ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094

K062712 · Erbe USA, Inc. · GEI · Jan 26, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062712
• Device Name: ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
• Applicant: Erbe USA, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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 (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 Story

Device is a mechanical attachment for the ERBE Helix Hydro-Jet™ applicator; enables integration of water jet dissection and monopolar electrosurgical cutting/coagulation into a single handheld instrument. Input: hydraulic pressure (saline) for dissection and high-frequency (HF) electrical energy from an ERBE ESU for tissue effect. Device features a channel/ring to secure the Hydro-Jet applicator; stainless steel construction with plastic insulation to isolate HF energy to the electrode tip. Used by surgeons in clinical settings to reduce instrument switching during procedures. Output: physical tissue dissection and thermal coagulation/cutting. Benefits include improved procedural efficiency by combining two distinct surgical modalities into one handheld device.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design verification and validation of the mechanical integration of existing, cleared technologies.

Technological Characteristics

Stainless steel construction with plastic insulation for HF energy isolation. Mechanical interface (channel/ring) for Helix Hydro-Jet applicator. Compatible with standard 3-pin monopolar bovie receptacles. Reusable, non-sterile (requires cleaning/sterilization).

Indications for Use

Indicated for use in surgical procedures requiring soft tissue dissection via water jet and simultaneous or sequential monopolar electrosurgical coagulation and cutting. Intended for use by clinicians in a surgical environment using compatible ERBE ESU generators.

Regulatory Classification

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.

Predicate Devices

• ERBE Helix Hydro-Jet™ System (K033590)
• ERBE ESU (ICC or VIO Models) Systems (K953738, K953159, K935815, K933002, K933157, K060484)
• ERBE Disposable Push Button Pencil (K936304)

Submission Summary (Full Text)

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K062712

## 510K SUMMARY

| Submitted By: | ERBE USA, Inc.<br>2225 Northwest Parkway<br>Marietta, GA 30067<br>Tel: [phone] Fax: [phone] |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Tartal<br>QA/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 cutting<br>and coagulation device and accessories (21 CFR 878.4400) |
| Product Code: | FQH and GEI |
| Legally Marketed<br>Predicate Devices: | ERBE Helix Hydro-Jet™ System, 510(k) Number: K033590<br>ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers:<br>K953738; K953159; K935815; K933002; K933157; K060484<br>ERBE 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).

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.

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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 [phone]. 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 [phone] or [phone] 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:

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.

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

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