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 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 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.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Centerline Biomedical Intra-Operative Positioning System (IOPS). Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table of quantitative acceptance criteria with corresponding performance metrics like a typical validation study might. Instead, it broadly states that performance testing was conducted to demonstrate the performance and accuracy of the IOPS and verify substantial equivalence to the predicate device, not raising new safety or effectiveness concerns.

The functional performance testing included:

Lag testing
Accuracy testing per ASTM F2554
X-ray artifact testing

However, the specific acceptance criteria (e.g., maximum lag accepted, accuracy tolerance, X-ray artifact visibility limits) and the quantitative results (e.g., actual lag measured, accuracy values achieved) are NOT provided in this 510(k) summary.

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

The document mentions "Porcine animal studies for usability testing and functional evaluation" but does not specify the sample size (number of animals or number of tests conducted within those animals) for these studies. The data provenance is animal (porcine) and would be considered prospective for the purposes of the study described.

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

This information is not provided in the document. The document refers to "usability testing and functional evaluation" in animal studies, but it doesn't detail how ground truth was established, especially regarding expert involvement.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

An MRMC comparative effectiveness study was not conducted, or at least not described in this 510(k) summary. The study focuses on device performance and usability in animal models. The indication for use states the IOPS is an "adjunct to fluoroscopy" and "does not make a diagnosis," suggesting it augments human performance rather than replacing it, but no study quantifying this improvement is presented.

6. Standalone Performance Study

The document describes "functional performance testing" including "accuracy testing per ASTM F2554," "Lag testing," and "X-ray artifact testing." These are standalone performance tests of the algorithm/system without human-in-the-loop performance. However, as noted in point 1, the specific quantitative results are not disclosed.

7. Type of Ground Truth Used for the Test Set

For the "functional evaluation" in porcine animal studies, the ground truth would likely be established through direct observation during the procedures, physical measurements taken from the animal, or potentially correlation with other imaging modalities (e.g., 3D imaging from the animal) if applied. The document does not explicitly state the method. For "accuracy testing per ASTM F2554," ASTM standards typically define methods for establishing a traceable ground truth (e.g., using a reference measurement system with known accuracy).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This 510(k) summary describes a hardware and software system for navigation, not a machine learning or AI model trained on a large dataset for diagnostic purposes. The software generates 3D renderings from previously acquired CT scan data and utilizes electromagnetic tracking.

9. How Ground Truth for the Training Set Was Established

Since a training set for an AI model is not mentioned or implied by the device's description, this section is not applicable. The device's operation is based on electromagnetic tracking principles and 3D rendering of CT data, not on learning from a large dataset with established ground truth.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

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

Intended Use:

	Subject DeviceCenterline BiomedicalIOPS	Predicate DeviceMediGuide TechnologySystem	Comparison
Product Code	DQK	DQK	Same
IntendedUse/Indicationsfor Use	The IOPS (Intra-Operative PositioningSystem) is intended forthe evaluation ofvascular anatomy ascaptured via 3Dmodeling frompreviously acquiredscan data. It is intendedfor real time tippositioning andnavigation using sensorequipped compatiblecatheters andguidewires used inendovascularinterventions in thedescending aorta. Thesystem is indicated foruse as an adjunct to	The MediGuide™Technology System isintended for the evaluationof vascular and cardiacanatomy. It is intended toenable real time tippositioning and navigationof a MediGuideEnabled™/SensorEnabled™ (equipped with amagnetic sensor) invasivedevice used in vascular orcardiac interventions in theCath Lab environment, onboth live fluoroscopy orrecorded background.	The IOPS is onlyintended for theevaluation ofvascular anatomyfor vascularinterventionsonly. Bothsensors enablereal time tippositioning andnavigation ofmagnetic sensorequipped devices.
	fluoroscopy. The IOPSdoes not make adiagnosis.
DeviceDescription	The IOPS systemdisplays the positionand orientation ofsensor equippedguidewires andcatheters utilizingelectromagnetictracking technology.The system enablesmapping of thepatient's vascularsystem utilizingpreviously acquired CTscan data. IOPSregisters the locationand orientation of thesensors in real timesuperimposingnavigation of thecatheters andguidewires to thepatient's vascular map.	MediGuide Technologyenables navigation ofdevices on pre-recorded X-ray images allowing thephysician to reduce theduration of live X-rayduring a procedure.MediGuide Technologyapplies 3D visualizationand precise navigation topre-recorded 2D X-rayimages and can be used bythe physician to performcomplex electrophysiologyprocedures and CRTimplants. MediGuideTechnology is analogous toa global positioning system(GPS) in that it uses a lowpowered electromagneticfield to locate device-basedsensors in three-dimensional space. Thesystem uses this locationinformation to overlayMediGuide™Enabled/Sensor Enabled™devices on thecorresponding pre-recordedX-ray image, which allowsthe physician to reduce theduration of live X-rayduring a procedure.MediGuide creates a real-time clinical environmentby compensating for patientmotion, respiration andheart rate variability.	IOPS enablesnavigation ofdevices on a 3Drendering of thevasculature. Bothsystemscompensate forpatient motion.
Class	Class II	Class II	Same
ClassificationIdentification	21 CFR 870.1425ProgrammableDiagnostic computer	21 CFR 870.1425Programmable Diagnosticcomputer	Same
Systemdedicatedtracking devices	2 Catheters1 Guidewire	Variety of catheters,guidewire, connectoraccessories	Both systemsinclude magneticsensor equippedcatheters andguidewires

Substantial Equivalence:

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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

Regulation Number and Section

§ 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).