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.

AI/ML Overview

This document is a 510(k) premarket notification for the PressureWire™ X device, which is a catheter tip pressure transducer and guidewire. The content primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, device performance metrics, or specific study designs as would be found in a clinical trial report.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. The document describes design verification and validation testing rather than acceptance criteria for a diagnostic algorithm studied in a clinical setting.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria for a diagnostic performance study (e.g., sensitivity, specificity, accuracy). Instead, it refers to compliance with various standards and internal design control procedures for physical, mechanical, and coating integrity.

Acceptance Criteria (General Categories)	Reported Device Performance (Summary statement from document)
Biocompatibility	In compliance with ISO 10993-1:2009 with C1:2010
Sterilization	In compliance with ISO TS 11135-2:2008 (Ethylene Oxide)
Particulate Matter	In compliance with USP 33-NF 28 General chapter <788>
Container Materials	In compliance with USP 36 <661>
Physical, Mechanical, and Coating Integrity (e.g., fractures, friction force, wire diameter, straightness)	Design verification and validation performed in compliance with internal design control procedures. Conclusion: "determined to be safe and effective and is substantially equivalent to the predicate device PressureWire™ Certus TM and PressureWire™ Aeris cleared in K140466."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical study on a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided because the document describes verification and validation against pre-defined engineering and material standards, not the establishment of ground truth for a diagnostic performance test set by clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device (PressureWire™ X) is a physical guidewire with sensing capabilities, not an AI or imaging diagnostic algorithm that assists human readers.

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

A standalone performance evaluation for a diagnostic algorithm is not applicable here as the device is a medical instrument (guidewire) for measuring physiological parameters, not an algorithm. Its performance relates to its ability to accurately measure pressure and temperature, as well as its physical and mechanical properties. The document states a "testing summary" was done, concluding it is "safe and effective."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the physical and mechanical tests, the "ground truth" would be the established engineering specifications and manufacturing standards (e.g., specific friction force values, wire diameter tolerances). For biocompatibility and sterilization, the ground truth is compliance with the cited ISO and USP standards.

8. The sample size for the training set

This information is not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

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

This information is not provided as it's not applicable to this type of device.

Summary

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

August 15, 2016

St. Jude Medical Inc. Huda Yusuf Regulatory Specialist II 5050 Nathan Lane North Plymouth, Minnesota 55442

Re: K161171

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: April 25, 2016 Received: April 26, 2016

Dear Huda Yusuf:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mude Yellman
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) K161171

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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For the St. Jude Medical PressureWire™ X (per 21CFR 807.92)

1. SUBMITTER/510(K) HOLDER

St. Jude Medical 5050 Nathan Lane North Plymouth, MN 55442

Contact Person:	Huda Yusuf
Telephone:	612-900-9527
Date Prepared:	April 25, 2016
Alternative Contact Person:	Erdie De Peralta
Telephone:	978-577-3481
Date Prepared:	April 25, 2016

2. DEVICE NAME

Proprietary Name:	PressureWire™ X
Common/Usual Name:	PressureWire™ X
Classification Name:	Transducer, Pressure, Catheter Tip (870.2870)Wire, Guide, Catheter (870.1330)Transmitters and Receivers, physiological signal, radiofrequency (870.2910)

3. PREDICATE DEVICE

PressureWire™ Certus™ and Aeris™, cleared November 13, 2014 under K140466 .

4. DEVICE DESCRIPTION

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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.

5. INDICATIONS FOR USE

6. PREDICATE DEVICE COMPARISON

PressureWire™ Certus™ and Aeris™ were cleared by FDA under 510(k) K140466 on November 13, 2014. The subject device is substantially equivalent to the predicate device in terms of intended uses, indication for use, operational characteristics, and fundamental design and technology characteristics.

The subject device, PressureWire™ X guidewire, is different from the last previous version of PressureWire™, PressureWire™ Certus™ and Aeris™ in the following ways:

New Distal Tip Design ●
New Shipping Box Design ●
New Single IFU Booklet ●
New Coating on Sensor Guidewire ●

7. TESTING SUMMARY

The PressureWire™ X guidewire has been tested and is in compliance with ISO 10993-1:2009 with C1:2010), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO TS 11135-2:2008, Sterilization of health care products - Ethylene Oxide - Part 2 Guidance on the application of ISO 11135-1, USP 33-NF 28 General chapter <788> Particulate matter in injections, and USP 36 <661> Containers -Plastics.

In addition to the Biocompatibility, Sterilization and Particulate testing performed, design verification and validation was performed on the PressureWire™ X guidewire in compliance with internal design control procedures which included bench testing. This bench testing

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included physical, mechanical and coating integrity testing for fractures, friction force, and wire diameter and straightness.

The results of this testing concludes the PressureWire™ X guidewire is determined to be safe and effective and is substantially equivalent to the predicate device PressureWire™ Certus TM and PressureWire™ Aeris cleared in K140466.

8. Substantial Equivalence

The fundamental scientific technology for the subject device is the same for predicate device regarding signal transfer, mechanical properties and intended use. PressureWire™ X guidewire is substantially equivalent to the predicated device in intended use, indication for use, fundamental design and technology, and operating principles. Both devices connect to a diagnostic computer or a catheter laboratory hemodynamic recording system to enable measurements of physiological parameters with minor design changes incorporated into the PressureWire™ X guidewire from the predicate device:

New Distal Tip Design
New Shipping Box Design
New Single IFU Booklet ●
New Coating on Sensor Guidewire

The subject device, PressureWire™ X Guidewire, meets the design inputs and raises no new safety or efficacy concerns. PressureWire™ X Guidewire is determined to be substantially equivalent to the presently marketed predicated device, K140466.

9. Conclusion

The results of these activities demonstrate that the PressureWire™ X Guidewire is as safe, as effective, and performs as well as or better than the predicate device.

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).