Ultiri Measurement System

K220243 · ABBOTT MEDICAL · DQK · Apr 30, 2022 · Cardiovascular

Device Facts

• Record ID: K220243
• Device Name: Ultiri Measurement System
• Applicant: ABBOTT MEDICAL
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Diagnostic computer system; records, computes, displays, and stores physiological data received wirelessly from PressureWire™ guidewire and Wi-Box AO transmitter. Used in catheterization and cardiovascular labs by physicians. Inputs include pressure signals; system processes these to calculate systolic/diastolic/mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR). Output displayed as waveforms and numerical values on an all-in-one PC screen. Supports DICOM integration for patient lists and data export. Physician uses output, combined with clinical judgment, to assess coronary lesion severity and determine if therapeutic intervention is required. Benefits include objective physiological assessment of coronary lesions.

Clinical Evidence

No clinical data was completed or relied upon. Substantial equivalence is supported by non-clinical bench performance testing, verification, and validation activities.

Technological Characteristics

All-in-one PC hardware; Windows 10 OS; wireless connectivity to PressureWire™ X and Wi-Box AO transmitter. Measures physiological parameters (FFR, RFR, pressure waveforms). Non-sterile device, intended for use with sterile drapes. Software-based computation of hemodynamic data. Cybersecurity controls include penetration testing, vulnerability scanning, and static code analysis.

Indications for Use

Indicated for use in catheterization and cardiovascular specialty labs to compute and display physiological parameters (e.g., FFR, RFR, blood pressure) from electrodes/transducers to assist physicians in determining the need for therapeutic intervention.

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

• OPTIS™ Mobile Next Imaging System, Optis Integrated Next Imaging System (K210458)
• QUANTIENT™ Measurement System (K183099)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(K) SUMMARY

| 510(k) Summary | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Per 21 CFR §807.92 | |
| 510(k) Number | K220243 |
| Date Prepared | March 22, 2022 |
| Submitter<br>Name &<br>Address | Abbott Medical<br>4 Robbins Road<br>Westford, MA 01886 |
| Contact<br>Person | Kenny M Bello<br>240-302-8627<br>[e-mail] |
| Alternative<br>Contact<br>Person | Jose Marquez<br>978-846-2640<br>[e-mail] |
| Proprietary /<br>Trade Name | Ultiri™ Measurement System |
| Common /<br>Usual Name | Programmable Diagnostic Computer, Blood Pressure Computer |
| Product<br>Classification | Product Code: DQK, DSK<br>Classification Name: Computer, Diagnostic, Programmable |
| Product<br>Regulation<br>Number | 21 CFR 870.1425<br>21 CFR 870.1110 |
| Device Class | II |
| Predicate<br>Devices | Primary Predicate: OPTIS™ Mobile Next Imaging System, Optis Integrated Next<br>Imaging System (K210458)<br>Secondary Predicate: QUANTIENT™ Measurement System (K183099) |
| Device<br>Description | The Ultiri™ Measurement System is a diagnostic computer designed to record, compute,<br>display and store data received wirelessly from the PressureWire™ guidewire and Wi-box.<br>The system's main component is an all-in-one personal computer (AiO-PC) operating<br>Ultreon™ Software for Ultiri™ Measurement System. It is compatible with the<br>PressureWire X Guidewire and Wi-Box AO Transmitter. The information is displayed as<br>graphs as well as numerical values on the screen. Data includes, but is not limited to:<br>systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and<br>Resting Full-cycle Ratio (RFR). The physician may use FFR, Pd/Pa at rest and RFR<br>parameters, along with knowledge of patient history, medical expertise and clinical<br>judgment 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<br>(K210458)<br>DQS, DSK,<br>NQQ | Abbott<br>(K183099)<br>DQS, DSK | Abbott<br>(tbd)<br>DQS, DSK | Equivalent<br>NQQ Imaging |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Subject to<br>Predicate Device | Indications for Use | OCT and<br>physiology<br>indications | Physiology-only<br>indications | Physiology-only<br>indications | Physiology-only<br>indications.<br>Included in the<br>primary predicate<br>and secondary<br>predicate |
| | Software /<br>GUI /<br>Workflow | Ultreon<br>Software | Quantien<br>Software (SW<br>Version 1.12.1) | Ultreon<br>Software | Same as the<br>primary predicate,<br>OPTIS Next<br>System |
| | Operating<br>System | Windows 10 | Linux Software | Windows 10 | Same as the<br>primary predicate<br>System |
| | Measurement &<br>Display<br>Features | • Physiological<br>parameters<br>• OCT Image<br>recordings | • Physiological<br>parameters | • Physiological<br>parameters | same as the<br>secondary<br>predicate System<br>and Included in<br>the primary<br>predicate |
| | Physiology<br>Functionality | • FFR & RFR<br>• Pa data from<br>an external<br>hemodynamic<br>• Pd receiver<br>Thermo View<br>• Wi-Box<br>transmitter. | • FFR & RFR<br>• Pa data from<br>an external<br>hemodynamic<br>• Pd receiver<br>Thermo View<br>• Wi-Box<br>transmitter. | • FFR & RFR<br>• Pa data from<br>an external<br>hemodynamic<br>• Pd receiver<br>Thermo View<br>• Wi-Box<br>transmitter. | Same algorithms<br>as used in the<br>predicates.<br>Same output<br>Receiver as used<br>in the primary<br>predicate |
| | Data<br>Receiver | • PressureWire<br>X (Wireless)<br>• PressureWire<br>X (corded) | • PressureWire<br>X (Wireless)<br>• PressureWire<br>X (corded) | • PressureWire<br>X (Wireless) | Same<br>Only wireless<br>PressureWire X is<br>supported by Ultiri<br>Measurement<br>System. |
| | Compatible<br>devices | • PressureWire X<br>(Wireless)<br>• Wi-Box | Same | Same | No change |
| Summary of<br>Technological<br>Characteristics<br>of the Subject | The proposed Ultiri™ Measurement System with Ultreon™ Software is substantially<br>equivalent to the commercially available Abbott OPTIST™ Next Imaging Systems with<br>Ultreon™ Software (K210458) and the Abbott QUANTIEN Measurement System<br>(K183099) | | | | |

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