SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE

K122106 · Veran Medical Technologies, Inc. · JAK · Dec 21, 2012 · Radiology

Device Facts

• Record ID: K122106
• Device Name: SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
• Applicant: Veran Medical Technologies, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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. 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 Story

SPiN Drive is a CT stereotactic accessory using electromagnetic (EM) tracking to navigate endoscopic tools within the tracheobronchial tree. System components include EM field generator, patient referencing system, computer workstation, and software. Inputs include CT-based models of the pulmonary tract and real-time EM tracking data from Always-On Tip Tracked guidewires, catheters, sheaths, needles, brushes, or forceps. The system registers tools to the CT model and performs respiratory gating to compensate for patient breathing. Output is a visual display on a monitor showing instrument position relative to the target organ model. Used in clinical settings by physicians to guide interventions; assists in navigation and biopsy/ablation procedures. Benefits include improved visualization and guidance during pulmonary procedures.

Clinical Evidence

No clinical data required. Safety and effectiveness demonstrated via bench testing, including navigation accuracy on static phantoms, airway segmentation validation for pulmonary planning, and functional instrumentation testing.

Technological Characteristics

Electromagnetic tracking system; includes EM field generator, patient referencing system, and workstation. Navigated instrumentation includes guidewires, catheters, sheaths, needles, brushes, and forceps. Software-based pulmonary pathway reconstruction and planning. Respiratory gating for soft tissue motion compensation.

Indications for Use

Indicated for patients undergoing clinical interventions where CT and/or endoscopic bronchoscopy are used. Aids physicians in guiding endoscopic tools, catheters, or guidewires in the pulmonary tract and displaying interventional instruments (biopsy, aspiration, or ablation needles) relative to a CT-based model of target organs.

Regulatory Classification

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.

Predicate Devices

• ig4™ Endobronchial (K091934)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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.

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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

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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 [phone]. 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 [phone] or [phone] 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.

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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