(113 days)
This instrument is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.
This instrument is intended 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.
This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.
The HIGH FLOW INSUFFLATION UNIT UHI-4 is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment. This instrument is intended 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. This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment
The HIGH FLOW INSUFFLATION UNIT UHI-4 has the following system functions which are identical to the predicate device:
Cavity mode
Two modes including "Normal" and "Small" can be selected according to the cavity size.
Adiustment of the cavity pressure
The pressure inside the cavity can be set in the range between 3 and 25 mmHg (or max, 15 mmHg in the Small cavity mode).
Adiustment of the gas flow rate
The CO2 flow rate can be set in the range from 0.1 - 45 1/min. (or max. 10 1/min. in the Small cavity mode). Three flow rate modes including "High", "Medium" and "Low" can be selected with a one-touch operation.
Display mode
The information displayed on the front panel can be limited as required bv the user.
Relief mode
When the cavity pressure exceeds the set value by 5 mmHg or more, the relief mode is activated to open the channels inside the instrument and release the internal gas until the cavity pressure drops to the set value. The relief mode can be set to ON or OFF as required. Default set value is ON.
Smoke evacuation
When the MAJ-1939 foot switch for smoke evacuation (optional) is used, the smoke and mist generated inside the cavity can be exhausted while maintaining the cavity pressure at a constant level.
Automatic smoke evacuation
The smoke evacuation operation can be interlocked with the output of Olympus generator units such as the SonoSurge-G2, UES-40, ESG-400 and USG-400.
The provided document describes the K122180 Premarket Notification for the HIGH FLOW INSUFFLATION UNIT UHI-4.
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Rectal Cavity Model Validation | Not explicitly stated, but implies the model accurately represents the colon environment. | "Validation of the Rectal Cavity Model" was conducted. The acceptance criteria were met. |
| Insufflation Control | Not explicitly stated, but implies accurate and stable control of insufflation. | "Insufflation Control" test was conducted. The acceptance criteria were met. |
| Pressure Measurement | Not explicitly stated, but implies accurate measurement of internal cavity pressure. | "Pressure Measurement" test was conducted. The acceptance criteria were met. |
| Overpressure Protection | Not explicitly stated, but implies effective activation and function of the relief mode. | "Overpressure Protection" test was conducted. The acceptance criteria were met. |
| Overall Performance for Expanded Use | "Performs safely and functionally for the expanded indications for use." | "The results of these tests indicate that, when used in the colon under the recommended insufflation settings, the HIGH FLOW INSUFFLATION UNIT UHI-4 performs as intended." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "Bench testing was performed...". No information on the number of individual tests or repetitions is provided.
- Data provenance: Bench testing. The location of the testing is not explicitly stated, but the manufacturer is based in Japan (SHIRAKAWA OLYMPUS CO., LTD.). It is retrospective as it was conducted to support a premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical instrument (insufflator), and its performance testing typically involves objective measurements against engineering specifications and simulated physiological conditions (like the "Rectal Cavity Model"), rather than expert-established ground truth related to diagnostic image interpretation or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. As noted above, the testing described is bench testing of an instrument's functional performance, not clinical evaluation requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. An MRMC study is not relevant for this type of device. The study described focuses on the functional performance of the insufflator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study (bench testing) was performed. This device is an instrument, not an AI algorithm. The performance evaluation focuses on the device itself operating according to its design specifications.
7. The type of ground truth used:
The "ground truth" for this device's testing would be the pre-defined engineering specifications and expected physiological responses (e.g., maintaining a set pressure within a model cavity, proper function of overpressure relief). The document refers to "acceptance criteria" which suggests predefined performance benchmarks.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.