(70 days)
The Helix Hydro-Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.
Not Found
This 510(k) submission for the Helix Hydro-Jet did not include any clinical studies or performance data in relation to acceptance criteria. The submission focused on establishing substantial equivalence through non-clinical testing and comparison to predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document explicitly states: "The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."
Instead, the submission relied on the following non-clinical testing to establish substantial equivalence:
- Biocompatibility Testing: Successfully completed for patient contact materials, according to ISO 10993-1.
- Safety Testing: Successfully completed according to EN 60601-1 / IEC 601-1.
- EMC Testing: Successfully completed according to EN 60601-1-2.
The conclusion drawn by Andreas Pein Medizintechnik, GmbH was that the device is "safe and effective when used as instructed by knowledgeable and trained personnel, and performs as well as or better than the legally marketed predicate devices for the purposes intended." This conclusion was based on the non-clinical testing and comparison to predicate devices, not on a study proving the device meets specific performance acceptance criteria from clinical data.
§ 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.