PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER

K113584 · St Jude Medical · DXO · Mar 2, 2012 · Cardiovascular

Device Facts

• Record ID: K113584
• Device Name: PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
• Applicant: St Jude Medical
• Product Code: DXO · Cardiovascular
• Decision Date: Mar 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

PressureWire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on temperature or pressure, e.g. Fractional Flow Reserve (FFR).

Device Story

PressureWire is a 0.014'' guidewire with an integrated pressure and temperature sensor at the tip. It functions as a guidewire to direct catheters through vessels while simultaneously measuring physiological parameters. Available in wired (Certus) and wireless (Aeris) configurations, it connects to a diagnostic computer or catheter laboratory hemodynamic recording system. The device is used by clinicians in a catheter laboratory setting. The sensor output is processed by the diagnostic system to calculate and present physiological indices, such as Fractional Flow Reserve (FFR). This information assists healthcare providers in clinical decision-making regarding coronary and peripheral vessel assessment, potentially benefiting patients by providing real-time hemodynamic data during interventional procedures.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed the device meets product specifications, including biocompatibility, sterilization, bioburden, and endotoxin requirements. No clinical data was required for this submission.

Technological Characteristics

0.014'' guidewire with integrated pressure and temperature sensor. Available in 183 cm or 300 cm lengths. Two configurations: wired (PressureWire Certus) and wireless (PressureWire Aeris). Connects to diagnostic computer or hemodynamic recording system. Sterilization validated for bioburden and endotoxin.

Indications for Use

Indicated for directing a catheter through a blood vessel and measuring physiological parameters in the heart and in the coronary and peripheral blood vessels.

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® Aeris & Receiver (K080813)

Submission Summary (Full Text)

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## 510 (k) Summary

ﺮ

Submitter's information:

K113584

| Submitter's<br>Name: | St. Jude Medical |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 4 Robbins Road<br>Westford, MA 01886 USA |
| Contact: | Bryan Cowell, RAC<br>Principal Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date of preparation: | 28 November 2011 |
| Device Name: | Pressure Guidewire |
| Trade Name. | Pressure Wire® |
| Common/ Classification | Transducer, Pressure, Catheter Tip (870.2870)<br>Wire, Guide Catheter (870.1330)<br>Transmitters and Receivers, physiological signal<br>radiofrequency (870.2910) |
| Product Code | DXO, DQX and DRG |
| Predicate Device: | K080813 PressureWire® Aeris & Receiver. |

Establishment Registration: 8030904

Establishment: St. Jude Medical Systems AB

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### Device Description:

The Subject Device, PressureWire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.

The PressureWire is available in 2 configurations:

- . Wired version using a cable (PressureWire Certus) to connect with the diagnostic computer
- . Wireless version (PressureWire Aeris).

Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system and are available in two lengths, 183 cm or 300 cm.

### Intended Use:

PressureWire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on temperature or pressure, e.g. Fractional Flow Reserve (FFR).

### Indications for Use:

Pressure Wire® 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.

### Substantial Equivalence:

The fundamental scientific technology for the subject device is the same as for predicate device regarding signal transfer, mechanical properties and intended use. The subject device, Pressure Wire, meets the design inputs and raises no new safety or efficacy concerns. Pressure Wire is determined to be substantially equivalent to the presently marketed predicate device.

### Technological Characteristics:

The modifications of design apply to the corewire and guidewire and do not change the operational principle of the device and maintains the same fundamental scientific technology as the predicate device.

### Functional/ Safety testing

The verification/validation conducted indicate that PressureWire satisfy safety and performance requirements of the device specifications and do not raise additional safety issues for software or hardware.

### Sterilization:

Pressure Wire is validated for sterilization, bioburden and endotoxin, described in report R2847-09 Sterilization Validation PressureWire.

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# KII35584

### Biocompatibility:

Biocompatibility testing was performed in accordance with applicable standards and meets the requirements of testing standards.

### Summary of performance testing

The successful completion of verification activities demonstrates that the PressureWire meets the required product specifications.

The PressureWire is substantially equivalent to the presently marketed predicate device and incorporates the required specifications with all defined requirements and risk mitigation tests having passed or mitigated. In conclusion, the PressureWire meets the design inputs and raises no new safety or efficacy concerns.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 2 2012

St. Jude Medical c/o Bryan Cowell Principal Regulatory Affairs Specialist 4 Robbins Road Westford, MA 01886

Re: K113584

Trade/Device Name: PressureWire Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DQX, DRG Dated: November 30, 2011 Received: December 5, 2011

### Dear Mr. Cowell:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(k) premainer is the time markets (for the indications referenced above and have usedinated the devices marketed newices marketed in interstate for use stated in the encrosule) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior in May 28, 1970, the chartinent with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approvins provisions provisions of the Act. The You may, therefore, market the device, subject on the genirements for annual registration, listing of
general controls provisions of the Act include requirements michrending general controls provisions of the Act merace reading against mistranding and devices, good manufacturing placitics, label information related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to adulteration. Please note: CDRT docs not evaluate international be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and he If your device is classified (Sec adove) mio times affecting your device can be
may be subject to additional controls. Existing major regulations affecting your device can b may be subject to addinonal confrois. Existing major regarded on 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio found in the Code of I cacial Regarations, Four device in the Federal Register.

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### Page 2 -- Mr. Bryan Cowell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase be actived 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 or any I vith 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) by over of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice to: your conters Offices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer for Devices and reactors of the ence to premarket notification" (21CFR Part note the 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.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other government and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, .

M. G. Killersen

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): K113584

Device Name: PressureWire

Indications For Use: PressureWire™ 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.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.G.Killebrew

(Division Sign-Off) Division of Čardiovascular Devices

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510(k) Number_ 611358