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.

Device Description

The subject device, PressureWire™ Aeris™, is a new version of the predicate device (K131452), with the same name. The PressureWire 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 is available in two different lengths.

The guidewire is uniquely paired with a specific connection cable for PressureWire Certus ( not subject device for this submission) or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

AI/ML Overview

The provided document describes a 510(k) summary for the PressureWire™ Aeris™ device, which is a new version of a previously cleared predicate device. This submission focuses on modifications to the transmitter part of the device. Therefore, the presented information does not contain a typical "study" proving performance against acceptance criteria in the sense of a clinical trial or a standalone algorithm evaluation. Instead, it details a design control activity demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/algorithm-based device. This is because the submission is for a medical device (a guidewire with a pressure sensor and its transmitter), not an AI algorithm.

Instead, the "acceptance criteria" are implied by successful completion of verification activities ensuring the modified components (transmitter hardware, software, enclosure, packaging, IFU, sterilization cycle) continue to meet required product specifications and do not negatively impact the operational principle or the fundamental scientific technology.

The "reported device performance" is summarized as:

"The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications."
"Based on passing verification criteria for mechanical and signal testing, PressureWire™ performs substantially equivalent to predicate devices."
"The subject device, PressureWire™ Aeris™, meets the design inputs and raises no new safety or efficacy concerns."

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

This information is not provided in the document. The "tests" mentioned are verification and validation activities related to hardware and software changes, not a clinical study on a patient sample. Therefore, sample size and data provenance in the context of patient data are not relevant or discussed here.

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

This information is not provided and is not applicable to this type of device submission. The "ground truth" for verification of hardware changes would be engineering specifications and design inputs, verified by engineers and quality assurance personnel rather than medical experts interpreting clinical data.

4. Adjudication Method

This information is not provided and is not applicable. Adjudication methods are typically used in clinical trials or studies where expert consensus is needed to establish ground truth for clinical endpoints.

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

No, an MRMC comparative effectiveness study was not done. This device is a guidewire for measuring physiological parameters, not an AI diagnostic or assistive tool for human readers. Therefore, there's no mention of AI assistance or its effect on human readers.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm but a medical device (guidewire and transmitter).

7. The Type of Ground Truth Used

The "ground truth" for the verification activities described in this submission would be the design specifications, pre-established performance metrics for the previous version of the device, and engineering requirements. The intent was to show that the modified components function as intended and do not alter the established performance characteristics. It's essentially "engineering ground truth" rather than clinical or pathology ground truth.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is not a machine learning or AI algorithm development for which a "training set" would be used.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided for the same reason as above.

Summary

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T. JUDE MEDICA

Jude Medical Systems AB +46 (0)18 161000 Fax +46 (0)18 161099

. 2 0 2013

Corporate ID no: 556335-9446

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements in 21 CFR $807.92

Submitted by:	St. Jude Medical Systems ABPalmbladsgatan 10, Box 6350SE-751 35 Uppsala, SwedenPhone:+46 18 161000Fax: +46 18 161099
Contact Person:	Ellinor Nami
Date Prepared:	November 15, 2013
Proprietary Name:	PressureWire™
Common Name:	PressureWire™ Guidewire
Classification Name:	Transducer, Pressure, Catheter Tip (870.2870)Wire, Guide, Catheter (870.1330)Transmitters and Receivers, physiological signal,radiofrequency (870.2910)
Predicate Device:	(K131452) PressureWire™ Aeris™ cleared September 5,2013PressureWire™ Aeris™ and PressureWire™ Receiver™,K080813, cleared July 1, 2008.

Device Description:

Indication 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.

Predicate Device Comparison:

PressureWire was cleared by FDA under 510(k) K131452 on September 5, 2013. The subject device is substantially equivalent to the predicate device in terms of indication for use, operational

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Image /page/1/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, with the words "ST. JUDE MEDICAL" in a serif font to the right. Below the company name, in smaller letters, is the phrase "MORE CONTROL LESS RISK".

St. Jude Medical Systems AB almbladsgatan 10 x 6350, SE-751 35 Uppsala Tel +46 (0)18 161000 Fax +46 (0)18 161099

Corporate ID no: 556335-9446

characteristics, and fundamental design and technology characteristics. Below list identifies the changes to the subject device.

Change to PressureWire Aeris Transmitter Hardware -
Change to PressureWire Aeris Transmitter Software *
-Change to PressureWire Aeris Transmitter Enclosure
Change to PressureWire Aeris packaging ..
Change to PressureWire Aeris IFU .
Change to the sterilization cycle .

Testing summary:

A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission. The modifications applies to the transmitter part of the PressureWire™ Aeris™ and do not change the operational principle. The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications. Based on passing verification criteria for mechanical and signal testing, PressureWire™ performs substantially equivalent to predicate devices.

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. Pressure Wire 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 changes incorporated into the Pressure Wire from the predicate device including:

Change to PressureWire Aeris Transmitter Hardware -
-Change to PressureWire Aeris Transmitter Software
Change to PressureWire Aeris Transmitter Enclosure .
Change to PressureWire Aeris packaging -
Change to PressureWire Aeris IFU -
Change to the sterilization cycle -

The subject device, PressureWire™ Aeris™, meets the design inputs and raises no new safety or efficacy concerns. PressureWire™ is determined to be substantially equivalent to the presently marketed predicate device, K131452.

Conclusion:

Based on the similarities in indication for use, design features and functional features, the modified PressureWire™ Aeris™ is substantially equivalent to the currently marketed predicate device PressureWire™ Aeris™, K131452.

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Public Health Service

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

Image /page/2/Picture/3 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that represents human services.

December 20, 2013

St. Jude Medical Systems Ab Erdulfo De Peralta 4 Robbins Rd. Westford, MA 01886 US

Re: K133587

Trade/Device Name: PressureWire Aeris Agile Tip; PressureWire Aeris Agile Tip 300 Regulation Number: 21 CFR 870.1330 Regulation Name: Pressure Wire Guide Wire Regulatory Class: Class II Product Code: DRG, DQX, DXO Dated: November 18, 2013 Received: November 21, 2013

Dear Erdulfo De Peralta:

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 (QS) 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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Page 2 - Erdulfo De Peralta

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

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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K133587

Indications for Use Statement

510(k)Number(if known)	K133587
Device Name	PressureWire
Indicationsfor 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801. 109)	X	OR	Over-The-Counter Use
-------------------------------------------	---	----	----------------------

Signature
Digitally signed by
Owen P. Faris -S
Date: 2013.12.20
16:22:48 -05'00'

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).