(64 days)
K 021306, K014256
K 021306, K014256
No
The description focuses on image-guided navigation, landmark registration, and 3D reconstruction based on acquired landmarks and pre-existing models, without mentioning AI or ML techniques for analysis, prediction, or decision support beyond standard image processing and spatial tracking.
No.
The device is a surgical navigation system that aids in patient-specific planning and accuracy during orthopedic surgery, rather than directly treating a medical condition itself.
No
The device is described as an image-guided localization system that aids surgeons in navigating during minimally invasive orthopedic surgery, not to diagnose a condition.
No
The device description explicitly mentions linking a freehand probe and flexible passive markers, which are hardware components used for tracking and navigation. The system relies on these physical 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Ci TKR/UKR system is an intraoperative image-guided localization system. Its purpose is to assist surgeons during surgery by providing navigation and guidance based on anatomical landmarks and pre-operative imaging. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "intraoperative image guided localization" and "aids the surgeon to accurately navigate a knee prosthesis." This is a surgical guidance tool, not a diagnostic test performed on a sample.
Therefore, the Ci TKR/UKR system falls under the category of surgical navigation or image-guided surgery systems, not In Vitro Diagnostics.
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 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
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.
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
Knee, skull, a long bone, or vertebra
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)
The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K 021306) and of the Kolibri IGS System (K014256).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 021306, K014256
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
K03/170
AUG 1 2 2003
510 (k) Summary of Safety and Effectiveness for Ci TKR/UKR (Kolibri Knee)
| Manufacturer: | BrainLAB AG | |
|---|---|---|
| Address: | Ammerthalstrasse 8 | |
| 85551 Heimstetten | ||
| Germany | ||
| Phone: +49 89 99 15 68 0 | ||
| Fax: +49 89 99 15 68 33 | ||
| Contact Person: | Mr. Rainer Birkenbach | |
| Summary Date: | June 2, 2003 | |
| Device Name: | ||
| Trade name: | Ci TKR/UKR | |
| Common/Classification Name: | Ci TKR/UKR (Kolibri Knee), BrainLAB Image Guided Surgery System / | |
| Instrument, Stereotaxic |
Predicate Devices:
BrainLAB Vector Vision® CT-free knee (K 021306)
BrainLAB Kolibri™ Image Guided Surgery System (K014256)
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 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.
1
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
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.
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 information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K 021306) and of the Kolibri IGS System (K014256).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K031770
Trade/Device Name: Ci TKR/ÜKR (Kolibri Knee) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 2, 2003 Received: June 9, 2003
Dear Mr. Birkenbach :
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 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.
3
Page 2 - Mr. Rainer Birkenbach
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Wily Witt
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
Ci TKR/UKR (Kolibri Knee)
Ko31770
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Wla Witt
(Division Sign-Off)
510(k) Number K03177