PressureWire X

K180558 · St. Jude Medical (Now Part of Abbott Medical) · DXO · Mar 28, 2018 · Cardiovascular

Device Facts

• Record ID: K180558
• Device Name: PressureWire X
• Applicant: St. Jude Medical (Now Part of Abbott Medical)
• Product Code: DXO · Cardiovascular
• Decision Date: Mar 28, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

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).

Device Story

PressureWire™ X is a guidewire with an integrated distal sensor for measuring blood pressure and temperature in heart, coronary, and peripheral vessels. Used in clinical settings (e.g., catheter labs) by physicians to steer catheters through vasculature. The device connects to a diagnostic computer or hemodynamic recording system via a cable or transmitter. The sensor output is transmitted to external equipment for analysis, calculation, and display of physiological indices like Fractional Flow Reserve (FFR). The device aids clinical decision-making by providing real-time hemodynamic data during interventional procedures.

Clinical Evidence

No clinical testing was performed or relied upon. Evidence consists of bench testing and simulated-use validation.

Technological Characteristics

Integrated sensor element at distal tip; operates at -30 to +300 mmHg pressure range and 34-42°C temperature range. Radio frequency transmission (2.4000 - 2.4835 GHz ISM-band). Available in two lengths. Connects to external hemodynamic recording systems.

Indications for Use

Indicated for directing a catheter through a blood vessel and measuring physiological parameters (blood pressure, blood temperature) in the heart and coronary/peripheral blood vessels. Contraindicated for use in cerebral vasculature.

Regulatory Classification

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.

Predicate Devices

• PressureWire™ X (K161171)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K180558

Device Name PressureWire™ X

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:100%">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:100%">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary

| 510(k) Number: | K180558 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | March 27, 2018 |
| Submitter Name &<br>Address: | St. Jude Medical<br>One St. Jude Medical Dr.<br>St. Paul, MN 55117 |
| Contact Person: | Josh Johnson<br>Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Alternative Contact<br>Person: | Marlene Peterson<br>Regulatory Affairs Manager<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Proprietary Name: | PressureWire™ X |
| Common/Usual<br>Name: | PressureWire |
| Product Classification<br>Code: | Primary: DXO<br>Secondary: DQX & DRG |
| Product Regulation<br>Number and Name: | 870.2870, Catheter tip pressure transducer<br>870.1330 – Wire, Guide, Catheter<br>870.2910 - 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 enable<br>measurements of physiological parameters. The wire is introduced into the patient's<br>blood vessel. A torque device is used to steer the wire and sensor into the required<br>position for pressure measurements according to standard clinical practice.<br>PressureWire™ X guidewire is available in two different lengths. |
| Intended Use: | The guidewire is uniquely paired with a specific connection cable or with a specific<br>transmitter. Both PressureWire™ X guidewire connection configurations connect to a<br>diagnostic computer or a catheter laboratory hemodynamic recording system.<br>The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the<br>purpose of directing the catheter through a vessel. The signal output from the sensor is<br>transmitted to associated equipment for analysis, calculations, and display of<br>physiological parameters or indices based on pressure or temperature, e.g. Fractional<br>Flow Reserve (FFR). |
| Indications for Use: | The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel<br>and to measure physiological parameters in the heart and in the coronary and peripheral<br>blood vessels. Physiological parameters include blood pressure. The PressureWire™ X<br>guidewire can also measure blood temperature. |
| Comparison of<br>Subject to Predicate<br>Device: | A minor design modification was made to the pressure sensor jacket component of the<br>PressureWire™ X guidewire. Specifically, the sensor jacket design changed from a one-<br>window to a three-window jacket design, and the window length was extended. The<br>sensor jacket is located near the distal tip of the PressureWire™ X, and functions to<br>protect the pressure sensor. The openings in the sensor jacket, or windows, function to<br>allow fluid flow to the sensor. There were no other changes to the device or IFU. |

{4}------------------------------------------------

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<br>(Subject Device, K180558) | PressureWire™ X<br>(Predicate Device, K161171) | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary<br>Name: | PressureWire™ X | PressureWire™ X | |
| Common<br>Name: | PressureWire | PressureWire | |
| Product<br>Classific-<br>ation Code: | Primary: DXO<br>Secondary: DQX & DRG | Primary: DXO<br>Secondary: DQX & DRG | |
| Product<br>Regulation<br>Number &<br>Name: | Primary: 870.2870, Catheter tip<br>pressure transducer<br>Secondary: 870.1330, catheter<br>guide wire and 870.2910<br>radiofrequency physiological<br>signal transmitters and receivers | Primary: 870.2870, Catheter tip<br>pressure transducer<br>Secondary: 870.1330, catheter<br>guide wire and 870.2910<br>radiofrequency physiological<br>signal transmitters and receivers | |
| Device<br>Class: | II | II | |
| Device<br>Description: | The PressureWire™ X guidewire<br>has an integrated sensor element<br>at the tip to enable measurements<br>of physiological parameters. The<br>wire is introduced into the<br>patient's blood vessel. A torque<br>device is used to steer the wire<br>and sensor into the required<br>position for pressure<br>measurements according to<br>standard clinical practice.<br>PressureWire™ X guidewire is<br>available in two different lengths.<br>The guidewire is uniquely paired<br>with a specific connection cable<br>or with a specific transmitter.<br>Both PressureWire™ X<br>guidewire connection<br>configurations connect to a<br>diagnostic computer or a catheter<br>laboratory hemodynamic<br>recording system. | The PressureWire™ X guidewire<br>has an integrated sensor element<br>at the tip to enable measurements<br>of physiological parameters. The<br>wire is introduced into the<br>patient's blood vessel. A torque<br>device is used to steer the wire<br>and sensor into the required<br>position for pressure<br>measurements according to<br>standard clinical practice.<br>PressureWire™ X guidewire is<br>available in two different lengths.<br>The guidewire is uniquely paired<br>with a specific connection cable<br>or with a specific transmitter.<br>Both PressureWire™ X<br>guidewire connection<br>configurations connect to a<br>diagnostic computer or a catheter<br>laboratory hemodynamic<br>recording system. | |
| Intended<br>Use: | The PressureWire™ guidewire is<br>designed to fit inside a<br>percutaneous catheter for the<br>purpose of directing the catheter<br>through a vessel. The signal<br>output from the sensor is<br>transmitted to associated<br>equipment for analysis,<br>calculations, and display of | The PressureWire™ guidewire is<br>designed to fit inside a<br>percutaneous catheter for the<br>purpose of directing the catheter<br>through a vessel. The signal<br>output from the sensor is<br>transmitted to associated<br>equipment for analysis,<br>calculations, and display of | |
| | | temperature, e.g. Fractional Flow<br>Reserve (FFR). | temperature, e.g. Fractional Flow<br>Reserve (FFR). |
| | Indications<br>for Use: | The PressureWire™ X guidewire<br>is indicated to direct a catheter<br>through a blood vessel and to<br>measure physiological parameters<br>in the heart and in the coronary<br>and peripheral blood vessels.<br>Physiological parameters include<br>blood pressure. The<br>PressureWire™ X guidewire can | The PressureWire™ X guidewire<br>is indicated to direct a catheter<br>through a blood vessel and to<br>measure physiological<br>parameters in the heart and in the<br>coronary and peripheral blood<br>vessels. Physiological parameters<br>include blood pressure. The<br>PressureWire™ X guidewire can |
| | Contra-<br>indications: | also measure blood temperature.<br>This guidewire is contraindicated<br>for use in the cerebral<br>vasculature. | also measure blood temperature.<br>This guidewire is contraindicated<br>for use in the cerebral<br>vasculature. |
| | Technical<br>Specifi-<br>cations | Operating Pressure: -30 to +300<br>mmHg<br>Temp. Performance<br>Specification:<br>34 - 42°C<br>Radio Frequency Range:<br>2.4000 - 2.4835 GHz (ISM-band) | Operating Pressure: -30 to +300<br>mmHg<br>Temp. Performance<br>Specification:<br>34 - 42°C<br>Radio Frequency Range:<br>2.4000 - 2.4835 GHz (ISM-band) |
| Summary on Non-<br>Clinical Testing | Performance bench testing was completed as part of design verification to demonstrate<br>safety and effectiveness, and that the subject device performed as intended. Tests were<br>conducted to evaluate the following:<br>• Guidewire Tensile Strength<br>• Torque Strength<br>• Fatigue Resistance<br>• Fracture Resistance<br>• Signal Quality in Severe Bend<br>• Signal Quality during Pullback Procedure<br>Additionally, simulated-use testing was completed as part of design validation to<br>demonstrate the subject device met user needs and the intended use. The following test<br>was performed:<br>• Signal Drift | | |
| Summary of Clinical<br>Testing: | No new clinical testing was completed, nor relied upon, in support of this Special<br>510(k) submission. | | |
| Statement of<br>Equivalence: | The PressureWire™ X device described in this Special 510(k) submission is<br>substantially equivalent to the currently-marketed predicate device, K161171, based on<br>comparisons of the device classifications, technological characteristics, intended use,<br>and indications for use. The subject device met the pre-determined requirements, and<br>raised no new safety or effectiveness concerns. | | |

{5}------------------------------------------------