(290 days)
This instrument has been designed for insufflation of abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment. This instrument is also designed for controlled CO2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure.
The subject device , UHI-4, has new insufflation function, small mode, for insufflation of cavities along the saphenous vein and radial artery. Therefore, the insufflation pressure of small mode is designed to be less than the normal mode which is implemented in UHI-3. The small mode is not intended for pediatric use. This subject device has user-friendly displays for indicating gas flow rate, cavity pressure, and insufflated CO2 gas volume on the front panel of UHI-4. lt has several safety functions, such as follows: warning lamps, alarms for excessive pressure and tube obstruction, suction activated for excessive pressure. Gas pressure is controlled by reading sensors and switching valves. lt has a function for evacuating smoke (clearing the field of vision) when either an Electro Surgical Instrument or Ultrasonic Surgical Instrument is used during the operation. This function may be controlled with an optional foot switch. A FlexRay interface enables the UHI-4 to communicate its setting data, measured values, and other parameters between UHI-4 and the SonoSurg Generator SonoSurg-G2 or the ELECTROSURGICAL UNIT UES-40. The standard set of HIGH FLOW INSUFFLATION UNIT UHI-4 consists of an INSUFFLATION TUBE MAJ-590, a SUCTION TUBE MAJ-591 and a CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080.
This document is a 510(k) Summary for the HIGH FLOW INSUFFLATION UNIT UHI-4. It describes the device, its intended use, a comparison to predicate devices, and a summary of nonclinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Insufflation in endoscopic harvest of saphenous vein via CABG Applicator: Control pressure in an environment saphenous vein model. | "It was confirmed that UHI-4 can control the pressure in an environment saphenous vein model and the acceptance criteria was met." |
| Insufflation in endoscopic harvest of radial artery via CABG Applicator: Control pressure in an environment radial artery model. | "It was confirmed that UHI-4 can control the pressure in an environment radial artery model and the acceptance criteria was met." |
| Simulated use testing: Accurately deliver CO2 at specified flow rates and pressure settings; provide protection from over pressurization. | "The results from the tests above demonstrate that UHI-4 can properly control each setting pressure and function as intended." |
| Risk analysis: Compliance with established in-house acceptance criteria based on ISO 14971:2007. | "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." |
| Software validation: Compliance with FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major Level of Concern). | "The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Major Level of Concern."" |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and simulated use testing.
- Sample Size: The document does not specify exact sample sizes for the test sets (e.g., number of saphenous vein models, radial artery models, or simulated runs). It broadly states, "Bench testing demonstrates that UHI-4 performs safely and functionally..."
- Data Provenance: The tests are described as nonclinical bench tests performed by the manufacturer, Olympus Medical Systems Corp. and SHIRAKAWA OLYMPUS CO., LTD. The data is thus internal, retrospective for the purpose of this submission, and originating from Japan (where the manufacturers are located) or potentially the US (where Olympus America Inc. is located and the official correspondent resides). No country of origin for the "models" or actual "data" is explicitly stated beyond the manufacturing locations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the involvement of experts for establishing ground truth for the bench and simulated use tests. The acceptance criteria appear to be based on engineering specifications and performance targets for controlling pressure and flow in the described models.
4. Adjudication Method for the Test Set:
No adjudication method is described. The results were confirmed by the manufacturer's testing, indicating an internal assessment against pre-defined engineering criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is an insufflation unit, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of an "algorithm" as typically referred to in AI/software for interpretation. The device itself is a standalone medical instrument that performs insufflation. The "software validation" mentioned implies evaluating the embedded software's performance, which is inherently "standalone" in controlling the device's functions.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests appears to be engineering specifications and established functional requirements for pressure control, flow delivery, and safety features (like protection from over-pressurization). For example, the criteria for the saphenous vein and radial artery models were met by the device's ability to "control the pressure." Risk analysis ground truth was compliance with ISO 14971:2007. Software validation ground truth was compliance with FDA guidance.
8. The Sample Size for the Training Set:
This is not applicable. The document describes a medical device (insufflator) that undergoes engineering and functional validation, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reason as point 8.
§ 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.