Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

K190106 · Centerline Biomedical, Inc. · DQK · Jun 24, 2019 · Cardiovascular

Device Facts

• Record ID: K190106
• Device Name: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
• Applicant: Centerline Biomedical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Device Story

IOPS provides real-time visualization of sensor-equipped catheters and guidewires during endovascular interventions. System inputs include patient-specific 3D vascular models generated from pre-acquired contrast-enhanced CT scans. Principle of operation utilizes electromagnetic tracking; a field generator creates a time-varying magnetic field to detect the position and orientation of sensors embedded in catheters and guidewires. The computing unit overlays these real-time sensor positions onto the 3D vascular map. Used in the operating room by trained clinicians; system components include a mobile cart, monitor, computer, and tracking hardware. Output allows clinicians to navigate branch vessels near lesions, promoting efficient OR time and reducing fluoroscopy reliance. IOPS does not perform diagnosis; it functions as an adjunct to standard imaging.

Clinical Evidence

No human clinical data provided. Evidence includes bench testing (electrical safety, electromagnetic compatibility, biocompatibility, sterilization, packaging integrity, mechanical evaluation of catheters/guidewires), summative usability testing in a simulated environment, and porcine animal studies for functional evaluation and usability. Accuracy testing performed per ASTM F2554.

Technological Characteristics

System comprises a mobile cart, monitor, computer, and electromagnetic tracking system (control unit, interface unit, field generator). Catheters and guidewires are sensor-embedded. Materials meet ISO 10993 biocompatibility standards. Mechanical testing per ISO 10555-1 and FDA guidewire guidance. Sterilization via ISO 11135. Connectivity involves integrated software for 3D mapping and sensor overlay. Operates via electromagnetic field sensing.

Indications for Use

Indicated for patients undergoing endovascular interventional procedures of the descending aorta, such as stent grafting, requiring real-time tip positioning and navigation of sensor-equipped catheters and guidewires as an adjunct to fluoroscopy.

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

• St. Jude Medical, MediGuide Technology (K162643)
• MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K151622)
• CPS Excel MediGuide Enabled Guidewire (K120298)

Submission Summary (Full Text)

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June 24, 2019

Centerline Biomedical, Inc. % Lauren Smith Senior Quality and Regulatory Engineer JALEX Medical 30311 Clemens Rd Suite 5D Westlake, Ohio 44145

### Re: K190106

Trade/Device Name: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter : Angled Tip Guidewire : Tracking Pad : Guidewire Handle Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 21, 2019 Received: June 24, 2019

### Dear Lauren Smith:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190106

Device Name Intra-Operative Positioning System (IOPS)

#### Indications for Use (Describe)

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a blue circular design with the letter C in the center, and the words "Centerline" and "Biomedical" are written in gray next to the design. Below the logo, the text "510(k) Submission Intra-Operative Positioning System" is written in black.

# VIII. 510(k) Summary

| Submitted By: | Centerline Biomedical, Inc. |
|------------------------------|--------------------------------------------------------|
| | 10000 Cedar Ave |
| | Cleveland, Ohio 44106 |
| Date: | 6/7/2019 |
| Contact Person: | Lauren Smith, Senior Quality/Regulatory Engineer |
| Contact Telephone: | 440.541.0060 |
| Contact Fax: | 440.933.7839 |
| Device Trade Name: | Intra-Operative Positioning System (IOPS) |
| Device Classification Name: | Programmable diagnostic computer (21 CFR 870.1425) |
| Device Classification: | Class II |
| Reviewing Panel: | Cardiovascular |
| Product Code: | DQK |
| Primary Predicate Device: | St. Jude Medical, MediGuide Technology (K162643) |
| Secondary Predicate Devices: | MediGuide Enabled Livewire Steerable Electrophysiology |
| | Catheter (K151622) |
| | CPS Excel MediGuide Enabled Guidewire (K120298) |

### Device Description:

The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.

The patient's vascular map is generated using a contrast enhanced, high resolution CT scan. The IOPS creates a 3D rendering of that structure. A bone segmented 3D rendering may optionally be created to provide anatomical, skeletal points visible in relation to the vascular rendering.

The main principles of action for the IOPS are similar to those used in Global Positioning System (GPS) tracking. The navigation components generate a time-varying magnetic field in which the position and orientation of sensor embedded catheters and guidewires are read. The computing unit visually displays the location of the sensor on the patient's vascular map.

The system is intended for use by trained clinicians for patients undergoing endovascular interventional procedures of the descending aorta, such as stent grafting. The system promotes more efficient use of operating room time and minimizes the need for fluoroscopy. The clinician uses the IOPS catheters and guidewires to navigate through the aorta to access branch vessels

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Image /page/4/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a circular symbol with concentric circles in blue and gray, along with the text "Centerline" above "Biomedical" in gray. Below the logo, the text "510(k) Submission Intra-Operative Positioning System" is displayed.

near to, or involved in, the lesion. The catheters and guidewires are not for angiographic or diagnostic use.

IOPS is composed of a mobile cart which houses a monitor, computer, keyboard, pointing device, uninterruptable power supply (UPS), and cables. IOPS includes a tracking system composed of a system control unit (SCU), system interface unit (SIU), field generator, mounting brackets, and cables. These components are reusable and not patient contacting. The IOPS is integrated with software to generate the mapping and overlay of the live sensors. The IOPS works with a sensor embedded catheter, guidewire, and tracking pad which are provided sterile and not intended for re-use.

## Intended Use:

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

| | Subject Device<br>Centerline Biomedical<br>IOPS | Predicate Device<br>MediGuide Technology<br>System | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK | DQK | Same |
| Intended<br>Use/Indications<br>for Use | The IOPS (Intra-<br>Operative Positioning<br>System) is intended for<br>the evaluation of<br>vascular anatomy as<br>captured via 3D<br>modeling from<br>previously acquired<br>scan data. It is intended<br>for real time tip<br>positioning and<br>navigation using sensor<br>equipped compatible<br>catheters and<br>guidewires used in<br>endovascular<br>interventions in the<br>descending aorta. The<br>system is indicated for<br>use as an adjunct to | The MediGuide™<br>Technology System is<br>intended for the evaluation<br>of vascular and cardiac<br>anatomy. It is intended to<br>enable real time tip<br>positioning and navigation<br>of a MediGuide<br>Enabled™/Sensor<br>Enabled™ (equipped with a<br>magnetic sensor) invasive<br>device used in vascular or<br>cardiac interventions in the<br>Cath Lab environment, on<br>both live fluoroscopy or<br>recorded background. | The IOPS is only<br>intended for the<br>evaluation of<br>vascular anatomy<br>for vascular<br>interventions<br>only. Both<br>sensors enable<br>real time tip<br>positioning and<br>navigation of<br>magnetic sensor<br>equipped devices. |
| | fluoroscopy. The IOPS<br>does not make a<br>diagnosis. | | |
| Device<br>Description | The IOPS system<br>displays the position<br>and orientation of<br>sensor equipped<br>guidewires and<br>catheters utilizing<br>electromagnetic<br>tracking technology.<br>The system enables<br>mapping of the<br>patient's vascular<br>system utilizing<br>previously acquired CT<br>scan data. IOPS<br>registers the location<br>and orientation of the<br>sensors in real time<br>superimposing<br>navigation of the<br>catheters and<br>guidewires to the<br>patient's vascular map. | MediGuide Technology<br>enables navigation of<br>devices on pre-recorded X-ray images allowing the<br>physician to reduce the<br>duration of live X-ray<br>during a procedure.<br>MediGuide Technology<br>applies 3D visualization<br>and precise navigation to<br>pre-recorded 2D X-ray<br>images and can be used by<br>the physician to perform<br>complex electrophysiology<br>procedures and CRT<br>implants. MediGuide<br>Technology is analogous to<br>a global positioning system<br>(GPS) in that it uses a low<br>powered electromagnetic<br>field to locate device-based<br>sensors in three-<br>dimensional space. The<br>system uses this location<br>information to overlay<br>MediGuide™<br>Enabled/Sensor Enabled™<br>devices on the<br>corresponding pre-recorded<br>X-ray image, which allows<br>the physician to reduce the<br>duration of live X-ray<br>during a procedure.<br>MediGuide creates a real-<br>time clinical environment<br>by compensating for patient<br>motion, respiration and<br>heart rate variability. | IOPS enables<br>navigation of<br>devices on a 3D<br>rendering of the<br>vasculature. Both<br>systems<br>compensate for<br>patient motion. |
| Class | Class II | Class II | Same |
| Classification<br>Identification | 21 CFR 870.1425<br>Programmable<br>Diagnostic computer | 21 CFR 870.1425<br>Programmable Diagnostic<br>computer | Same |
| System<br>dedicated<br>tracking devices | 2 Catheters<br>1 Guidewire | Variety of catheters,<br>guidewire, connector<br>accessories | Both systems<br>include magnetic<br>sensor equipped<br>catheters and<br>guidewires |

### Substantial Equivalence:

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Image /page/5/Picture/1 description: The image shows the logo for Centerline Biomedical. The logo consists of a blue target-like symbol on the left, with the words "Centerline" and "Biomedical" in gray on the right. A horizontal line extends from the target symbol to separate the two words.

510(k) Submission Intra-Operative Positioning System

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n Intra-Operative Positioning System

### Non-Clinical Testing:

Performance testing was conducted to demonstrate the performance and accuracy of the IOPS and to verify that it does not raise any new safety and effectiveness concerns. Test results indicate that the IOPS is substantially equivalent to the predicate device and does not raise any new safety or effectiveness concerns. All testing was performed on production equivalent devices.

- IEC 60601-1 and IEC 60601-1-2 Electrical Safety and Electromagnetic Compatibility ● Testing
- Biocompatibility testing for guidewires and catheters (Externally Communicating Device, Circulating blood contact. A - limited < 24h) per ISO 10993
- Biocompatibility testing for tracking pads (Surface device, intact skin, A limited ≤ 24h) ●
- Sterilization validation per ISO 11135
- Packaging integrity testing for sterile components: ●
- Accelerated aging per ASTM F1980 O
- Bubble leak test per ASTM F2096 o
- Seal strength per ASTM F88 O
- Distribution testing per ASTM D4169 о
- Software documentation and validation per:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff O
- Guidance for the Content of Premarket Submissions for Software Contained in Medical O Devices; Guidance for Industry and FDA Staff
- Mechanical evaluation of catheters per ISO 10555-1 and guidewires per FDA's Guidance on Coronary and Cerebrovascular Guidewires
- Summative Usability testing in a simulated use environment per Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff
- Porcine animal studies for usability testing and functional evaluation
- Functional performance testing ●
- o Lag testing
- Accuracy testing per ASTM F2554 O
- X-ray artifact testing O