K Number
K063408
Device Name
CTLOGICS NAVIGATIONS SYSTEMS
Date Cleared
2007-02-28

(107 days)

Product Code
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure. Example procedures include but are not limited to: Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column. Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.
Device Description
The CTLOGICS 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 - . CTLOGICS Software
More Information

Not Found

No
The summary describes an optically based surgical navigation system that uses preoperative CT data for anatomical localization. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The system appears to rely on traditional image processing and registration techniques for navigation.

No
This device is a surgical navigation system intended to aid surgeons in locating anatomical structures during stereotaxic surgery; it does not directly treat or prevent a disease or condition.

No

Explanation: The device is described as an optically based surgical navigation system intended to aid surgeons in locating anatomical structures during stereotaxic surgery. Its primary function is to guide surgical procedures, not to diagnose medical conditions or diseases.

No

The device description explicitly lists hardware components like a mobile computer system, an optical localizer, ancillary instruments, and reflective markers, in addition to the software.

Based on the provided information, the CTLOGICS 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.
  • CTLOGICS Function: The CTLOGICS Navigation System is a surgical navigation system that uses pre-operative imaging data (CT scans) to guide a surgeon during surgery. It does not analyze biological samples from the patient.
  • Intended Use: The intended use clearly states it's for "stereotaxic surgery to aid the surgeon in locating anatomical structures." This is a surgical tool, not a diagnostic test performed on a sample.

Therefore, the CTLOGICS Navigation System falls under the category of a surgical guidance system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.

The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure.

Example procedures include but are not limited to:

Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column.

Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.

Product codes (comma separated list FDA assigned to the subject device)

HAW

Device Description

The CTLOGICS 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
  • . CTLOGICS Software

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

preoperative image data, CT-based model

Anatomical Site

skull, the pelvis, a long bone, or a vertebra, Posterior spinal implant procedures, pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine, tumor surgery on the spinal column, Superolateral and deltopectoral shoulder, glenoid component on the scapula.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon, stereotaxic surgery

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 CTLOGICS Navigation System was tested to assess that no 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.)

accuracy, performance

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.

K053159, K062146, K022239

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

Ko63408

Page 1 of 2

510(k) Summary for CTLOGICS Navigation System

FEB 2 8 2007

1. Submitter Name and Address:

Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France

Contact Name: Jihane ZEMMOURI Telephone: (0033) 4 76 54 95 03

Date Prepared: February 8th, 2007

で Device Name:

Proprietary Name: CTLOGICS Navigation System Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory)

నా Equivalent to:

:

K053159 - VectorVision spine - BrainLAB AG K062146 - UNI KNEE SURGETICS Navigation System - PRAXIM S.A. K022239 - Surgetics ENTact Endonasal Navigation System -- PRAXIM S.A.

4. Intended Use:

The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.

The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure.

1

Ko63408

Page 2

Example procedures include but are not limited to:

Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column.

Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.

5. Device Description:

The CTLOGICS 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
  • . CTLOGICS Software

6. Technological Characteristics and Substantial Equivalence

The CTLOGICS Navigation System is specifically designed for use in surgeries using pre-acquired patient images. During these surgeries, the system allows the navigation of instruments on pre-acquired images. It can be used in posterior spinal implant procedures, superolateral shoulder procedures, and deltopectoral shoulder procedures.

7 . Performance Testing

The CTLOGICS Navigation System was tested to assess that no 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 CTLOGICS Navigation System is substantially equivalent to the Vector Vision Spine #K053159, the Surgetics ENTact Endonasal Navigation System #K022239 and Uni Knee Navigation System #K062146.

February 8th, 2007

Praxim 510(k) CTLOGICS Navigation System

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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2007

Praxim Medivision, SA % Jihane Zemmouri Quality Manager Le Grand Sablon 4 Avenue De L'Obiou La Tronche, France 38700

Re: K063408

Trade/Device Name: CTLOGICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 8, 2007 Received: February 14, 2007

Dear Jihane Zemmour:

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 - Jihane Zemmouri

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

STATEMENT OF INDICATIONS FOR USE

CTLOGICS Navigation System

510(k) Number (if known): K063408

Device Name: CTLOGICS Navigation System

Indications for Use:

The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.

The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure.

Example procedures include but are not limited to:

Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column.

Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.

Prescription Use XAND / OROver-The-Counter Use ____
(Part 21 CFR 801 Subpart D)(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Concurrence of Division of General Restorative Evaluation (ODE)

Praxim 510(k)and Neurological DevicesCONFIDENTIAL
CTLOGICS Navigation SystemPage 1 / 1
510(k) Number6003408
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