(65 days)
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.
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.
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.
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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).
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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.
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Adjudication Method:
- Not applicable in the context of this substantial equivalence submission, which relies on a comparison of technical specifications and performance data.
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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.
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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.
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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.
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Sample Size for Training Set:
- Not applicable as this is not a machine learning or AI-driven device.
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How Ground Truth for Training Set Was Established:
- Not applicable.
§ 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.