(92 days)
No
The document describes a system for measuring and displaying physiological parameters. It mentions computing and displaying data, but there is no mention of AI, ML, or related terms, nor any description of algorithms that would typically involve these technologies. The performance studies section also indicates no clinical testing was performed, which is often a component of validating AI/ML-based devices.
No.
Explanation: The device is described as a "diagnostic computer" and its purpose is to "record, compute, display and store data" related to physiological parameters. It assists the physician in determining if intervention is indicated, but it does not directly provide therapeutic intervention itself.
Yes
The "Device Description" explicitly states, "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." It also mentions that the physician uses the acquired physiological parameters (including FFR, Pd/Pa, and RFR) in conjunction with other clinical information to determine if therapeutic intervention is indicated, which is a common function of diagnostic devices.
No
The device description explicitly states that the Ultiri™ Measurement System is distributed as a package with multiple hardware components, including an All-in-One PC, DC power supply, AC power cords, and a USB flash drive, in addition to the Ultreon Software. While the software is a key component, the system is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the Ultiri™ Measurement System clearly states it receives data wirelessly from a guidewire and Wi-box, which are used within the patient's body to measure physiological parameters like blood pressure and FFR. It does not process samples like blood, urine, or tissue.
- The device is used in a catheterization lab setting. This is an in-vivo procedure, not an in-vitro laboratory setting where IVDs are typically used.
- The device measures physiological parameters directly from the patient. It is not analyzing a sample taken from the patient.
The Ultiri™ Measurement System is a diagnostic device used in a clinical setting to acquire and display physiological data from a patient during a procedure. This falls under the category of in-vivo diagnostic devices, not in-vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
DQK, DSK
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / catheterization and related cardiovascular specialty laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The differences in technological characteristics were evaluated through non-clinical bench performance testing. No clinical testing was completed, nor relied upon, in support of this Traditional 510(k). The proposed Ultiri Measurement System was tested and found to be as safe and effective as the predicate device for intended users, uses and use environments, and met design specifications through the Abbott quality management system design control verification and validation processes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OPTIM™ Mobile Next Imaging System, Optis Integrated Next Imaging System (K210458), QUANTIENT™ Measurement System (K183099)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'a' on the left and the word 'Abbott' in black on the right. The 'a' is a geometric shape with rounded corners, and the word 'Abbott' is in a bold, sans-serif font.
510(K) SUMMARY
| 510(k) Summary | |
|---|---|
| Per 21 CFR §807.92 | |
| 510(k) Number | K220243 |
| Date Prepared | March 22, 2022 |
| Submitter | |
| Name & | |
| Address | Abbott Medical |
| 4 Robbins Road | |
| Westford, MA 01886 | |
| Contact | |
| Person | Kenny M Bello |
| 240-302-8627 | |
| kennym.bello@abbott.com | |
| Alternative | |
| Contact | |
| Person | Jose Marquez |
| 978-846-2640 | |
| jose.marquez1@abbott.com | |
| Proprietary / | |
| Trade Name | Ultiri™ Measurement System |
| Common / | |
| Usual Name | Programmable Diagnostic Computer, Blood Pressure Computer |
| Product | |
| Classification | Product Code: DQK, DSK |
| Classification Name: Computer, Diagnostic, Programmable | |
| Product | |
| Regulation | |
| Number | 21 CFR 870.1425 |
| 21 CFR 870.1110 | |
| Device Class | II |
| Predicate | |
| Devices | Primary Predicate: OPTIS™ Mobile Next Imaging System, Optis Integrated Next |
| Imaging System (K210458) | |
| Secondary Predicate: QUANTIENT™ Measurement System (K183099) | |
| 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. |
4
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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Image /page/5/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'A' on the left and the word 'Abbott' in black font on the right. The 'A' is a geometric shape with rounded corners, and the word 'Abbott' is in a bold, sans-serif typeface.
| | 510k | Abbott
(K210458)
DQS, DSK,
NQQ | Abbott
(K183099)
DQS, DSK | Abbott
(tbd)
DQS, DSK | Equivalent
NQQ Imaging |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Comparison of
Subject to
Predicate Device | Indications for Use | OCT and
physiology
indications | Physiology-only
indications | Physiology-only
indications | Physiology-only
indications.
Included in the
primary predicate
and secondary
predicate |
| | Software /
GUI /
Workflow | Ultreon
Software | Quantien
Software (SW
Version 1.12.1) | Ultreon
Software | Same as the
primary predicate,
OPTIS Next
System |
| | Operating
System | Windows 10 | Linux Software | Windows 10 | Same as the
primary predicate
System |
| | Measurement &
Display
Features | • Physiological
parameters
• OCT Image
recordings | • Physiological
parameters | • Physiological
parameters | same as the
secondary
predicate System
and Included in
the primary
predicate |
| | Physiology
Functionality | • FFR & RFR
• Pa data from
an external
hemodynamic
• Pd receiver
Thermo View
• Wi-Box
transmitter. | • FFR & RFR
• Pa data from
an external
hemodynamic
• Pd receiver
Thermo View
• Wi-Box
transmitter. | • FFR & RFR
• Pa data from
an external
hemodynamic
• Pd receiver
Thermo View
• Wi-Box
transmitter. | Same algorithms
as used in the
predicates.
Same output
Receiver as used
in the primary
predicate |
| | Data
Receiver | • PressureWire
X (Wireless)
• PressureWire
X (corded) | • PressureWire
X (Wireless)
• PressureWire
X (corded) | • PressureWire
X (Wireless) | Same
Only wireless
PressureWire X is
supported by Ultiri
Measurement
System. |
| | Compatible
devices | • PressureWire X
(Wireless)
• Wi-Box | Same | Same | No change |
| Summary of
Technological
Characteristics
of the Subject | The proposed Ultiri™ Measurement System with Ultreon™ Software is substantially
equivalent to the commercially available Abbott OPTIST™ Next Imaging Systems with
Ultreon™ Software (K210458) and the Abbott QUANTIEN Measurement System
(K183099) | | | | |
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Image /page/7/Picture/1 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" in blue, followed by the word "Abbott" in black. The letter "a" is made up of three horizontal lines, with the middle line being the shortest. The word "Abbott" is written in a bold, sans-serif font.
| | measures/mitigations to verification and validation testing, and a summary of
cybersecurity-related instructions for use. The results of penetration testing,
vulnerability scanning, static code analysis, cybersecurity bill of materials and
component scanning, and other cybersecurity documentation are provided.
The proposed Ultiri Measurement System was tested and found to be as safe and effective as
the predicate device for intended users, uses and use environments, and met design
specifications through the Abbott quality management system design control verification and
validation processes. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Clinical Testing | The proposed UltiriTM Measurement System device has the same intended use and similar
technological characteristics as the predicate devices. The differences in technological
characteristics were evaluated through non-clinical bench performance testing. No clinical
testing was completed, nor relied upon, in support of this Traditional 510(k). |
| Statement of
Equivalence | The proposed UltiriTM Measurement System with UltreonTM Software design leverages on
the previously cleared Abbott predicates, Abbott OPTISTM Next Imaging Systems with
UltreonTM 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 and
effectiveness. Based on the successful verification and validation testing, performance
testing, conformance to standards, and development under Abbott Quality Management
System, we believe that the subject device UltiriTM Measurement System is substantially
equivalent to the predicate devices. |