(108 days)
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 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.
Here's a breakdown of the acceptance criteria and the study information for the FluoroMap Computer Assisted Surgery System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Characteristic) | Target (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Accuracy | 2 mm (maximal deviation between displayed and actual implant position) | Accuracy target met with statistical significance in cadaveric test, saw bone 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, identify 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 specific 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 (patient contact, sterile) tested to comply with all specified standards |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "cadaveric test," "saw bones and computer simulation" for accuracy testing, and "cadaveric test with simulated use case scenarios" for usability.
- Sample Size: The exact number of cadavers or saw bones used is not specified. The number of computer simulations is also not specified.
- Data Provenance: The data is described as non-clinical performance tests using simulated use scenarios. The country of origin of the data is not explicitly stated, but the submitter is based in Germany. The tests were retrospective in the sense that they were conducted for the purpose of the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. For usability, it notes "simulated use case scenarios" and compliance with usability standards, implying evaluation by users, but specific details about these users (e.g., surgeons, clinic staff) and their role in establishing ground truth are not provided. For accuracy, the "actual implant position" would serve as the ground truth, but how this "actual" position was precisely measured and verified by experts is not detailed.
4. Adjudication Method for the Test Set
The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document explicitly states: "No clinical tests have been conducted."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The accuracy and usability tests described appear to be for the overall FluoroMap System, which is a "computer assisted surgical planning device to assist the surgeon." While the "Accuracy" testing would involve the algorithm's performance in localizing implants, the "Usability" testing inherently involves a human user's interaction with the system. Therefore, a purely standalone algorithm-only performance without any human interaction is not explicitly detailed as a separate study. The accuracy results likely reflect the system's ability to localize, but within the context of assisting a user.
7. Type of Ground Truth Used
- Accuracy: The ground truth for accuracy was the "actual implant position" in cadaveric tests, saw bones, and computer simulations. The method for determining this "actual" position is not elaborated beyond its use as a reference for deviation from the displayed position.
- Usability: Ground truth for usability would be derived from subjective assessments against specified user needs and compliance with usability standards during simulated use.
- Safety: Ground truth for safety is established through risk analysis and verification of mitigation measures.
- Standards Compliance: Compliance with recognized consensus standards serves as the ground truth for those categories.
8. Sample Size for the Training Set
The document does not specify a training set sample size. The performance tests described are for verification and validation of the device, not for training an AI model. Given the submission date (2011), the AI/machine learning paradigms prevalent today for deep learning models that require large training sets might not have been applied in the same way, or the "image processing" might be based on more traditional algorithms.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is not provided.
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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, K062358TenZing System from Mazor Surgical Technologies Ltd., K102130Gamma3 Lag Screw from Stryker Trauma GmbH, K020677Gamma3 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 markerspheres. It is attached to a standard C-arm, an intra-operative mobile 2D X-ray imaging device. The FluoroMap Software is a surgery planning systemwhich recognizes the metal marker spheres of the FluoroDisc and the CloseTube Clip and performs a registration of the X-ray images to localize theposition of the implant system, e.g. the Gamma3 Nail system. TheFluoroMap Software overlays virtual implants and instruments onto the X-ray images and provides visual and numerical information to assist thesurgeon in selecting the appropriate implant and to position it precisely. | ||
| Intended use of thedevice | FluoroMap is a computer controlled stereotaxic image guided surgerysystem. It provides static localization information derived from imageprocessing of intra-operatively acquired X-ray images, by superposition ofvirtual implants and instruments onto those X-ray images. | |
| Indications for use | FluoroMap assists the surgeon to determine the needed size and positionof orthopedic implants during proximal femur fracture surgery using theStryker Gamma3 Nail system.The system should be operated only by trained personnel such assurgeons and clinic staff. | |
| Summary of the technological characteristics of the device compared to the predicate device1 | ||
| Characteristic | Subject DeviceFluoroMap | Predicate device 1VectorVision trauma, BrainLABAG, K062358 |
| Intended Use /Indication for UseStatement | Intended Use:FluoroMap is a computer controlledstereotaxic image guided surgerysystem. It provides static localizationinformation derived from imageprocessing of intra-operatively acquiredX-ray images, by superposition of virtualimplants and instruments onto those X-ray images.Indications:FluoroMap assists the surgeon todetermine the needed size and positionof orthopedic implants during proximalfemur fracture surgery using the StrykerGamma3 Nail system.The system should be operated only bytrained personnel such as surgeons andclinic staff. | BrainLAB VectorVision trauma isintended to be a pre- and intraoperativeimage guided localization system toenable minimally invasive surgery. Itlinks a freehand probe, tracked by apassive marker sensor system to virtualcomputer image space on a patient'spre- or intraoperative image data beingprocessed by a VectorVisionworkstation. The system is indicated forany medical condition in which the useof stereotactic surgery may beappropriate and where a reference to arigid anatomical structure, such as theskull, a bone structure like tubularbones, pelvic, calcaneus and talus, orvertebra, can be identified relative to aCT, fluoroscopic, X-ray or MR basedmodel of the anatomy. |
| Intended PatientPopulation | Patients undergoing orthopedic surgery | Patients undergoing orthopedic surgery |
| Surgical Approach | Orthopedic surgery, specifically at theproximal femur | Orthopedic surgery, specifically surgeryat tubular bones, pelvic, calcaneus andtalus, or vertebra |
| OperationalEnvironment | Surgical suite | Surgical suite |
| Primary DeviceFunction | Assistance in planning and positioning oforthopedic implants using intra-operativeX-ray images | Assistance in planning and positioningof orthopedic implants using intra-operative X-ray images |
| Main SystemComponents | 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 insimulated use scenarios using cadavers,saw bones and computer simulation;system accuracy of 2 mm | Unknown, expected to be similaraccuracy tests with similar results |
| Conformance toRecognizedConsensusStandards | Compliance with standards in regard torisk management, usability, software,sterilization, biocompatibility, packaging,development process and qualitysystem, see section 1.11 | Unknown |
| Body Contact andUse | Reference device for instrumentation(Closed Tube Clip) has patient contact | Reference device for instruments andreference device for patient have bodycontact |
| Sterile, Single-use | Reference device for instrumentation(Closed Tube Clip) is delivered sterileand as a single use product | Parts of the reference device (infra-redreflectors) are delivered sterile and aresingle use products |
| Summary of the technological characteristics of the device compared to the predicate device2 | ||
| Characteristic | Subject DeviceFluoroMap | Predicate device 2TenZing System, Mazor, K102130 |
| Intended Use /Indication for UseStatement | Intended Use:FluoroMap is a computer controlledstereotaxic image guided surgerysystem. It provides static localizationinformation derived from imageprocessing of intra-operatively acquiredX-ray images, by superposition of virtualimplants and instruments onto those X-ray images.Indications:FluoroMap assists the surgeon todetermine the needed size and positionof orthopedic implants during proximalfemur fracture surgery using the StrykerGamma3 Nail system.The system should be operated only bytrained personnel such as surgeons andclinic staff. | The TenZing System is a combination ofthe SpineAssist system and C-InSightSystem, allowing the C-InSightapplication to run on the SpineAssistWorkstation: The SpineAssist System isindicated for precise positioning ofsurgical instruments or implants duringgeneral spinal surgery. The SpineAssistSystem may be used in either open orpercutaneous procedures.The C-InSight software provides aprocessing and conversion of 2Dfluoroscopic projections from standardC-Arms into volumetric 3D image. It isintended to be used whenever theclinician and/or patient benefits fromgenerated 3D imaging of high contrastobjects particularly in orthopedicapplications. |
| Intended PatientPopulation | Patients undergoing orthopedic surgery | Patients undergoing orthopedic surgery |
| Surgical Approach | Orthopedic surgery, specifically at theproximal femur | Orthopedic surgery, specifically at thespine |
| Intended Users | Surgeons and clinical staff | Surgeons and clinical staff |
| OperationalEnvironment | Surgical suite | Surgical suite |
| Primary DeviceFunction | Assistance in planning and positioning oforthopedic implants using intra-operativeX-ray images | Assistance in planning and positioningof orthopedic implants using intra-operative X-ray images |
| Main SystemComponents | Software Reference device for C-arm Reference device forinstrumentation | 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 insimulated use scenarios using cadavers,saw bones and computer simulation;system accuracy of 2 mm | Unknown, expected to be similaraccuracy tests with similar results |
| Body Contact andUse | Reference device for instrumentation,Closed Tube Clip, has patient contact | Reference device for patient andmotorized guide have body contact |
| Summary of the technological characteristics of the device compared to the predicate device | ||
| 3 | ||
| Characteristic | Subject DeviceFluoroMap | Predicate device 3Gamma3 Lag Screw K020677 |
| Intended Use /Indication for UseStatement | Intended Use:FluoroMap is a computer controlledstereotaxic image guided surgerysystem. It provides static localizationinformation derived from imageprocessing of intra-operatively acquiredX-ray images, by superposition of virtualimplants and instruments onto those X-ray images.Indications:FluoroMap assists the surgeon todetermine the needed size and positionof orthopedic implants during proximalfemur fracture surgery using the StrykerGamma3 Nail system.The system should be operated only bytrained personnel such as surgeons andclinic staff. | Indications for Use:The Gamma 3 Lag Screw is intended tobe used with both the Long Length DyaxNail and the Trochanteric Dyax Nail.Intended Use for the Long Length DyaxNailThe product is intended to be used infixation of femoral fractures occurringfrom the base of the femoral neckextending distally to a pointapproximately 10 cm proximal to theintracondylar notch. Fracture typesinclude basilar neck, intertrochanteric,subtrochanteric fractures and femoralshaft fractures. These femoral fracturesmay occur as a result of trauma, non-union, mal-union, pathological fractures,and impending pathological fractures.Intended Use for the Trochanteric DyaxNail:The product is intended for use instabilizing various types ofintertrochanteric fractures of the femur. |
| Summary of the technological characteristics of the device compared to the predicate device4 | ||
| Characteristic | Subject DeviceFluoroMap | Predicate device 4Gamma3 Trochanteric NailK032244 |
| Intended Use /Indication for UseStatement | Intended Use:FluoroMap is a computer controlledstereotaxic image guided surgerysystem. It provides static localizationinformation derived from imageprocessing of intra-operatively acquiredX-ray images, by superposition of virtualimplants and instruments onto those X-ray images.Indications:FluoroMap assists the surgeon todetermine the needed size and positionof orthopedic implants during proximalfemur fracture surgery using the StrykerGamma3 Nail system.The system should be operated only bytrained personnel such as surgeons andclinic staff. | Indications for Use:The Gamma 3 Lag Screw is intended tobe used with both the Long Length DyaxNail and the Trochanteric Dyax Nail.Intended Use for the Long Length DyaxNailThe product is intended to be used infixation of femoral fractures occurringfrom the base of the femoral neckextending distally to a pointapproximately 10 cm proximal to theintracondylar notch. Fracture typesinclude basilar neck, intertrochanteric,subtrochanteric fractures and femoralshaft fractures. These femoral fracturesmay occur as a result of trauma, non-union, mal-union, pathological fractures,and impending pathological fractures.Intended Use for the Trochanteric DyaxNail:The product is intended for use instabilizing various types ofintertrochanteric fractures of the femur. |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Accuracy | 2 mm accuracy (maximal deviationbetween displayed and actualimplant position) | Accuracy target met with statisticalsignificance in cadaveric test, saw bonestests and computer simulation |
| Usability | Meet all specified user needs,comply with usability standard IEC62366:2007 | In cadaveric test with simulated use casescenarios the specified user needs werevalidated and the system was usable inaccordance with usability standards |
| Safety | Perform risk analysis, indentify riskmitigation measures and verifythat the measures are effective,comply with risk managementstandard ISO 14971:2007 | All safety measures are verified to beeffective |
| RecognizedConsensus Standards | Comply with the following sterilityand biocompatibility standards:AAMI/ANSI/ISO 11737-1:2006. | The Closed Tube Clip which has bodycontact 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 |
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| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | New Device | Predicate Device |
| Accuracy | 2 mm (maximaldeviation betweendisplayed andactual implantposition) | All accuracy testspassed the 2 mmaccuracy target withstatistical significance | The TenZing System was tested inpre-clinical and clinical trialsproving that an accuracy of 2 mm isreached (see Attachment 3-B).For the VectorVision traumasystem a similar accuracy isexpected. |
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.
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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
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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
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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
§ 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).