(66 days)
No
The document describes a surgical navigation system based on optical localization and software, with no mention of AI or ML terms, training data, or performance metrics typically associated with AI/ML.
No
The device is a navigation system intended to aid surgeons during stereotaxic surgery for Total Knee Arthroplasty by locating anatomical structures and aligning endoprostheses; it does not directly treat or cure a disease or condition.
No
The device is a navigation system intended to aid surgeons during stereotaxic surgery for locating anatomical structures and aligning endoprostheses, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a mobile computer system, an optical localizer, ancillary instruments, and reflective markers, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures." This describes a surgical navigation system used during a surgical procedure, not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The components listed (computer system, optical localizer, instruments, software) are consistent with a surgical navigation system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM is a surgical navigation device, not an IVD.
N/A
Intended Use / Indications for Use
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for :
- . Total Knee Arthroplasty
Product codes
HAW
Device Description
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM 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
- TOTAL KNEE SURGETICS software .
The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Surgetics TOTAL KNEE SURGETICS Navigation System was tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency issues were raised in the device. Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031196 - Surgetics ORTHO KNEELOGICS Navigation System
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
510(k) Summary
for
TOTAL KNEE SURGETICS Navigation System
1. Submitter Name and Address:
APR 1 0 2006
Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Mady BATAILH Telephone: (0033) 4 76 54 95 03
Date Prepared: January, XX 2006
2. Device Name:
Proprietary Name: TOTAL KNEE SURGETICS Navigation System Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory)
3. Equivalent to:
K031196 - Surgetics ORTHO KNEELOGICS Navigation System
4. Intended Use:
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for :
- . Total Knee Arthroplasty
1
5. Device Description:
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM 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
- TOTAL KNEE SURGETICS software .
The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
6. Technological Characteristics and Substantial Equivalence
The underlying technology of the TOTAL KNEE SURGETICS Navigation System is the same as for the predicate device. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance for the same surgery. The main changes with respect to the predicate device concern software and engineering modifications with regard to easy integration of new implants (modularization). In addition, the software was modified in order to allow easier adaptation of the workflow to the characteristics of each implant and to different surgical techniques. New navigated instruments have been developed also with respect to easier integration of new implants.
7. Performance Testing
The Surgetics TOTAL KNEE SURGETICS Navigation System was tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency issues were raised in the device. Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device. In conclusion the TOTAL KNEE SURGETICS Navigation System is substantially equivalent to the Surgetics ORTHO KNEELOGICS Navigation System.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). 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 an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2006
Praxim S.A. c/o Medical Device Consultants, Inc. Mr. Randy Veale 49 Plain Street North Attleboro, Massachusetts 02760
Re: K060282
Trade/Device Name: TOTAL KNEE SURGETICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 13, 2006 Received: March 16, 2006
Dear Mr. Veale:
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 - Mr. Randy Veale
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 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,
Mark N. Mullan
Mark N. Melkarson 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): K060282
Device Name: TOTAL KNEE SURGETICS Navigation System
Indications for Use:
The TOTAL KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning and the endoprostheses with the anatomical structures.
It is specifically indicated for :
Total Knee Arthroplasty .
Prescription Use
(Part 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 OF NEEDED)
Concurrence of (DRH Officer Sign-Off Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| Additional information K060282
| TOTAL KNEE SURGETICS | March 13, 2006 | CONFIDENTIAL |
|---|---|---|
| -------------------------------------------------------- | ---------------- | -------------- |
| 510(k) Number | K060282 |
|---|---|
| --------------- | --------- |