(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.
§ 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.