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 peripheral, aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Device Description

The Intra-Operative Positioning System (IOPS) consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact reusable multi-patient use device. The associated accessories are single use devices provided sterile (EtO).

The IOPS displays the position and orientation of sensor equipped catheters, guidewires, and tracking pad 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 displayed on a monitor. The system is for use as an adjunct to fluoroscopy and does not make a diagnosis.

The associated accessories include:

Guidewire
Catheters
Fiducial Tracking Pad
Guidewire Handle

AI/ML Overview

The provided text is a 510(k) summary for the Intra-Operative Positioning System (IOPS®). It outlines the device, its indications for use, and a comparison to predicate devices, focusing on the justification for substantial equivalence. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the structured format requested.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, highlighting that changes in indications for use and software versions do not raise new questions of safety or effectiveness. It states that "Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness" and "Design Validation, including usability testing, was performed to support the inclusion of all peripheral, aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness."

Without a specific performance study report, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail the sample sizes, data provenance, expert qualifications, or adjudication methods for a test set, nor can I provide information on MRMC studies or effect sizes. The document explicitly states "No animal testing was completed as a part of this submission," and "No clinical testing was completed as a part of this submission."

Therefore, based solely on the provided text, a comprehensive answer to your request is not possible. The information regarding acceptance criteria and performance data, as typically found in a detailed study, is not present here.

However, I can interpret what is provided and explain why the specific details you're asking for are missing from this type of FDA document:

This document is an FDA 510(k) clearance letter and summary. Its purpose is to demonstrate "substantial equivalence" of a new device to an already legally marketed predicate device, not necessarily to present a full, detailed clinical or performance study with all the metrics you've requested.

The "performance data" section states:

Bench Testing: "Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness." "Design Validation, including usability testing, was performed to support the inclusion of all peripheral, aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness." It mentions that "physician targeting of three regions for cannulation" and "technicians were given test case scenarios and asked to place the tracking pad" were part of these studies.
Animal Testing: "No animal testing was completed as a part of this submission."
Clinical Testing: "No clinical testing was completed as a part of this submission."

This implies that the "proof" for meeting acceptance criteria was primarily based on:

Software Verification: Ensuring the new software version functions correctly and reliably, likely against pre-defined software requirements and potentially compared to the predicate's software performance. The acceptance criteria would be internal software validation metrics (e.g., bug rates, functional correctness tests).
Design Validation / Usability Testing (Benchtop): Assessing if the device, with its expanded indications, can be used safely and effectively as intended. This would involve simulated use cases. Acceptance criteria would likely relate to successful navigation/targeting within specified tolerances, ease of use, and lack of critical errors.

Based on the available text, here's what can be inferred or stated directly, along with what is missing:

Acceptance Criteria and Device Performance (Inferred/General from Text):

Acceptance Criteria Category	Reported Device Performance / Justification
Overall Equivalence	"The successful completion of non-clinical testing demonstrates that IOPS performs as intended and is substantially equivalent to the predicate device."
Software Performance	"Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness."Specific metrics (e.g., accuracy, precision, latency) are not provided in this summary.
Design Validation / Usability (for expanded indications)	"Design Validation, including usability testing, was performed to support the inclusion of all peripheral, aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness.""These studies included physician targeting of three regions for cannulation: branches of the aortic arch, distal branches of the descending aorta, and branches of the peripheral vasculature.""In addition, technicians were given test case scenarios and asked to place the tracking pad in each of the three proposed expanded indications regions." Specific performance outcomes (e.g., targeting accuracy, success rates) and quantitative acceptance thresholds are not detailed in this summary.
Safety	"There are no hardware changes to IOPS and its associated accessories and therefore Electrical, Mechanical and Thermal Safety Testing is not needed.""The change in the indications for use does not raise new or different questions of safety or effectiveness."

Detailed Study Information (Based on provided text):

A table of acceptance criteria and the reported device performance:
- As shown above, the document infers acceptance criteria from the statements about "software verification" and "design validation/usability testing" for "equivalency" and "safety and effectiveness" for the expanded indications.
- Specific quantitative acceptance criteria (e.g., "accuracy > X mm") and their corresponding reported values are NOT detailed in this summary document. This level of detail would typically be found in the full submission, not the public-facing summary.
Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified for the software verification or design validation/usability testing. It mentions "physician targeting of three regions" and "technicians were given test case scenarios," implying a small, representative sample, likely for a benchtop study, but no numbers are given.
- Data Provenance: Implied to be prospective benchtop testing conducted specifically for this submission. Country of origin is not explicitly stated, but the company is US-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document refers to "physician targeting" and "technicians." It does not specify the number or detailed qualifications beyond "physician" and "technician."
- No "ground truth" in the sense of a diagnostic consensus is mentioned, as the device "does not make a diagnosis." The "ground truth" for these performance tests would likely be the known anatomical targets in the 3D models and potentially physical measurements of the device's accuracy during tracking.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The testing described is operational/performance testing, not diagnostic interpretation requiring adjudication among readers.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, nor is the device described as an AI or diagnostic device that assists human readers. The device is a "real time tip positioning and navigation system" that is an "adjunct to fluoroscopy." It does not involve human readers interpreting images with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Software verification" and underlying accuracy measurements (though not detailed here) would represent the standalone performance of the algorithm for tracking and positioning without human interaction, but its intended use is always human-in-the-loop as a navigation aid.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of navigation device, the "ground truth" would be the physical accuracy of the electromagnetic tracking system relative to a known model or phantom, and the real-time overlay accuracy onto pre-acquired 3D CT scan data. This is an engineering and spatial accuracy ground truth, not a diagnostic or pathological ground truth as seen in imaging AI.
The sample size for the training set:
- Not applicable/Not mentioned as this device is not described as a machine learning/AI device that requires a training set of images or data in the conventional sense. Its function is based on electromagnetic tracking and anatomical registration, not on learning from a large dataset to identify patterns or make predictions.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or machine learning components requiring labeled data.

Summary

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March 6, 2025

Centerline Biomedical, Inc. Kevin Reed Director, Quality & Regulatory 4535 Renaissance Pkwy Cleveland, Ohio 44128

Re: K243842

Trade/Device Name: Intra-Operative Positioning System (IOPS®) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQY, DQX Dated: December 13, 2024 Received: December 13, 2024

Dear Kevin Reed:

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 (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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

MARCO CANNELLA -S

for

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243842

Device Name

Intra-Operative Positioning System (IOPS®)

Indications for Use (Describe)

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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SUBMITTER

Centerline Biomedical, Inc. 4535 Renaissance Pkwy Cleveland, OH 44128

Phone: 330-577-5033 Email: kevin.reed@centerlinebiomedical.com

Contact Person: Kevin Reed Date Prepared: 21 FEB 2023

DEVICE

Trade Name:	Intro-Operative Positioning System (IOPS®)
Common Name:	Programmable diagnostic computer
Classification Name:	Computer, diagnostic, programmable
Regulatory Class:	II
Product Codes:	DQK, DQY, DQX
Regulation Number:	870.1425

PREDICATE DEVICE

The legally marketed device to which equivalence is being claimed [807.92(a)(3)] is as follows:

510(k) Number	Name	Product Code
K190106	Intra-Operative Positioning System (IOPS)	DQK
K230309	Intra-Operative Positioning System (IOPS®)	DQK
K241243	Intra-Operative Positioning System (IOPS®) Viewpoint	DQK
K242133	Intra-Operative Positioning System (IOPS®)	DQK

Primary predicate is listed first. The predicates have not been the subject of any design-related recalls.

DEVICE DESCRIPTION

The associated accessories include:

Guidewire
Catheters
Fiducial Tracking Pad
· Guidewire Handle

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INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Indications for Use statement for the IOPS and its associated accessories is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data and for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires.

All technological characteristics of the IOPS and its associated accessories are the same as the predicate devices except for IOPS software version.

Table 1 lists the differences between the subject device and the predicate device.

Table 1: Summary Comparison
	Subject Device	Predicate Device(K190106, K230309,K2414243, K242133)*	Discussion
Trade Name	Intra-Operative PositioningSystem (IOPS)	Intra-Operative PositioningSystem (IOPS)	Same
ModelName/Number	Mobile CartMC-1	Mobile CartMC-1	Same
Product Code	DQK	DQK	Same
Class	II	II	Same
ClassificationIdentification	870.1425	870.1425	Same
DeviceDescription	The IOPS displays theposition and orientation ofsensor equipped guidewiresand catheters utilizingelectromagnetic trackingtechnology. The systemenables mapping of thepatient's vascular systemutilizing previously acquiredCT scan data. IOPS registersthe location and orientationof the sensors in real timesuperimposing navigation ofthe catheters and guidewiresto the patient's vascularmap.	The IOPS displays theposition and orientation ofsensor equipped guidewiresand catheters utilizingelectromagnetic trackingtechnology. The systemenables mapping of thepatient's vascular systemutilizing previously acquiredCT scan data. IOPS registersthe location and orientationof the sensors in real timesuperimposing navigation ofthe catheters and guidewiresto the patient's vascularmap.	Same
DeviceAccessories	• IOPS Guidewire (ATW-2)• IOPS Viewpoint SimpleCurve Catheters	• IOPS Guidewire (ATW-2)• IOPS Viewpoint SimpleCurve Catheters	Similar
	(C00751; C01251)IOPS Viewpoint DoubleCurve Catheters(C00752; C01252) IOPS Fiducial TrackingPad (T02111) IOPS Guidewire Handle(H01035)	(C00751; C01251)IOPS Viewpoint DoubleCurve Catheters(C00752; C01252) IOPS Fiducial TrackingPad (T02111;TP-1) IOPS Guidewire Handle(H01035)	subject device in thissubmission is not intended tobe used with the firstgeneration IOPS Tracking Pad(TP-1).
IntendedUse/Indicationsfor Use	The IOPS (Intra-OperativePositioning System) isintended for the evaluationof vascular anatomy ascaptured via 3D modelingfrom previously acquiredscan data. It is intended forreal time tip positioning andnavigation using sensor-equipped compatiblecatheters and guidewiresused in endovascularinterventions in theperipheral, aortic and aorticside branch vasculature. Thesystem is indicated for use asan adjunct to fluoroscopy.The IOPS does not make adiagnosis.	The IOPS (Intra-OperativePositioning System) isintended for the evaluationof vascular anatomy ascaptured via 3D modelingfrom previously acquiredscan data. It is intended forreal time tip positioning andnavigation using sensorequipped compatiblecatheters and guidewiresused in endovascularinterventions in thedescending aorta. Thesystem is indicated for use asan adjunct to fluoroscopy.The IOPS does not make adiagnosis.	The Indications for Usestatement for the IOPS andits associated accessories isnot identical to the predicatedevice; however, thedifferences do not alter theintended use of the devicenor do they affect the safetyand effectiveness of thedevice relative to thepredicate. Both the subjectand predicate devices havethe same intended use forthe evaluation of vascularanatomy as captured via 3Dmodeling from previouslyacquired scan data and forreal time tip positioning andnavigation using sensorequipped compatiblecatheters and guidewires.The subject device has beenevaluated through designvalidation.
Intended UsePopulation	Adults Only	Adults Only	Same
Software Version	1.5.81	1.0.5056	The difference in thesoftware version does notraise new questions of safetyor effectiveness. The subjectdevice has been evaluatedthrough software verificationtesting

Table 1: Summary Comparison

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The predicate device was originally cleared in K190106 and cleared with updated labeling (changed Applied Part designations from Type BF to Defibrillation-Proof Type BF) in K230309. IOPS Viewpoint Catheters were cleared in K241243. IOPS Fiducial Tracking Pad and Guidewire Handle were cleared in K242133.

PERFORMANCE DATA

Bench Testing

Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness. There are no hardware changes to IOPS and its associated accessories and therefore Electrical, Mechanical and Thermal Safety Testing is not needed.

Design Validation, including usability testing, was performed to support the inclusion of all peripheral,

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aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness. These studies included physician targeting of three regions for cannulation: branches of the aortic arch, distal branches of the descending aorta, and branches of the peripheral vasculature. In addition, technicians were given test case scenarios and asked to place the tracking pad in each of the three proposed expanded indications regions.

Animal Testing

No animal testing was completed as a part of this submission.

Clinical Testing

No clinical testing was completed as a part of this submission.

CONCLUSIONS

The change in the indications for use does not raise new or different questions of safety or effectiveness. The successful completion of non-clinical testing demonstrates that IOPS performs as intended and is substantially equivalent to the predicate device.

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).