(189 days)
Not Found
No
The summary describes a fluid management system with heating and pumping capabilities, controlled by closed-loop systems. There is no mention of AI, ML, or image processing, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is used for irrigation, fluid warming, and distention during surgical procedures, which are supportive functions for the procedure rather than direct therapeutic interventions.
No
The device description and intended use clearly state that it is a fluid management system for irrigation, fluid warming, distention, and volume/deficit measurements in surgical procedures. It does not mention any function for diagnosing conditions.
No
The device description explicitly states it consists of a "main unit and disposable tubing sets" and a "rolling stand-mounted device" housing hardware components like infrared fluid heating technology and a peristaltic fluid pump. This indicates it is a hardware-based medical device with potential software control, not a software-only device.
Based on the provided information, the Thermedx Fluid Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in surgical procedures (irrigation, fluid warming, distention, volume/deficit measurements) performed on the patient, not on samples taken from the patient.
- Device Description: The description focuses on the physical components and their function in delivering and managing fluids during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Thermedx device's function is entirely focused on supporting surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
The Thermedx Fluid Management System 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
HIG, LGZ, HRX
Device Description
The Thermedx device is a fluid management system intended for surgical applications. The device consists of a main unit and disposable tubing sets. A rolling stand-mounted device houses infrared fluid heating tecnnology and a peristaltic fluid pump with closed-loop controls. The Thermedx monopolar electrocautery probes are an optional accessory for electrosurgical cutting and coaqulation,
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
Non clinical testing performed including the following. Biological testing of tube-sets based on 10993-1:2009 including: Cytotoxicity using the MEM Elution Assay method (10993-5.2009); Sensitization using the Kligman or Buehler methods (10993-10 2010); Irritation using the Intraculaneous Reactivity/Irritation Test (10993-10.2010). Software verification testing: Verify individual setting limits within table and regression testing via running range of simulated use cases. Verify crack pressures of valve for HLL003 is within 240-360mmHg range. Clinical Information: In support to the changes to the procedures and settings please refer to the numerous journal articles, practical guidelines, hospital guidelines.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
JUN 2 0 2014
510(k) Summary
Thermedx Fluid Management System Thermedx, LLC
510(k) Submitter Thermedx, LLC 31200 Solon Road, Unit #1 Solon. Ohio 44139 Douglas L. Carr Contact Person Phone: (440) 542-0883 (440) 542-0920 Fax: E-mail: Dcarn@thermedx.com 30 April 2014 Date Prepared Proprietary Name: Thermedx Fluid Management System Device Name Common Name: Hysteroscopic Insuffiator Requlation Number: 21 CFR & 884 1700 Requiatory Class: II Classification Name: HIG, LGZ, HRX The Thermedx Fluid Management System is intended for irrigation and fluid Intended Use warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology. urology, and orthopedic disciplines. The Thermedx device is a fluid management system intended for surgical Device Description applications. The device consists of a main unit and disposable tubing sets. A rolling stand-mounted device houses infrared fluid heating tecnnology and a peristaltic fluid pump with closed-loop controls. The Thermedx monopolar electrocautery probes are an optional accessory for electrosurgical cutting and coaqulation, Thermedx Fluid Management System is identical to the previous version. with Technological no technological differences. Packaging and sterilization means remain Comparison unchanged as well. Changes relate solely to the individual procedure settings and the addition of a high pressure disposable tubing set HLL003 Non clinical testing performed including the following. Non Clinical Tests Biological testing of tube-sets based on 10993-1:2009 including: 1. a. Cytotoxicity using the MEM Elution Assay method (10993-5.2009) b. Sensitization using the Kligman or Buehler methods (10993-10 2010) Irritation using the Intraculaneous Reactivity/Irritation Test (10993-ﻥ 10.2010) 2. Software verification testing: Verify individual setting limits within table and regression testing via running range of simulated use cases. Verify crack pressures of valve for HLL003 is within 240-360mmHg range. 3. Clinical In support to the changes to the procedures and settings please refer to the Information numerous journal articles, practical guidelines, hospital guidelines. Substantial The Thermedx Fluid Management System is substantially equivalent in terms Equivalence of safety and effectiveness to the device as originally cleared. Thermedx 37-5 (K091939).
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2014
Thermedx LLC Jeff B. Williams Engineering Manager 31200 Solon Rd., Unit 1 Solon, OH 44139
Re: K133799
Trade/Device Name: Thermedx Fluid Management System Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: Class II Product Code: HIG, LGZ, HRX Dated: May 23, 2014 Received: May 27, 2014
Dear Jeff B. 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 docs 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 (sec 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 (21CFR 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
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Page 2 - Jeff B. Williams
forth in the quality systems (OS) 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2)CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 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,
Image /page/2/Picture/8 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The text is black against a white background, making it highly legible. The name appears to be a signature or title, with the "- S" possibly indicating a designation or affiliation.
for 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
3
Indications for Use
510(k) Number
Device Name
Thermedx Fluid Management System
Indications for Use
The Thermedx Fluid Management System is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit messurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
Type of Use
8 Prescription Use (Part 21 CFR 801 Subpart D)
J Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH)
Herbert P. Lerner 2014.06.20 12:40:56 -04'00'
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