(157 days)
No
The description focuses on electromagnetic tracking, CT-based modeling, and respiratory gating, with no mention of AI or ML techniques for image analysis, navigation, or other functions.
No.
The ig4 System is explicitly stated to be a "stereotactic accessory" that aids in displaying interventional instruments and images for guidance, rather than directly treating a condition. Its function is to facilitate procedures, not to provide therapy itself.
No
The device is an image-guided system used for real-time navigation and visualization of instruments during interventional procedures, such as biopsies and ablations, and for guiding endoscopic tools in the pulmonary tract. It aids in surgical precision and guidance rather than diagnosing a condition itself.
No
The device description explicitly lists multiple hardware components including an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, and a computer system, in addition to software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The ig4™ Image Guided System is used to guide instruments within the human body during procedures, not to analyze samples taken from the body.
- The intended use and device description clearly describe a system for image-guided navigation during interventional procedures. This involves displaying real-time or pre-operative images and tracking instruments within the patient.
- There is no mention of analyzing biological samples, reagents, or any of the typical components associated with IVD testing.
The ig4™ System is a medical device used for image-guided surgery/interventions, specifically in the pulmonary tract.
N/A
Intended Use / Indications for Use
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope Systems. The ig4 System is indicated for displaying:
• An interventional instrument such as a biopsy needle, an aspiration needle, or . ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
• · Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract.
The ig4™ System compensates for a patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.
Indications For Use:
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:
- . An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
- . Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.
The ig4™ System compensates for the patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.
Product codes
JAK
Device Description
The SPiN Drive® is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Drive® consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Drive® include Veran's Always-On Tip Tracked™ guidewire, steerable catheter, sheath, aspiration needle, brush or forceps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Pulmonary tract, tracheobronchial tree, target organ(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, clinical interventions
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)
Bench accuracy testing was completed to demonstrate navigation accuracy on a static phantom. Airway segmentation validation was completed to demonstrate pulmonary planning function equivalence. Functional instrumentation testing was completed on new instrumentation. As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device.
Clinical tests were not required to demonstrate the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ig4™ Endobronchial (K091934)
Reference Device(s)
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summarv Veran Medical Technologies Traditional 510(k) SPiN Drive®
DEC 2 1 2012
Date Prepared:
November 21, 2012
510(k) Applicant:
Veran Medical Technologies. Inc. 1908 Innerbelt Business Center Drive. St. Louis, MO 63114 Telephone: (314) 659-8500 Fax: (314) 659-8560
Contact: Scott Wrightstone
Device Information:
| Trade Name: | SPIN Drive® |
|---|---|
| Common Name: | CT stereotactic accessory |
| Classification Name: | Computed Tomography X-ray System |
| Classification Code: | JAK |
Equivalent Legally-Marketed Device:
ig4™ Endobronchial (K091934)
Device Description:
The SPiN Drive® is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Drive® consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Drive® include Veran's Always-On Tip Tracked™ guidewire, steerable catheter, sheath, aspiration needle, brush or forceps.
Intended Use:
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope Systems. The ig4 System is indicated for displaying:
- An interventional instrument such as a biopsy needle, an aspiration needle, or . ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
- · Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract.
The ig4™ System compensates for a patient's respiratory phases.
1
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures. Substantial Equivalence:
The SPiN Drive® has been shown to be substantially equivalent to the iq4™ Endobronchial for electromagnetic tracking of endoscopic tools, catheters or guidewires in the pulmonary tract. The SPiN Drive® has been shown to be substantially equivalent to the ig4™ Endobronchial for pulmonary pathway reconstruction and planning. The technological characteristics that have changed from the ig4 Endobronchial to the SPiN Drive include the introduction of an incrementally improved planning workstation (SPiN Planning™) for pulmonary pathway reconstruction and planning and the introduction of additional navigated endoscopic instrumentation (steerable catheter, sheath, aspiration needle, brush and forceps). Dissimilarities between the SPiN Drive® and the predicate device do not affect the safety or effectiveness of the device.
Performance Data:
Bench accuracy testing was completed to demonstrate navigation accuracy on a static phantom. Airway segmentation validation was completed to demonstrate pulmonary planning function equivalence. Functional instrumentation testing was completed on new instrumentation. As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device.
Clinical Data:
Clinical tests were not required to demonstrate the safety and effectiveness of the device.
Conclusion:
The information provided in the 510(k) notification supports that the SPiN Drive® was shown to be substantially equivalent to the ig4™ Endobronchial for its intended use of navigating endoscopic tools, catheters and guidewires in the pulmonary tract and for pulmonary pathway reconstruction and planning.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image. The Department of Health and Human Services is a cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 21, 2012
Mr. Scott Wrightstone Veran Medical Technologies. Inc. 1908 Innerbelt Bussiness Center Drive ST. LOUIS MO 63114
Re: K122106
Trade/Device Name: SPiN Drive Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: November, 21, 2012 Received: November 26, 2012
Dear Mr. Wrightstone:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Wrightstone
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M: Morris -S
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: SPiN Drive®
Indications For Use:
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:
- . An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
- . Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.
The ig4™ System compensates for the patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.
Prescription Use × (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 In Vitro Diagnostics and Radiological Health (OIR)
Janine M. Morris -S 2012.12.21 15:48:10 -05'00'
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