(63 days)
Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery.
The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring.
The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.
Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments available in different angled sheath configurations. They are to be connected to the bipolar output of the Sutter CURIS® RF Generator. The electrodes are provided sterile and are single-use devices.
The Sutter RaVoR™ Bipolar Electrodes are not an AI device, therefore, the information requested is not available in the provided text. The document refers to the device as an electrosurgical instrument for soft tissue ablation and coagulation in ENT surgery. It describes non-clinical performance data and concludes substantial equivalence to a predicate device, but does not pertain to AI/ML or require the typical acceptance criteria and study designs associated with AI devices.
However, based on the provided text, here is a breakdown of the non-clinical performance data and the study types conducted to demonstrate substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by "Pass" for each test, indicating that the device met the design specifications and performance requirements.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility and Electrical Safety | Pass relevant IEC standards | Pass |
| Mechanical Strength | Meet strength requirements | Pass |
| System Performance / Bench-top validation testing | Meet performance requirements | Pass |
| Thermal effects on tissue | Meet thermal effect targets | Pass |
| Transport and Storage | Maintain functionality | Pass |
| Sterility Assurance Level (SAL) | 10⁻⁶ | 10⁻⁶ |
| Shelf Life | Up to 3 years | Up to 3 years |
| Biocompatibility | Compliance to ISO 10993-1 | Performed |
| Thermal damage / thermal spread testing | Comparable to predicate | Comparable to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI device. Instead, it refers to a series of bench tests.
- Sample Sizes: Not explicitly stated for each bench test. For "Thermal damage / thermal spread testing," experiments were performed for both the subject and predicate device, implying multiple tests or observations to draw comparisons.
- Data Provenance: The data is from "Bench Testing" and "Non-Clinical Performance Data" conducted by the applicant, Sutter Medizintechnik GmbH. This is laboratory-based testing, not human data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable, as this is not an AI device and the ground truth for performance was established through engineering and scientific testing standards rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method
Not applicable. The performance was assessed against technical standards and benchmarks, not through expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted as this device is not an AI algorithm requiring human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established through:
- Engineering Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 11137-1, ISO 11137-2, and ISO 10993-1.
- Benchmarking against Predicate Device: Comparison of thermal effects, lesion size, and cool-down time to the legally marketed predicate device (Celon AG medical instruments, Celon ENT System, K032838).
- Laboratory Measurements: Direct measurements of physical properties, electrical characteristics, and biological interactions in controlled environments.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
§ 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.