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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.

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This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including:

CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates
CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring
CelonProSleep PLUS: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Celon ENT System is comprised of a power control unit (CelonLab EN7) and bipolar coagulation electrodes. The CelonLab ENT power control unit delivers a bipolar output via the bipolar coagulation electrodes of type CelonProBreath, CelonProSleep, and CelonProSleep PLUS. A neutral electrode (return conductor) is not required. The power control unit is user-friendly with a user display showing all the necessary process parameters. After switching on the equipment, the user selects the level of power and activates the radio frequency (RF) current by depressing the foot switch. The power control unit delivers an acoustic signal as an indicator of the coaqulation status. Usually, general electrosurgical units have a fixed activation tone. However, in the case of the CelonLab ENT power control unit, the frequency of the acoustic signal is proportional to the tissue impedance. This permits acoustic monitoring of the coagulation status by the operator, since the latter is directly correlated with the impedance. If the impedance increases above a certain limit, signifying that the coagulation process is complete, this is additionally indicated by a clock pulsed sound and the power output is ceased automatically. Overdose effects in the treated tissue area are excluded by this power control function. The procedure time will be set automatically by the power control unit. The time interval between activation of the power control unit and the end of the coagulation procedure depends on applicator type, tissue properties and power setting, and can vary between 3 seconds and several minutes.

Accessories included with the power control unit include a line power cable and single pedal foot pedal (CelonFootSwitch).

The provided text reports a 510(k) summary for the Celon ENT System, which is an electrosurgical device. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance criteria against a predefined set of acceptance criteria with a formal study.

Therefore, a table of acceptance criteria and proven device performance as requested cannot be directly extracted or inferred.

Here's an analysis of other requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific power output range with associated tolerance) and an explicit study designed to prove the device meets these. Instead, it asserts substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general safety and biocompatibility standards.

2. Sample size used for the test set and the data provenance:
Not applicable. There is no mention of a clinical or performance "test set" in the context of statistical evaluation for specific performance metrics. The submission focuses on regulatory compliance and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "test set" and associated ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No "test set" and adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The Celon ENT System is an electrosurgical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As an electrosurgical device, it is inherently a human-in-the-loop system. There is no standalone algorithm performance that would be applicable to this device type.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. There is no mention of specific ground truth used for performance validation in the manner typically applied to diagnostic or AI-based devices. The "performance validation testing" mentioned generally refers to ensuring the device operates as intended and is safe, rather than validating against a clinical ground truth for a specific medical condition.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of medical device.

Summary of Device and Regulatory Basis:

The K032838 submission for the Celon ENT System primarily asserts substantial equivalence to legally marketed predicate devices (ArthroCare AccENT Electrosurgery System, ArthroCare ENTec Reflex Wand Electrodes, Somnus Somnoplasty System). The basis for this claim includes:

• Intended Use: The Celon ENT System has the same intended use as the predicate devices, specifically for ablation and coagulation of soft tissue in ENT surgery (submucosal tissue shrinkage for nasal airway obstruction and snoring treatment).
• Technological Characteristics: The device is described as a bipolar electrosurgical coagulation device with an automatic power control, similar to the predicate devices. Key features include a power control unit (CelonLab EN7) and bipolar coagulation electrodes (CelonProBreath, CelonProSleep, CelonProSleep PLUS).
• Compliance with Standards: The materials and design comply with international electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF-18) and biocompatibility standards (ISO 10993 or USP 23 Class VI) for patient-contacting components.
• Performance Validation Testing: The document states that "performance validation testing has been done to validate the performance of the device." However, the specifics of this testing, including acceptance criteria or study design, are not provided in this summary. This type of testing typically involves bench testing to confirm power output specifications, safety features, and functional performance, rather than a clinical trial with statistical performance metrics against a defined ground truth.

In essence, the submission relies on demonstrating that the new device is as safe and effective as existing legally marketed devices through design, material, and functional similarities, rather than presenting a de novo performance study against explicit acceptance criteria.

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