(68 days)
The SurgASSIST™ System with Circular Stapler DLU, has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.
The SurgASSIST™ System with Right Angle Cutter Digital Loading Unit has applications in gastrointestinal, gynecological, surgical procedures for resection, transection, and creation of anastomosis.
The SurgASSIST™ Wireless Remote Control Unit is a battery powered, hand held device that transmits control commands to the SurgASSIST™ System Power Console (PC).
The existing wired Remote control version will remain as a component of the SurgASSIST System. The wireless version of the Remote Control will be commercialized in addition to the existing wired version, and sold as an accessory to the System.
A battery capable of supplying power throughout the predictive life of the Remote Control Unit is permanently installed inside the hermetically sealed case or housing. All Wireless Remote Control Units share identical transmittance frequencies, however each Unit is preprogrammed with a unique identification code. When the Wireless Remote Control Unit is used to poweron the SurgASSIST™ Power Console (PC), this unique identification code is read and stored by the Console. The Power Console, with the stored identification code will then only respond to commands sent by its corresponding Remote Control Unit.
The radio frequency commands sent via the hand-held Remote Control Unit are Not considered Wireless Medical Telemetry, as defined by FCC. The frequencies assigned to the transmitter will not be in Medical Telemetry MHz bands set aside by the Wireless Medical Telemetry Service (WMTS).
The provided text does not contain information regarding quantitative acceptance criteria or a study that proves the device meets such criteria for the SurgASSIST™ System with Wireless Remote Control.
The document is a Special 510(k) Device Modification PreMarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a clinical or bench study with acceptance criteria.
The information primarily discusses:
- Device Description: The SurgASSIST™ Wireless Remote Control Unit is a battery-powered, handheld device that transmits control commands to the SurgASSIST™ System Power Console.
- Predicate Devices: It lists existing wired SurgASSIST™ systems (K003277, K012809) and a Skylight Imaging System (K000908) for comparison.
- Indications for Use: The system is intended for use throughout the alimentary tract for anastomosis and in gastrointestinal, gynecological, and thoracic surgical procedures for resection, transection, and creation of anastomosis. The indications for use are stated to be substantially identical to the predicate devices.
- Comparison to Predicate Devices: A table compares features like intended use, FDA class, human factors, size, materials, command buttons, transmitter/receiver, power, software, and sterilization methods. The primary modification highlighted is the wireless capability.
- FDA Clearance: The letter from the FDA confirms substantial equivalence based on the provided information.
Therefore, I cannot provide the requested details because the document does not include:
- A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., latency, signal range, battery life duration targets) are mentioned, nor are results of tests against such criteria.
- Sample size, data provenance: No test set or study is described.
- Number of experts, qualifications, adjudication method: No expert review or ground truth establishment relevant to performance testing is mentioned.
- MRMC comparative effectiveness study: This type of study is not mentioned as the device is a control unit for a surgical stapling system, not an imaging AI.
- Standalone performance: No standalone performance metrics are provided beyond the device description of its function.
- Type of ground truth used: Not applicable as no study with ground truth is described.
- Sample size for training set: Not applicable; the document describes a hardware modification, not an AI or software device that would typically have a training set in this context.
- How ground truth for training set was established: Not applicable.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.