(188 days)
This instrument has been designed for insufflation of the abdominal cavity, and automatio suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
This instrument has been designed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation. This instrument uses CO2 gas for distension, and it may be used for diagnostic and/or operative laparoscopy.
This instrument is constituted of High Flow Insufflation Unit UHI-3, Suction Tube and Insufflation Tube, and they are used with Recommended Accessories (Optional) and Ancillary Equipment.
And auto smoke evacuating function of UHI-3 works by combining with the Olympus high frequency unit (UES-20 / 30) or ultrasonic surgery unit (SonoSurg-G / G2)
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High Flow Insufflation Unit UHI-3
The High Flow Insufflation Unit UHI-3 has been designed for insufflating CO2 gas into abdominal cavity during a laparoscopic procedure. This provides a clear view and space for laparoscopic instrumentation to be used. The UHI-3 has suction capability for the purpose of evacuating smoke caused by HF instruments. The suction ability can also be used as a secondary system to evacuate the abdominal cavity in an over-pressure condition. The suction is controlled with an external suction unit through the pinch valve. -
Suction Tube
The suction tube is designed to be used with the Olympus UHI-3 High Flow Insufflation Unit, and a trocar to assist in maintaining a clear field of view by evacuating smoke from the operating sight during laparoscopic surgery. -
Insufflation Tube
The Insufflation tube is designed to be connected to the Olympus UHI-3 High Flow Insufflation Unit, to supply CO2 gas to the abdominal cavity.
This 510(k) summary does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a study proving the device meets them. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing performance data from studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided 510(k) summary. The document does not specify any quantitative acceptance criteria for device performance or present study results to demonstrate that the UHI-3 meets such criteria. It mentions the maximum flow rate of the UHI-3 (35 l/min) in comparison to predicate devices, but this is a specification, not an acceptance criterion with associated performance data.
2. Sample size used for the test set and the data provenance
This information is not available. The document explicitly states: "Then it is judged that clinical data is not needed." This implies that no formal test set, clinical data, or studies that would involve a sample size or data provenance were conducted to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available. As no clinical or performance study data is presented, there's no mention of experts establishing a ground truth for a test set.
4. Adjudication method for the test set
This information is not available. No test set or study is described, so no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. The document explicitly states that clinical data was not required because the device is substantially equivalent to predicate devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical instrument (High Flow Insufflation Unit), not an algorithm or AI system.
7. The type of ground truth used
This information is not available. As no clinical or performance study data is presented, there's no mention of the type of ground truth used.
8. The sample size for the training set
This question is not applicable for this type of medical device. There is no "training set" in the context of an insufflation unit. The device's design and functionality are based on engineering principles and comparison to existing, cleared devices.
9. How the ground truth for the training set was established
This question is not applicable for this type of medical device. There is no "training set" or "ground truth" for a training set as described for AI/ML algorithms.
Summary of what is stated regarding acceptance criteria and studies:
The document explicitly states that clinical data is not needed for the Olympus UHI-3 High Flow Insufflation Unit. This decision is based on its substantial equivalence to legally marketed predicate devices, specifically the OLYMPUS High Flow Insufflation Unit (UHI, K953162) and the NORTECH Omniflator 7640 (K983326). The rationale for not requiring clinical data is that the UHI-3 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety and effectiveness compared to these predicate devices. The primary difference noted is the increased maximum flow rate (35 l/min for UHI-3 compared to 12 l/min for the older Olympus UHI and 40 l/min for the Omniflator 7640), which is still within the range of cleared devices.
Therefore, the "study that proves the device meets the acceptance criteria" in this context is the comparison to predicate devices and the determination of substantial equivalence, rather than a specific clinical or performance study with defined acceptance criteria and collected data.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.