ERBE ERBEJET 2 SYSTEM

{0}------------------------------------------------ K072404 # CONFIDENTIAL #### ERBE USA Incorporated Abbreviated 510(k) - ERBE ERBEJET® 2 System # 510K SUMMARY | Submitted By: | ERBE USA, Inc.<br>2225 Northwest Parkway<br>Marietta, GA 30067<br>Tel: 770-955-4400 Fax: 770-955-2577 | OCT 31 2007 | |----------------------------------------|-------------------------------------------------------------------------------------------------------|-------------| | Contact Person: | John Tartal<br>QA/RA Manager | | | Date Prepared: | August 23, 2007 | | | Common Name: | Water Jet Dissector | | | Trade/Proprietary Name: | ERBE ERBEJET® 2 System | | | Classification Name: | Jet Lavage (21 CFR Part 880.5475) | | | Product Code: | FQH | | | Legally Marketed<br>Predicate Devices: | ERBE Helix Hydro-Jet™ System, 510(k) Numbers: K033590;<br>K022613; K012464 | | #### Device Description: The ERBEJET® 2 System delivers pressurized normal saline solution (0.9% saline solution for irrigation) to cut and dissect soft tissue. The ERBEJET® 2 Unit together with its accessories is an active invasive surgical product. The sterile normal saline solution is the "cutting medium" which is projected under pressure through a nozzle. The pressure is generated by a sterile single-use double piston Pump Cartridge and is controlled by means of a Footswitch. The Footswitch has a "ReMode" button that allows the user to switch between two established or "set" programs during the surgical procedure. The ERBEJET® 2 Unit has a display screen that allows the user to adjust the desired pressure settings using effect levels (1 to 80). The user may use the BASIC program that comes preprogrammed or set up to nine additional personalized programs. The cutting medium is isolated from the pressure generation Unit (i.e. the ERBEJET® 2 Unit) except at the sterile Pump Cartridge. A range of Applicators with a nozzle diameter of 120 µm is available for a wide range of applications. An integrated suction function (i.e. the Suction Module, Model ESM 2 which is separate and optional) can be used with the Unit and is adjustable up to -12 psi. Settings for the suction are adjusted on the display screen of the ERBEJET® 2 Unit. #### Intended Use: The ERBEJET® 2 System is intended for the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as endoscopic surgery. {1}------------------------------------------------ #### ERBE USA Incorporated Abbreviated 510(k) - ERBE ERBEJET® 2 System #### 510K SUMMARY Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence): #### Similarities The ERBEJET® 2 System has the same indications for use as the predicate device. The mechanical and technical aspects of creating the pressurized "cutting medium" have changed; however, the performance (i.e. the pressure and volume flow) is substantially equivalent. See Section I, Chart on I-10 as well as Section III, Comparison of System Outputs and Performance Testing. The Applicators are similar to the predicate device with slight differences. See Section III, Comparison Table. However, the volume flow and pressures through the nozzle are equivalent. Under testing, the ERBEJET® 2 System shows improved linear distribution than the predicate device. See Section I, Chart on I-10. Although the suction pump (i.e. Suction Module, Model ESM 2) is separate from the ERBEJET® 2 Unit, the functions are integrated into the ERBEJET® 2 Unit via its display screen which is equivalent to the predicate device. While both systems have a display screen, the display of the ERBEJET® 2 Unit is easier for the user to understand and navigate through. #### Differences The ERBEJET® 2 System uses a two head piston Pump Cartridge to create the pressurized "cutting medium" while the predicate device uses a hydraulic piston. The predicate device has a high-pressure range up to 2,175 psi; however, it was determined by user feedback that this high-pressure range was not utilized. The modified device has a high-rovousure range up to 1,160 psi (80 bar). With the removal of the large hydraulic piston, the size and weight of the ERBEJET® 2 Unit has decreased substantially and the procent the one the proposed unit has improved because there is no hydraulic oil to change. The Applicators have differences in materials, which were tested under biocompatibility. See Spetion III, Biocompatibility. In addition, the Applicators have slight differences in their dimensions. See, Section III, Comparison Table. The changes were made as a result of user forely ack. There is a small amount of fluid, less than 0.2 ml, released at the end of activation with the ERBEJET® 2 System due to the way the flow shutoff valves close off. Conversely, the Helix Hydro-Jet has shown almost no water released at the end of activation. No safety or efficacy issues are expected from the release of the small amount of residual fluid a the end of activation with the ERBEJET® 2 System. The ERBEJET® 2 System has been verified or validated in design control by ERBE Elektromedizin GmbH. #### Conclusion: The ERBEJET® 2 System has the same intended use, principles of operation, and technological characteristics as the predicate device. The ERBEJET® 2 System is smaller and easier to use. In conclusion, all the changes were verified or validated. As a mailer the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness. {2}------------------------------------------------ ### ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System | Characteristics | Predicate Device | Proposed Device | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | HumanMed AG<br>[Used to be Andreas Pein<br>Medizintechnik GmbH] | ERBE Elektromedizin GmbH | | 510(k) Applicant | ERBE USA, Inc. and Andreas<br>Pein Medizintechnik GmbH | ERBE USA, Inc. | | 510(k) Number | K033590; K022613; K012464 | Pending | | Classification Regulation<br>Product Code, Name | Class II, 21 CFR 880.5475<br>FQH, Jet Lavage | Same | | Device Name | Helix Hydro-Jet™ System<br>[Includes Fluid Cartridge,<br>Applicators, etc.] | ERBEJET® 2 System<br>[Includes Pump Cartridge,<br>Applicators, Separate/Optional<br>Suction Module ESM 2, etc.] | | Indications For Use | The Helix Hydro-Jet™ is intended<br>for the cutting and dissection of<br>soft tissue in neurosurgery and<br>soft tissue such as the liver,<br>kidney, etc. within the abdomen,<br>including Total Mesorectal<br>Excision (TME), in open as well<br>as endoscopic surgery. | Same | | Materials | | | | • Unit | Metal Sheet, Glass Display<br>Screen, Plastics, Wiring | Same | | • Components | | | | • Connecting Cables | Insulation Plastic, Wiring, Metals | Same | | • Footswitch | Aluminum, Plastics, Insulation<br>Plastics, Rubber | Same | | • Fluid (Application)<br>Cartridge | 0.9% Normal Saline Solution,<br>Plastics (Polyethylene), Silicone | Not Applicable | | • Pump Cartridge | Not Applicable | Plastics (PA, TPE, PC, PVC),<br>Silicone | | • Applicators | Plastics (PEEK, PA, PVC),<br>Stainless Steel, Silicone,<br>Synthetic Jewel (Corundum) | Plastics (ABS, PA, PVC),<br>Stainless Steel, Silicone, Rubber,<br>Synthetic Jewel (Corundum) | | • Suction Module<br>(ESM 2) | The suction system of the Helix<br>Hydro-Jet™ is integrated inside<br>the Unit's case (see above). | Metal Sheet, Plastics, Wiring | | Characteristics | Predicate Device | Proposed Device | | • Suction Accessories | Container and Top:<br>Polycarbonate and<br>thermoplastic elastomer | Container:<br>Shock-resistant polycarbonate<br>Top:<br>Reinforced polyamide with<br>santoprene seal | | | Bag:<br>Two layers (Polyethylene inner<br>lining with polypropylene) | Bag:<br>Three layers for durability and<br>odor protection (polyethylene/<br>polyamide / polyester) | | | Hose: Silicone, Rubber O-rings<br>Filter: Not Applicable<br>Switching Valve: Not Applicable<br>Rails & Brackets: Not Applicable | Hose: Silicone, Rubber O-rings<br>Filter: Plastics<br>Switching Valve: Plastics<br>Rails & Brackets: Aluminum | | | | Note: The suction accessories<br>are manufactured by Medela AG<br>in Switzerland (see additional<br>information at the end of the<br>Table). | | Physical and Dimensional Attributes | | | | • Unit | | | | • Length | 13.8" (35 cm) | 14.6" (37 cm) | | • Width | 13.8" (35 cm) | 16.1" (41 cm) | | • Height | 4.0' (122 cm) | 5.1" (13 cm) | | • Mounting | Included, 19.6" (50 cm) x 19.6"<br>(50 cm) [Base including wheels] | Mountable to VIO Cart or Boom | | • Weight | 163 lbs (74 kg) | 24.3 lbs (11kg) | | • Components | | | | • Connecting Cables | Main Cable (Power Cord), UL-<br>Version, Length 4 m (13.2') | Same | | | Not Applicable –<br>Suction is integrated inside the<br>Unit | ECB Connecting Cable,<br>Connects ERBEJET 2 with<br>Suction Module, ESM 2 | | • Footswitch | One Pedal Footswitch, AP and IP<br>X8 Equipment | One Pedal Footswitch, AP and IP<br>X8 Equipment, with ReMode | | • Fluid Cartridge | Sterile 0.9% Normal Saline<br>Solution in Plastic Bottle, 485 ml | Not Applicable (see Pump<br>Cartridge) | | Characteristics | Predicate Device | Proposed Device | | • Pump Cartridge | Not Applicable (see Fluid<br>Cartridge) | User connects Sterile 0.9%<br>Normal Saline Solution for<br>Irrigation to Pump Cartridge;<br>Saline is purchased separately<br>from other sources | | • Applicators | Applicator, Blunt Dissector, Outer<br>Diameter (OD) 5mm x Length<br>180mm, Curved Tip | Same - except Length 183mm | | | Applicator, Blunt Dissector, Outer<br>Diameter (OD) 5mm x Length<br>336mm, Curved Tip | Same, | | | Applicator with Suction, Length 60<br>mm Flexible Sheath/Rigid Tip | Same - except Length 65 mm | | | Applicator with Suction, Outer<br>Diameter (OD) 6 mm x Length<br>300 mm Rigid Sheath/Tip | Same - except Length 306 mm | | | Applicator with Suction, Outer<br>Diameter (OD) 2.6 mm x Length<br>60 mm Bayonet Sheath/Tip | Same - except O.D. 2.8 mm and<br>Length 90 mm | | • Suction System | Integrated within the Helix Hydro-<br>Jet Unit | Integrated for use with the<br>ERBEJET 2 Unit but separate/<br>optional module - ESM 2 | | | Suction Container (2,000 ml) | ESM Suction Container (2,000<br>ml) | | | Suction Bag (2,000 ml) | ESM Suction Bag (2,000 ml) | | | Suction Container Top (included<br>with Suction Container above)<br>Suction Hose | ESM Suction Container Top (sold<br>separately from Container)<br>ESM Suction Hose, Length 30 cm | | | Not Applicable | ESM Membrane Filter, 0.3 µm | | | Not Applicable | Switching Valve w/ Suction<br>Hoses & Mounting Bracket | | | Not Applicable | Mounting Bracket to Connect to<br>Side Rails | | | Not Applicable | Brackets/Side Rails, Length 260<br>mm and 390 mm | | Energy Delivered | Pressurized sterile saline for<br>cutting and dissecting | Same | | Supply Voltage and<br>Current | 100-120 V; 10 A | 120-240 V; 3 A | | Frequency | 60 Hz | Same | | Characteristics | Predicate Device | Proposed Device | | Pressure Range | 1 to 2,175 psi | 14.5 to 1,160.3 psi | | Suction Range | -1.45 to -11.6 psi (-12 psi on<br>display) | Same | | Nozzle Diameter | 120 μm | Same | | Volume Flow | 1 to 55 ml/min<br>(As measured within same<br>pressure range as the proposed<br>device) | 1 to 55 ml/min | | Target Population | Patients requiring open or<br>endoscopic surgery in<br>neurosurgery and in and around<br>the abdomen | Same | | Anatomical Sites | Soft tissue in neurosurgery and<br>soft tissue such as the liver,<br>kidney, etc. within the abdomen,<br>including Total Mesorectal<br>Excision (TME), in open as well<br>as endoscopic surgery | Same | | • Unit, Connecting<br>Cables, Footswitches | Non-Sterile, Reusable | Same | | • Fluid Cartridge | Sterile, Single-Use, Radiation (R) | Not Applicable | | • Pump Cartridge | Not Applicable | Sterile, Single-Use, Radiation (R) | | • Applicators | Sterile, Single-Use, Ethylene<br>Oxide (EO) | Same | | • Suction System<br>Unit/Module | Within Helix Unit (see above) | Non-Sterile, Reusable | | Bags | Non-Sterile, Disposable | Same | | Containers and Hoses | Non-Sterile, Reusable | Same (includes Brackets/Rails) | | Performance<br>Standards Met | EN 60601-1; UL 2601-1; EN<br>60601-1-2; IEC 60529<br>(Footswitch Only) | EN 60601-1; UL 60601-1;<br>EN 60601-1-1; EN 60601-1-2;<br>EN 60601-1-4; EN 60601-1-6;<br>EN ISO 10079-1;<br>IEC 60529 (Footswitch Only) | | Other Standards<br>Used or Applied/Met | ISO 10993-1; ISO 10993-4; ISO-<br>10993-5; ISO 10993-10; ISO<br>10993-11; EN 556; EN 980; EN<br>868-1; EN 550; EN 552; EN 1441 | Same except for replaced or<br>newer standards:<br>ISO 11607; ISO 14971 | | Characteristics | Predicate Device | Proposed Device | | FDA Guidance<br>Documents Used | Not Known General Principles of Software<br>Validation, Version 1.1, dated<br>June 9, 1997 Guidance for FDA Reviewers<br>and Industry; Guidance for the<br>Content of Premarket<br>Submissions for Software<br>Contained in Medical Devices,<br>May 29, 1998 | Guidance Document for<br>Powered Suction Pump<br>510(k)s: Sep. 30, 1998 General Principles of<br>Software Validation; Final<br>Guidance for Industry and<br>FDA Staff; Jan. 11, 2002 Guidance for FDA Reviewers<br>and Industry; Guidance for<br>the Content of Premarket<br>Submissions for Software<br>Contained in Medical<br>Devices; May 11, 2005 | | Packaging and Labeling | Unit Unit Label Instruction Sheet/Quick Guide User Manual Components Not Applicable Not Applicable Applicators Outer Package<br>Labels Applicators Notes on Use<br>Labeling Fluid Cartridge Outer Package<br>Labels Fluid Cartridge Notes on Use<br>Labeling Not Applicable Not Applicable Suction Accessories Outer<br>Package Labels Not Applicable | Unit Unit Label Not Available User Manual Components ESM 2 Module Label ESM 2 User Manual Applicators Outer Package<br>Labels Applicators Notes on Use<br>Labeling Not Applicable Not Applicable Pump Cartridge Outer<br>Package Labels Pump Cartridge Notes on Use<br>Labeling Suction Accessories Outer<br>Package Labels ESM 2 Filter Package Label | {3}------------------------------------------------ ### ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System ### CONFIDENTIAL {4}------------------------------------------------ # CONFIDENTIAL ### ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {5}------------------------------------------------ ### ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ # CONFIDENTIAL {6}------------------------------------------------ ### CONFIDENTIAL #### ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System #### COMPARISON TABLE Suction Accessories: Medela AG 3002807523 in Switzerland has 510(k)s for their "powered suction pumps" under the product code "BTA" [510(k) # K061205 for the Vario 8/18ci Systems and 510(k) # K043544 for the Dominant 35c/i System] which includes their suction accessories. The ESM 2 suction modele is designed and manufactured by ERBE Elektromedizin GmbH and distributed by ERBE USA Incude 18 suction accessories that are being recommended and distributed for use with the ESM 2 suction module are the Medela AG suction accessories as designated under the Medela AG 510(k)s. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 3 1 2007 ERBE USA Inc. % Mr. John Tartal QA/RA Manager 2225 Northwest Parkway Marietta, Georgia 30067-9317 Re: K072404 Trade/Device Name: ERBE USA, Inc.'s ERBEJET® 2 System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQH Dated: August 23, 2007 Received: August 27, 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. {8}------------------------------------------------ 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html. Sincerely yours, Mark A. Milburn Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use 072404 510(k) Number (if known): Device Name: ERBE USA, Inc.'s ERBEJET® 2 System Indications For Use: The ERBEJET® 2 System is intended for the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open 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 Mark A. Melkerson (Division Sign-Off) (Division of General, Restorative, and Neurological Devices 510(k) Number K072404 Page 1 of 1