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The Monopolar Attachment combines the use of the Helix Hydro-Jet™ Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (optional drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).

The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie Note: receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.

The ERBE Monopolar Attachment [P/N 20139-094] is used with the Helix Hydro-Jet™ and the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Mc rels), The Helix Hydro-Jet™ is a hydraulic pressure delivery system that uses physiological same to cut and dissect soft tissue. The ERBE Electrosurgical Generator (ESU) Systems (IC or VIO Models) deliver High Frequency (HF) energy through the electrode tip of the ERBE Monopolar Attachment for coagulation and cutting of tissue. The ERBE Monopolar Attachment for Helix Hydro-Jet™ is made of stainless steel with plastic insulation except at the electrode to ribers isolates the HF energy to only the tip surface). The ERBE Monopolar Attachment has a channel and ring where the Helix Hydro-Jet™ Applicator slides into the Monopolar Attachment and is held in place for the Physician. The Monopolar Attachment is provided non-sterile and is reusable. (Note: The cleaning and sterilization processes are provided in the proposed draft labeling, "Notes on Use" - ERBE Monopolar Attachment, )

This 510(k) summary (K062712) for the ERBE Monopolar Attachment for Helix Hydro-Jet™ does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria in the way typically expected for AI/ML medical devices.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Here's a breakdown based on your request, highlighting what is (and isn't) present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific performance metrics or acceptance criteria are presented in a table format. The core of this submission is a "comparison of similarities and differences" to predicate devices, asserting that the new device's intended use, principles of operation, and technological characteristics are the same.

2. Sample Sizes and Data Provenance:

No information regarding sample sizes for test sets or data provenance (country of origin, retrospective/prospective) is provided. This type of detail is not typically included in a 510(k) submission focused on substantial equivalence for a design change that combines existing functionalities.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is not a study assessing diagnostic accuracy or similar performance.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned as there's no diagnostic performance study described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This submission does not include any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a surgical accessory, not an AI diagnostic tool.

6. Standalone Algorithm Performance:

No. This device is a physical attachment for existing surgical equipment, not a standalone algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no "ground truth" as it pertains to diagnostic accuracy or similar performance. The "proof" is based on the claim that the device's design changes have been "verified or validated in design control by ERBE Elektromedizin GmbH," implying internal engineering and testing to ensure the combined functionality works as intended and safely.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable.

Summary of Device and Evidence Presented:

The ERBE Monopolar Attachment for Helix Hydro-Jet™ is essentially an accessory that combines two existing functionalities into one handheld piece:

1. Water jet dissection: via the Helix Hydro-Jet™ Applicator.
2. Monopolar coagulation and cutting: via an ERBE Electrosurgical Generator (ESU).

The "study" or evidence presented for this 510(k) is a claim of substantial equivalence based on:

• Identical Intended Use: The combined use of the two predicate devices, now integrated into one instrument.
• Identical Principles of Operation: The device still uses the same water jet mechanism and the same electrosurgical energy, but in a combined form.
• Identical Technological Characteristics: The materials (stainless steel with plastic insulation, electrode tip) and basic function remain consistent with predicate devices.
• Design Control Validation: The manufacturer states that "All the instrument design changes have been verified or validated in design control by ERBE Elektromedizin GmbH." This refers to internal quality system processes to ensure the new design meets specifications and safety requirements.

The FDA's decision to clear the device (K062712) indicates they agreed that the device is substantially equivalent to the predicate devices and does not raise new safety or efficacy concerns. This type of submission relies on the established safety and effectiveness of the individual components that are being integrated, rather than requiring extensive new clinical performance trials.

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