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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the SPiN Drive® device, outlining the acceptance criteria and study details based on the given information:

Note: The provided document is a 510(k) summary for a medical device which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about specific acceptance criteria and detailed clinical studies as would be found in a full clinical trial report or a performance study for a novel device. As such, some of the requested information (like specific numerical acceptance criteria, detailed test set characteristics, expert qualifications, effect size of MRMC studies, or training set ground truth establishment) is not present in this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to a predicate device (ig4™ Endobronchial, K091934). The core acceptance criteria revolve around showing that the SPiN Drive® is "as safe and effective" as the predicate for its intended use. Specific, quantitative acceptance criteria for performance metrics are not explicitly stated in this summary.

Acceptance Criterion (Implicit from Substantial Equivalence Goal)	Reported Device Performance
Navigation Accuracy (for endoscopic tools, catheters, guidewires in pulmonary tract)	Bench accuracy testing completed to demonstrate navigation accuracy on a static phantom.
Pulmonary Pathway Reconstruction and Planning Functionality	Airway segmentation validation completed to demonstrate pulmonary planning function equivalence.
Functional Equivalence of New Instrumentation (steerable catheter, sheath, aspiration needle, brush, forceps)	Functional instrumentation testing completed on new instrumentation.
Overall Safety and Effectiveness (comparable to predicate)	All verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device. Dissimilarities between the SPiN Drive® and the predicate device do not affect the safety or effectiveness of the device.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for any of the tests. The bench accuracy testing was on a "static phantom," and airway segmentation validation was performed, but the number of phantoms or datasets used is not specified.
Data Provenance: Not specified. Given the nature of bench testing and phantom studies, it's likely lab-generated data rather than patient data from a specific country. The study is retrospective in the sense that the data used for bench testing would be pre-defined inputs for the system's performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Adjudication Method: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not stated to have been done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the device." This implies no studies involving human readers and clinical cases were performed for this submission.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done? Yes, the performance tests described appear to be standalone algorithm/device performance studies:
- "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."
  These types of tests evaluate the device's intrinsic performance against a known ground truth (e.g., precise phantom measurements, pre-segmented airway models) without human intervention in the loop.

7. Type of Ground Truth Used

Type of Ground Truth:
- For navigation accuracy: The ground truth was based on a "static phantom," implying known, precise locations or trajectories within the phantom that the device's navigation was compared against. This would likely be metrology-based or precisely engineered phantom features.
- For airway segmentation validation: The ground truth for "pulmonary planning function equivalence" would likely be a precisely defined "ideal" segmentation of an airway model, possibly generated manually by experts or from high-resolution scans.

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. The document does not discuss the training of any machine learning models, as it predates the widespread regulatory focus on AI/ML. The "planning workstation" improvements are presented as incremental, suggesting refinement of existing algorithms rather than a new AI model requiring a dedicated training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable/not specified. The document does not describe any machine learning components that would necessitate a dedicated training set with established ground truth. The technical changes are described as "incrementally improved planning workstation" and "additional navigated endoscopic instrumentation," which implies engineering improvements and functional validation rather than AI model training.

Summary

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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:

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.

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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

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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

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K122106

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.

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'

Page 1 of

Regulation Number and Section

§ 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.