(388 days)
Not Found
No
The document describes a fluid management system with standard closed-loop controls for flow and pressure, and mentions no AI/ML components or related performance metrics.
No
Explanation: The device is a fluid management system used for distention and warming fluids during surgical procedures, not for treating a disease or condition itself.
No
The device is described as a "multi-purpose fluid management system" and a "general purpose fluid management system" used for managing fluid during various surgical procedures. While it can "monitor fluid deficit" during some procedures, this monitoring primarily serves to manage the fluid balance during intervention, rather than to diagnose a medical condition.
No
The device description explicitly states it consists of a "Base Unit and Disposable Tubing Sets" and includes hardware components like "infrared fluid heating technology and a peristaltic fluid pump."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a fluid management system for surgical procedures (laparoscopy, hysteroscopy, cystoscopy, arthroscopy). It focuses on warming, irrigating, aspirating, and monitoring fluid deficit during these procedures.
- Device Description: The description details a system with a base unit, tubing sets, heating technology, and a pump. This aligns with a surgical fluid management system, not a device used to examine specimens in vitro (outside the body).
- No mention of analyzing biological specimens: There is no indication that this device is used to analyze blood, tissue, urine, or any other biological sample to provide diagnostic information.
- Performance Studies: The performance studies described are focused on simulated surgical procedures and safety testing related to fluid management parameters (temperature, pressure, flow, deficit). They do not involve testing with biological specimens or evaluating diagnostic accuracy.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on managing fluids within the body during surgical interventions.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LGZ, HIG, HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus (uterine), Bladder, Knee, Shoulder, Small joints
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 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.
-
- Electrical Safety Testing in accordance to IEC 60601-1 electrical safety standards
These tests demonstrate the device meets all performance specifications
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BK050058, BK 0700755, K060939, K072080, K011876, K011876
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
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.
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.
-
- 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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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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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
4
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
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