nylon, silicone, PTFE, ABS, polypropylene. Dimensions/form factor: Supports (4) 5-Liter fluid vessels. Connectivity: Touchscreen GUI. Sterilization: Ethylene Oxide (ISO 11135). Software: Major level of concern. Power: 120-240 VAC. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993, ASTM F198-16, ASTM F1929-15, ASTM F88.

Indications for Use

Indicated for patients undergoing endoscopic procedures in gynecology (uterus), urology (bladder/kidneys), and orthopedics (shoulder, knee, small joints) requiring fluid distention, flushing, and deficit monitoring.

Regulatory Classification

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.

Predicate Devices

• FluidSmart (K172048)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

· 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.

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: [phone] Fax: [phone]

Contact Person: Daniel Marijan; Quality & Regulatory Manager Email: [e-mail] Phone: [phone] 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

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.

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Image /page/4/Picture/1 description: The image shows the logo for Thermedx. The word "Thermedx" is written in gray, sans-serif font. Above and below the word are curved lines in different colors. The top curve is made of red, orange, and yellow, while the bottom curve is made of blue.

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.

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-FLO<br>Subject Device<br>K210628 | FluidSmart<br>Predicate Device<br>K172048 | Summary |
|-----------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Attributes | Manufacturer Name | Thermedx, LLC | Thermedx, LLC | The X-FLO has similar general<br>attributes to the FluidSmart. The<br>difference in device accessories is<br>explained below in the Deficit<br>Monitoring section. The difference in<br>power does not raise different<br>questions of safety and effectiveness. |
| | Device Description | A surgical fluid management system using a pump for delivering<br>pressurized fluid. Monitors fluid deficit and warms fluid | A surgical fluid management system using a pump for delivering<br>pressurized fluid. Monitors fluid deficit and warms fluid | |
| | Device Accessories | Various tubing sets; Includes<br>optional deficit module for deficit<br>monitoring | Various tubing sets; Includes<br>canister ring for deficit<br>monitoring | |
| | Location of Use | Operating Room or Physician Office | Operating Room or Physician Office | |
| | User Interface | Touch screen with a graphical interface displaying measured<br>temperature, pressure, and deficit. | Touch screen with a graphical interface displaying measured<br>temperature, pressure, and deficit. | |
| | Software controlled | - | Yes | |
| | Power | 120-240±10% VAC, 50/60 Hz | 120V±5% VAC, 60Hz | |
| | Disposables<br>Component<br>Materials | EPDM, polycarbonate, PVC, nylon,<br>adhesive, silicone, PTFE, cotton,<br>polypropylene, ABS | Polycarbonate cartridge; PVC<br>tubing; ABS and nylon fittings;<br>and PTFE air vent | |
| | Tubing Sterile? | Yes, for all indirect tissue contacting tubing sets | Yes, for all indirect tissue contacting tubing sets | |
| Irrigation Fluid<br>Warming | Irrigation Fluid /<br>Warming | Yes | Yes | The difference in Fluid Warming Rate<br>for the X-FLO does not raise different<br>questions of safety and |
| | Heating Technology | Infrared lamps | Infrared lamps | effectiveness. |
| | Fluid Warming Rate | Capable of increasing inlet fluid<br>temperature from 18 °C ± 1 °C<br>to 40 °C ± 3 °C for flow rates <<br>800 mL/min<br>Capable of heating 18 ±1 °C<br>inlet fluid to a 15 ±3 ℃<br>temperature rise at flow rates | Capable of increasing inlet fluid<br>temperature from 15.5 °C to<br>40 °C for flow rates < 500<br>ml/min | |
| | Maximum Set point | of >800 mL/min.<br>40 °C | 40 °C | |
| | Temperature<br>Measurement | Irrigation fluid temperature measured at exit from the cartridge<br>component of the tubing set | Irrigation fluid temperature measured at exit from the cartridge<br>component of the tubing set | |
| | Temperature<br>Displayed | Irrigation fluid temperature displayed at GUI. | Irrigation fluid temperature displayed at GUI. | |
| | Initial Temperature<br>Signal | Set point +3 °C (43 °C max) | Set point +3 °C (43 °C max) | |
| | | | | |
| Fluid Delivery | Pressure /<br>Pumping<br>Mechanism | Peristaltic pump with ability to reverse to relieve pressure | | The X-FLO can hold four 5-Liter fluid<br>vessels at a time. This volume<br>increase does not raise different<br>questions of safety and<br>effectiveness. The maximum<br>distention pressure has increased |
| | Pressure<br>Measurement<br>Mechanism | Dual transducers measuring fluid pressure | | |
| | | | | from 300 mmHg to 350 mmHg for<br>ureteroscopy procedures only. The |
| | Maximum Flow<br>Rate | 1200 mL/min | | pressure increase does not raise<br>different questions of safety and |
| | Fluid Pressure | 30-350 mmHg | 30-300 mmHg | effectiveness. |
| | Procedure-based<br>limits and ranges | Yes, default settings and limits established for pressure, flowrate,<br>temperature, and suction pressure | | |
| | Maximum Fluid<br>Vessel Size (number<br>of vessels in<br>parentheses) | (4) 5-Liter | (2) 5-Liter | |
| | Max Fluid Capacity | 5500 g per hook | | |
| | Fluid Weight<br>Accuracy | $\pm$ 5 mL | $\pm$ 10% or 250 mL | |
| | Temporary Pressure<br>Increase Mechanism | Foot pedal or User interface | User interface | The foot pedal has been added as a<br>feature to allow for a physician<br>controlled, configurable, temporary<br>pressure increase within the<br>procedural limits established by X-<br>FLO. The additional foot pedal does<br>not raise different questions of safety<br>and effectiveness. |
| Deficit Monitoring | Fluid Deficit<br>Monitoring | Yes | | The X-FLO, with the optional deficit<br>module, calculates deficit based on |
| | | | | fluid flow through a deficit cartridge |
| | Monitoring<br>Accuracy<br>Specification | 1 – 1000 mL: $\pm$ 75 mL<br>1000 – 2500 mL: $\pm$ 5 %<br>2500 – 5000 mL: $\pm$ 3 %<br>$\ge$ 5000 mL: $\pm$ 2.2 % | The greater of 250ml or 10% of<br>the volume pumped | and, therefore, does not require that<br>the fluid returning from the surgical |
| | | | | site to be collected in canisters and |
| | Measurement<br>Means | Measurement by flow | Measurement by weight | weighed, like the predicate device.<br>The subject device also uses suction<br>to pass fluid through the deficit |
| | Fluid Deficit Display | Displayed on GUI | | cartridge. The change to deficit<br>monitoring does not raise different |
| | External Suction<br>Regulation | 0-400 mmHg Suction Setpoint<br>Range | None | questions or safety and<br>effectiveness. Both methods can be<br>evaluated through performance<br>testing. |
| Safety Features | Information Signals | Visual and Audible | | The X-FLO offers similar safety |
| | | Audible and visual notifications and<br>disable pumping if the fluid pressure<br>exceeds the setpoint by the greater<br>of 10% or 12 mmHg. | Audible and visual notification and<br>fluid flow suspension if the fluid<br>pressure is outside the setpoint<br>by the greater of $\pm$ 10% or 12<br>mmHg. | features to the predicate device,<br>with the same types of information<br>signals. |
| | Over-pressure | Disable pumping prior to irrigation<br>pressure exceeding the maximum<br>set point by more than the higher | An automatic reset shall occur<br>when values return to the<br>acceptable range. | |

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Image /page/8/Picture/1 description: The image shows the logo for Thermedx. The logo consists of the word "Thermedx" in gray letters, with a registered trademark symbol after the "x". Above and below the word are curved shapes in different colors. The top curve is red, orange, and yellow, while the bottom curve is light blue and dark blue.

| Over-temperature | The device will disable the lamps if the fluid temperature reaches $41.5 \pm 1$ °C.<br><br>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<br>(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<br>(Hypotonic Solutions) | The device will disable pumping and provide audible notification when the deficit level reaches the deficit alarm setpoint inputted by the user.<br><br>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.<br><br>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.<br><br>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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Image /page/9/Picture/1 description: The image shows the logo for Thermedx. The logo consists of the word "Thermedx" in gray, with a stylized graphic above and below the text. The graphic is made up of curved shapes in different colors, with the top shapes in red, orange, and yellow, and the bottom shapes in light and dark blue. The logo is simple and modern, and the colors are bright and eye-catching.

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.