(108 days)
Not Found
No
The description focuses on image processing and registration based on physical markers, not AI/ML algorithms.
No
The device is a computer-assisted surgical planning device that assists surgeons by providing localization information and overlaying virtual implants onto X-ray images, but it does not directly treat or diagnose a disease or condition.
No.
The device is described as a computer-assisted surgical planning and image-guided surgery system that assists in determining the size and position of implants during surgery. It provides navigational support and visual information, not a diagnostic assessment of a patient's medical condition.
No
The device description explicitly states that the FluoroMap System consists of the FluoroMap Software, the FluoroDisc, and the Closed Tube Clip, with the latter two being physical devices containing metal marker spheres. This indicates the system includes hardware components beyond just the software.
Based on the provided information, the FluoroMap system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- FluoroMap's Function: FluoroMap is a surgical planning and guidance system. It uses image processing of intra-operative X-ray images to assist surgeons in positioning orthopedic implants during surgery. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states that it is a "computer controlled stereotaxic image guided surgery system" that provides "static localization information derived from image processing of intra-operatively acquired X-ray images." This is a surgical assistance function, not an in vitro diagnostic function.
- Device Description: The description details the components (software, clips, disc) and how they work together to overlay virtual implants onto X-ray images for surgical guidance. There is no mention of analyzing biological samples.
In summary, FluoroMap is a surgical navigation and planning tool, not a device that performs tests on samples taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 X-ray images, by superposition of virtual implants and instruments onto those X-ray images.
Indications:
FluoroMap assists the surgeon to determine the needed size and position of orthopedic implants during proximal femur fracture surgery using the Stryker Gamma3 Nail system.
The system should be operated only by trained personnel such as surgeons and clinic staff.
Product codes (comma separated list FDA assigned to the subject device)
OLO, LLZ
Device Description
The FluoroMap System is designed as a computer assisted surgical planning device to assist the surgeon in proximal femur fracture surgery.
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.
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 spheres. It is attached to a standard C-arm, an intra-operative mobile 2D X-ray imaging device. The FluoroMap Software is a surgery planning system which recognizes the metal marker spheres of the FluoroDisc and the Close Tube Clip and performs a registration of the X-ray images to localize the position of the implant system, e.g. the Gamma3 Nail system. The FluoroMap Software overlays virtual implants and instruments onto the X-ray images and provides visual and numerical information to assist the surgeon in selecting the appropriate implant and to position it precisely.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel such as surgeons and clinic staff.
Surgical suite
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test Summary-New Device:
- Accuracy: 2 mm accuracy (maximal deviation between displayed and actual implant position). Accuracy target met with statistical significance in cadaveric test, saw bones tests and computer simulation.
- Usability: Meet all specified user needs, comply with usability standard IEC 62366:2007. In cadaveric test with simulated use case scenarios the specified user needs were validated and the system was usable in accordance with usability standards.
- Safety: Perform risk analysis, indentify risk mitigation measures and verify that the measures are effective, comply with risk management standard ISO 14971:2007. All safety measures are verified to be effective.
- Recognized Consensus Standards: Comply with the following sterility and biocompatibility standards: AAMI/ANSI/ISO 11737-1:2006, AAMI/ANSI/ISO 11737-2:2009, AAMI/ANSI/ISO 11607-1, AAMI/ANSI/ISO 11137-1:2006/(R) 2010, AAMI/ANSI/ISO 11137-2:2006, AAMI/ANSI/ISO 10993-1:2009, AAMI/ANSI/ISO 10993-5:2009, AAMI/ANSI/ISO 10993-10:2010, AAMI/ANSI/ISO 10993-18:2005. The Closed Tube Clip which has body contact and which is delivered sterile is tested to comply with all specified standards.
Comparative Performance Information Summary:
- Accuracy: New Device (FluoroMap) - All accuracy tests passed the 2 mm accuracy target with statistical significance. Predicate Device (The TenZing System, K102130) - was tested in pre-clinical and clinical trials proving that an accuracy of 2 mm is reached. For the VectorVision trauma system a similar accuracy is expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 2 mm accuracy (maximal deviation between displayed and actual implant position)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062358, K102130, K020677, K032244
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 | |
| TenZing System from Mazor Surgical Technologies Ltd., K102130 | ||
| Gamma3 Lag Screw from Stryker Trauma GmbH, K020677 | ||
| 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. | |
| 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. | ||
| 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 | ||
| spheres. It is attached to a standard C-arm, an intra-operative mobile 2D X- | ||
| ray imaging device. The FluoroMap Software is a surgery planning system | ||
| which recognizes the metal marker spheres of the FluoroDisc and the Close | ||
| Tube Clip and performs a registration of the X-ray images to localize the | ||
| position of the implant system, e.g. the Gamma3 Nail system. The | ||
| FluoroMap Software overlays virtual implants and instruments onto the X- | ||
| ray images and provides visual and numerical information to assist the | ||
| surgeon in selecting the appropriate implant and to position it precisely. | ||
| Intended use of the | ||
| device | FluoroMap is a computer controlled stereotaxic image guided surgery | |
| system. It provides static localization information derived from image | ||
| processing of intra-operatively acquired X-ray images, by superposition of | ||
| virtual implants and instruments onto those X-ray images. | ||
| Indications for use | FluoroMap assists the surgeon to determine the needed size and position | |
| of orthopedic implants during proximal femur fracture surgery using the | ||
| Stryker Gamma3 Nail system. | ||
| The system should be operated only by trained personnel such as | ||
| surgeons and clinic staff. | ||
| Summary of the technological characteristics of the device compared to the predicate device | ||
| 1 | ||
| Characteristic | Subject Device | |
| FluoroMap | Predicate device 1 | |
| VectorVision trauma, BrainLAB | ||
| AG, K062358 | ||
| Intended Use / | ||
| Indication for Use | ||
| Statement | 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 | ||
| X-ray images, by superposition of virtual | ||
| implants and instruments onto those X- | ||
| ray images. | ||
| Indications: | ||
| FluoroMap assists the surgeon to | ||
| determine the needed size and position | ||
| of orthopedic implants during proximal | ||
| femur fracture surgery using the Stryker | ||
| Gamma3 Nail system. | ||
| The system should be operated only by | ||
| trained personnel such as surgeons and | ||
| clinic staff. | BrainLAB VectorVision trauma is | |
| intended to be a pre- and intraoperative | ||
| image guided localization system to | ||
| enable minimally invasive surgery. It | ||
| links a freehand probe, tracked by a | ||
| passive marker sensor system to virtual | ||
| computer image space on a patient's | ||
| pre- or intraoperative image data being | ||
| processed by a VectorVision | ||
| workstation. The system is indicated for | ||
| any medical condition in which the use | ||
| of stereotactic surgery may be | ||
| appropriate and where a reference to a | ||
| rigid anatomical structure, such as the | ||
| skull, a bone structure like tubular | ||
| bones, pelvic, calcaneus and talus, or | ||
| vertebra, can be identified relative to a | ||
| CT, fluoroscopic, X-ray or MR based | ||
| model of the anatomy. | ||
| Intended Patient | ||
| Population | Patients undergoing orthopedic surgery | Patients undergoing orthopedic surgery |
| Surgical Approach | Orthopedic surgery, specifically at the | |
| proximal femur | Orthopedic surgery, specifically surgery | |
| at tubular bones, pelvic, calcaneus and | ||
| talus, or vertebra | ||
| Operational | ||
| Environment | Surgical suite | Surgical suite |
| Primary Device | ||
| Function | Assistance in planning and positioning of | |
| orthopedic implants using intra-operative | ||
| X-ray images | Assistance in planning and positioning | |
| of orthopedic implants using intra- | ||
| operative X-ray images | ||
| Main System | ||
| 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 | |
| simulated use scenarios using cadavers, | ||
| saw bones and computer simulation; | ||
| system accuracy of 2 mm | Unknown, expected to be similar | |
| accuracy tests with similar results | ||
| Conformance to | ||
| Recognized | ||
| Consensus | ||
| Standards | Compliance with standards in regard to | |
| risk management, usability, software, | ||
| sterilization, biocompatibility, packaging, | ||
| development process and quality | ||
| system, see section 1.11 | Unknown | |
| Body Contact and | ||
| Use | Reference device for instrumentation | |
| (Closed Tube Clip) has patient contact | Reference device for instruments and | |
| reference device for patient have body | ||
| contact | ||
| Sterile, Single-use | Reference device for instrumentation | |
| (Closed Tube Clip) is delivered sterile | ||
| and as a single use product | Parts of the reference device (infra-red | |
| reflectors) are delivered sterile and are | ||
| single use products | ||
| Summary of the technological characteristics of the device compared to the predicate device | ||
| 2 | ||
| Characteristic | Subject Device | |
| FluoroMap | Predicate device 2 | |
| TenZing System, Mazor, K102130 | ||
| Intended Use / | ||
| Indication for Use | ||
| Statement | 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 | ||
| X-ray images, by superposition of virtual | ||
| implants and instruments onto those X- | ||
| ray images. |
Indications:
FluoroMap assists the surgeon to
determine the needed size and position
of orthopedic implants during proximal
femur fracture surgery using the Stryker
Gamma3 Nail system.
The system should be operated only by
trained personnel such as surgeons and
clinic staff. | The TenZing System is a combination of
the SpineAssist system and C-InSight
System, allowing the C-InSight
application to run on the SpineAssist
Workstation: The SpineAssist System is
indicated for precise positioning of
surgical instruments or implants during
general spinal surgery. The SpineAssist
System may be used in either open or
percutaneous procedures.
The C-InSight software provides a
processing and conversion of 2D
fluoroscopic projections from standard
C-Arms into volumetric 3D image. It is
intended to be used whenever the
clinician and/or patient benefits from
generated 3D imaging of high contrast
objects particularly in orthopedic
applications. |
| Intended Patient
Population | Patients undergoing orthopedic surgery | Patients undergoing orthopedic surgery |
| Surgical Approach | Orthopedic surgery, specifically at the
proximal femur | Orthopedic surgery, specifically at the
spine |
| Intended Users | Surgeons and clinical staff | Surgeons and clinical staff |
| Operational
Environment | Surgical suite | Surgical suite |
| Primary Device
Function | Assistance in planning and positioning of
orthopedic implants using intra-operative
X-ray images | Assistance in planning and positioning
of orthopedic implants using intra-
operative X-ray images |
| Main System
Components | Software Reference device for C-arm Reference device for
instrumentation | Software Reference device for C-arm Reference system for patient Motorized guide |
| User Interface | Computer and monitor | Computer and monitor |
| Bench Testing | Accuracy testing of implant positioning in
simulated use scenarios using cadavers,
saw bones and computer simulation;
system accuracy of 2 mm | Unknown, expected to be similar
accuracy tests with similar results |
| Body Contact and
Use | Reference device for instrumentation,
Closed Tube Clip, has patient contact | Reference device for patient and
motorized guide have body contact |
| | Summary of the technological characteristics of the device compared to the predicate device | |
| 3 | | |
| Characteristic | Subject Device
FluoroMap | Predicate device 3
Gamma3 Lag Screw K020677 |
| Intended Use /
Indication for Use
Statement | 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
X-ray images, by superposition of virtual
implants and instruments onto those X-
ray images.
Indications:
FluoroMap assists the surgeon to
determine the needed size and position
of orthopedic implants during proximal
femur fracture surgery using the Stryker
Gamma3 Nail system.
The system should be operated only by
trained personnel such as surgeons and
clinic staff. | Indications for Use:
The Gamma 3 Lag Screw is intended to
be used with both the Long Length Dyax
Nail and the Trochanteric Dyax Nail.
Intended Use for the Long Length Dyax
Nail
The product is intended to be used in
fixation of femoral fractures occurring
from the base of the femoral neck
extending distally to a point
approximately 10 cm proximal to the
intracondylar notch. Fracture types
include basilar neck, intertrochanteric,
subtrochanteric fractures and femoral
shaft fractures. These femoral fractures
may occur as a result of trauma, non-
union, mal-union, pathological fractures,
and impending pathological fractures.
Intended Use for the Trochanteric Dyax
Nail:
The product is intended for use in
stabilizing various types of
intertrochanteric fractures of the femur. |
| Summary of the technological characteristics of the device compared to the predicate device
4 | | |
| Characteristic | Subject Device
FluoroMap | Predicate device 4
Gamma3 Trochanteric Nail
K032244 |
| Intended Use /
Indication for Use
Statement | 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
X-ray images, by superposition of virtual
implants and instruments onto those X-
ray images.
Indications:
FluoroMap assists the surgeon to
determine the needed size and position
of orthopedic implants during proximal
femur fracture surgery using the Stryker
Gamma3 Nail system.
The system should be operated only by
trained personnel such as surgeons and
clinic staff. | Indications for Use:
The Gamma 3 Lag Screw is intended to
be used with both the Long Length Dyax
Nail and the Trochanteric Dyax Nail.
Intended Use for the Long Length Dyax
Nail
The product is intended to be used in
fixation of femoral fractures occurring
from the base of the femoral neck
extending distally to a point
approximately 10 cm proximal to the
intracondylar notch. Fracture types
include basilar neck, intertrochanteric,
subtrochanteric fractures and femoral
shaft fractures. These femoral fractures
may occur as a result of trauma, non-
union, mal-union, pathological fractures,
and impending pathological fractures.
Intended Use for the Trochanteric Dyax
Nail:
The product is intended for use in
stabilizing various types of
intertrochanteric fractures of the femur. |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Accuracy | 2 mm accuracy (maximal deviation
between displayed and actual
implant position) | Accuracy target met with statistical
significance in cadaveric test, saw bones
tests and computer simulation |
| Usability | Meet all specified user needs,
comply with usability standard IEC
62366:2007 | In cadaveric test with simulated use case
scenarios the specified user needs were
validated and the system was usable in
accordance with usability standards |
| Safety | Perform risk analysis, indentify risk
mitigation measures and verify
that the measures are effective,
comply with risk management
standard ISO 14971:2007 | All safety measures are verified to be
effective |
| Recognized
Consensus Standards | Comply with the following sterility
and biocompatibility standards:
AAMI/ANSI/ISO 11737-1:2006. | The Closed Tube Clip which has body
contact and which is delivered sterile is |
| AAMI/ANSI/ISO 11737-2:2009,
AAMI/ANSI/ISO 11607-1, AAMI/
ANSI/ISO 11137-1:2006/(R) 2010,
AAMI/ANSI/ISO 11137-2:2006,
AAMI/ANSI/ISO 10993-1:2009,
AAMI/ANSI/ISO 10993-5:2009,
AAMI/ANSI/ISO 10993-10:2010.
AAMI/ANSI/ISO 10993-18:2005 | tested to comply with all specified standards | |
1
2
3
.
.
:
ﺗ
4
.
·
.
5
| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | New Device | Predicate Device |
| Accuracy | 2 mm (maximal | ||
| deviation between | |||
| displayed and | |||
| actual implant | |||
| position) | All accuracy tests | ||
| passed the 2 mm | |||
| accuracy target with | |||
| statistical significance | The TenZing System was tested in | ||
| pre-clinical and clinical trials | |||
| proving that an accuracy of 2 mm is | |||
| reached (see Attachment 3-B). | |||
| For the VectorVision trauma | |||
| system a similar accuracy is | |||
| expected. |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests have been conducted.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The performance tests demonstrate that an accuracy of 2 mm is reached in simulated clinical scenarios. The system fulfills all usability needs proven in simulated use case scenarios. All system safety measures are effective and all components pass safety testing.
All requirements of the stated standards are met. The intended use and technological characteristics of the FluoroMap System are similar to the predicate devices.
According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the FluoroMap System is substantially equivalent to the predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Stryker Corporation % Ms. Lilian Eckert Senior Regulatory Affairs Specialist Boetzinger Strasse 41 79111 Freiburg, Germany
MAR - 7 2811
Re: K103400
Trade/Device Name: FluoroMap Computer Assisted Surgery System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: February 11, 2011 Received: February 14, 2011
Dear Ms. Eckert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
7
Page 2 - Ms. Lilian Eckert
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A. B. R.
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
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Navigation
Indications for Use Statement
510(K) Number (if known):
Device Name: FluoroMap
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.
Indications:
FluoroMap assists the surgeon to determine the needed size and position of orthopedic implants during proximal femur fracture surgery using the Stryker Gamma3 Nail system.
The system should be operated only by trained personnel such as surgeons and clinic staff.
Prescription Use Over-The-Counter Use X - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ned R. Reber Sir Nixon
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103400