(247 days)
Not Found
No
The description details a system based on peristaltic pumps, infrared lamps, weight sensors, and vacuum regulation, controlled by a GUI with user-defined setpoints. There is no mention of AI, ML, or any learning or adaptive algorithms. The software is described as "major" level of concern, which is common for medical devices with significant control functions, but doesn't inherently imply AI/ML.
No
The device is used for fluid management (warming, pumping, distention, flushing, and deficit measurement) during surgical procedures, primarily for visualization and maintaining the surgical field, not for directly treating a disease or condition. While fluid distention could be seen as part of a therapeutic procedure, the device itself is a surgical accessory rather than a standalone therapeutic device.
Yes
The device description explicitly states, "The X-FLO Fluid Management System... 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." The phrase "for diagnostic and/or operative" indicates its use in diagnostics, and its ability to measure fluid deficit is part of this diagnostic function.
No
The device description clearly outlines hardware components such as a peristaltic pump, infrared lamps, a touchscreen user interface, and an optional deficit module with external suction and a single-use deficit cartridge. It also mentions a foot pedal accessory. These are physical components, not solely software.
Based on the provided information, the X-FLO Fluid Management System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for warming and pumping fluid for distention and flushing during surgical procedures (gynecology, urology, and orthopedics). While it measures fluid deficit, this is a measurement of fluid used and returned during the procedure, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system for fluid delivery, warming, and volume/deficit monitoring during a surgical procedure. It does not describe any components or processes for analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on the analysis of such samples. The deficit measurement is a procedural metric, not a diagnostic one.
Therefore, the X-FLO Fluid Management System is a surgical device used to manage fluid during procedures, not an IVD device used for diagnostic testing on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HIG, LGZ, HRX
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.
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.
-
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, bladder, kidneys, shoulder, knee, other small joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room or Physician Office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Study Type: Biocompatibility testing
- Sample Size: Not specified
- Data Source: Not specified
- Annotation Protocol: Not specified
- Key Results: 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." Tests conducted: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017). The single use tubing sets have been assessed as an externally communicating medical device with tissue/bone/dentin contact for a limited (
§ 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.
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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
1
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
2
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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Image /page/3/Picture/0 description: The image shows the logo for Thermedx. The logo features the company name in a gray, sans-serif font. Above and below the name are curved shapes in a gradient of colors. The top curve transitions from red to orange to yellow, while the bottom curve transitions from light blue to dark blue.
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
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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Image /page/5/Picture/0 description: The image shows the text "K210628 Page 3 of 7" in a light gray font. The text appears to be a page number within a larger document. The page number is 3, and the total number of pages in the document is 7. The text is simple and straightforward, providing clear information about the document's structure.
Image /page/5/Picture/1 description: The image shows the logo for Thermedx. The logo consists of the word "Thermedx" in gray letters. Above the word is a curved design with orange, yellow, and red colors. Below the word is a curved design with light blue and dark blue colors.
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/0 description: The image shows the text 'K210628' and 'Page 4 of 7'. The text is in a sans-serif font and is light gray in color. The text is likely a page number or document identifier.
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
Subject Device
K210628 | FluidSmart
Predicate Device
K172048 | Summary |
|-----------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Attributes | Manufacturer Name | Thermedx, LLC | Thermedx, LLC | The X-FLO has similar general
attributes to the FluidSmart. The
difference in device accessories is
explained below in the Deficit
Monitoring section. The difference in
power does not raise different
questions of safety and effectiveness. |
| | Device Description | A surgical fluid management system using a pump for delivering
pressurized fluid. Monitors fluid deficit and warms fluid | A surgical fluid management system using a pump for delivering
pressurized fluid. Monitors fluid deficit and warms fluid | |
| | Device Accessories | Various tubing sets; Includes
optional deficit module for deficit
monitoring | Various tubing sets; Includes
canister ring for deficit
monitoring | |
| | Location of Use | Operating Room or Physician Office | Operating Room or Physician Office | |
| | User Interface | Touch screen with a graphical interface displaying measured
temperature, pressure, and deficit. | Touch screen with a graphical interface displaying measured
temperature, pressure, and deficit. | |
| | Software controlled | - | Yes | |
| | Power | 120-240±10% VAC, 50/60 Hz | 120V±5% VAC, 60Hz | |
| | Disposables
Component
Materials | EPDM, polycarbonate, PVC, nylon,
adhesive, silicone, PTFE, cotton,
polypropylene, ABS | Polycarbonate cartridge; PVC
tubing; 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 Fluid
Warming | Irrigation Fluid /
Warming | Yes | Yes | The difference in Fluid Warming Rate
for the X-FLO does not raise different
questions of safety and |
| | Heating Technology | Infrared lamps | Infrared lamps | effectiveness. |
| | Fluid Warming Rate | Capable of increasing inlet fluid
temperature from 18 °C ± 1 °C
to 40 °C ± 3 °C for flow rates 800 mL/min.
40 °C | 40 °C | |
| | Temperature
Measurement | Irrigation fluid temperature measured at exit from the cartridge
component of the tubing set | Irrigation fluid temperature measured at exit from the cartridge
component of the tubing set | |
| | Temperature
Displayed | Irrigation fluid temperature displayed at GUI. | Irrigation fluid temperature displayed at GUI. | |
| | Initial Temperature
Signal | Set point +3 °C (43 °C max) | Set point +3 °C (43 °C max) | |
| | | | | |
| Fluid Delivery | Pressure /
Pumping
Mechanism | Peristaltic pump with ability to reverse to relieve pressure | | The X-FLO can hold four 5-Liter fluid
vessels at a time. This volume
increase does not raise different
questions of safety and
effectiveness. The maximum
distention pressure has increased |
| | Pressure
Measurement
Mechanism | Dual transducers measuring fluid pressure | | |
| | | | | from 300 mmHg to 350 mmHg for
ureteroscopy procedures only. The |
| | Maximum Flow
Rate | 1200 mL/min | | pressure increase does not raise
different questions of safety and |
| | Fluid Pressure | 30-350 mmHg | 30-300 mmHg | effectiveness. |
| | Procedure-based
limits and ranges | Yes, default settings and limits established for pressure, flowrate,
temperature, and suction pressure | | |
| | Maximum Fluid
Vessel Size (number
of vessels in
parentheses) | (4) 5-Liter | (2) 5-Liter | |
| | Max Fluid Capacity | 5500 g per hook | | |
| | Fluid Weight
Accuracy | $\pm$ 5 mL | $\pm$ 10% or 250 mL | |
| | Temporary Pressure
Increase Mechanism | Foot pedal or User interface | User interface | The foot pedal has been added as a
feature to allow for a physician
controlled, configurable, temporary
pressure increase within the
procedural limits established by X-
FLO. The additional foot pedal does
not raise different questions of safety
and effectiveness. |
| Deficit Monitoring | Fluid Deficit
Monitoring | Yes | | The X-FLO, with the optional deficit
module, calculates deficit based on |
| | | | | fluid flow through a deficit cartridge |
| | Monitoring
Accuracy
Specification | 1 – 1000 mL: $\pm$ 75 mL
1000 – 2500 mL: $\pm$ 5 %
2500 – 5000 mL: $\pm$ 3 %
$\ge$ 5000 mL: $\pm$ 2.2 % | The greater of 250ml or 10% of
the volume pumped | and, therefore, does not require that
the fluid returning from the surgical |
| | | | | site to be collected in canisters and |
| | Measurement
Means | Measurement by flow | Measurement by weight | weighed, like the predicate device.
The subject device also uses suction
to pass fluid through the deficit |
| | Fluid Deficit Display | Displayed on GUI | | cartridge. The change to deficit
monitoring does not raise different |
| | External Suction
Regulation | 0-400 mmHg Suction Setpoint
Range | None | questions or safety and
effectiveness. Both methods can be
evaluated through performance
testing. |
| Safety Features | Information Signals | Visual and Audible | | The X-FLO offers similar safety |
| | | Audible and visual notifications and
disable pumping if the fluid pressure
exceeds the setpoint by the greater
of 10% or 12 mmHg. | Audible and visual notification and
fluid flow suspension if the fluid
pressure is outside the setpoint
by the greater of $\pm$ 10% or 12
mmHg. | features to the predicate device,
with the same types of information
signals. |
| | Over-pressure | Disable pumping prior to irrigation
pressure exceeding the maximum
set point by more than the higher | An automatic reset shall occur
when values return to the
acceptable range. | |
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Image /page/7/Picture/1 description: The image shows the logo for Thermedx. The logo features the word "Thermedx" in gray, with a stylized circle above and below the text. The top half of the circle is made up of curved shapes in red, orange, and yellow, while the bottom half is made up of curved shapes in light blue and dark blue.
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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.
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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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 (