(61 days)
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.
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.
This document is a 510(k) summary for the FluidSmart device, which is a hysteroscopic insufflator. Such summaries typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results in the manner requested for AI/ML devices. Therefore, much of the requested information, which is common in regulatory submissions for AI/ML or novel devices, is not present here.
Here's a breakdown of the available information and what is not present:
1. Table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics to predicate devices, but it does not specify quantitative acceptance criteria for performance benchmarks, nor does it present device performance against such criteria directly in a table format as might be expected for software performance metrics.
| Technological Characteristic | Acceptance Criteria (Implicit from Predicate/Study Purpose) | FluidSmart® Reported Performance |
|---|---|---|
| Fluid Warming Method | Same as Predicate (Infrared heating of fluid) | Infrared heating of fluid |
| Pressure Generation Method | Same as Predicate (Peristaltic pump) | Peristaltic pump |
| User Interface | Same as Predicate (Touch Screen) | Touch Screen |
| Device Type | Same as Predicate (Electro-Mechanical) | Electro-Mechanical |
| Maximum Pressure (ureteroscopy procedures) | 300 mmHg (matching secondary predicate at 300-500 mmHg) | 300 mmHg |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This device is a hardware device (insufflator, fluid warmer) with associated software for control. The testing involved non-clinical design verification, not analysis of a "test set" of patient data in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable, as this is not an AI/ML device requiring expert adjudication of a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an AI/ML device and thus an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm. The device itself (FluidSmart®) is a standalone system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as this is not an AI/ML device. The "ground truth" for a device like this would involve engineering specifications, safety standards, and functional performance benchmarks (e.g., temperature accuracy, pressure regulation accuracy, leak tests), which are evaluated through non-clinical testing.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device with a training set.
Summary of the Study Mentioned (Non-Clinical Testing):
The document states:
- Non-clinical testing performed including the following design verification testing:
- Software verification testing.
- Tubing set verification testing.
This indicates that Thermedx conducted internal testing to ensure the software functions as designed and the disposable tubing sets meet their specifications (e.g., integrity, pressure relief valve operation, biocompatibility, and expiration dating, as mentioned elsewhere). No clinical testing was conducted or submitted. The "study" here is essentially internal design verification and validation against engineering specifications and regulatory standards for safety and effectiveness for a medical device.
Key takeaway: This 510(k) submission primarily focuses on demonstrating substantial equivalence to existing predicate devices by comparing technological characteristics and asserting that the minor proposed changes (specifically, increasing maximum pressure for ureteroscopy procedures from 200 mmHg to 300 mmHg) do not raise new questions of safety or effectiveness. It is not an AI/ML device, and therefore, the typical AI/ML study parameters are not applicable or provided.
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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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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
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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
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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.
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Table 6
| TechnologicalCharacteristic | Modified Device | PrimaryPredicate Device | Secondary PredicateDevice |
|---|---|---|---|
| Name:FluidSmart® | Name: ThermedxFluid ManagementSystem | Name: NormoFlo®Irrigation Fluid WarmerModel H-1129 | |
| Fluid WarmingMethod | Infrared heatingof fluid | Same | Heat exchanger |
| PressureGeneration Method | Peristaltic pump | Same | On-board compressor andtwo pressure chambers |
| User Interface | Touch Screen | Same | Controls+ adjustable gauge |
| Device Type | Electro-Mechanical | Same | Same |
| Maximum Pressure(ureteroscopyprocedures) | 300 mmHg | 200 mmHg | Same(300 mmHg - 500mmHg) |
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).
§ 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.