(25 days)
Not Found
No
The summary does not mention AI or ML, and the description focuses on software architecture improvements and new instruments, not advanced algorithms.
No
Explanation: This device is a surgical navigation system that aids the surgeon in locating anatomical structures and aligning endoprostheses during surgery. It does not directly treat or diagnose a disease.
No
The device is a navigation system intended to aid surgeons in locating anatomical structures and aligning endoprostheses during surgery, not for diagnosing 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 surgical navigation during knee arthroplasty to aid the surgeon in locating anatomical structures and aligning implants. This is a surgical tool used during a procedure on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The components described (computer system, optical localizer, instruments, software) are consistent with a surgical navigation system, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In vitro diagnostics are tests performed outside of the body on biological samples to provide information for diagnosis, monitoring, or screening. This device is a surgical aid used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The UNI 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:
- UniKnee Arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS navigation System consists of the following major components and subsystems:
- The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer
- Ancillary instruments and reflective markers used for reference and . registration
- UNI KNEE SURGETICS software.
The main modifications to the predicate devices 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 UNI 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 devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1062146 510(k) Summary
for
UNI KNEE SURGETICS Navigation System
1. Submitter Name and Address:
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: July 17th, 2006
2. Device Name:
Proprietary Name: UNI 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 K060282 - TOTAL KNEE SURGETICS Navigation System
4. Intended Use:
The UNI 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 :
- UniKnee Arthroplasty .
1
న. Device Description:
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS navigation System consists of the following major components and subsystems:
- The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer
- Ancillary instruments and reflective markers used for reference and . registration
- UNI KNEE SURGETICS software .
The main modifications to the predicate devices 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.
Technological Characteristics and Substantial Equivalence 6.
The underlying technology of the UNI KNEE SURGETICS Navigation System is the same as for the predicate devices. 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.
Performance Testing 7.
The UNI 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 devices. In conclusion the UNI KNEE SURGETICS Navigation System is substantially equivalent to the Surgetics ORTHO KNEELOGICS Navigation System and the TOTAL KNEE SURGETICS Navigation System.
. . .
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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
Praxim % Mady Batailh Quality and Regulatory Affairs Director Le Grand Sablon 4 Avenue de l'Obiou 38700 La Tronche France
Re: K062146
Trade/Device Name: UNI KNEE SURGETICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 17, 2006 Received: July 27, 2006
Dear Mady Batailh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becalent of (-) production is substantially equivalent (for the indications for referenced above und navo acterially marketed predicate devices marketed in interstate commerce use stated in the encreated is the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic have been rochassified in asserval 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 controls provibitions or and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your de nee is classified (controls. Existing major regulations affecting your device can be may of subject to stan adala 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 1 that FDA has made a determination that your device complies with other requirements of the Act or that I Dr. I has mude a actesmations administered by other Federal agencies. You must comply with ally i cochi stututes and regulations and limited to: registration and listing (21 CFR Part 807); an the Ave of equirement 201); good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800), good for art 820); and if applicable, the electronic product radiation
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Page 2 - Mady Batailh
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to control provided (Docusion (Docure as described in your Section 510(k) premarket notification. The FDA oglir marketing your device 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 If you dosire 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Palillo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO62146 Indications for Use Statement for
UNI KNEE SURGETICS Navigation System
510(k) Number (if known):
Device Name: UNI KNEE SURGETICS Navigation System
Indications for Use:
દુ,
The UNI 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 :
- UniKnee Arthroplasty t
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 CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K062/46 |
Praxim S.A. 510(k) July 17, 2006 UNI KNEE SURGETICS Navigation System
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