(65 days)
Indications for Use - Hydrosurgical unit:
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.
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.
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.
§ 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.