(48 days)
The CoreCath 2.7S is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures.
The CoreCath 2.7S is a disposable, single-use monopolar RF (radiofrequency) surgical device intended to be use for ablation and hemostasis of soft tissue obstructions in upper airways and tracheobronchialtree. The CoreCath 2.7S is terminally sterilized via ETO. It is comprised of a cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric. flexible multi lumen shaft and cabling, intended for connection to the monopolar output port of the Medtronic Advanced Energy AEX Generator (K143175). The CoreCath 2.7S is intended to be energized for use by the footswitch accessory supplied with the AEX Generator. It has an active length of approximately 750 mm and a maximum diameter crossing profile of 2.68 mm. It is sized such that may be delivered through the working channel of a flexible bronchoscope 2.8 mm diameter working channel and working length of 600 mm.
The provided text describes a medical device, the CoreCath 2.7S, and its regulatory submission (510(k)). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML device.
The document is a 510(k) premarket notification decision letter from the FDA, along with the device's Indications for Use and a 510(k) Summary. It focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than what would be required for an AI/ML-powered diagnostic or treatment device with specific performance metrics.
Specifically, the document states:
- "Summary of Clinical Tests: Clinical testing was not required for this product." This indicates that no human clinical efficacy study was performed or required for this device to gain market clearance.
- "Summary of Non-Clinical Testing: The design and performance of the modified CoreCath 2.7S were verified and validated through bench testing." This refers to engineering and safety bench tests, not performance against specific clinical or diagnostic metrics as one would find for an AI/ML device.
- "Comparative performance testing was conducted in an in-vivo animal model. Ex-vivo tissue testing was also completed. Thermal effect of the CoreCath 2.7S in both the in-vivo and ex-vivo model was substantially equivalent to that of the predicate device." This confirms substantial equivalence primarily on thermal effects and other aspects related to an electrosurgical instrument, not AI/ML performance.
Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional electrosurgical device, not an AI/ML product.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.