(310 days)
Not Found
No
The description focuses on image processing for triangulation and 3D reconstruction, which are traditional computer vision techniques, not explicitly AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device is an aid to the surgeon for precisely locating anatomical structures and facilitating surgical planning and navigation; it does not directly treat or alleviate a medical condition.
No
The device is described as an aid for precisely locating anatomical structures and helping define the exact anatomical relations of lesions to surrounding structures during surgery. It assists with surgical planning and navigation, but it does not make a diagnosis of a disease or condition.
No
The device description explicitly states it is a "system" that "continuously monitors the position of a pointing instrument" and uses "video cameras" to process images and calculate 3D coordinates. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Argos device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Argos's Function: Argos is a surgical navigation system. Its purpose is to aid the surgeon in precisely locating anatomical structures during surgical procedures by linking tracked instruments to pre- or intraoperative medical images. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's an "aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures." This is a surgical guidance function, not an in vitro diagnostic function.
- Device Description: The description reinforces its role in computer-assisted stereotactic surgery, monitoring instrument position in relation to patient anatomy visualized on a monitor.
Therefore, Argos falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR , fluoroscopic or ultrasound images.
Example procedures include but are not limited to:
Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies
Spinal Procedures: Spinal implant procedures such as pedicle screw placement
ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies. Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
Argos is a system for computer-assisted stereotactic surgery. It is designed to be used as an aid to the location of, and surgical approach to, lesions within the anatomical structures on the human body and to help define the exact anatomical relations of such lesions to surrounding structures.
Prior to the brain surgery, the Argos system acquires contiguous MRI or CT scans of the area containing the lesion and uses them to construct an accurate three-dimensional representation of the patient's anatomy used initially to facilitate surgical planning. During the operation the Argos system continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen in relation to the three-dimensional virtual anatomy of the patient. It is therefore possible to verify during the operation that the real position of various anatomical reference points, including the lesion, corresponding to those identified during surgical planning.
Device main components:
Argos Controller, consisting of computers and touch-screen monitor.
The Camera System, consisting of infrared cameras that can be stand alone (on wheels), mounted on the controller or mounted on the operating microscope.
Localizers and Pointers
Planning Workstation (optional), that allows the pre-operative planning
Physical characteristics:
Main Unit:
Height 152cm
Width 51 cm
Depth 54 cm
Weight ca. 80Kg
Camera System (Type SS):
Height 12 cm (30cm width the handle)
Width 62cm
Depth 16
Weight ca. 4.0kg
Camera System (Type M):
Height 4.6 cm
Width 16cm
Depth 9.5
Weight ca. 0.8 kg
Localization technology:
Optical tracking, based on infrared cameras and wire-less passive instruments (by means of retro-reflective markers). The objects to be tracked are fitted with retro-reflective markers. The images coming from the video cameras are processed and the 3D coordinates of the markers are calculated by triangulation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, fluoroscopic or ultrasound images
Anatomical Site
human body (e.g., skull, long bone, vertebra), brain, spine, ENT (maxillary, ethmoid, sphenoid, frontal sinuses, turbinates)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical (surgical procedures)
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): 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
APR 5 - 2007 061479
APPENDIX 2
510(k) Summary of Safety and Effectiveness for ARGOS
Submitted By:
3D Line Medical System ,srl Address: via Bernardo Rucellai 23 - 20161 MILAN - ITAL Y Tel.: + 39 02 2550161 Fax: + 39 02 25501642
Contact Person: Marco Luzzara, Director, QA Manager
Summary Date: January 18,2006
Device Trade Name: ARGOS
Common Name: Image guided surgery system
Classification name: instrument, stereotaxic.
Predicate Device:
Vectorvision, (K003589) manufactured by BRAINLAB AG Ammerthalstrasse 8 Heimstetten, GM 85551
Description of the Device:
Argos is a system for computer-assisted stereotactic surgery. It is designed to be used as an aid to the location of, and surgical approach to, lesions within the anatomical structures on the human body and to help define the exact anatomical relations of such lesions to surrounding structures.
Prior to the brain surgery, the Argos system acquires contiguous MRI or CT scans of the area containing the lesion and uses them to construct an accurate three-dimensional representation of the patient's anatomy used initially to facilitate surgical planning. During the operation the Argos system continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen in relation to the three-dimensional virtual anatomy of the patient. It is therefore possible to verify during the operation that the real position of various anatomical reference points, including the lesion, corresponding to those identified during surgical planning.
1 /
1
Intended use of the device:
Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR , fluoroscopic or ultrasound images.
Example procedures include but are not limited to:
Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies
Spinal Procedures: Spinal implant procedures such as pedicle screw placement
ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies. Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies
2
Substantial Equivalence to Predicate Device:
ARGOS and VECTORVISION are both image guided surgery systems. They link tracked probes to virtual computer image space on a patient's image. The relevant characteristics are compared below.
| ARGOS | VECTORVISON | |
|---|---|---|
| Indication for | ||
| Use | 3Dline Argos is intended as an aid | |
| to the surgeon for precisely locating | ||
| anatomical structures on the human | ||
| body in either open or percutaneous | ||
| procedures. It links tracked probes | ||
| to virtual computer image space on a | ||
| patient's preoperative or | ||
| intraoperative image data. The | ||
| system is indicated for any medical | ||
| condition in which the use of | ||
| stereotactic surgery may appropriate | ||
| and where the reference to a rigid | ||
| anatomical structure, such as the | ||
| skull, a long bone, or vertebra can be | ||
| identified relative to medical images | ||
| such as CT, MR, fluoroscopic or | ||
| ultraosund images. | BRAINLAB VectorVision is intended to | |
| be an intraoperative image guided | ||
| localizaton system to enable minimally | ||
| invasive surgery. It links a freehand | ||
| probe, tracked by a passive marker | ||
| sensor system to virtual computer image | ||
| space on a patient's preoperative image | ||
| data being processed by a VectorVision | ||
| workstation. The system is indicated for | ||
| any medical condition in which the use | ||
| of stereotactic surgery may be | ||
| considered to be safe and effective and | ||
| where a reference to a rigid anatomical | ||
| structure, such as the skull, a long bone, | ||
| or vertebra, can be identified relative to | ||
| a CT, X-ray or MR based model of | ||
| anatomy. | ||
| Device main | ||
| components | 발 | |
| Argos Controller, consisting | ||
| of computers and touch- | ||
| screen monitor. | ||
| The Camera System, | ||
| ■ | ||
| consisting of infrared | ||
| cameras that can be stand | ||
| alone (on wheels), mounted | ||
| on the controller or mounted | ||
| on the operating microscope. | ||
| Localizers and Pointers | ||
| ■ | ||
| 트 | ||
| Planning Workstation | ||
| (optional), that allows the | ||
| pre-operative planning | I | |
| Brainlab VectorVision navigation | ||
| system integrates computers, | ||
| touch-screen monitors and | ||
| infrared cameras. The video | ||
| cameras cannot be separated | ||
| from the main unit. | ||
| 트 | ||
| Workstation for pre-operative | ||
| planning | ||
| 에 | ||
| Localizers and pointers | ||
| Physical | ||
| characteristics | Main Unit: | |
| Height 152cm | ||
| Width 51 cm | ||
| Depth 54 cm | ||
| Weight ca. 80Kg | ||
| Camera System (Type SS): | ||
| Height 12 cm (30cm width the | ||
| handle) | ||
| Width 62cm | ||
| Depth 16 | ||
| Weight ca. 4.0kg | ||
| Camera System (Type M): | ||
| Height 4.6 cm | ||
| Width 16cm | ||
| Depth 9.5 | ||
| Weight ca. 0.8 kg | Main Unit: | |
| Height 162cm | ||
| Width 95cm (115cm max) | ||
| Depth | ||
| 72cm | ||
| Weight ca. 150Kg | ||
| Camera System: | ||
| Height 9.5 cm | ||
| Width 62cm | ||
| Depth 16.5 | ||
| Weight 2.5kg | ||
| ARGOS | VECTORVISON | |
| Localization | ||
| technology | Optical tracking, based on infrared | |
| cameras and wire-less passive | ||
| instruments (by means of retro- | ||
| reflective markers). | ||
| The objects to be tracked are fitted | ||
| with retro-reflective markers. | ||
| The images coming from the video | ||
| cameras are processed and the 3D | ||
| coordinates of the markers are | ||
| calculated by triangulation. | Optical tracking, based on infrared | |
| cameras and wire-less passive | ||
| instruments (by means of retro-reflective | ||
| markers). | ||
| The objects to be tracked are fitted with | ||
| retro-reflective markers. | ||
| The images of the video cameras are | ||
| processed and the 3D coordinates of | ||
| the markers are calculated by | ||
| triangulation. |
ਾ ।
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
3
Conclusion: ARGOS has been found to be substantially equivalent to BRAINLAB VECTORVISION, 510/k) No. K003589.
1 : 1
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its head facing left and three stripes representing the three levels of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 - 2007
3D Line Medical Systems S.R.L. % TUV America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K061479
Trade/Device Name: ARGOS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 19, 2007 Received: March 21, 2007
Dear Mr. Preiss:
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 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.
5
Page 2 - Mr. Stefan Preiss
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 vours
Paz Pelo Rmz
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ARGOS
Indications for Use:
Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the Argos is intended in an an an apercutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is configure mago bpace on condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR, fluoroscopic or ultrasound images. Example procedures include but are not limited to:
Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies
Spinal Procedures: Spinal implant procedures such as pedicle screw placement
ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies, Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONJINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office
(Division
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