(23 days)
The NICO Myriad™ is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.
Specific neurosurgical indications may include diseases such as the following:
- Primary/Secondary Brain Tumors
- Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation)
- Intraventricular Tumors/Cysts
The Myriad is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The disposable handpiece is capable of precise tissue shaving and rapid tissue debulking.
The various handpieces, components, and optional accessories are outlined in tables below. Of note, the system also consists of optional Tissue Preservation System (TPS) accessories. The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS is comprised of three parts:
- Specimen Collector with filter element which collects tissue;
- Specimen Infusion Valve (SIV) which provides the desired biological environment;
- Specimen Preserver which provides the desired thermal condition
The provided text describes a 510(k) premarket notification for the NICO Myriad device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with predefined metrics.
Therefore, the document does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them in the context of an AI/ML medical device. Specifically:
- Acceptance Criteria Table and Reported Performance: The document does not define specific performance metrics (e.g., sensitivity, specificity, AUC) for the device. Instead, it focuses on demonstrating that design changes do not raise new questions of safety or effectiveness compared to the predicate device.
- Sample Size and Data Provenance (Test Set): This information is not applicable as there is no mention of a clinical "test set" being used to evaluate performance against specific metrics like an AI/ML model would require. The testing described is primarily non-clinical (e.g., biocompatibility, longevity, IEC 60601-1 testing).
- Number of Experts and Qualifications (Ground Truth): Not applicable, as there's no mention of expert-established ground truth for a test set.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Study: Not applicable. This type of study is common for evaluating the impact of AI on human reader performance, which isn't the focus of this 510(k) summary.
- Standalone Performance: Not applicable. The NICO Myriad is an electrosurgical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable. The device is not an AI/ML model.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of what is in the document:
The document outlines the NICO Myriad's substantial equivalence to a predicate device (K161307). The new submission (K182340) addresses changes such as:
- New contract manufacturer
- Design enhancements/process improvements (e.g., electronic components, bonding methods, adhesives)
- Capital equipment changes
- Packaging changes
- Additional handpiece offering (11 ga x 13 cm Pre-Bent handpiece)
- Labeling updates
The non-clinical testing performed to support substantial equivalence includes:
- Biocompatibility per ISO 10993-1
- Longevity Testing
- Specification Review & Dimensional Analysis
- Usability & Design Validation
- IEC 60601-1 Testing
- Sterility Testing
- Packaging Stability and Performance
- Product Stability
- Various Process Validations
The conclusion is that these changes "do not raise new questions of safety or effectiveness," indicating that the device "is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad." This is the typical standard for a 510(k) clearance, which differs significantly from the type of performance evaluation required for AI/ML-based medical devices.
§ 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.