The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.

Indications for Use (capital equipment hardware)

Device Description

The Ultiri™ Measurement System is a diagnostic computer designed to record, compute, display and store data received wirelessly from the PressureWire™ guidewire and Wi-box. The system's main component is an all-in-one personal computer (AiO-PC) operating Ultreon™ Software for Ultiri™ Measurement System. It is compatible with the PressureWire X Guidewire and Wi-Box AO Transmitter. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR). The physician may use FFR, Pd/Pa at rest and RFR parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

AI/ML Overview

The Ultiri™ Measurement System, which includes the Ultreon™ Software, is a diagnostic computer designed to record, compute, display, and store data received wirelessly from the PressureWire™ guidewire and Wi-box. The system measures and displays physiological parameters such as systolic, diastolic, and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR). These parameters help assess the severity of coronary lesions by measuring the pressure drop across them.

Here's an analysis of the acceptance criteria, study details, and ground truth establishment:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device's physiological measurements. Instead, it relies on demonstrating substantial equivalence to predicate devices through design characteristics and non-clinical bench performance testing.

The "Comparison of Subject to Predicate Device" table on page 5 details the functional equivalences, which serve as the implicit acceptance criteria for technological characteristics.

Feature / Criteria	Predicate Device (K210458)	Predicate Device (K183099)	Proposed Device (Ultiri™ Measurement System)	Reported Device Performance
Indications for Use (Physiology)	Included	Physiology-only	Physiology-only	Equivalent to predicates; uses FFR & RFR.
Software / GUI / Workflow	Ultreon™ Software	Quantien™ Software	Ultreon™ Software	Same as primary predicate (OPTIS™ Next System).
Operating System	Windows 10	Linux Software	Windows 10	Same as primary predicate System.
Measurement & Display Features (Physiology)	Physiological parameters	Physiological parameters	Physiological parameters	Same as secondary predicate and included in primary.
Physiology Functionality (FFR, RFR, Pa, Pd, Wi-Box)	FFR & RFR, Pa from external hemodynamic, Pd receiver Thermo View, Wi-Box transmitter	FFR & RFR, Pa from external hemodynamic, Pd receiver Thermo View, Wi-Box transmitter	FFR & RFR, Pa from external hemodynamic, Pd receiver Thermo View, Wi-Box transmitter	Uses same algorithms as predicates, same output receiver.
Data Receiver	PressureWire X (Wireless & Corded)	PressureWire X (Wireless & Corded)	PressureWire X (Wireless only)	Only wireless PressureWire X is supported.
Compatible Devices	PressureWire X (Wireless), Wi-Box	PressureWire X (Wireless), Wi-Box	PressureWire X (Wireless), Wi-Box	No change.
Safety and Effectiveness	As safe and effective as predicate	As safe and effective as predicate	Tested and found as safe and effective	Met design specifications through Abbott quality management system design control verification and validation processes.

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

Sample Size for Test Set: Not specified in the provided documents. The filing states that "non-clinical bench performance testing" was conducted. This typically involves a set of predefined test cases rather than patient data.
Data Provenance: Not applicable in the context of clinical data for the 510(k) submission. The testing was non-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective, as it was not a clinical study involving patient data.

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

Number of Experts: Not applicable. Since no clinical testing was performed or relied upon, there was no ground truth established by experts on patient data for the purpose of demonstrating device performance in this 510(k). The "ground truth" for bench testing would be defined by engineering specifications and expected output values in controlled environments, verified by engineers.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was utilized for this 510(k) submission. Bench testing results would be compared against expected outputs and engineering specifications.

5. 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:

MRMC Study: No. The document explicitly states: "No clinical testing was completed, nor relied upon, in support of this Traditional 510(k)." Therefore, no MRMC study, or any clinical study involving human readers and AI assistance, was performed or presented.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: The core of the device's functionality is a standalone algorithm that computes and displays physiological parameters. The non-clinical bench performance testing would have validated the accuracy of these computations in a standalone manner, generating outputs that are then interpreted by a physician. While not explicitly termed "standalone performance" in the document, the "Measurement & Display Features" and "Physiology Functionality" sections imply that the algorithms for FFR, RFR, and other parameters were validated for their accuracy in processing input data.

7. The Type of Ground Truth Used:

Type of Ground Truth: For the non-clinical bench performance testing, the ground truth would be based on:
- Engineering specifications and controlled inputs: Known pressure/flow values (simulated or generated) fed into the system.
- Mathematical accuracy: Verification that the algorithms correctly calculate FFR, RFR, and other parameters based on the known inputs and established physiological models used in the predicate devices.
- Comparison to predicate device outputs: Direct comparison of the Ultiri™ Measurement System's output to the known outputs or established performance of the legally marketed predicate devices under identical simulated conditions.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is a diagnostic computer that computes physiological parameters using established algorithms. It does not appear to employ machine learning or AI that requires a "training set" in the conventional sense for image recognition or predictive modeling. The algorithms are based on scientific principles and, as stated, are the "Same algorithms as used in the predicates."

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for machine learning/AI. The algorithms themselves, derived from scientific understanding of physiology and validated in predicate devices, form the basis of the device's functionality.

Summary

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April 30, 2022

Abbott Medical Kenny Bello Regulatory Affairs Project Manager 4 Robbins Road Westford, Massachusetts 01886

Re: K220243/S001

Trade/Device Name: Ultiri™ Measurement System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DSK Dated: January 27, 2022 Received: January 28, 2022

Dear Kenny Bello:

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 and Part 809 ); medical device reporting (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,

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 U.S. Food and Drug Administration

Enclosure

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Indications for Use

510(k) Number (if known) K220243

Device Name

Ultiri™ Measurement System

Indications for Use (Describe)

Indications for Use (Software)

The Ultreon™ Software for Ultiri™ Measurement System is intended to be used only with compatible Ultiri™ Measurement Systems.

Indications for Use (capital equipment hardware)

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) Summary
Per 21 CFR §807.92
510(k) Number	K220243
Date Prepared	March 22, 2022
SubmitterName &Address	Abbott Medical4 Robbins RoadWestford, MA 01886
ContactPerson	Kenny M Bello240-302-8627kennym.bello@abbott.com
AlternativeContactPerson	Jose Marquez978-846-2640jose.marquez1@abbott.com
Proprietary /Trade Name	Ultiri™ Measurement System
Common /Usual Name	Programmable Diagnostic Computer, Blood Pressure Computer
ProductClassification	Product Code: DQK, DSKClassification Name: Computer, Diagnostic, Programmable
ProductRegulationNumber	21 CFR 870.142521 CFR 870.1110
Device Class	II
PredicateDevices	Primary Predicate: OPTIS™ Mobile Next Imaging System, Optis Integrated NextImaging System (K210458)Secondary Predicate: QUANTIENT™ Measurement System (K183099)
DeviceDescription	The Ultiri™ Measurement System is a diagnostic computer designed to record, compute,display and store data received wirelessly from the PressureWire™ guidewire and Wi-box.The system's main component is an all-in-one personal computer (AiO-PC) operatingUltreon™ Software for Ultiri™ Measurement System. It is compatible with thePressureWire X Guidewire and Wi-Box AO Transmitter. The information is displayed asgraphs as well as numerical values on the screen. Data includes, but is not limited to:systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), andResting Full-cycle Ratio (RFR). The physician may use FFR, Pd/Pa at rest and RFRparameters, along with knowledge of patient history, medical expertise and clinicaljudgment to determine if therapeutic intervention is indicated.

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The Ultreon™ Software provides guided instructions for the physician to setup a physiology procedure. The display of the user interface can be output to an external video monitor. Additional functions allow the user to import patient lists from the hospital's DICOM (Digital Imaging Communications server) system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick. Ultiri™ Measurement System is not intended for patient contact and is a non-sterile device that can be draped for sterile interaction. Ultir™ Measurement System is distributed as a package with the following components: ● All-in-One PC (with Ultreon Software) DC power supply ● AC power cords ● Instructions for use ● . USB flash drive ● Video output adapter(s) With the Ultreon™ Software application, the proposed Ultiri Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and computes and displays physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest physiological waveforms are also measured by the system to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure). The physician may use the RFR or FFR parameter, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated. Indications for Use (Software) The Ultreon™ Software for Ultiri™ Measurement System is intended to be used only with compatible Ultiri™ Measurement Systems. The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if Indications for therapeutic intervention is indicated. Use Indications for Use (capital equipment hardware) The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated. Primary Secondarv Proposed Predicate Predicate Device Ultiri™ Comparable OPTISTM Next QUANTIENTM Feature Measurement Properties Imaging Measurement System System System

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	510k	Abbott(K210458)DQS, DSK,NQQ	Abbott(K183099)DQS, DSK	Abbott(tbd)DQS, DSK	EquivalentNQQ Imaging
Comparison ofSubject toPredicate Device	Indications for Use	OCT andphysiologyindications	Physiology-onlyindications	Physiology-onlyindications	Physiology-onlyindications.Included in theprimary predicateand secondarypredicate
	Software /GUI /Workflow	UltreonSoftware	QuantienSoftware (SWVersion 1.12.1)	UltreonSoftware	Same as theprimary predicate,OPTIS NextSystem
	OperatingSystem	Windows 10	Linux Software	Windows 10	Same as theprimary predicateSystem
	Measurement &DisplayFeatures	• Physiologicalparameters• OCT Imagerecordings	• Physiologicalparameters	• Physiologicalparameters	same as thesecondarypredicate Systemand Included inthe primarypredicate
	PhysiologyFunctionality	• FFR & RFR• Pa data froman externalhemodynamic• Pd receiverThermo View• Wi-Boxtransmitter.	• FFR & RFR• Pa data froman externalhemodynamic• Pd receiverThermo View• Wi-Boxtransmitter.	• FFR & RFR• Pa data froman externalhemodynamic• Pd receiverThermo View• Wi-Boxtransmitter.	Same algorithmsas used in thepredicates.Same outputReceiver as usedin the primarypredicate
	DataReceiver	• PressureWireX (Wireless)• PressureWireX (corded)	• PressureWireX (Wireless)• PressureWireX (corded)	• PressureWireX (Wireless)	SameOnly wirelessPressureWire X issupported by UltiriMeasurementSystem.
	Compatibledevices	• PressureWire X(Wireless)• Wi-Box	Same	Same	No change
Summary ofTechnologicalCharacteristicsof the Subject	The proposed Ultiri™ Measurement System with Ultreon™ Software is substantiallyequivalent to the commercially available Abbott OPTIST™ Next Imaging Systems withUltreon™ Software (K210458) and the Abbott QUANTIEN Measurement System(K183099)

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	measures/mitigations to verification and validation testing, and a summary ofcybersecurity-related instructions for use. The results of penetration testing,vulnerability scanning, static code analysis, cybersecurity bill of materials andcomponent scanning, and other cybersecurity documentation are provided.The proposed Ultiri Measurement System was tested and found to be as safe and effective asthe predicate device for intended users, uses and use environments, and met designspecifications through the Abbott quality management system design control verification andvalidation processes.
Summary ofClinical Testing	The proposed UltiriTM Measurement System device has the same intended use and similartechnological characteristics as the predicate devices. The differences in technologicalcharacteristics were evaluated through non-clinical bench performance testing. No clinicaltesting was completed, nor relied upon, in support of this Traditional 510(k).
Statement ofEquivalence	The proposed UltiriTM Measurement System with UltreonTM Software design leverages onthe previously cleared Abbott predicates, Abbott OPTISTM Next Imaging Systems withUltreonTM Software (K210458) and the Abbott QUANTIEN TM Measurement System(K183099). It uses the same scientific technology as the predicate devices.The differences discussed in this section does not raise different questions of safety andeffectiveness. Based on the successful verification and validation testing, performancetesting, conformance to standards, and development under Abbott Quality ManagementSystem, we believe that the subject device UltiriTM Measurement System is substantiallyequivalent to the predicate devices.

measures/mitigations to verification and validation testing, and a summary ofcybersecurity-related instructions for use. The results of penetration testing,vulnerability scanning, static code analysis, cybersecurity bill of materials andcomponent scanning, and other cybersecurity documentation are provided.The proposed Ultiri Measurement System was tested and found to be as safe and effective asthe predicate device for intended users, uses and use environments, and met designspecifications through the Abbott quality management system design control verification andvalidation processes.

Summary ofClinical Testing

The proposed UltiriTM Measurement System device has the same intended use and similartechnological characteristics as the predicate devices. The differences in technologicalcharacteristics were evaluated through non-clinical bench performance testing. No clinicaltesting was completed, nor relied upon, in support of this Traditional 510(k).

Statement ofEquivalence

The proposed UltiriTM Measurement System with UltreonTM Software design leverages onthe previously cleared Abbott predicates, Abbott OPTISTM Next Imaging Systems withUltreonTM Software (K210458) and the Abbott QUANTIEN TM Measurement System(K183099). It uses the same scientific technology as the predicate devices.The differences discussed in this section does not raise different questions of safety andeffectiveness. Based on the successful verification and validation testing, performancetesting, conformance to standards, and development under Abbott Quality ManagementSystem, we believe that the subject device UltiriTM Measurement System is substantiallyequivalent to the predicate devices.

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).