(189 days)
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.
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 technology and a peristaltic fluid pump with closed-loop controls. The Thermedx monopolar electrocautery probes are an optional accessory for electrosurgical cutting and coagulation.
This document is a 510(k) summary for the Thermedx Fluid Management System. It outlines the device's intended use, description, and non-clinical testing performed. However, it does not contain any information about acceptance criteria or specific studies that prove the device meets said acceptance criteria. The document primarily focuses on establishing substantial equivalence to a previously cleared device (Thermedx 37-5, K091939) based on identical technology and unchanged packaging/sterilization. The changes relate to individual procedure settings and the addition of a high-pressure disposable tubing set.
Therefore, I cannot provide the requested information. The document explicitly states:
- No acceptance criteria or device performance table.
- No specific study proving device meets acceptance criteria.
- No sample sizes for test sets or training sets.
- No information on data provenance.
- No mention of experts for ground truth or adjudication methods.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- No standalone algorithm performance study.
- No type of ground truth used.
- No details on how ground truth for training set was established.
The "Non Clinical Tests" section lists biological testing of tube-sets and software verification testing. These are general tests for safety and functionality, not performance studies against specific acceptance criteria. For example, "Verify crack pressures of valve for HLL003 is within 240-360mmHg range" is a functional verification, not a performance study proving a clinical outcome or meeting specific efficacy criteria within a clinical context.
The document refers to "numerous journal articles, practical guidelines, hospital guidelines" in support of changes to procedures and settings, implying reliance on existing knowledge and practices rather than new clinical trials for this specific device version.
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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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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
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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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§ 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.