(388 days)
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.
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.
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.
§ 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.