(136 days)
THE NORTECH OMNIFLATOR® 7640 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.
The Omniflator® Model 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO, from a central supply or E-Cylinder tank.
The provided text is a 510(k) summary for the Nortech Omniflator® 7640 Laparoscopic Insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about:
- Specific acceptance criteria for device performance (numerical thresholds for accuracy, precision, etc.).
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number/qualifications of experts or ground truth establishment methods.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
The document is a regulatory submission demonstrating substantial equivalence to existing devices, which is a different type of evaluation than a study proving performance against specific acceptance criteria. The substantial equivalence relies on the device being similar in design, materials, and intended use to previously cleared devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text.
§ 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.