(61 days)
No
The description details a closed-loop control system based on sensors (temperature, pressure, load cells) and a processor, which is standard automation and not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device performs functions like irrigation, fluid warming, and measurement of fluid volume/deficit during endoscopic procedures. These are supportive functions for surgery and do not directly treat a disease or condition.
Yes
Explanation: The device performs "volume/deficit measurements" which involves collecting data to assess a physiological state (fluid balance/loss).
No
The device description explicitly mentions hardware components like a main unit, rolling stand, peristaltic pump, touch-screen processor, temperature and pressure sensors, and load cells. While software is mentioned for control, it is integrated into a physical system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The FluidSmart® device is described as being used for irrigation, distention, fluid warming, and fluid volume/deficit measurements during surgical procedures (laparoscopic and endoscopic). It handles fluids that are introduced into and removed from the body during the procedure.
- Lack of Sample Analysis: The device does not analyze samples taken from the patient's body to provide diagnostic information. Its function is related to managing fluids used in the surgical field.
Therefore, the intended use and device description clearly indicate that this is a surgical fluid management system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FluidSmart® is 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.
Product codes (comma separated list FDA assigned to the subject device)
HIG, HRX, LGZ
Device Description
FluidSmart® is intended for irrigation, distention, fluid warming, and fluid volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines. Fluids commonly used include 0.9% saline, lactated ringer's solution, 5% mannitol, 1.5% glycine, and sterile water.
The main unit is mounted on a rolling stand which houses the technology used to warm the fluids and the peristaltic pump used to pressurize the fluids. A touch-screen operated processor provides closed loop controls for fluid warming and pumping. The processor monitors temperature and pressure sensors to adjust warming power and pump speed as required. Load cells attached to the fluid bag hooks and suction canister ring allow the processor to monitor fluid levels pumped to and suctioned from the surgical site.
Disposable Tubing Sets
Several versions of the disposable tubing sets are available. The LL0002 is an inflow tubing set used for endoscopic procedures with maximum fluid pressures up to 150 mmHg. The LL0004 is an inflow and outflow tubing set used for endoscopic procedures with maximum pressures up to 150 mmHq. The LL0006 is an inflow tubing set used for endoscopic procedures with maximum fluid pressures up to 300 mmHg. The tubing sets terminate in a luer lock fitting for use with existing hospital equipment, typically an endoscope. Each tubing set includes spikes for the fluid bags, tubing clamps, a cartridge for fluid warming, and a luer lock for connection to the surgical instrument or to a tube that connects to the surgical instrument. The luer lock features a pressure relief valve operating in a range specific to that model of tubing set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 testing performed including the following design verification testing: 1. Software verification testing. 2. Tubing set verification testing.
No clinical testing was conducted by or on behalf of Thermedx.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.
September 5, 2017
Thermedx, LLC. Homer Gregory Director. OA/RA 31200 Solon Road, Unit #1 Solon, OH 44139
K172048 Re:
Trade/Device Name: FluidSmart Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG, LGZ, HRX Dated: August 29, 2017 Received: August 31, 2017
Dear Homer Gregory:
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. 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.
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1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
FluidSmart
Indications for Use (Describe)
Intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, and orthopedic disciplines.
| 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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K172048 Page 1 of 4
Section 024
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Attachment 4
Special 510(k) Summary
l. SUBMITTER, OWNER/OPERATOR
Thermedx, LLC 31200 Solon Rd., Unit #1 Solon, OH 44139
Phone: 440.542.0883, Fax: 440.542.0920
Registration Number: 3007495879
Contact Person: Homer Gregory
Date Prepared: 30 June 2017
II. DEVICE
Trade Name of Device: FluidSmart®
Common or Usual Name: Thermal infusion fluid warmer
Classification Name: Insufflator, Hysteroscopic
Subsequent Classification Names: Arthroscope and Warmer, Thermal, Infusion Fluid
Regulatory Class: II
Regulation Number: 21 CFR 884.1700
Subsequent Regulation Numbers: 21 CFR 888.1100 and 21 CFR 880.5725
Product Code: HIG
Subsequent Product Codes: HRX and LGZ
4
PREDICATE (LEGALLY MARKETED) DEVICE SUBSTANTIAL EQUIVALENCE
Thermedx believes FluidSmart® is substantially equivalent in terms of safety and effectiveness to the following predicate (legally marketed) devices:
-
- Primary: Thermedx Fluid Management System (K133799)
-
- Secondary: Smiths Medical's NormoFlo® Irrigation Warmer Model H-1129 (K072080)
IV. REFERENCE DEVICE
Kosin Technologies' Piggyback Irrigating System (K040094) used as a reference as to clinicians' current utilization of 300 mmHg pressure in urology procedures.
V. DEVICE DESCRIPTION
FluidSmart® is intended for irrigation, distention, fluid warming, and fluid volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines. Fluids commonly used include 0.9% saline, lactated ringer's solution, 5% mannitol, 1.5% glycine, and sterile water.
The main unit is mounted on a rolling stand which houses the technology used to warm the fluids and the peristaltic pump used to pressurize the fluids. A touch-screen operated processor provides closed loop controls for fluid warming and pumping. The processor monitors temperature and pressure sensors to adjust warming power and pump speed as required. Load cells attached to the fluid bag hooks and suction canister ring allow the processor to monitor fluid levels pumped to and suctioned from the surgical site.
Disposable Tubing Sets
Several versions of the disposable tubing sets are available. The LL0002 is an inflow tubing set used for endoscopic procedures with maximum fluid pressures up to 150 mmHg. The LL0004 is an inflow and outflow tubing set used for endoscopic procedures with maximum pressures up to 150 mmHq. The LL0006 is an inflow tubing set used for endoscopic procedures with maximum fluid pressures up to 300 mmHg. The tubing sets terminate in a luer lock fitting for use with existing hospital equipment, typically an endoscope. Each tubing set includes spikes for the fluid bags, tubing clamps, a cartridge for fluid warming, and a luer lock for connection to the surgical instrument or to a tube that connects
5
to the surgical instrument. The luer lock features a pressure relief valve operating in a range specific to that model of tubing set.
VI. INDICATIONS FOR USE
FluidSmart® is 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.
VII. TECHNOLOGICAL CHARACTERISTICS
Technological Comparison:
The modified device, FluidSmart®, is essentially identical to the primary predicate device, Thermedx Fluid Management System, and substantially equivalent to the secondary predicate device with no fundamental technological differences. Essential design, the material, the chemical composition, the energy source, basic safety/essential performance, etc., are unchanged between the modified device and the primary predicate device. Other than the change to maximum fluid pressure for ureteroscopy going from 200 mmHg to 300 mmHg, there are no changes between the modified device and the primary predicate.
Packaging of the modified device and disposable tubing sets, sterilization means for the disposable tubing sets, expiration dating for the disposable tubing sets, and biocompatibility acceptability for the disposable tubing sets remain unchanged from the primary predicate as well.
Changes between the modified device and the primary predicate device relate to the ureteroscopy procedure pressure being increased from the currently cleared 200 mmHg to 300 mmHg utilized by the secondary predicate device.
6
Table 6
| Technological
Characteristic | Modified Device | Primary
Predicate Device | Secondary Predicate
Device |
|--------------------------------------------------|------------------------------|----------------------------------------------|------------------------------------------------------------|
| | Name:
FluidSmart® | Name: Thermedx
Fluid Management
System | Name: NormoFlo®
Irrigation Fluid Warmer
Model H-1129 |
| Fluid Warming
Method | Infrared heating
of fluid | Same | Heat exchanger |
| Pressure
Generation Method | Peristaltic pump | Same | On-board compressor and
two pressure chambers |
| User Interface | Touch Screen | Same | Controls
- adjustable gauge |
| Device Type | Electro-
Mechanical | Same | Same |
| Maximum Pressure
(ureteroscopy
procedures) | 300 mmHg | 200 mmHg | Same
(300 mmHg - 500
mmHg) |
NON-CLINICAL TESTS VIII.
Non-clinical testing performed including the following design verification testing: 1. Software verification testing. 2. Tubing set verification testing.
IX. CLINICAL INFORMATION
No clinical testing was conducted by or on behalf of Thermedx.
X. CONCLUSION
The proposed device is safe and effective and is substantially equivalent to the predicate devices. Any differences are minor and we believe they raise no new questions of safety and effectiveness.
All statements and representations set forth above regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration, and are not made in the context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).