(177 days)
The Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy.
The Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy.
Olympus ESG-100: The ESG-100 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. It has two displays. One display shows the selected power level, the other display shows the currently selected program mode. Buttons are used to set the power level or to change the modes. Different connectors allow connecting mono- and bipolar electrosurgical instruments, a neutral electrode, a footswitch, or an ancillary pump. The maximum output power is 120 W.
Olympus AFU-100: The AFU-100 peristaltic flushing pump employs tubing to deliver fluid to the tissue/mucosa. Sterile liquids (e.g. isotonic saline solution) thus remain sterile, provided that a sterile tube set is used. The maximum flow rate is 270 ml and 600 ml per minute with two different tube sets offered as single use items. In addition, three memory buttons provide fast access to preset flow levels. The AFU-100 can be connected to the electrosurgical generator ESG-100 by an interface, allowing operation of the peristaltic pump unit by a special button of the electrosurgical unit's footswitch. The pump rotor is equipped with a protective cover, which automatically stops the rollers from rotating if it is opened while the peristaltic pump unit is activated, and thus prevents possible injuries.
Accessories: A-Cord, P-Cord, Footswitch (ESG-100), Footswitch (AFU-100), Pump Tube.
The provided text describes the Olympus Electrosurgical System (K073207), which includes the Olympus ESG-100 electrosurgical generator and the Olympus AFU-100 peristaltic flushing pump. The primary purpose of this 510(k) summary is to demonstrate substantial equivalence to previously marketed predicate devices rather than to present a de novo study with acceptance criteria for device performance.
Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.
Instead, the submission focuses on:
- Comparison to Predicate Devices: The core of the submission is to show that the Olympus Electrosurgical System has the "same indication statement, the same intended use statement and similar technological characteristics" as its predicate devices (ERBE VIO ESU, ERBE EIP 2, ERBOTOM ICC 200, and Olympus OFP-1).
- Bench Testing for Equivalence: The document states, "Nevertheless bench tests of the subject ESG-100 and the predicate devices ICC 200 and VIO 300 D were performed and demonstrate substantial equivalence." This indicates that comparative bench tests were conducted to confirm the new device's performance aligns with the established predicate devices.
- Compliance with Standards: The design of both the Olympus ESG-100 and AFU-100 complies with several international standards (e.g., IEC 60601-1, UL 60601-1, ISO 14971). Compliance with these standards is a form of acceptance criteria, ensuring electrical safety, electromagnetic compatibility, and risk management.
In summary, none of the specific criteria points requested for AI/diagnostic device studies (such as diagnostic accuracy, sensitivity, specificity, sample sizes, expert consensus, etc.) can be extracted from this 510(k) summary because it is for an electrosurgical system, not an AI or diagnostic imaging device. The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through design comparisons and bench testing against established performance within electrosurgical functions and safety standards.
§ 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.