(102 days)
Not Found
No
The description focuses on passive marker tracking, 3D visualization, and navigation based on pre-operative imaging (CT/MR) and intraoperative landmark acquisition. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device aids the surgeon in precise navigation and planning during orthopaedic knee surgery, but it does not directly treat or restore function to a diseased or damaged body part.
No
Explanation: The device is described as a surgical navigation system that assists surgeons with precise bone cuts and accurate implant positioning during orthopedic knee reconstructive procedures. It uses a virtual 3D computer image and tracks instruments, but its primary function is to guide surgical intervention, not to diagnose medical conditions or diseases.
No
The device description explicitly mentions "computer hardware and software" and "instruments and hardware/software," indicating the system includes both hardware and software components, not just 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 intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states that this device is an instrument system used during surgical procedures to track instruments and navigate bone cuts and implant placement based on imaging data (CT or MR). It interacts directly with the patient's anatomy during surgery, not with specimens in vitro.
- Intended Use: The intended use is for "orthopaedic surgical intervention" and "minimally invasive orthopaedic knee reconstructive procedures." This is a surgical navigation system, not a diagnostic test performed on samples outside the body.
Therefore, this device falls under the category of surgical navigation systems or computer-assisted surgery devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Instruments are tracked by a passive marker sensor system that acquires instruments are tracked by a passere interfaced with computer hardware and landmants on the bone camargeon to accurately navigate the position of sollware. This enables a surgeon to usearch mage for precise bone cuts Instrumentation by a virtual o D comparentive knee reconstructive procedures. The duning minimally invasive intrasperation in which the use of stereotaxic surgery system is mulcated for any moulour somalism in a rigid anatomical structure, such as a a may be appropriate, and where reference to a rigid anatomical structure and may may be approphate, and where reative to a CT or MR based model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- •Total Knee Replacement
- •Unicondylar Knee Replacement
- ·Ligament Balancing
- ·Range of Motion Analysis
- ·Cruciate Ligament Surgery
- ·Patella Tracking
Product codes
HAW
Device Description
DePuy CAS Knee Instruments are computer recognized by application specific Ci TKR/UKR, VectorVision CT-Free Knee and VectorVision Knee hardware/software owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery. BrainLAB designed the Ci System exclusive to DePuy specific instrument/implant data tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and tibial cutting guides and implants for the most accurate position.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Not Found
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
MAR 3 - 2035
KO43223 SUMMARY OF SAFETY AND EFFECTIVENESS
| Name of Firm: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|----------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randa Franklin
Sr. Regulatory Specialist |
| Trade Name: | DePuy CAS Knee Instrumentation |
| Common Name: | Computer Assisted Surgery (CAS) Knee
Instrumentation |
| Regulatory Classification: | 882.4560; Stereotaxic Instrument; Class II |
| Device Product Code: | HAW |
| Substantially Equivalent Device: | K021306
• K021306 VectorVision CT-Free Knee |
| | •K031337 Acumen Surgical Navigation
System |
| | • K033011 Zimmer Ortho Guidance System
Knee Instruments |
Device Description and Intended Use:
DePuy CAS Knee Instruments are computer recognized by application specific Ci TKR/UKR, VectorVision CT-Free Knee and VectorVision Knee hardware/software owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery. BrainLAB designed the Ci System exclusive to DePuy specific instrument/implant data tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and tibial cutting guides and implants for the most accurate position.
Basis of Substantial Equivalence:
Computer Assisted Surgical Knee Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments that are tracked through infrared tracking passive markers imposed onto computer images.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in bold black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/1/Picture/2 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 design featuring three horizontal lines that curve and converge, resembling an abstract representation of the human form.
MAR 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Randa Franklin Senior Regulatory Specialist DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K043223
R043E25
Trade/Device Name: DePuy CAS Knee Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 4, 2005 Reccived: February 7, 2005
Dear Ms. Franklin:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premaince insubstantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced anove and nave determined the acres to the devices marketed in interstate for use stated in the enclosure) to regally mancede profits in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food. Dr commerce prior to May 28, 1970, the enactinent and economisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of any instit devices that have been reciassified in accordance with the previously of the Act (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . This and Cosment Act (Act) that do not require approvate as a seperal controls provisions of the Act. The You may, inerelore, market the devices, belyer to the g
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Feet merator required in the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (sec above) no existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EUA may be subject to such additional controller antiblions, Title 21, Parts 800 to 898. In addition. FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to be found in the Code of Peachar Inneerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not member Please be advised that FDA s issuance of a backanna.
that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a determination that your and your Federal agencies. You must of any Federal statutes and regulations annuality, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moraans, and managements as setting the counter CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Randa Franklin
This letter will allow you to begin marketing your device as described in your Section 5 [0(k) I his letter will anow you to begin manceing your are of your dever to a legally premarket nother in the PDA midning of backence of the since 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 for your do not our car .. Also, please note the regulation entitled, Contact the Office of Complance at (210) = i & a = = = = 807.97). You may obtain "Misbranding by reference to premailer nothlied.com the Division of Small .
other general information on your responsibilities under the Act from the 2000 . (200) . (200) other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Malluracturers, Internet and Octisa http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
3
Image /page/3/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle on the left, followed by the word "DePuy" in a bold, sans-serif font. A horizontal line is present under the word "DePuy". Below the line, the words "a Johnson & Johnson company" are written in a smaller, serif font.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: DePuy CAS Knee Instruments
Indications for Use:
Instruments are tracked by a passive marker sensor system that acquires instruments are tracked by a passere interfaced with computer hardware and landmants on the bone camargeon to accurately navigate the position of sollware. This enables a surgeon to usearch mage for precise bone cuts Instrumentation by a virtual o D comparentive knee reconstructive procedures. The duning minimally invasive intrasperation in which the use of stereotaxic surgery system is mulcated for any moulour somalism in a rigid anatomical structure, such as a a
may be appropriate, and where reference to a rigid anatomical structure and may may be approphate, and where reative to a CT or MR based model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- •Total Knee Replacement
- •Unicondylar Knee Replacement
- ·Ligament Balancing
- ·Range of Motion Analysis
- ·Cruciate Ligament Surgery
- ·Patella Tracking
![An angle]
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Winning (Division Sign-Off
l of of lo Page __
Division of General Restorative. and Neurological Devices
0000006
510(k) Number K043223