FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
Device Facts
| Record ID | K103400 |
|---|---|
| Device Name | FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP |
| Applicant | Stryker Corporation |
| Product Code | OLO · Neurology |
| Decision Date | Mar 7, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Intended Use
FluoroMap is a computer controlled stereotaxic image guided surgery system. It provides static localization information derived from image processing of intra-operatively acquired Xray images, by superposition of virtual implants and instruments onto those X-ray images.
Device Story
FluoroMap is a computer-assisted surgical planning system for proximal femur fracture surgery. It utilizes intra-operative 2D X-ray images as input. The system includes the FluoroMap software, a FluoroDisc (attached to a C-arm), and a Closed Tube Clip (attached to the Gamma3 Nail implant). The software recognizes metal marker spheres on the FluoroDisc and Closed Tube Clip to register X-ray images and localize the implant system. It overlays virtual implants and instruments onto the X-ray images, providing visual and numerical guidance to the surgeon. Used in the surgical suite by surgeons and clinical staff, the system assists in selecting and precisely positioning implants. This guidance aims to improve surgical accuracy and implant placement, potentially benefiting patients by optimizing fracture fixation.
Clinical Evidence
No clinical tests were conducted. Evidence is based on bench testing, including cadaveric studies, saw bone tests, and computer simulations. The system demonstrated a 2 mm accuracy (maximal deviation between displayed and actual implant position) with statistical significance. Usability was validated against IEC 62366:2007 standards in simulated use scenarios.
Technological Characteristics
Computer-assisted stereotaxic image-guided surgery system. Components: FluoroMap software, FluoroDisc (radiolucent plate with metal marker spheres), and Closed Tube Clip (radiolucent body with metal marker spheres). Connectivity: Integrates with standard C-arm imaging. Sterilization: Closed Tube Clip is sterile, single-use. Compliance: ISO 14971 (risk management), IEC 62366 (usability), and various AAMI/ANSI/ISO standards for biocompatibility and sterility (e.g., 10993 series, 11137 series).
Indications for Use
Indicated for surgeons and clinic staff to determine the size and position of orthopedic implants during proximal femur fracture surgery using the Stryker Gamma3 Nail system.
Regulatory Classification
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Predicate Devices
- VectorVision trauma (K062358)
- TenZing System (K102130)
- Gamma3 Lag Screw (K020677)
- Gamma3 Trochanteric Nail (K032244)
Related Devices
- K173946 — ADAPT for Gamma3 · Stryker GmbH · May 2, 2018
- K181848 — ADAPT for Gamma3, Gamma3 · Stryker GmbH · Oct 12, 2018
- K202749 — ADAPT for Gamma3 · Stryker GmbH · Dec 18, 2020
- K212245 — Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning · Brainlab AG · Apr 13, 2022
- K081672 — C-INSIGHT · Mazor Surgical Technologies , Ltd. · Aug 15, 2008
Submission Summary (Full Text)
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K103400
# MAR - 7 2011
# 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 .
| Submitter Information | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Stryker Leibinger GmbH & Co. KG - Navigation | |
| Address | Boetzinger Strasse 41, D-79111 Freiburg, Germany | |
| Phone number | +49-761-4512-117 | |
| Fax number | +49-761-4512-49117 | |
| Establishment Registration Number | 3007582679 | |
| Name of contact person | Lilian Eckert | |
| Date prepared | 17 November 2010 | |
| Name of device | | |
| Trade or proprietary name | FluoroMap Computer Assisted Surgery System | |
| Common or usual name | FluoroMap System | |
| Classification name | Orthopedic stereotaxic instrument and Picture archiving and communications system | |
| Classification panel | Orthopedic and Radiology | |
| Regulation | §882.4560 | |
| Product Code(s) | OLO and LLZ | |
| Legally marketed device(s) to which equivalence is claimed | VectorVision trauma from BrainLAB AG, K062358<br>TenZing System from Mazor Surgical Technologies Ltd., K102130<br>Gamma3 Lag Screw from Stryker Trauma GmbH, K020677<br>Gamma3 Trochanteric Nail from Stryker Trauma GmbH, K032244 | |
| Reason for 510(k) submission | Traditional 510(k) Notification | |
| Device description | The FluoroMap System is designed as a computer assisted surgical planning device to assist the surgeon in proximal femur fracture surgery.<br>The FluoroMap System provides static localization information derived through image processing of intra-operatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images.<br>The FluoroMap System consists of the FluoroMap Software, the FluoroDisc and the Closed Tube Clip. The Closed Tube Clip is a device which contains a radiolucent body with integrated metal marker spheres. The Closed Tube Clip is attached to the implant system of the Gamma3 Nail. The FluoroDisc | |
| is a device which contains a radiolucent plate with integrated metal marker<br>spheres. It is attached to a standard C-arm, an intra-operative mobile 2D X-<br>ray imaging device. The FluoroMap Software is a surgery planning system<br>which recognizes the metal marker spheres of the FluoroDisc and the Close<br>Tube Clip and performs a registration of the X-ray images to localize the<br>position of the implant system, e.g. the Gamma3 Nail system. The<br>FluoroMap Software overlays virtual implants and instruments onto the X-<br>ray images and provides visual and numerical information to assist the<br>surgeon in selecting the appropriate implant and to position it precisely. | | |
| Intended use of the<br>device | FluoroMap is a computer controlled stereotaxic image guided surgery<br>system. It provides static localization information derived from image<br>processing of intra-operatively acquired X-ray images, by superposition of<br>virtual implants and instruments onto those X-ray images. | |
| Indications for use | FluoroMap assists the surgeon to determine the needed size and position<br>of orthopedic implants during proximal femur fracture surgery using the<br>Stryker Gamma3 Nail system.<br>The system should be operated only by trained personnel such as<br>surgeons and clinic staff. | |
| Summary of the technological characteristics of the device compared to the predicate device<br>1 | | |
| Characteristic | Subject Device<br>FluoroMap | Predicate device 1<br>VectorVision trauma, BrainLAB<br>AG, K062358 |
| Intended Use /<br>Indication for Use<br>Statement | Intended Use:<br>FluoroMap is a computer controlled<br>stereotaxic image guided surgery<br>system. It provides static localization<br>information derived from image<br>processing of intra-operatively acquired<br>X-ray images, by superposition of virtual<br>implants and instruments onto those X-<br>ray images.<br>Indications:<br>FluoroMap assists the surgeon to<br>determine the needed size and position<br>of orthopedic implants during proximal<br>femur fracture surgery using the Stryker<br>Gamma3 Nail system.<br>The system should be operated only by<br>trained personnel such as surgeons and<br>clinic staff. | BrainLAB VectorVision trauma is<br>intended to be a pre- and intraoperative<br>image guided localization system to<br>enable minimally invasive surgery. It<br>links a freehand probe, tracked by a<br>passive marker sensor system to virtual<br>computer image space on a patient's<br>pre- or intraoperative image data being<br>processed by a VectorVision<br>workstation. The system is indicated for<br>any medical condition in which the use<br>of stereotactic surgery may be<br>appropriate and where a reference to a<br>rigid anatomical structure, such as the<br>skull, a bone structure like tubular<br>bones, pelvic, calcaneus and talus, or<br>vertebra, can be identified relative to a<br>CT, fluoroscopic, X-ray or MR based<br>model of the anatomy. |
| Intended Patient<br>Population | Patients undergoing orthopedic surgery | Patients undergoing orthopedic surgery |
| Surgical Approach | Orthopedic surgery, specifically at the<br>proximal femur | Orthopedic surgery, specifically surgery<br>at tubular bones, pelvic, calcaneus and<br>talus, or vertebra |
| Operational<br>Environment | Surgical suite | Surgical suite |
| Primary Device<br>Function | Assistance in planning and positioning of<br>orthopedic implants using intra-operative<br>X-ray images | Assistance in planning and positioning<br>of orthopedic implants using intra-<br>operative X-ray images |
| Main System<br>Components | Software Reference device for C-arm Reference device for instrumentation | Software Reference device for C-arm Reference device for instrumentation Reference system for patient |
| User Interface | Computer and monitor | Computer and monitor |
| Bench Testing | Accuracy testing of implant positioning in<br>simulated use scenarios using cadavers,<br>saw bones and computer simulation;<br>system accuracy of 2 mm | Unknown, expected to be similar<br>accuracy tests with similar results |
| Conformance to<br>Recognized<br>Consensus<br>Standards | Compliance with standards in regard to<br>risk management, usability, software,<br>sterilization, biocompatibility, packaging,<br>development process and quality<br>system, see section 1.11 | Unknown |
| Body Contact and<br>Use | Reference device for instrumentation<br>(Closed Tube Clip) has patient contact | Reference device for instruments and<br>reference device for patient have body<br>contact |
| Sterile, Single-use | Reference device for instrumentation<br>(Closed Tube Clip) is delivered sterile<br>and as a single use product | Parts of the reference device (infra-red<br>reflectors) are delivered sterile and are<br>single use products |
| Summary of the technological characteristics of the device compared to the predicate device<br>2 | | |
| Characteristic…
