Laparoscopy: warming fluids for irrigation and aspiration .
Hysteroscopy: uterine distention during diagnostic and operative procedures .
Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional . fluid warming)
Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic . and operative procedures

During hysteroscopic, cystoscopic and arthroscopic procedures, the 37~5 can be used to monitor fluid deficit.

Device Description

The Thermedx 37-5 is a general purpose fluid management system intended for standard surgical fluid management applications. The device consists of a Base Unit and Disposable Tubing Sets. A rolling standmounted device houses infrared fluid heating technology and a peristaltic fluid pump with closed-loop controls. The unit operates in 2 primary modes with fluid heating; flow control and pressure control. The Disposable Tubing Sets include IV bag spike, heating cartridge, and trumpet valve or luck connectors for endoscopes or other devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Thermedx 37-5 Fluid Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with specific numerical acceptance criteria (e.g., target temperature ranges, flow rates with specific tolerances, pressure ranges with specific accuracies) or detailed numerical performance results for the Thermedx 37-5. Instead, it makes a general statement about meeting specifications.

Acceptance Criterion	Reported Device Performance
Simulated Laparoscopy Performance: Ensure safe and effective fluid management during simulated laparoscopic procedures.	"demonstrate the device meets all performance specifications"
Simulated Uterine Distension Performance: Ensure safe and effective uterine distension during simulated hysteroscopic procedures.	"demonstrate the device meets all performance specifications"
Over-temperature Protection: Mitigate risks associated with excessively heated fluids.	"Over-temperature...testing. These tests demonstrate the device meets all performance specifications"
Over-pressure Protection: Mitigate risks associated with excessive fluid pressure.	"Over-pressure...testing. These tests demonstrate the device meets all performance specifications"
Over-Flow Protection: Mitigate risks associated with excessive fluid flow rates.	"Over-Flow...testing. These tests demonstrate the device meets all performance specifications"
Over-Deficit Protection: Mitigate risks associated with excessive fluid deficit measurement errors.	"Over-Deficit testing. These tests demonstrate the device meets all performance specifications"
Electrical Safety (IEC 60601-1): Conform to international standards for electrical safety in medical devices.	"Electrical Safety Testing in accordance to IEC 60601-1 electrical safety standards. These tests demonstrate the device meets all performance specifications"

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "non-clinical performance testing" which typically involves a series of tests, but not a "sample size" in the statistical sense of a patient cohort. The tests are simulated, indicating no human or animal subjects were used.
Data Provenance: Not applicable, as the testing was "non-clinical" and "simulated." This would imply in-house laboratory testing rather than data from a country of origin or retrospective/prospective studies on patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish a "ground truth" in the context of this 510(k) summary. The testing conducted was non-clinical and simulated, implying engineering and technical validation against pre-defined specifications rather than expert clinical judgment.

4. Adjudication Method for the Test Set

Not applicable. As no expert ground truth or clinical data requiring adjudication is mentioned, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not relevant for this type of medical device (fluid management system) which does not involve image interpretation or diagnostic performance that would require human readers. The document details performance testing of the device's physical functions.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not directly applicable in its typical sense for an AI/algorithm-based diagnostic device. However, the "non-clinical performance testing" described (simulated laparoscopy, uterine distension, over-temperature, etc.) is standalone device performance testing, as it assesses the device's functions without direct human intervention in its operation for the purpose of the test. The device itself is designed to be used with human operators in a clinical setting.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined performance specifications and safety standards. For instance:

Temperature accuracy (e.g., maintaining fluid at approximately body temperature).
Pressure limits (e.g., maintaining pressure within safe ranges).
Flow rates (e.g., meeting specified flow capabilities).
Electrical safety standards (IEC 60601-1).

The device was tested against these pre-defined engineering and safety specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical/electronic fluid management system, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary

Traditional 510(k) Notification Thermedx 37~5TM Fluid Management System Thermedx, LLC

JUL 2-3 2010

Applicant

Thermedx, LLC 31200 Solon Rd. Unit#1, Solon Oh 44139 440-542-0883 Contact Person: Eng Mgr, Jeff Williams Date Prepared: June 10, 2010

Device Name

Proprietary Name: Thermedx 37~5TM Fluid Management System Common Name: Thermal infusion fluid warmer Classification Name: Unclassified device (product code LGZ)

Substantial Equivalence

The Thermedx 37~5 is substantially equivalent in terms of safety and effectiveness to the following combination of predicate devices:

Fluido@ Blood and Fluid Warmer (BK050058) and Fluido Accessories (BK 0700755), The Surgical 1. Company International
Ranger® Irrigation Fluid Warming System (K060939), Arizant Healthcare Inc. 2.
Level 1 @ NORMOFLO @ Irrigation Fluid Warmer (K072080), Smiths Medical ASD, Inc. 3.
Dolphin ® II Fluid Management System (K011876), Gyrus ACMI, Inc. 4.
vi HydroFlex® Irrigation System AD/LVHD, (K011876) Davol

Device Description

Intended Use

The 37-5 is a multi-purpose fluid management system indicated for the following:

Laparoscopy: warming fluids for irrigation and aspiration .
. Hysteroscopy: uterine distention during diagnostic and operative procedures
. Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional fluid warming)
Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic and . operative procedures

During hysteroscopic, cystoscopic and arthroscopic procedures, the 37-5 can be used to monitor fluid deficit.

Technological Characteristics

The technological characteristics of the Thermedx 37~5 are substantially equivalent to the predicate devices.

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Infrared for fluid heating as does Fluido®. This differs from the methods used by the Ranger® and . Level 1@ devices, but provides the same function of heating the irrigation fluid to approximately body temperature.
Peristaltic pump for fluid delivery. The Dolphin® II, Fluido®, Ranger® and Level 1® use pressure . vessels to achieve the same pressure ranges, and the HydroFlex® uses a centrifugal pump, however neither the pressure vessels nor the centrifugal pump can measure flow as with a peristaltic pump can.
Fluid Deficit Monitoring. Load-cells are used to measure fluid volumes and deficit as does the . Dolphin® II.
Pressure transducers to measure line pressure as does the Dolphin® II. The locations used do differ, . the 37-5 transducers (dual) are located in the system instead of at the end of the tubing as is the Dolphin's single transducer. Both the 37-5 and HydroFlex® contain a pressure relief valve the Dolphin® II lacks providing additional over pressure protection.
Both the 37~5 and HydroFlex® provide an additional safety feature, not available on the other . predicate devices; this feature adds a database of pressures/flow rates/temperatures by procedure, which limit these settings to safe ranges.

Summary of Testing

Non-clinical performance testing has been performed to ensure the device is safe and effective and meets the associated clinical requirements. In order to verify performance, testing included the following:

l. Simulated Laparoscopy
Simulated Uterine Distensions 2.
Over-temperature, Over-pressure, Over-Flow, and Over-Deficit testing. 3.
1. Electrical Safety Testing in accordance to IEC 60601-1 electrical safety standards

These tests demonstrate the device meets all performance specifications

Conclusion

This 510(k) Notification demonstrates the substantial equivalence of the Thermedx 37-5 using the substantial equivalence criteria in FDA's K86-3 510(k) Guidance. The new device has the same intended use as the predicate devices, and the minor differences in indications for use statements do not alter the device's intended therapeutic effect. The new device also has similar technological characteristics to those of the predicate devices, and the minor differences are not significant with respect to the safety or effectiveness of the new device.

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).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN." and "USA" arranged around the eagle. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

JUL 2:3 2010

ﺍﻟﻤﺘﻘﺪ

Mr. Jeff B. Williams Engineering Manager Thermedx LLC 31200 Solon Rd, Unit 1 SOLON OH 44139

Re: K091939

Trade/Device Name: Thermedx 37~57M Fluid Management System Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: HIG, LGZ, HRX Dated: April 5, 2010 Received: April 7, 2010

Dear Mr. Williams:

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. 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

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Page 2 -

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the auverse events) (21 CFR 805), good will and if applicable, the electronic product a 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 811), please 11 you desire aposted as no reboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.laangom. Health's (CDRH's) Office of Compliance Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part ) note the regulation children 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 Tou may other other generational and Consumer Assistance 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 yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known): K091939

Device Name: Thermedx 37~5 MFluid Management System

Indications for Use: The 37-5 is a multi-purpose fluid management system indicated for the following:

Laparoscopy: warming fluids for irrigation and aspiration .
Hysteroscopy: uterine distention during diagnostic and operative procedures .
Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional . fluid warming)
Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic . and operative procedures

During hysteroscopic, cystoscopic and arthroscopic procedures, the 37~5 can be used to monitor fluid deficit.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Leman

(Division Sign-Off) (Division Bigh-Ont)
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 884.1700 Hysteroscopic insufflator.

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