ERBE HYBRID KNIFE

K083608 · Erbe USA, Inc. · GEI · Aug 26, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083608
• Device Name: ERBE HYBRID KNIFE
• Applicant: Erbe USA, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.

Device Story

Hybrid Knife combines water-jet dissection and electrosurgical cutting/coagulation; used with ERBEJET 2 Water Jet System and VIO Electrosurgical Unit (ESU). Input: pressurized sterile saline for water-jet cutting; HF energy for cautery. Device features retractable electrode (up to 5 mm extension) for monopolar cutting/coagulation. Operated by clinician in open or endoscopic surgery (via >2.8 mm working channel). Footswitches control water-jet and ESU activation. Output: physical tissue dissection and thermal coagulation. Benefits: enables precise tissue management in single device; reduces instrument exchanges. Single-use, sterile.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on specific materials. Performance testing conducted to verify functionality of the Hybrid Knife with a specifically designed software version of the ERBEJET 2 Unit.

Technological Characteristics

Single-use, sterile, disposable device. Components: handle, probe tubing, retractable electrode, tubing to Water Jet, cable to ESU. Dimensions: 2 mm outer diameter, 2200 mm length. Energy: HF electrosurgical energy and pressurized saline water-jet. Sterilization: Ethylene Oxide. Connectivity: connects to ERBEJET 2 and VIO ESU.

Indications for Use

Indicated for patients undergoing neurosurgery or abdominal soft tissue surgery (e.g., liver, kidney, TME) requiring tissue dissection and coagulation. Used in open or endoscopic procedures.

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 Monopolar Attachment for Helix Hydro-Jet (K062712)
• ERBE ERBEJET 2 System (Includes Applicator) (K072404)

Submission Summary (Full Text)

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Ko836.08

ERBE USA Incorporated Traditional 510(k): ERBE Hybrid Knife™

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#### 510(k) SUMMARY

AUG 2 6 2009

ERBE USA, Inc. Submitted By: 2225 Northwest Parkway Marietta, GA 30067 Tel: [phone] Fax: [phone]

John Tartal Contact Person: QA/RA Manager

February 26, 2008 Date Prepared:

Water Cutter/Dissector with Electrosurgical Cutting and Common Name: Coagulation Capabilities

ERBE Hybrid Knife™ Trade/Proprietary Name:

Jet Lavage (21 CFR Part 880.5475) and Electrosurgical Classification Name: cutting and coagulation device and accessories (21 CFR 878.4400)

FQH and GEI Product Code:

Legally Marketed Predicate Device:

ERBE Monopolar Attachment for Helix Hydro-Jet 510(k) Number: K062712 and ERBE ERBEJET 2 System (Includes Applicator) 510(k) Number: K072404

#### Device Description:

The ERBE Hybrid Knife™ is used with the Water Jet Model ERBEJET® 2 and an ERBE ElectroSurgical Unit (ESU), VIO Model. The Water Jet delivers pressurized sterile normal saline through the Hybrid Knife to cut and dissect soft tissue. The ESU supplies High Frequency (HF) energy through a retractable electrode of the Hybrid Knife for the cutting and coaqulation of tissue. The ERBE Hybrid Knife™ consists of tubing to the Water Jet, a cable to the ESU, a handle, probe tubing, and an electrode. Clinicians would assemble the device and attach it respectively to the Water Jet and ESU. For endoscopic procedures, the Hybrid Knife is placed down the channel of an endoscope that has a working channel greater than 2.8 mm. Upon the set up of the Water Jet and ESU, the Hybrid Knife is ready for use. The pedal of the ERBEJET 2 Footswitch activates its water-jet cutting capabilities. To activate cautery, the recessed electrode is extended out its tip (up to 5 mm) and the ESU's Footswitch is depressed. The ERBE Hybrid Knife™ is provided sterile and is single use.

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### ERBE USA Incorporated Traditional 510(k): ERBE Hybrid Knife™

#### Intended Use:

The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.

## Similarities and Differences of the Proposed Device to the Current Devices (Predicate Comparison/Substantial Equivalence):

#### Similarities

The ERBE Hybrid Knife™ has the same basic intended use as the predicate ERBE Monopolar Attachment for Helix Hydro-Jet. That is it combines water-jet cutting and dissection of soft tissue with the ability of providing cautery. It is similar to the other predicate, ERBEJET 2 Applicator, in that it works with the ERBEJET 2 Unit, functions upon the same operating principles as well as is sterilized via Ethylene Oxide, single use, and disposable. The ERBE Hybrid Knife is also manufactured by ERBE Elektromedizin GmbH.

#### Differences

The types of materials used for the ERBE Hybrid Knife™ are similar to the predicates but specific materials are slightly different. Therefore, biocompatibility of the specific materials for the Hybrid Knife was demonstrated. See Biocompatibility Study, III-18 to III-27. One of the other differences is that the electrode is retractable for the Hybrid Knife as opposed to being just at the end of the tip of the predicate ERBE Monopolar Attachment for Helix Hydro-Jet. Structurally and dimensionally the Hybrid Knife is different than the predicate ERBEJET 2 Applicator, in that its tip is internally different and its Outer Diameter is much smaller (2 mm versus 5 mm) with a much longer length 2200 mm versus 336 mm). The size was altered for use in 2.8 mm or larger working channels of endoscopic scopes. With a specifically designed software version of the ERBEJET 2 Unit, performance testing demonstrated the functionality of the Hybrid Knife. See Performance Testing, III-28 to III-31.

#### Conclusion:

The ERBE Hybrid Knife™ has the same basic intended use, principles of operation, and technological characteristics as the predicate devices in the previously cleared 510(k)s. The modifications involve having a device that connects to the Water Jet Model ERBEJET 2 and an ESU VIO Model, has a smaller outer diameter and longer working length for endoscopic use if desired, as well as retractable electrode. In conclusion, all the changes were verified or validated. As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles a stylized bird or a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

## AUG 2 6 2009

Re: K083608

Trade/Device Name: ERBE USA, Inc.'s ERBE Hybrid Knife" Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH and GEI Dated: August 19, 2009 Received: August 20, 2009

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 1 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. John Tartal

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Sincerely yours,

for

Mark N. Melkerson

Mark N. Melkerson Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 6083608

## Indications for Use

510(k) Number (if known):

Device Name: ERBE USA, Inc.'s ERBE Hybrid Knife™

Indications For Use:

The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.

Prescription Use X (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)

Pth

Jassion Sign-Off) ion of Surgical, Orthopedic, Restorative Devices

510(k) Number K083608

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