(37 days)
Insuflow® Synergy™ XL Port (10mm and 12mm) and Insuflow® Synergy™ XLR Port (10mm and 12mm with endoscopic cannula seal) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
The Insuflow® Synergy™ XL and XLR Port are a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ XL and XLR Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system. The integral path of entry access device in the Insuflow Synergy™ XL and XLR Port is designed and constructed similarly to the Insuflow® Synergy™ Port but comes in larger sizes just as the predicate EndoPath trocar device. The Insuflow® Synergy™ XL Port and the Insuflow® Synergy™ XLR Port have access devices in 10 mm and 12 mm configurations with a single-lumen working channel configuration for conditioned gas delivery. The access device has a working channel with duckbill and tool seals for instrument entry into the surgical cavity and delivers conditioned insufflation gas through the working channel. The Insuflow® Synergy™ XLR Port has an endoscope compatible configuration that has an additional seal at the bottom of the main cannula, which serves as a means to seal off around the endoscope, forcing all gas flow out of the peripheral gas exhaust ports. This minor change is intended to reduce fogging and improve visualization. The obturator for the Insuflow Synergy™ XL and XLR Port has a transparent optical window at the distal end, which when used with an endoscope, provides visibility of individual tissue layers during insertion.
The provided text describes a 510(k) summary for the Insuflow Synergy™ XL and XLR Port devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert involvement, or statistical analysis typically associated with AI/ML device evaluations.
Therefore, the requested information, particularly regarding specific acceptance criteria with numerical targets, the study proving the device meets them (including sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment for test and training sets), is not present in the provided text.
The text indicates that "Extensive performance testing has been conducted to assure that the Insuflow® Synergy™ XL and XLR Port perform in accordance with its specifications and applicable standards." and lists the types of tests performed. However, it does not provide the results of these tests in a quantifiable way against pre-defined acceptance criteria, nor does it detail the methodology (sample sizes, expert involvement, ground truth) as would be expected for a diagnostic AI/ML device.
What is provided regarding "performance testing" are general categories of tests:
- Flow/pressure performance
- Gas temperature and humidity characterization
- Insertion/removal testing
- Seal leak integrity testing
- A test to confirm that the cannula seal configuration (for the XLR Port) reduces scope fogging and improves visualization.
Conclusion:
Based on the provided text, it's not possible to generate the requested table of acceptance criteria and reported device performance, nor can we answer the subsequent questions about study specifics (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth establishment) as these details are not included in this 510(k) summary. This document primarily focuses on establishing substantial equivalence to predicate devices through design description and a high-level summary of testing.
§ 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.