(106 days)
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current.
The products are intended for use in endoscopically performed or supported surgeries.
The types of surgery intended are:
- Endoscopic procedures
- Orthopedic procedures
- Neurosurgical coagulation
FlexTip Bipolar electrodes single-use consist of a handpiece with electrode front part, cable and plug. The Bipolar electrodes are available in two different working lengths. The FlexTip electrodes are encoded for RF generators Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). The electrodes are provided sterile and are single-use instruments. Electrode shaft and tips are made of stainless steel and are insulated with PEBAX tubing.
The provided text describes the 510(k) premarket notification for the "FlexTip Bipolar electrodes single-use" device. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than detailing clinical studies with specific acceptance criteria in the context of AI/ML device performance.
Therefore, many of the requested details about acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, or multi-reader studies are not applicable to this submission, as it is for a physical medical device (electrosurgical electrodes) and not an AI/ML-based diagnostic or therapeutic software.
The document primarily covers bench testing, biocompatibility testing, and sterilization validation.
Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of quantitative acceptance criteria with numerical performance targets in the way one might for an AI/ML device (e.g., AUC > X, sensitivity > Y%). Instead, the acceptance criteria are implicitly that the device passes various engineering and biological tests, performing equivalently to the predicate device.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety & Electromagnetic Compatibility | Compliance with FDA recognized standards (IEC 60601-1, -1-2, -2-2, -2-18). | Pass |
| Mechanical Strength & Functionality | Design specifications are met under mechanical stress tests. | Pass |
| Thermal Effects on Tissue | Equivalent coagulation performance to predicate device across different power levels, application times, and tissue types (visual and digital morphometric measurement via histology). | Equivalent coagulation performance to predicate device |
| Systems Performance / Bench-top Validation | Design specifications are met; proper interaction with compatible RF generator. | Pass |
| Biocompatibility | Compliance with ISO 10993-1. | Requirements met |
| Sterilization Validation | Compliance with ISO 11135, ISO 11737-1, ISO 11137-2, ISO 14937, ISO 10993-7. SAL 10^-6, EO/ECH residuals below limits. | Compliance demonstrated; SAL 10^-6; EO/ECH limits met |
| Shelf Life Testing | Maintain functionality and sterility for specified duration per ISO 11607-1. | 1 year shelf life |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in numerical terms for each test.
- For "Thermal effects on tissue": "Three different types of tissue were used, and tests were performed in triplicate." This describes 3 samples per tissue type, tested 3 times.
- For other bench tests, the sample size is not specified but is implicitly part of the standard testing for device validation.
- Data Provenance: The testing was conducted in line with internal R&D processes and FDA guidance. The location of the testing is not specified, but the applicant (Sutter Medizintechnik GmbH) is based in Germany. These are non-clinical bench tests, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is a physical device, and the "ground truth" is established by engineering and standard medical device performance testing, not by expert interpretation of patient data or images. "Visual comparison" for thermal effects implies a human assessment, but not by a panel of "experts" in the sense of clinical readers.
4. Adjudication Method for the Test Set
Not Applicable. No human-in-the-loop clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are typically for evaluating diagnostic performance of imaging devices or AI algorithms. This submission is for an electrosurgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Not Applicable. This is not an algorithm or AI device. The phrase "standalone" might refer to the device's intrinsic performance, which is assessed through the various bench tests described (electrical safety, mechanical strength, thermal effects, systems performance).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance validation is established through:
- Engineering specifications and test standards: Compliance with IEC and ISO standards for electrical safety, biocompatibility, sterilization, and packaging.
- Physical measurements and visual assessment: For mechanical strength and thermal effects on tissue (including digital morphometric measurement using histology).
- Comparison to predicate device: Demonstration of equivalent performance and characteristics to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. No training set exists.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.