MediGuide Technology System

K162643 · St Jude Medical · DQK · Dec 13, 2016 · Cardiovascular

Device Facts

• Record ID: K162643
• Device Name: MediGuide Technology System
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™/Sensor Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

Device Story

MediGuide Technology System (v17.0) functions as a GPS-like navigation tool for cardiac/vascular interventions. System uses low-powered electromagnetic fields to track magnetic sensors embedded in invasive devices in 3D space. Inputs include real-time sensor data and pre-recorded 2D X-ray images. System transforms inputs by overlaying device position onto X-ray images, compensating for patient motion, respiration, and heart rate variability. Output is a real-time visual display of device location relative to anatomy, used by physicians in the Cath Lab. By providing continuous visualization, the system allows for reduced reliance on live fluoroscopy, potentially lowering radiation exposure for both patient and clinician. System is operated by physicians during complex electrophysiology procedures and CRT implants.

Clinical Evidence

Bench testing only. Software verification and validation confirmed performance against specifications. Non-GLP study conducted to confirm customer requirements and system compatibility. No clinical data presented.

Technological Characteristics

Electromagnetic tracking system; low-powered electromagnetic field generator; magnetic sensors in invasive devices. Connectivity: Networked system. Software: Moderate level of concern. Standards: EN ISO 14971 (risk management), IEC 60601-1 (safety/performance), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), IEC 62366 (usability).

Indications for Use

Indicated for patients undergoing vascular or cardiac interventions in the Cath Lab environment requiring real-time tip positioning and navigation of sensor-enabled invasive devices.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• MediGuide™ Technology System (K120301)

Reference Devices

• Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™ (K160335)
• EnSite Precision™ Cardiac Mapping System (K160210)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 13, 2016

St. Jude Medical Marlene Peterson Sr. Regulatory Affairs Manager One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K162643

Trade/Device Name: MediGuide Technology System (Version 17.0) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 20, 2016 Received: September 22, 2016

Dear Marlene Peterson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Sincerely,

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162643

Device Name MediGuide™ Technology System Version 17.0

## Indications for Use (Describe)

The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10px;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10px;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| 510(k) Summary | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K162643 |
| Submitter Information: | |
| Date Prepared: | November 7, 2016 |
| Manufacturer | St. Jude Medical |
| Name & Address: | One St. Jude Medical Drive |
| | St. Paul, MN 55117 |
| Contact Person: | Marlene Peterson |
| | Sr. Regulatory Manager |
| | Phone [phone] |
| | Fax [phone] |
| | [e-mail] |
| Device Information: | |
| Trade Name: | MediGuide™ Technology System Version 17.0 |
| Common Name: | Programmable Diagnostic Computer |
| Classification Name: | 870.1425, computer, diagnostic, programmable |
| Product Code: | DQK |
| Class: | Class II |
| Predicate Device: | K120301-MediGuide™ Technology System |
| Reference<br>Applications | K160335 – Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™<br>K160210 – EnSite Precision™ Cardiac Mapping System |
| Device Description: | MediGuide Technology enables navigation of devices on pre-recorded X-ray<br>images allowing the physician to reduce the duration of live X-ray during a<br>procedure. MediGuide Technology applies 3D visualization and precise<br>navigation to pre-recorded 2D X-ray images and can be used by the physician<br>to perform complex electrophysiology procedures and CRT implants.<br>MediGuide Technology is analogous to a global positioning system (GPS) in<br>that it uses a low powered electromagnetic field to locate device-based<br>sensors in three-dimensional space. The system uses this location information<br>to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the<br>corresponding pre-recorded X-ray image, which allows the physician to<br>reduce the duration of live X-ray during a procedure. MediGuide creates a<br>real-time clinical environment by compensating for patient motion,<br>respiration and heart rate variability |
| Intended Use:<br>(Indications for Use) | The MediGuide™ Technology system is intended for the evaluation of<br>vascular and cardiac anatomy. It is intended to enable real time tip<br>positioning and navigation of a MediGuide Enabled™/Sensor Enabled™<br>(equipped with a magnetic sensor) invasive device used in vascular or cardiac<br>interventions in the Cath Lab environment, on both live fluoroscopy or<br>recorded background. The System is indicated for use as an adjunct to<br>fluoroscopy. |
| Comparison to<br>Predicate Devices | The proposed MediGuide™ Technology System software version v17.0 has<br>the same intended use and fundamental scientific technology as the predicate<br>device, MediGuide™ Technology cleared under MediGuide™ Technology<br>System K120301 (decision date on Feb 24 2012). The modified<br>MediGuide™ Technology System is identical to the cleared device<br>(K120301), with the following modifications: |
| 510(k) Summary | |
| 510(k) Number | K162643 Upgrading of operation system from Microsoft Windows XP to Microsoft Windows 7 Updates to existing software features and bug fixes Introducing the new hardware , MediGuide ™ Sensor Enabled Devices Minor hardware change to (elimination of one computer and corresponding routing changes) New MediGuide™ Cath Connect, Sensor Enabled™ hardware unit compatible with Sensor Enabled™ Device Updated Indications for Use for compatibility with Sensor Enabled™ devices |
| Summary on Non-Clinical Testing | MediGuide™ Technology System has the same intended use as the predicate device. The technological characteristic for the devices are the same as predicate devices.<br>Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that software modifications and hardware addition do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications.<br>The changes to the application software and operating system were evaluated through software verification and validation to show that the application software is acceptable for use and meets requirements.<br>The MediGuide™ Technology System v17.0 is developed and tested in accordance with the following industry guidance documents and standards: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as part of this submission. The MediGuide™ Technology System conforms to the following standards: EN ISO 14971 (2012) Medical Devices – Applications of risk management to medical devices IEC 60601-1 (2005 + CORR.1 (2006) + CORR.2 (2007) + AM1:2012) Medical electrical equipment- Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 (2007) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic disturbances - requirements and tests IEC 62304 (2006) Medical Device Software- Software Life Cycle Process |
| 510(k) Summary | |
| 510(k) Number | K162643 |
| | IEC 62366 (2007) Medical devices – Application of usability engineering to medical devices |
| | A non GLP study confirming customer requirements and system<br>compatibility was conducted.<br>Risk Management<br>The changes to the application software and operating system were evaluated<br>through review of risk management to ensure no new hazards have been<br>introduced by this change. The risk analysis was completed and risk controls<br>were implemented to mitigate identified hazards. |
| Statement of<br>Equivalence | The MediGuide™ Technology System v17.0 has the same intended use as the<br>predicate device. The technological characteristics for the device are the same<br>as the predicate device. Based on this and the data provided in this pre-market<br>notification, the subject device and predicate device have been shown to be<br>substantially equivalent. |

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