(783 days)
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No
The document does not mention AI, ML, deep learning, or any related terms. The description focuses on traditional navigation system components and functionalities.
No
The device aids the surgeon in locating anatomical structures and aligning endoprostheses, which is a supportive rather than a therapeutic function.
No
The device is a surgical navigation system intended to aid surgeons in locating anatomical structures and aligning endoprostheses during surgery, not to diagnose diseases or conditions.
No
The device description explicitly lists hardware components like the "Surgetics Station, consisting of a mobile computer system and an optical localizer" and "Ancillary instruments and reflective markers," in addition to the software.
Based on the provided information, the Surgetics ORTHO KNEELOGICS Navigation System 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Surgetics ORTHO KNEELOGICS Navigation System is used during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses. This is an in vivo (within the living body) application, not an in vitro (outside the living body) test.
- Intended Use: The intended use is for assisting surgeons during specific surgical procedures (ACL surgery, Total Knee Arthroplasty, UniKnee Arthroplasty). This is a surgical navigation system, not a diagnostic test performed on a sample.
- Device Components: The components listed (computer system, optical localizer, instruments, markers, software) are consistent with a surgical navigation system, not an IVD.
Therefore, the Surgetics ORTHO KNEELOGICS Navigation System falls under the category of a surgical device or navigation system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
- Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of . potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant .
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant .
Product codes
HAW
Device Description
The Surgetics ORTHO KNEELOGICS Navigation System (ORTHO The KNEELOGICS) consists of the following major components and subsystems:
- . The Surgetics Station, consisting of a mobile computer system and an optical localizer
- Ancillary instruments and reflective markers used for reference and . registration
- . ORTHO KNEELOGICS Navigation applications software
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Surgetics ORTHO KNEELOGICS Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and specimen bench testing and results of a clinical study were provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BrainLab Vector Vision CT-Free (K021306), OrthoSoft Navitrack System-Optical TKR CT-Less (K021760)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JUN 7 - 2005
K 03//96
510(k) Summary
for
Surgetics ORTHO KNEELOGICS Navigation System
Submitter Name and Address 1.
- Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Stéphane Lavallée 33-4 76 54 95 03 Telephone:
Date Prepared: April 28, 2005
Device Name 2.
Surgetics ORTHO KNEELOGICS Navigation System Proprietary Name: Common/Usual Name: Image guided surgical navigation system Computed tomography x-ray system (accessory) Classification Name:
3. Predicate Device
BrainLab Vector Vision CT-Free (K021306) OrthoSoft Navitrack System-Optical TKR CT-Less (K021760)
4. Intended Use
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
- Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of . potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant .
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant .
1
5. Device Description
Surgetics ORTHO KNEELOGICS Navigation System (ORTHO The KNEELOGICS) consists of the following major components and subsystems:
- . The Surgetics Station, consisting of a mobile computer system and an optical localizer
- Ancillary instruments and reflective markers used for reference and . registration
- . ORTHO KNEELOGICS Navigation applications software
6. Technological Characteristics and Substantial Equivalence
The Surgetics ORTHO KNEELOGICS Navigation System is substantially equivalent to other stereotaxic instruments that have been cleared for use in knee surgery without CT imaging, including the BrainLab Vector Vision CT-Free (K021306) and the OrthoSoft Navitrack System-Optical TKR CT-Less (K021760). The ORTHO KNEELOGICS and the predicate systems all acquire positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, and then use this data to display virtual 3D images used for subsequent planning and navigation during surgery. The three systems can all be used with different manufacturer's implant components.
7. Performance Testing
The Surgetics ORTHO KNEELOGICS Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and specimen bench testing and results of a clinical study were provided.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a symbol on the right and text on the left. The symbol is three curved shapes that resemble human profiles. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 - 2005
Praxim C/o Ms. Sheila Hemeon-Heyer, J.D., RAC Medical Device Consultants Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K031196
Trade/Device Name: Surgetics ORTHO KNEELOGICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 28, 2005 Received: April 29, 2005
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de nees that hat to been roll tequire approval of a premarket approval application (PMA). and Cosmetic Free, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, market of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 indy be subject to back as a 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 i lease be devilsed that I Dr i issum that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I occrained and 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 form in the qualisms of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Sheila Hemeon-Heyer, J.D., RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mainening of substantial equivalence of your device to a legally premarket notification: "The PDT Intently sification 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 II you desire specific advice ion your at (240) 276-0120 . Also, please note the regulation entitled, Comacs the Office of Compuners (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K031196
Device Name: Surgetics ORTHO KNEELOGICS Navigation System
Indications for Use:
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
- · Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Euchth
ivision Sign-Off) Division Sign-On)
Division of General, Restorative
Oivision of General, Revices Division of Gical Devices
510(k) Number K031196
April 28, 2005