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.

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.

AI/ML Overview

The ERBEJET® 2 System is intended for cutting and dissecting soft tissue in neurosurgery and within the abdomen (e.g., liver, kidney), including Total Mesorectal Excision (TME), in both open and endoscopic surgery.

Acceptance Criteria and Device Performance:

The provided document asserts that the ERBEJET® 2 System is substantially equivalent to its predicate devices (ERBE Helix Hydro-Jet™ System, K033590; K022613; K012464) based on performance testing and comparison of characteristics. The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device, particularly regarding "performance (i.e., the pressure and volume flow)." The study indicates that the performance of the proposed device is "substantially equivalent" to the predicate.

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (ERBEJET® 2 System)	Meets Acceptance Criteria?
Pressure Range	1 to 2,175 psi	14.5 to 1,160.3 psi	Yes (within a more focused and utilized range)
Suction Range	-1.45 to -11.6 psi (-12 psi on display)	-1.45 to -11.6 psi (-12 psi on display)	Yes
Nozzle Diameter	120 µm	120 µm	Yes
Volume Flow	1 to 55 ml/min (within same pressure range as the proposed device)	1 to 55 ml/min	Yes

Study Details:

The provided information focuses on demonstrating substantial equivalence to a predicate device rather than an independent clinical trial with specific acceptance criteria in the traditional sense (e.g., statistical endpoints for efficacy). The primary study performed is a comparison and performance testing against the predicate device.

Sample Size and Data Provenance:
- There is no mention of a "test set" in terms of patient data. The evaluation appears to be based on engineering and bench testing of the device itself and its components.
- The data provenance would be internal testing conducted by ERBE Elektromedizin GmbH for the ERBEJET® 2 System and historical data for the predicate device. The country of origin for the proposed device's manufacturer is Germany (ERBE Elektromedizin GmbH).
Number of Experts and Qualifications for Ground Truth:
- This type of evaluation (substantial equivalence for a device modification) does not typically involve experts establishing ground truth for a test set in the same way as, for example, an AI diagnostic device.
- User feedback is mentioned as a driver for some design changes (e.g., pressure range, applicator dimensions), implying input from surgical professionals, but their number and specific qualifications are not detailed as formal "experts" for ground truth establishment.
Adjudication Method:
- Not applicable in the context of this substantial equivalence submission, which relies on a comparison of technical specifications and performance data.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically for evaluating diagnostic or interpretive devices where human readers provide assessments. The ERBEJET® 2 System is a surgical instrument.
Standalone (Algorithm Only) Performance Study:
- No. The device is a surgical instrument, not an algorithm. Its performance is evaluated through output measurements (pressure, flow) and mechanical characteristics.
Type of Ground Truth Used:
- The "ground truth" here is the established performance and safety profile of the legally marketed predicate device. The proposed device is deemed acceptable if its performance and safety characteristics are substantially equivalent, or improved without raising new safety or effectiveness concerns. This is based on standardized measurements and engineering verification/validation.
Sample Size for Training Set:
- Not applicable as this is not a machine learning or AI-driven device.
How Ground Truth for Training Set Was Established:
- Not applicable.

Summary

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K072404

CONFIDENTIAL

ERBE USA Incorporated Abbreviated 510(k) - ERBE ERBEJET® 2 System

510K SUMMARY

Submitted By:	ERBE USA, Inc.2225 Northwest ParkwayMarietta, GA 30067Tel: 770-955-4400 Fax: 770-955-2577	OCT 31 2007
Contact Person:	John TartalQA/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 MarketedPredicate Devices:	ERBE Helix Hydro-Jet™ System, 510(k) Numbers: K033590;K022613; K012464

Device Description:

Intended Use:

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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.

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ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System

Characteristics	Predicate Device	Proposed Device
Manufacturer	HumanMed AG[Used to be Andreas PeinMedizintechnik GmbH]	ERBE Elektromedizin GmbH
510(k) Applicant	ERBE USA, Inc. and AndreasPein Medizintechnik GmbH	ERBE USA, Inc.
510(k) Number	K033590; K022613; K012464	Pending
Classification RegulationProduct Code, Name	Class II, 21 CFR 880.5475FQH, Jet Lavage	Same
Device Name	Helix Hydro-Jet™ System[Includes Fluid Cartridge,Applicators, etc.]	ERBEJET® 2 System[Includes Pump Cartridge,Applicators, Separate/OptionalSuction Module ESM 2, etc.]
Indications For Use	The Helix Hydro-Jet™ is intendedfor the cutting and dissection ofsoft tissue in neurosurgery andsoft tissue such as the liver,kidney, etc. within the abdomen,including Total MesorectalExcision (TME), in open as wellas endoscopic surgery.	Same
Materials
• Unit	Metal Sheet, Glass DisplayScreen, Plastics, Wiring	Same
• Components
• Connecting Cables	Insulation Plastic, Wiring, Metals	Same
• Footswitch	Aluminum, Plastics, InsulationPlastics, Rubber	Same
• Fluid (Application)Cartridge	0.9% Normal Saline Solution,Plastics (Polyethylene), Silicone	Not Applicable
• Pump Cartridge	Not Applicable	Plastics (PA, TPE, PC, PVC),Silicone
• Applicators	Plastics (PEEK, PA, PVC),Stainless Steel, Silicone,Synthetic Jewel (Corundum)	Plastics (ABS, PA, PVC),Stainless Steel, Silicone, Rubber,Synthetic Jewel (Corundum)
• Suction Module(ESM 2)	The suction system of the HelixHydro-Jet™ is integrated insidethe Unit's case (see above).	Metal Sheet, Plastics, Wiring
Characteristics	Predicate Device	Proposed Device
• Suction Accessories	Container and Top:Polycarbonate andthermoplastic elastomer	Container:Shock-resistant polycarbonateTop:Reinforced polyamide withsantoprene seal
	Bag:Two layers (Polyethylene innerlining with polypropylene)	Bag:Three layers for durability andodor protection (polyethylene/polyamide / polyester)
	Hose: Silicone, Rubber O-ringsFilter: Not ApplicableSwitching Valve: Not ApplicableRails & Brackets: Not Applicable	Hose: Silicone, Rubber O-ringsFilter: PlasticsSwitching Valve: PlasticsRails & Brackets: Aluminum
		Note: The suction accessoriesare manufactured by Medela AGin Switzerland (see additionalinformation at the end of theTable).
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"(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-Version, Length 4 m (13.2')	Same
	Not Applicable –Suction is integrated inside theUnit	ECB Connecting Cable,Connects ERBEJET 2 withSuction Module, ESM 2
• Footswitch	One Pedal Footswitch, AP and IPX8 Equipment	One Pedal Footswitch, AP and IPX8 Equipment, with ReMode
• Fluid Cartridge	Sterile 0.9% Normal SalineSolution in Plastic Bottle, 485 ml	Not Applicable (see PumpCartridge)
Characteristics	Predicate Device	Proposed Device
• Pump Cartridge	Not Applicable (see FluidCartridge)	User connects Sterile 0.9%Normal Saline Solution forIrrigation to Pump Cartridge;Saline is purchased separatelyfrom other sources
• Applicators	Applicator, Blunt Dissector, OuterDiameter (OD) 5mm x Length180mm, Curved Tip	Same - except Length 183mm
	Applicator, Blunt Dissector, OuterDiameter (OD) 5mm x Length336mm, Curved Tip	Same,
	Applicator with Suction, Length 60mm Flexible Sheath/Rigid Tip	Same - except Length 65 mm
	Applicator with Suction, OuterDiameter (OD) 6 mm x Length300 mm Rigid Sheath/Tip	Same - except Length 306 mm
	Applicator with Suction, OuterDiameter (OD) 2.6 mm x Length60 mm Bayonet Sheath/Tip	Same - except O.D. 2.8 mm andLength 90 mm
• Suction System	Integrated within the Helix Hydro-Jet Unit	Integrated for use with theERBEJET 2 Unit but separate/optional module - ESM 2
	Suction Container (2,000 ml)	ESM Suction Container (2,000ml)
	Suction Bag (2,000 ml)	ESM Suction Bag (2,000 ml)
	Suction Container Top (includedwith Suction Container above)Suction Hose	ESM Suction Container Top (soldseparately from Container)ESM Suction Hose, Length 30 cm
	Not Applicable	ESM Membrane Filter, 0.3 µm
	Not Applicable	Switching Valve w/ SuctionHoses & Mounting Bracket
	Not Applicable	Mounting Bracket to Connect toSide Rails
	Not Applicable	Brackets/Side Rails, Length 260mm and 390 mm
Energy Delivered	Pressurized sterile saline forcutting and dissecting	Same
Supply Voltage andCurrent	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 ondisplay)	Same
Nozzle Diameter	120 μm	Same
Volume Flow	1 to 55 ml/min(As measured within samepressure range as the proposeddevice)	1 to 55 ml/min
Target Population	Patients requiring open orendoscopic surgery inneurosurgery and in and aroundthe abdomen	Same
Anatomical Sites	Soft tissue in neurosurgery andsoft tissue such as the liver,kidney, etc. within the abdomen,including Total MesorectalExcision (TME), in open as wellas endoscopic surgery	Same
• Unit, ConnectingCables, 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, EthyleneOxide (EO)	Same
• Suction SystemUnit/Module	Within Helix Unit (see above)	Non-Sterile, Reusable
Bags	Non-Sterile, Disposable	Same
Containers and Hoses	Non-Sterile, Reusable	Same (includes Brackets/Rails)
PerformanceStandards Met	EN 60601-1; UL 2601-1; EN60601-1-2; IEC 60529(Footswitch Only)	EN 60601-1; UL 60601-1;EN 60601-1-1; EN 60601-1-2;EN 60601-1-4; EN 60601-1-6;EN ISO 10079-1;IEC 60529 (Footswitch Only)
Other StandardsUsed or Applied/Met	ISO 10993-1; ISO 10993-4; ISO-10993-5; ISO 10993-10; ISO10993-11; EN 556; EN 980; EN868-1; EN 550; EN 552; EN 1441	Same except for replaced ornewer standards:ISO 11607; ISO 14971
Characteristics	Predicate Device	Proposed Device
FDA GuidanceDocuments Used	Not Known General Principles of SoftwareValidation, Version 1.1, datedJune 9, 1997 Guidance for FDA Reviewersand Industry; Guidance for theContent of PremarketSubmissions for SoftwareContained in Medical Devices,May 29, 1998	Guidance Document forPowered Suction Pump510(k)s: Sep. 30, 1998 General Principles ofSoftware Validation; FinalGuidance for Industry andFDA Staff; Jan. 11, 2002 Guidance for FDA Reviewersand Industry; Guidance forthe Content of PremarketSubmissions for SoftwareContained in MedicalDevices; May 11, 2005
Packaging and Labeling	Unit Unit Label Instruction Sheet/Quick Guide User Manual Components Not Applicable Not Applicable Applicators Outer PackageLabels Applicators Notes on UseLabeling Fluid Cartridge Outer PackageLabels Fluid Cartridge Notes on UseLabeling Not Applicable Not Applicable Suction Accessories OuterPackage Labels Not Applicable	Unit Unit Label Not Available User Manual Components ESM 2 Module Label ESM 2 User Manual Applicators Outer PackageLabels Applicators Notes on UseLabeling Not Applicable Not Applicable Pump Cartridge OuterPackage Labels Pump Cartridge Notes on UseLabeling Suction Accessories OuterPackage Labels ESM 2 Filter Package Label

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ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System

CONFIDENTIAL

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CONFIDENTIAL

ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System

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ERBE USA Incorporated Abbreviated 510(k) – ERBE ERBEJET® 2 System

CONFIDENTIAL

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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.

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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.

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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 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

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Indications for Use

072404 510(k) Number (if known):

Device Name: ERBE USA, Inc.'s ERBEJET® 2 System

Indications For Use:

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

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.