(115 days)
K-021306, K-041899, K-031770
CAS Knee Instrumentation (K-043223)
No
The summary describes a traditional image-guided surgical navigation system based on landmark registration and 3D modeling, without mentioning AI or ML technologies.
No
The device is an image-guided localization and navigation system used during orthopedic surgery to aid the surgeon, rather than directly providing therapy.
No
The device is an intraoperative image-guided localization and navigation system for minimally invasive surgery, not a diagnostic device. It aids surgeons in performing procedures like knee replacement by providing navigation and measurements, rather than identifying or diagnosing medical conditions.
No
The device description explicitly states that "Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery." This indicates the device includes hardware components in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Ci TKR/UKR system is an intraoperative image-guided localization system. Its purpose is to assist the surgeon during surgery by providing navigation and guidance based on anatomical landmarks and a 3D model of the patient's bone. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "intraoperative image guided localization to enable minimally invasive surgery" and "aids the surgeon to accurately navigate a knee prosthesis". This is a surgical guidance tool, not a diagnostic test performed on a sample.
The system uses imaging modalities (CT, X-ray, MR) and anatomical information, but it uses this information for surgical planning and navigation during the procedure, not for diagnosing a condition from a biological sample.
N/A
Intended Use / Indications for Use
Ci TKR/UKR is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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 long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.
Example orthopedic surgical procedures include but are not limited to:
Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Product codes
HAW
Device Description
Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.
Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.
The CAS Knee Instrumenation (K-043223) developed and manufactured by DePuy is integrated in the Ci TKR/UKR software. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, MR based model of the anatomy
Anatomical Site
rigid anatomical structure, such as the skull, a long bone, or vertebra (for the general system indication). Specifically the knee for orthopedic procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative
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)
Ci TKR/UKR has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VectorVision® CT-free knee (K-021306), VectorVision® Uni-Knee (K-041899), Ci TKR/UKR (K-031770)
Reference Device(s)
CAS Knee Instrumentation (K-043223)
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
FEB 1 3 2006
510 {k} Summary of Safety and Effectiveness for Ci TKR/UKR
Manufacturer:
| Address: | BrainLAB AG |
|---|---|
| Ammerthalstrasse 8 | |
| 85551 Heimstetten | |
| Germany | |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 33 | |
| Contact Person: | Mr. Per Persson |
October 7, 2005
Device Name:
Summary Date:
Trade name: Ci™ Knee, Ci™ MI TKR Common/Classification Name: Ci TKR/UKR, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Devices: VectorVision® CT-free knee (K-021306) VectorVision® Uni-Knee (K-041899) Ci TKR/UKR (K-031770)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
Intended Use:
Ci TKR/UKR is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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 long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.
1
Example orthopedic surgical procedures include but are not limited to:
Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Device Description:
Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.
Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.
The CAS Knee Instrumenation (K-043223) developed and manufactured by DePuy is integrated in the Ci TKR/UKR software. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery.
Substantial equivalence:
Ci TKR/UKR has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (k) application includes the CAS Knee Instrumentation (K-043223), developed and manufactured by DePuy and was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K-021306), VectorVision® Uni-Knee (K-041899) and of Ci TKR/UKR (K-031770).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2006
Mr. Per Persson Manager, Regulatory Affairs BrainLAB AG Ammerthalstrasse 8 85551 Hiemstetten GERMANY
Re: K052966
Trade/Device Name: Ci TKR/UKR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 19, 2006 Received: January 19, 2006
Dear Mr. Persson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the Merror a 976, the enactment date of the Medical Device Amendments, or 10 conniner be prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmotion For (110) that the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controll profice, 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 it may be subject to basil 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 r tease of actived a determination that your device complies with other requrements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I 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 CI N Fart 007); adoling (21 (2) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Persson
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to begin manieting your antial equivalence of your device to a legally prematication. "The PDF Imaning of Colline of 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 If you desire specific advice its 700.700. 276-0115. Also, please note the regulation entitled, Comact the Office of Compulation and (21 CFR Part 807.97). You may obtain Misolalling by Icrerchee to premanterialities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octiber : http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Mehm
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K0559966
Device Name: Ci TKR/UKR
Indications For Use:
Ci TKR/UKR is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereo tactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K052966 |