(68 days)
Not Found
No
The description focuses on image guidance, 3D tracking, and displaying positional information based on user-identified landmarks and digitized points. There is no mention of AI, ML, or any learning algorithms used for analysis, interpretation, or decision support beyond basic positional calculations and display.
No.
The device is a computer-controlled image-guidance system intended to assist surgeons in precisely positioning hip femoral resurfacing components intra-operatively. It does not directly treat or cure a disease or condition, but rather aids in a surgical procedure.
No
This device is an image-guidance system designed to assist surgeons in precisely positioning partial hip resurfacing components during surgery. It does not perform diagnostic functions such as identifying or characterizing a disease or condition.
No
The device description explicitly states that the system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, indicating it is a hardware and software system, not software-only.
Based on the provided information, the Navitrack® System - Partial Hip Resurfacing Universal is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Navitrack System Function: The Navitrack System is a surgical guidance system used during surgery to assist the surgeon in positioning components within the patient's body. It uses tracking and imaging technology to provide real-time positional information.
- No Sample Analysis: The system does not analyze any samples taken from the patient's body. Its function is entirely focused on guiding the surgical procedure based on anatomical landmarks and instrument positions.
Therefore, the Navitrack® System falls under the category of a surgical instrument or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Navitrack® System - Partial Hip Resurfacing Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Product codes
HAW
Device Description
The Navitrack® System – Partial Hip Resurfacing Universal system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of partial hip resurfacing components. Tracking devices are incorporated onto given surgical instruments and onto fixation bases attached to the femur by which the system tracks their relative locations and displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components. The instruments that are tracked include a drill guide to help position the implant's system guide wire or pin that sets the central axis for the implants. The femoral reference geometries relative to which the guide wire location is to be positioned include representations of the femoral head and neck surfaces as rendered by clouds of points that are digitized by the user using the system. In addition, the system also allows for specific implant models as obtained from the implant manufacturers to also be included in the system. In this mode, the system also displays the implant models relative to the bony geometries corresponding to the placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use, equivalently as in the Navitrack® predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 9 2007
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS NAVITRACK® SYSTEM - PARTIAL HIP RESURFACING UNIVERSAL
KO71929
Applicant: ORTHOsoft Inc. 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel.: 514 861 4074 Fax: 514 866 2197
Contact Person: Christopher McLean
Date Summary Prepared: July 12, 2007
Device Trade Name: Navitrack System - Partial Hip Resurfacing Universal
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560
Predicate Devices:
-
- Vectorvision Hip SR; from Brainlab, AG; 510(k) # K063028
-
- Navitrack System -- Total Hip Replacement CT-Free; from Orthosoft Inc.; 510(k) # K032917
-
- Navitrack® System -- OS Knee Universal; from Orthosoft Inc; 510(k) # K060336
Device Description:
The Navitrack® System – Partial Hip Resurfacing Universal system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of partial hip resurfacing components.
Tracking devices are incorporated onto given surgical instruments and onto fixation bases attached to the femur by which the system tracks their relative locations and displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components.
The instruments that are tracked include a drill guide to help position the implant's system guide wire or pin that sets the central axis for the implants. The femoral reference geometries relative to which the guide wire location is to be positioned include representations of the femoral head and neck surfaces as rendered by clouds of points that are digitized by the user using the system.
In addition, the system also allows for specific implant models as obtained from the implant manufacturers to also be included in the system. In this mode, the system also displays the implant models relative to the bony geometries corresponding to the placement.
1
Indications for Use / Intended Use:
The Navitrack® System - Partial Hip Resurfacing Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Technological Comparisons to the Predicates:
The fundamental scientific technology of the predicates is unchanged. The main operating principle and control mechanism are maintained in the proposed device to similarly provide image guidance assistance in the placement of orthopedic implants.
Secondary software and instrument engineering changes were incorporated to the Navitrack® THR CT-Free and OS Knee Universal predicates for the design of the proposed system according to the requirements for the placement of partial hip resurfacing components as compared to the total hip and total knee components of the predicates. The computer system and the tracking system were unchanged.
The proposed system was also compared to the Vectorvision Hip SR from Brainlab as a predicate and was found to have the same general intended use and indication for use, and utilizes the same main technology.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use, equivalently as in the Navitrack® predicates.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the Navitrack System - Partial Hip Resurfacing Universal device is substantially equivalent to the predicates.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, rendered in black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, also in black. The overall design is simple and conveys a sense of authority and national identity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthosoft, Inc. % Christopher McLean, Eng. Regulatory Affairs & Quality Management Director 75, Queen Street, Suite 3300 Montréal, Quebec Canada H3C 2N6
SEP 1 9 2007
Re: K071929
Trade/Device Name: Navitrack® Partial Hip Resurfacing - Universal Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 12, 2007 Received: July 13, 2007
Dear Mr. McLean:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements as set
3
Page 2 - Christopher McLean, Eng.
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pari 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark H. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: |(07 |929
Device Name: Navitrack® Partial Hip Resurfacing - Universal
Indications for Use:
The Navitrack® Partial Hip Resurfacing - Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components.
It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Prescription Use (per 21CFR 801.109)
OR
Over-the-Counter Use
Concurrence of DRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
K07 1929
510(k) Number