The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures.

Indications for Use - Applicators and ERBEJET probe:

20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used free injection including lifting of mucosal lesions by injection into the submucosa.

20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery.

20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa.

20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

Device Description

The ERBEJET® 2 System includes the Hydrosurgical unit model ERBEJET® 2, the pump cartridge plus, instruments (applicators and ERBEJET probe), an optional suction model ESM 2 with accessories and a one- or two-pedal footswitch. Together these components form the ERBEJET® 2 System. The system provides an adjustable high-pressure water jet (pressurized normal saline solution) intended for tissue-selective hydrodissection and needle-free injection in endoscopic and/or surgical interventions. The ERBEJET® 2 unit together with its accessories is an active invasive surgical system. The sterile normal saline solution is the "medium" which is projected under pressure through a nozzle of the connected instrument to achieve the desired tissue effect.

AI/ML Overview

This document is an FDA 510(k) summary for the ERBEJET® 2 System, which is a hydrosurgical unit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in a study. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is largely not applicable or not provided in this type of submission.

The 510(k) summary outlines the device's indications for use, describes its components, compares its technological characteristics to predicate devices, and details non-clinical performance testing. The purpose of these tests is to show that the new device does not raise new questions of safety or effectiveness, not to establish new performance metrics against clinical acceptance criteria.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present clinical acceptance criteria with corresponding device performance metrics in a table format. The "performance" discussed is related to maintaining functional equivalence with the predicate device through non-clinical testing.

Acceptance Criteria (Not explicitly stated as clinical acceptance criteria)	Reported Device Performance (from non-clinical testing)
Electrical Safety: Compliance with IEC 60601-1	Verified by means of IEC 60601-1
Electromagnetic Compatibility: Compliance with IEC 60601-1-2 and FDA Guidance	Verified by means of IEC 60601-1-2 in combination with FDA Guidance "Electromagnetic Compatibility (EMC) of Medical Devices"
Functional Performance: Performs as intended and meets design specifications (for the subject device's components, including new pump cartridge)	Performed in compliance with 21 CFR 820.30; Bench testing showed performance specifications (i.e., delivery of the medium) remain unchanged for the new pump cartridge.
Biocompatibility: Absence of negative impact due to material changes	Performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..."
Sterilization: Sterility Assurance Level (SAL) of 10^-6	Performed in compliance with ISO 11135; Documentation provided according to FDA Guidance, showing an SAL of 10^-6. EO residual testing in compliance with ISO 10993-7.
Packaging and Shelf Life: Maintenance of integrity and function over time	Performed in compliance with ISO 11607-1 and real-time aged devices. Functional testing also performed on real-time aged devices.
Software Verification and Validation: Compliance with software standards	Performed in compliance with IEC 62304 and documentation provided according to FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The document describes non-clinical testing (bench testing, verification, validation) on the device components, not a clinical test set with patient data.
Data Provenance: Not applicable. The testing is described as internal verification and validation activities. No country of origin for clinical data or retrospective/prospective study design is mentioned because it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a clinical study involving expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is detailed as there's no clinical diagnostic test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The ERBEJET® 2 System is a medical device (hydrosurgical unit), not an AI-powered diagnostic system or an assistive technology that would involve "human readers" or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm with standalone performance in a diagnostic or interpretive capacity. Its function is to deliver a pressurized water jet.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of clinical ground truth. The "ground truth" for the non-clinical tests is adherence to established engineering standards, regulatory requirements (e.g., ISO, IEC, FDA guidances), and design specifications.

8. The sample size for the training set

Not applicable. This information pertains to machine learning models, which are not relevant to the described ERBEJET® 2 System.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned or relevant to this device submission.

Summary of the FDA 510(k) Submission Perspective:

The FDA 510(k) process for the ERBEJET® 2 System is about demonstrating substantial equivalence to legally marketed predicate devices, not about proving novel clinical performance or algorithmic efficacy. The non-clinical tests mentioned (electrical safety, EMC, functional, biocompatibility, sterilization, packaging, software) are standard engineering and regulatory verification/validation activities to ensure the device is safe and effective when compared to its predicates, despite minor modifications. The document successfully argues that the subject device "does not raise new or different questions of safety and effectiveness" compared to the predicate devices.

Summary

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June 15, 2023

Erbe Elektromedizin GmbH Matthias Kollek Regulatory Affairs Specialist Waldhoernlestrasse 17 Tuebingen, 72072 Germany

Re: K231023

Trade/Device Name: ERBEJET® 2 System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH, GEI Dated: April 4, 2023 Received: April 11, 2023

Dear Matthias Kollek:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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,

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See DICE (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.06.15
13:05:12 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231023

Device Name ERBEJET® 2 System

Indications for Use (Describe)

Indications for Use - Hydrosurgical unit:

Indications for Use - Applicators and ERBEJET probe:

20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]

Applicant	Erbe Elektromedizin GmbH
	Waldhoernlestrasse 17
	72072 Tuebingen
	Germany
	Tel: 0049-7071-755-0
	Fax: 0049-7071-755-179
Contact Person	Dr. Matthias Kollek

	Regulatory Affairs Specialist
	E-Mail: Matthias.Kollek@erbe-med.com
Date Prepared	June 6, 2023
Device Information
Trade/Proprietary Name:	ERBEJET® 2 System
Common Name:	Hydrosurgical Unit and Accessories
Classification Name	Jet lavage
Regulation Number:	21 CFR 880.5475
Class:	II
Product Code:	FQH
Legally Marketed Predicate Devices	ERBE ERBEJET 2 System - K072404 and
	ERBE Water Jet Model ERBEJET® 2 System
	with HybridAPC Probe - K143306

Device Description

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Hydrosurgical Unit

The ERBEJET® 2 Hydrosurgical Unit is a standalone Unit that can be mounted / secured to a cart. It has a monochromatic display (blue/white) that provides the user with settings and operational information. The display is surrounded by buttons allowing the user to control the unit (e.g., set the effect, select a program). In order to pressurize and deliver the medium to a connected Applicator, a pump cartridge (attached to the medium) must be connected to the ERBEJET 2. Activation of the Unit and subsequent delivery of the medium is possible with a connected footswitch. The pressure ranges from 1 to 80 bar (+/-20%) (14.5 - 1160.3psi (+/-20%)) which corresponds to a volume flow of 3.5 – 55 ml/min (± 10% or ± 1 ml, depending on which value is larger).

Applicators and ERBEJET probe

The applicators and ERBEJET probe are sterile, single-use instruments which are available in various length and diameters as well as with or without an additional suction line.

Accessories

Pump cartridge plus

The single use sterile pump cartridge is inserted into the ERBEJET® 2 unit. It has a chamber with two pistons and is the conduit for the medium which is connected to the cartridge via luer lock to be pressurized. The pressure is mechanically provided by the ERBEJET® 2 unit by engaging the pistons of the pump cartridge.

Footswitch

A one-pedal and two-pedal footswitch have been designed for the ERBEJET® 2. The footswitches are used to activate the Unit.

Suction module and accessories

The optional suction module ESM 2 can be integrated into the ERBEJET 2 System. Various accessories (i.e. filter, suction hose, etc.) connect the ESM 2 to a suction container and to the applicator to aspirate fluids from the surgical site.

Other accessories

Accessories that may be used for the mounting of the unit.

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Indications for Use

ERBEJET® 2

Applicators and ERBEJET probe

20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa.

20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery.

Compared to the legally marketed predicate devices, the subject device has a reworded indications for use statement. In general, Erbe would like to have a more encompassing indications for use (intended use) for the unit, and have more specifics as to applications in the instrument's indications for use (intended use). Erbe changed the term injection to needle-free injection for clarification since the instruments don´t have a needle. The phrase dissection of tissue was changed to tissue-selective hydrodissection since this is the commonly used clinical term which is used by physicians and supported by peer-reviewed literature. Furthermore, the term "cutting" has been omitted for clarification purposes since dissection/hydrodissection is a more accurate term for water jet application (Note: From a clinicians view point, "cutting" is a term in electrosurgery that is associated with the delivery of monopolar or bipolar energy or a term in general surgery of a mechanical nature, e.g. scalpel). Additionally, the indications for use of the associated instruments (i.e. applicators and ERBEJET probe) will then provide further specifics for optimal use in a clinical setting in accordance with the proposed intended use of the unit. Therefore, the phrases "lifting mucosal lesions by injection into the submucosa" which is associated with the function "needle-free injection" and "separation of soft tissue"

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Erbe Elektromedizin GmbH K231023 - Traditional 510(k) for ERBEJET® 2 System

which is associated with the function "tissue-selective hydrodissection" are additionally being used for the indications for use statement of the applicators and ERBEJET probe as applicable. Taken together, the indications for use statement was reworded for clarity in order to better describe the actual function without changing the original meaning. The intended use is substantially equivalent compared the predicate device.

Comparison of Technological Characteristics with the Predicate Device

Compared to the legally marketed predicate devices the subject device has additional applicators and the ERBEJET probe. The additional instruments have partially different materials and dimensions. However, the energy source and technological principle is the same. Since the ERBEJET® 2 system is a volume-controlled system, the flow rate is always the same and independent of the instruments design. The only performance parameter that is influenced by the instrument design is the dynamic pressure which depends on the nozzle geometry. Since all proposed applicators and the ERBEJET probe have the same nozzle geometry as the predicate devices, the generated dynamic pressure, and hence, the performance is also the same.

Another change is related to the pump cartridge. Compared to the legally marketed predicate device, the subject device has a new pump cartridge with optimized design modifications were made to improve the insertion behavior into the unit, to enable the change of instruments during surgery and to improve the priming process. Furthermore, the proposed pump cartridge also has slightly different materials compared to the predicate pump cartridge. However, bench testing showed that the performance specifications (i.e. delivery of the medium) remain unchanged and that the new pump cartridge is as safe and effective as the legally marketed pump cartridge, and does not raise different questions of safety and effectiveness.

Non-clinical performance testing

Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate devices.

Electrical safety and electromagnetic compatibility testing were verified by means of IEC 60601-1 and IEC 60601-1-2 in combination with FDA Guidance "Electromagnetic Compatibility (EMC) of Medical Devices", respectively.

Functional testing and design controls to verify adequate performance of the subject device was performed in compliance with 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.

Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to exclude a negative impact as

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a result of the material changes.

Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" showing an SAL of 10-6. EO residual testing and limits are in compliance with ISO 10993-7.

Packaging and shelf life validation was performed in compliance with ISO 11607-1 and realtime aged devices. Functional testing was also performed on real-time aged devices.

Software verification and validation was performed in compliance with IEC 62304 and documentation provided according FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Conclusion

The subject device has the same intended use, the same fundamental design, the same performance characteristics and energy source as the predicate device. The subject device was tested as described above and the minor differences in technological characteristics were assessed with regards to safety and effectiveness. Taken together, the subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate device.

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.