PressureWire X by St. Jude Medical (now part of Abbott Medical)

The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

Device Description

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).

AI/ML Overview

The provided text describes the PressureWire™ X guidewire, a medical device used to direct catheters and measure physiological parameters like blood pressure and temperature. The submission is a Special 510(k), indicating a minor design modification to an already cleared device (K161171). As such, a detailed comparative effectiveness study with human readers or extensive clinical trials are not typically required for this type of submission. The focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modification does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, the "acceptance criteria" are primarily based on demonstrating that the modified device performs comparably to the predicate device and meets established performance standards for its type. The reported device performance centers on various bench tests.

Acceptance Criterion (Based on Device Type and Modification)	Reported Device Performance (Summary of Bench Testing)
Maintain Guidewire Tensile Strength	Successfully demonstrated
Maintain Torque Strength	Successfully demonstrated
Maintain Fatigue Resistance	Successfully demonstrated
Maintain Fracture Resistance	Successfully demonstrated
Maintain Signal Quality in Severe Bend	Successfully demonstrated
Maintain Signal Quality during Pullback Procedure	Successfully demonstrated
Maintain Signal Drift within acceptable limits	Successfully demonstrated

Note: The text states "Tests were conducted to evaluate the following: ... Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed: Signal Drift." It implies all these items were successfully met to demonstrate safety and effectiveness.

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

Sample Size for Test Set: Not explicitly stated in terms of a specific number of units for each test. The text outlines categories of tests (e.g., Tensile Strength, Torque Strength) and generally states "Performance bench testing was completed as part of design verification" and "simulated-use testing was completed as part of design validation." Typically, for bench testing, a statistically relevant number of samples would be tested to ensure reliability. However, this specific number is not disclosed in the summary.
Data Provenance: The testing was "Performance bench testing" and "simulated-use testing." This indicates the data was generated in a controlled laboratory environment, not from human or animal subjects. Thus, there's no "country of origin of the data" in the typical sense, nor is it retrospective or prospective clinical data. It's pre-market engineering and product verification/validation data.

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

Number of Experts: Not applicable or mentioned. The "ground truth" for bench testing is defined by engineering specifications, validated test methods, and industry standards (e.g., for tensile strength, torque strength).
Qualifications of Experts: Not applicable. The tests are designed to objectively measure physical and electrical properties according to predefined methods and pass/fail criteria.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Bench tests typically involve objective measurements and comparisons against predetermined specifications rather than subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: No. The device is a physical guidewire with measurement capabilities, not an AI-powered diagnostic imaging tool that assists human readers in interpreting medical cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable here.

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

Standalone Performance: Not applicable in the context of an "algorithm only" device. The PressureWire™ X is a hardware device with an integrated sensor. Its "standalone performance" is demonstrated through the various bench tests ensuring the physical and measurement properties meet specifications.

7. The type of ground truth used

Type of Ground Truth: For the "test set" (bench and simulated-use testing), the ground truth is based on engineering specifications, established physical properties, and validated measurement techniques. For example, a tensile strength test would have a pre-defined acceptable range of force the wire must withstand, and the measured force is compared against that objective standard.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a physical hardware product. It does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing, not algorithmic data training.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" for an AI algorithm in this context. The "ground truth" during the device's development (design and iterative testing) would similarly be based on engineering principles, material science, and performance specifications derived from intended use and predicate device characteristics.

Summary

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March 28, 2018

St. Jude Medical (now part of Abbott Medical) Josh Johnson Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K180558

Trade/Device Name: PressureWire™ X Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter tip pressure transducer Regulatory Class: Class II Product Code: DXO, DQX, DRG Dated: February 26, 2018 Received: March 1, 2018

Dear Josh Johnson:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Hillemann

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180558

Device Name PressureWire™ X

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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510(k) Summary

510(k) Number:	K180558
Date Prepared:	March 27, 2018
Submitter Name &Address:	St. Jude MedicalOne St. Jude Medical Dr.St. Paul, MN 55117
Contact Person:	Josh JohnsonRegulatory Affairs SpecialistPhone (651) 756-3767Fax (651) 756-3301josh.johnson@abbott.com
Alternative ContactPerson:	Marlene PetersonRegulatory Affairs ManagerPhone (651) 756-3268Fax (651) 756-3301marlene.peterson@abbott.com
Proprietary Name:	PressureWire™ X
Common/UsualName:	PressureWire
Product ClassificationCode:	Primary: DXOSecondary: DQX & DRG
Product RegulationNumber and Name:	870.2870, Catheter tip pressure transducer870.1330 – Wire, Guide, Catheter870.2910 - Transmitters and Receivers, Physiological Signal, Radiofrequency
Device Class:	II
Predicate Device:	PressureWire™ X (K161171 )
Device Description:	The PressureWire™ X guidewire has an integrated sensor element at the tip to enablemeasurements of physiological parameters. The wire is introduced into the patient'sblood vessel. A torque device is used to steer the wire and sensor into the requiredposition for pressure measurements according to standard clinical practice.PressureWire™ X guidewire is available in two different lengths.
Intended Use:	The guidewire is uniquely paired with a specific connection cable or with a specifictransmitter. Both PressureWire™ X guidewire connection configurations connect to adiagnostic computer or a catheter laboratory hemodynamic recording system.The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for thepurpose of directing the catheter through a vessel. The signal output from the sensor istransmitted to associated equipment for analysis, calculations, and display ofphysiological parameters or indices based on pressure or temperature, e.g. FractionalFlow Reserve (FFR).
Indications for Use:	The PressureWire™ X guidewire is indicated to direct a catheter through a blood vesseland to measure physiological parameters in the heart and in the coronary and peripheralblood vessels. Physiological parameters include blood pressure. The PressureWire™ Xguidewire can also measure blood temperature.
Comparison ofSubject to PredicateDevice:	A minor design modification was made to the pressure sensor jacket component of thePressureWire™ X guidewire. Specifically, the sensor jacket design changed from a one-window to a three-window jacket design, and the window length was extended. Thesensor jacket is located near the distal tip of the PressureWire™ X, and functions toprotect the pressure sensor. The openings in the sensor jacket, or windows, function toallow fluid flow to the sensor. There were no other changes to the device or IFU.

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The intended use, indications for use, and technological characteristics of the PressureWire™ X device that is subject to this Special 510(K) submission are the same as the predicate, and are summarized in the following table:

	PressureWire™ X(Subject Device, K180558)	PressureWire™ X(Predicate Device, K161171)
ProprietaryName:	PressureWire™ X	PressureWire™ X
CommonName:	PressureWire	PressureWire
ProductClassific-ation Code:	Primary: DXOSecondary: DQX & DRG	Primary: DXOSecondary: DQX & DRG
ProductRegulationNumber &Name:	Primary: 870.2870, Catheter tippressure transducerSecondary: 870.1330, catheterguide wire and 870.2910radiofrequency physiologicalsignal transmitters and receivers	Primary: 870.2870, Catheter tippressure transducerSecondary: 870.1330, catheterguide wire and 870.2910radiofrequency physiologicalsignal transmitters and receivers
DeviceClass:	II	II
DeviceDescription:	The PressureWire™ X guidewirehas an integrated sensor elementat the tip to enable measurementsof physiological parameters. Thewire is introduced into thepatient's blood vessel. A torquedevice is used to steer the wireand sensor into the requiredposition for pressuremeasurements according tostandard clinical practice.PressureWire™ X guidewire isavailable in two different lengths.The guidewire is uniquely pairedwith a specific connection cableor with a specific transmitter.Both PressureWire™ Xguidewire connectionconfigurations connect to adiagnostic computer or a catheterlaboratory hemodynamicrecording system.	The PressureWire™ X guidewirehas an integrated sensor elementat the tip to enable measurementsof physiological parameters. Thewire is introduced into thepatient's blood vessel. A torquedevice is used to steer the wireand sensor into the requiredposition for pressuremeasurements according tostandard clinical practice.PressureWire™ X guidewire isavailable in two different lengths.The guidewire is uniquely pairedwith a specific connection cableor with a specific transmitter.Both PressureWire™ Xguidewire connectionconfigurations connect to adiagnostic computer or a catheterlaboratory hemodynamicrecording system.
IntendedUse:	The PressureWire™ guidewire isdesigned to fit inside apercutaneous catheter for thepurpose of directing the catheterthrough a vessel. The signaloutput from the sensor istransmitted to associatedequipment for analysis,calculations, and display of	The PressureWire™ guidewire isdesigned to fit inside apercutaneous catheter for thepurpose of directing the catheterthrough a vessel. The signaloutput from the sensor istransmitted to associatedequipment for analysis,calculations, and display of
		temperature, e.g. Fractional FlowReserve (FFR).	temperature, e.g. Fractional FlowReserve (FFR).
	Indicationsfor Use:	The PressureWire™ X guidewireis indicated to direct a catheterthrough a blood vessel and tomeasure physiological parametersin the heart and in the coronaryand peripheral blood vessels.Physiological parameters includeblood pressure. ThePressureWire™ X guidewire can	The PressureWire™ X guidewireis indicated to direct a catheterthrough a blood vessel and tomeasure physiologicalparameters in the heart and in thecoronary and peripheral bloodvessels. Physiological parametersinclude blood pressure. ThePressureWire™ X guidewire can
	Contra-indications:	also measure blood temperature.This guidewire is contraindicatedfor use in the cerebralvasculature.	also measure blood temperature.This guidewire is contraindicatedfor use in the cerebralvasculature.
	TechnicalSpecifi-cations	Operating Pressure: -30 to +300mmHgTemp. PerformanceSpecification:34 - 42°CRadio Frequency Range:2.4000 - 2.4835 GHz (ISM-band)	Operating Pressure: -30 to +300mmHgTemp. PerformanceSpecification:34 - 42°CRadio Frequency Range:2.4000 - 2.4835 GHz (ISM-band)
Summary on Non-Clinical Testing	Performance bench testing was completed as part of design verification to demonstratesafety and effectiveness, and that the subject device performed as intended. Tests wereconducted to evaluate the following:• Guidewire Tensile Strength• Torque Strength• Fatigue Resistance• Fracture Resistance• Signal Quality in Severe Bend• Signal Quality during Pullback ProcedureAdditionally, simulated-use testing was completed as part of design validation todemonstrate the subject device met user needs and the intended use. The following testwas performed:• Signal Drift
Summary of ClinicalTesting:	No new clinical testing was completed, nor relied upon, in support of this Special510(k) submission.
Statement ofEquivalence:	The PressureWire™ X device described in this Special 510(k) submission issubstantially equivalent to the currently-marketed predicate device, K161171, based oncomparisons of the device classifications, technological characteristics, intended use,and indications for use. The subject device met the pre-determined requirements, andraised no new safety or effectiveness concerns.

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Regulation Number and Section

§ 870.2870 Catheter tip pressure transducer.

(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).