(82 days)
K120301-MediGuide™ Technology System
No
The description focuses on electromagnetic tracking and 3D visualization on pre-recorded 2D images, analogous to GPS, with no mention of AI or ML techniques.
No.
The device is described as an adjunct to fluoroscopy for evaluating vascular and cardiac anatomy, enabling real-time tip positioning and navigation of invasive devices. Its purpose is to guide procedures and reduce live X-ray exposure, not to directly treat a disease or condition.
No
The device is described as enabling real-time tip positioning and navigation of invasive devices during vascular or cardiac interventions, acting as an adjunct to fluoroscopy to reduce live X-ray exposure. Its purpose is to guide procedures, not to diagnose a condition.
No
The device description explicitly mentions a "low powered electromagnetic field" and "device-based sensors," indicating the presence of hardware components beyond just software. The performance studies also mention "hardware addition."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The MediGuide™ Technology system is used during a medical procedure (vascular or cardiac interventions) to help guide and navigate invasive devices within the patient's body. It uses electromagnetic fields and pre-recorded images for real-time positioning.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is entirely focused on real-time navigation and visualization within the body.
Therefore, the MediGuide™ Technology system falls under the category of a medical device used for image-guided procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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™ (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.
Product codes
DQK
Device Description
MediGuide Technology enables navigation of devices on pre-recorded X-ray images allowing the physician to reduce the duration of live X-ray during a procedure. MediGuide Technology applies 3D visualization and precise navigation to pre-recorded 2D X-ray images and can be used by the physician to perform complex electrophysiology procedures and CRT implants. MediGuide Technology is analogous to a global positioning system (GPS) in that it uses a low powered electromagnetic field to locate device-based sensors in three-dimensional space. The system uses this location information to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the corresponding pre-recorded X-ray image, which allows the physician to reduce the duration of live X-ray during a procedure. MediGuide creates a real-time clinical environment by compensating for patient motion, respiration and heart rate variability
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
vascular and cardiac anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cath Lab environment
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)
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.
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.
A non GLP study confirming customer requirements and system compatibility was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120301-MediGuide™ Technology System
Reference Device(s)
K160335 – Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™, K160210 – EnSite Precision™ Cardiac Mapping System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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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 (800) 638-2041 or (301) 796-7100 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 (651) 756-3268 | |
| Fax (651) 756-3301 | |
| mpeterson07@sjm.com | |
| 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 | |
| Applications | K160335 – Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™ |
| K160210 – EnSite Precision™ Cardiac Mapping System | |
| Device Description: | MediGuide Technology enables navigation of devices on pre-recorded X-ray |
| images allowing the physician to reduce the duration of live X-ray during a | |
| procedure. MediGuide Technology applies 3D visualization and precise | |
| navigation to pre-recorded 2D X-ray images and can be used by the physician | |
| to perform complex electrophysiology procedures and CRT implants. | |
| MediGuide Technology is analogous to a global positioning system (GPS) in | |
| that it uses a low powered electromagnetic field to locate device-based | |
| sensors in three-dimensional space. The system uses this location information | |
| to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the | |
| corresponding pre-recorded X-ray image, which allows the physician to | |
| reduce the duration of live X-ray during a procedure. MediGuide creates a | |
| real-time clinical environment by compensating for patient motion, | |
| respiration and heart rate variability | |
| Intended Use: | |
| (Indications for 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. | |
| Comparison to | |
| Predicate Devices | The proposed MediGuide™ Technology System software version v17.0 has |
| the same intended use and fundamental scientific technology as the predicate | |
| device, MediGuide™ Technology cleared under MediGuide™ Technology | |
| System K120301 (decision date on Feb 24 2012). The modified | |
| MediGuide™ Technology System is identical to the cleared device | |
| (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. |
| 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. | |
| 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. | |
| 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 | |
| compatibility was conducted. | |
| Risk Management | |
| The changes to the application software and operating system were evaluated | |
| through review of risk management to ensure no new hazards have been | |
| introduced by this change. The risk analysis was completed and risk controls | |
| were implemented to mitigate identified hazards. | |
| Statement of | |
| Equivalence | The MediGuide™ Technology System v17.0 has the same intended use as the |
| predicate device. The technological characteristics for the device are the same | |
| as the predicate device. Based on this and the data provided in this pre-market | |
| notification, the subject device and predicate device have been shown to be | |
| substantially equivalent. |
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