7D Surgical System
by 7D Surgical, Inc. Canada 510(k)
510(k) K192140
Product code OLO
Overview
The 7D Surgical System is a machine-vision image-guided surgery (MvIGS) system for spine surgery, designed to enhance intraoperative visibility and precision. It employs advanced 3D optical technologies and machine vision to assist in accurate screw placement during spinal procedures. Unlike traditional radiation-based navigation systems, this device eliminates ionizing radiation exposure while maintaining real-time guidance. Its proprietary Flash Registration technology streamlines workflow efficiency, reducing registration time significantly compared to legacy systems.
The system is intended for use in operating rooms during spine surgeries, providing real-time visual feedback to surgeons. It is single-use and supplied as a complete intraoperative navigation platform, requiring no additional imaging modalities beyond standard preoperative scans. The device is FDA-cleared under the 510(k) pathway (K192140) and adheres to substantially equivalent regulatory standards for surgical navigation. Storage and handling follow standard sterile surgical instrument protocols, as specified by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192140 | Date5 Nov 2019 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OLO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from 7D Surgical, Inc.
Questions
What is the 7D Surgical System used for in spine surgery?
The 7D Surgical System is designed to assist surgeons during spine procedures by providing real-time, radiation-free 3D optical guidance for accurate screw placement. Its machine-vision technology replaces traditional radiation-based navigation, ensuring precise intraoperative visibility while reducing exposure risks. This makes it ideal for complex spinal surgeries where accuracy and workflow efficiency are critical.
How does the Flash Registration technology improve workflow efficiency?
Flash Registration is a proprietary feature of the 7D Surgical System that significantly reduces the time required to register the patient’s anatomy pre-surgery. Traditional systems often require lengthy alignment steps, but this technology streamlines the process, allowing surgeons to begin navigation faster and minimize delays during critical procedures.
Is the 7D Surgical System single-use or reusable?
The 7D Surgical System is supplied as a single-use device. This design choice ensures sterility and reduces the risk of cross-contamination between patients, aligning with standard sterile surgical instrument protocols. After use, the system should be disposed of according to manufacturer guidelines.
Does the 7D Surgical System require additional imaging beyond preoperative scans?
No, the 7D Surgical System operates independently of intraoperative imaging modalities. It relies solely on standard preoperative scans (e.g., CT or MRI) for planning, then provides real-time guidance during surgery using its integrated machine-vision technology. This eliminates the need for additional imaging devices in the operating room.
How should the 7D Surgical System be stored and handled?
The system must be stored and handled according to standard sterile surgical instrument protocols to maintain integrity and sterility. This includes keeping it in its original packaging until use, protecting it from contamination, and following manufacturer instructions for unpacking and setup in the operating room. Proper storage ensures readiness for surgery while preserving its single-use specifications.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K192140