(241 days)
Not Found
No
The document describes a navigation system based on optical tracking and a computed anatomical model derived from an intra-operative survey. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as a "planning and intra-operative guidance system" for surgery, which assists the surgeon but does not directly treat a medical condition.
No
This device is described as a planning and intra-operative guidance system for surgery, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of both software and a platform including a computer, navigation camera, IO-Tablet, and monitor, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "planning and intra-operative guidance system to enable open or percutaneous image-guided surgery." This describes a system used during a surgical procedure to assist the surgeon, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a system that uses optical tracking to display the location of surgical instruments relative to a computed anatomical model of the patient's leg. This is a surgical navigation system, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
The device is a surgical navigation system designed to aid surgeons during knee procedures.
N/A
Intended Use / Indications for Use
The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV31 platform family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery.
The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.
The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Stryker OrthoMap Express Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surqical software application (software), which runs on a platform, consisting of a Stryker computer, a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.
The Stryker OrthoMap Express Knee 2.0 software is compatible with the NAV3i Platform Family. The NAV3i platform family is a family of platforms that. when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications:
- . Stryker NAV3 Platform (K141551)
- Stryker NAV3i Platform (K130874) ●
- Stryker NAVSuite3 Kit (K150301) ●
The platforms consist of the following components:
- Stryker computer
- Navigation camera ●
- IO-Tablet
- Monitor ●
- Mobile cart (if applicable) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint / leg (femur and tibia)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, open or percutaneous image-guided surgery
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)
The following performance data were provided in support of the substantial equivalence decision:
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Electrical safety and EMC testing were conducted on the subject device in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (FDA Rec# 19-4) and IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA Rec#19-1).
- Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "MAJOR" level of concern.
- Performance Testing - Bench: The following design verification activities have been performed to ensure the correct functionality of the system as it has been specified:
- ASTM accuracy testing verifying the accuracy performance of the localization and tracking technology using the standardized test procedure according to ASTM Standard F2554-10.
- System accuracy testing verifying the specified accuracy of ± 2 mm and ± 1° using a mechanical leq mimicking the patient's anatomy.
- Clinical workflow testing verifying that all system components (application, computer platform and accessories) are compatible. Complete total knee arthroplasty procedures are simulated using Sawbones mimicking the patient's anatomy.
- Functional testing to ensure that all functional requirements are fulfilled.
- Safety testing verifying the effectiveness of all risk controls determined in the device risk analysis and in the risk analyses of the platforms.
- Animal Study: No animal studies were performed to support substantial equivalence.
- Clinical Studies: No clinical studies were performed to support substantial equivalence.
Key results: All tests have been successfully completed. The system enables the determination of the mechanical axes of the leg as well as cut and component alignment with a mean translational error of
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2016
Stryker Corporate Ms. Becky Ditty Principal Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K153240
Trade/Device Name: Stryker OrthoMap Express Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 6, 2016 Received: June 7, 2016
Dear Ms. Ditty:
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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Stryker OrthoMap Express Knee system
Indications for Use (Describe)
The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV31 platform family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery.
The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.
The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5. 510(k) Summary
Section 5.1 Submitter
| Submitter: | Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany
Phone number: +49-761-4512117
Fax number: +49-761-451249117 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Becky Ditty
Principal Regulatory Affairs Specialist
4100 E. Milham Ave
Kalamazoo, MI 49001
becky.ditty@stryker.com
(269) 389-3434 |
| Date Prepared: | June 23, 2016 |
Section 5.2 Device
| Name of Device: | Stryker OrthoMap Express Knee system |
|---|---|
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification Name: | §882.4560 – Stereotaxic Instrument |
| Regulatory Class: | Class II |
| Product Code: | OLO - Orthopedic Stereotaxic Instrument |
Section 5.3 Predicate Devices
| Primary Predicate | |
|---|---|
| Name | Stryker Navigation System – Knee Module |
| 510(k) Number | K022579 |
| Description | The Knee Module is a part of the product series of the |
| Stryker Navigation System. The system comprises a knee | |
| joint kinematics analysis module based on a wireless | |
| optical tracking localization device for use in primary total | |
| knee arthroplasty. |
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| Additional Predicates | |
|---|---|
| Name | PROFESS System (Stryker Nav3/Adapt Platform) |
| 510(k) Number | K141551 |
| Description | The PROFESS™ System, consisting of a computer platform, software and sterile single-use accessories, is designed to enable image guided surgery in intranasal and sinus surgery. Specifically, the system tracks and displays to the surgeon the intraoperative location of Navigated Surgical Instruments, such as suction tools, relative to a CT image. This submission included the NAV3 Platform. |
| Name | Stryker NAV3i Platform |
| 510(k) Number | K130874 |
| Description | The Stryker Nav3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k). |
| Name | NavSuite3 Kit |
| 510(k) Number | K150301 |
| Description | The NavSuite®3 Kit is a minor modification of the previously cleared Stryker NAV3i Platform. The NavSuite3 Kit consists of the same components that were cleared in K130874 without the mobile cart so that they can be configured and affixed in the operation room suite based on user preferences. The NavSuite3 Kit platform is compatible with the following Stryker Software Application Modules: K131214 CranialMap Neuro Navigation (Including CranialMap Express) and K141941 SpineMap Navigation. |
Section 5.4 Device Description
The Stryker OrthoMap Express Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a
5
computed anatomical model of the patient's leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surqical software application (software), which runs on a platform, consisting of a Stryker computer, a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.
The Stryker OrthoMap Express Knee 2.0 software is compatible with the NAV3i Platform Family. The NAV3i platform family is a family of platforms that. when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications:
- . Stryker NAV3 Platform (K141551)
- Stryker NAV3i Platform (K130874) ●
- Stryker NAVSuite3 Kit (K150301) ●
The platforms consist of the following components:
- Stryker computer
- Navigation camera ●
- IO-Tablet
- Monitor ●
- Mobile cart (if applicable) ●
Section 5.5 Indications for Use
The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 software and a platform of the NAV3i Computer Platform Family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery.
The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
Contraindications:
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The surgeon has to determine whether the patient's conditions are appropriate for this kind of procedure or not. A pathological condition against the use of this system could be in some cases advanced osteoporosis or a dysplastic hip.
Section 5.6 Substantial Equivalence Rationale
The intended uses of the subject and predicate devices are similar. The systems are intended as planning and intraoperative guidance systems to enable open or percutaneous computer assisted surgery. Minor modifications were made to the indication for use statement to provide clarification, but do not change the meaning of the indication for use statement.
Both the subject device and the primary predicate device use the same main system components, use similar modes of operation, and use the same localization and tracking technology. Also, both systems use similar accessories (Smart Instruments, Patient Tracker Fixation, Navigated Manual Instruments and other accessories).
The technological characteristics of the subject and predicate device are equivalent. None of the changes alter the operating principle, the control mechanism, the localization and tracking technology, the main system components or the system accuracy performance. The workflow, user interaction, the software architecture and the software features are similar. As demonstrated by the performance testing described in Section 18, the subject device continues to meet the same accuracy specifications as the predicate device. Therefore the differences in technological characteristics to do not raise new questions of safety and effectiveness.
In conclusion, the OrthoMap Express Knee system can be found substantially equivalent to the Stryker Navigation System - Knee Module.
The device comparison table below provides a comparison of the technological characteristics of the subject device to the primary predicate device.
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Device Comparison Table
| | Subject Device
Stryker OrthoMap Express Knee
system | Predicate Device - K022579
Stryker Navigation System – Knee
Module | Equivalence Assessment |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Under review | K022579 | N/A |
| Clearance Date | Under review | 06/01/2003 | N/A |
| Device Name | Stryker OrthoMap Express Knee
system | Stryker Navigation System – Knee
System | N/A |
| Regulation
Number | §882.4560 - Stereotaxic Instrument | §882.4560 - Stereotaxic Instrument | Identical |
| Product Code | OLO - Orthopedic Stereotaxic
Instrument | HAW - Neurological Stereotaxic
Instrument
Subsequent Product Code:
OLO - Orthopedic Stereotaxic Instrument | Identical
Both devices fall within the Class II
Stereotaxic Instrument regulation.
OLO is the Product Code specific to
Orthopedic Stereotaxic Instruments
and is the most appropriate product
code for the subject device. |
| Product Class | II | II | Identical |
| Localization and
Tracking
technology | Infrared optical active sensing
technology: Infrared light emitted by
diodes placed in a known fashion on
navigated surgical instruments is
sensed by a camera array (navigation
camera) on the computer platform,
thus allowing for computation of the
spatial information. | Infrared optical active sensing technology:
Infrared light emitted by diodes placed in
a known fashion on navigated surgical
instruments is sensed by a camera array
(navigation camera) on the computer
platform, thus allowing for computation of
the spatial information. | Identical |
| | Subject Device
Stryker OrthoMap Express Knee
system | Predicate Device - K022579
Stryker Navigation System – Knee
Module | Equivalence Assessment |
| Main System
Components | 1. Platform
2. OrthoMap Express Knee 2.0
Software
3. Smart Instruments
4. Patient Tracker Fixation
5. Navigated Manual Instruments
6. Instrument Battery, Trays | 1. Platform
2. Knee Software
3. Smart Instruments
4. Patient Tracker Fixation
5. Navigated Manual Instruments
6. Instrument Battery, Trays | Similar |
| Compatible
Platforms | NAV3i Computer Platform Family:
• Stryker NAV3 Platform (SPC-3.1)
• Stryker NAV3i Platform (SPC-3.1)
• Stryker NAVSuite3 Kit (SPC-3.1) | • Cart I | Similar |
| Registration and
Navigation Work
Flow | • Patient Preparation
• System Setup
• Patient Registration (femur)
• Navigation (femur)
• Patient Registration (tibia)
• Navigation (tibia) | • Patient Preparation
• System Setup
• Patient Registration (femur and tibia)
• Navigation (femur and tibia) | Similar |
| System Accuracy | • The system enables the
determination of the mechanical
axes of the leg as well as cut and
component alignment with a mean
translational error of