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.

Device Description

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, )

AI/ML Overview

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:

Water jet dissection: via the Helix Hydro-Jet™ Applicator.
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.

Summary

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K062712

510K SUMMARY

Submitted By:	ERBE USA, Inc.2225 Northwest ParkwayMarietta, GA 30067Tel: 770-955-4400 Fax: 770-955-2577
Contact Person:	John TartalQA/RA Manager
510(k) Number:
Date Prepared:	September 7, 2006
Common Name:	Monopolar Attachment for Water Jet Dissector
Trade/Proprietary Name:	ERBE Monopolar Attachment for Helix Hydro-Jet™
Classification Name:	Jet Lavage (21 CFR Part 880.5475) and Electrosurgical cuttingand coagulation device and accessories (21 CFR 878.4400)
Product Code:	FQH and GEI
Legally MarketedPredicate Devices:	ERBE Helix Hydro-Jet™ System, 510(k) Number: K033590ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers:K953738; K953159; K935815; K933002; K933157; K060484ERBE Disposable Push Button Pencil, 510(k) Number: K936304

JÁN 26 2007### Device Description:

General Description. 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, )

Intended Use:

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 (option drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).

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510K SUMMARY

Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence):

Similarities

The ERBE Monopolar Attachment allows the physician to combine the use of the ERBE Helix Hydro-Jet™ for water jet dissection with the ERBE Electrosurgical Generator (ESUL Systems (ICC or VIO Models) for monopolar coagulation and cutting, The use of the ERRE Monopolar Attachment does not change the way the Physician uses the ERBE Helix Hydro-Jet™ System and Applicators or the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Models). The ERBE Monopolar Attachment for Helix Hydro-Jet™ has the same intended use as the ERBE Helix Hydro-Jet™ System with the combined ability of the intended use of the ERBE ESU. While the energy sources are still used separately, the Monopolar Attachment combines their instrumentation parts into one handhed piece.

Differences

The ERBE Monopolar Attachment is different from the use of the ERBE Helix Hydro-Jet™ for water jet dissection with the ERBE Electrosurgical Generator (ESU) Systems (ICC over Models) for Monopolar coagulation/cutting in that the predicate method was for the Physician to pick up each instrument separately, use the instrument, then pick up the "the next instrument. Again while the energy sources are still used separately, the Monopolar Attachment combines their instrumentation parts into one handheld piece.

All the instrument design changes have been verified or validated in design control by ERBE Elektromedizin GmbH.

Conclusion:

The ERBE Monopolar Attachment for Helix Hydro-Jet™ has the same intended use, principles of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k).

The ERBE Monopolar Attachment differs only in that it allows the Physician to combine the instrumentation parts of the ERBE Helix™ Hydro-Jet for water jet dissection with the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Models) for monopolar coagulation and cutting into one handheld piece.

In conclusion, there are no issues with the ERBE Monopolar Attachment for Helix Hydro-Jet™ that would raise additional safety or efficacy issues when compared to the predicate devices.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 26 2007

ERBE USA, Inc. % Mr. John Tartal QA/RA Manager 2225 Northwest Parkway Marietta, Georgia 30067

Re: K062712

Trade/Device Name: ERBE Monopolar Attachment for Helix Hydro-Jet Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 18, 2007 Received: January 19, 2007

Dear Mr. Tartal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John Tartal

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for Dohm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ERBE Monopolar Attachment for Helix Hydro-JetTM

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-

Division of General, Restorative, and Neurological Devices

510(k) Number K062212

Page 1 of 1

Regulation Number and Section

§ 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.