The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used with evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with . MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy.

The SJM Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Description

The MediGuide Enabled Livewire Steerable Electrophysiology Catheter is designed to allow electrophysiological mapping at various endocardial and intravascular sites including the inferior vena cava, superior vena cava, pulmonary veins and coronary sinus. The use of the MediGuide Enabled Livewire diagnostic mapping catheter in conjunction with the MediGuide gMPS system allows real-time tip positioning and navigation during routine diagnostic evaluation. When connected to the ECG, the MediGuide Enabled Livewire Catheter will transmit routine electrical signals while the passive sensor at the tip of the catheter is tracked by gMPS and is superimposed on any 2D X-ray image in real time (“Live”) fluoroscopy mode (the actual 3D position of the catheter tip is projected on the real time 2D image).

The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter:

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than proving a new clinical benefit or detailed performance against specific acceptance criteria for a novel AI algorithm. Therefore, many of the questions you've asked, which are more relevant to AI/ML device evaluations, may not be fully answerable from this type of document.

Acceptance Criteria and Reported Device Performance

The document describes an amendment to an existing device, primarily related to a "buckle force requirement." This suggests the "acceptance criteria" discussed are likely engineering and design specifications rather than clinical performance metrics in the way AI/ML devices are typically evaluated (e.g., sensitivity, specificity, AUC).

The table above focuses on technical specifications related to the mechanical performance ("buckle force requirement") of the catheter. There are no clinical performance metrics (like accuracy, sensitivity, specificity, etc.) reported in this document that would typically be associated with an AI device's ability to 'diagnose' or 'identify'.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Buckle force requirement	Historical bench test data evaluated
Fundamental design	No alteration
Packaging	No alteration
Biocompatibility	No alteration
Sterilization	No alteration
Labeling	No alteration

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Historical bench test data."
- Data Provenance: Not explicitly stated. Given it's "historical bench test data," it would be internal to the manufacturer (St. Jude Medical) and likely generated in a laboratory setting. It is retrospective in nature regarding the setting of new specifications based on existing data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. The "ground truth" here relates to a mechanical specification ("buckle force"), which is typically measured objectively via engineering tests rather than expert interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. This is irrelevant for mechanical bench testing.
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. This device is a steerable electrophysiology catheter, and the "MediGuide Enabled" aspect refers to real-time tip positioning and navigation using a gMPS system as an adjunct to fluoroscopy. It is not an AI diagnostic or assistive device that would involve "human readers" interpreting images or data for diagnostic purposes with and without AI assistance. Therefore, an MRMC study and effect size for AI assistance are not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The device described is a physical catheter used with a navigation system (MediGuide Technology) and with human operators (physicians). There is no "algorithm only" performance reported in the context of an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "buckle force" change, the ground truth would be quantitative measurements from mechanical engineering tests. The document refers to "historical bench test data."
The sample size for the training set:
- Not applicable/Not stated. This document describes establishing a "proposed buckle force specification" based on "historical bench test data." There isn't a "training set" in the context of an AI/ML model for this type of device submission.
How the ground truth for the training set was established:
- Not applicable/Not stated. As above, there's no mention of a "training set" or "ground truth" being established in the context of an AI model for this device. The data is mechanical test data.

Summary of what the document does indicate:

The document, a 510(k) summary, asserts that the modified St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K150631) is substantially equivalent to its predicate device (K101955). The core change mentioned is to a "buckle force requirement." This change was supported by an evaluation of "historical bench test data." The manufacturer states that this change does not alter the fundamental design, packaging, biocompatibility, sterilization, or labeling, maintaining substantial equivalence. The device's function is for electrophysiological mapping and real-time tip positioning/navigation as an adjunct to fluoroscopy, not as an AI diagnostic tool.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

April 1, 2015

St. Jude Medical Harlan Jones Sr. Regulatory Affairs Specialist 14901 De Veau Place Minnetonka, Minnesota 55345-2126

Re: K150631

Trade/Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter Livewire Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: March 10, 2015 Received: March 11, 2015

Dear Harlan Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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

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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 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.

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,

Shawn W. Forrest -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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INDICATIONS FOR USE

510(k) Number (if known): K150631

Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter

Indications for Use:

The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used with ● evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with . MediGuide™ Technology to enable real-time tip positioning and navigation.
The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy.

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)

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INDICATIONS FOR USE

510(k) Number (if known): K150631

Device Name: Livewire™ Steerable Electrophysiology Catheter

Indications for Use:

St. Jude Medical (SJM™) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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)

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St. Jude Medical – 510(k) Summary

510(k) Summary
510(k) Number	K150631
Submitter Information:
Date Prepared:	06 March 2015
Submitter Name &Address:	St. Jude Medical - Atrial Fibrillation Division14901 DeVeau PlaceMinnetonka, MN 55345Establishment Registration Number: 3005188751
Contact Person:	Harlan JonesSenior Regulatory Affairs SpecialistPhone (651) 756-3429Fax (651) 756-3298HJones02@sjm.com
Device Information:
Trade Name:	St. Jude Medical MediGuide Enabled Livewire SteerableElectrophysiology Catheter
Common Name:	Diagnostic Electrophysiology Catheter
Classification Name:	Electrode recording catheter or electrode recording probe
Class:	Class II, 21 CFR 870.1220, Product Code DRF
Predicate Device:	St. Jude Medical MediGuide Enabled Livewire SteerableElectrophysiology Catheter (K101955)
Device Description:	The MediGuide Enabled Livewire Steerable ElectrophysiologyCatheter is designed to allow electrophysiological mapping atvarious endocardial and intravascular sites including the inferiorvena cava, superior vena cava, pulmonary veins and coronary sinus.
	The use of the MediGuide Enabled Livewire diagnostic mappingcatheter in conjunction with the MediGuide gMPS system allowsreal-time tip positioning and navigation during routine diagnosticevaluation.
	When connected to the ECG, the MediGuide Enabled LivewireCatheter will transmit routine electrical signals while the passivesensor at the tip of the catheter is tracked by gMPS and issuperimposed on any 2D X-ray image in real time (“Live”)fluoroscopy mode (the actual 3D position of the catheter tip isprojected on the real time 2D image).
Intended Use:(Indications for Use)	The SJM™ Livewire™ Diagnostic Catheter, MediGuideEnabled™ can be used in the evaluation of a variety of cardiacarrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ iscompatible with MediGuide™ Technology to enable real-time
	tip positioning and navigation.
	• The MediGuide™ Technology is indicated for use as an adjunct
	to fluoroscopy.
Comparison toPredicate Devices	The MediGuide Enabled Livewire Steerable ElectrophysiologyCatheter that is the subject of this application remains substantiallyequivalent to the predicate device. The changes made to the buckleforce requirement do not alter the fundamental design, packaging,biocompatibility, sterilization or labeling.
Summary on Non-Clinical Testing	Historical bench test data for buckle force was evaluated to set theproposed buckle force specifications.
Statement ofEquivalence	The MediGuide Enabled Livewire Steerable ElectrophysiologyCatheter that is the subject of this application has the sameindications for use and technological characteristics as the predicatedevice. Based on this and the data provided in this pre-marketnotification, the subject device remains substantially equivalent tothe predicate device.
Device Information:
Trade Name:	Livewire™ Steerable Electrophysiology Catheter
Common Name:	Diagnostic Electrophysiology Catheter
Classification Name:	Electrode recording catheter or electrode recording probe
Class:	Class II, 21 CFR 870.1220, Product Code DRF
Predicate Device:	Livewire™ Electrophysiology Catheter (K102721, K022380,K913940)
Device Description:	The SJM Livewire™ Steerable Electrophysiology Catheter is aflexible electrode catheter constructed of a polyurethaneinsulation/shaft and incorporates platinum electrodes. The active tipmay be manipulated by a remote means located at the proximal endof the catheter.
Intended Use:(Indications for Use)	The SJM Livewire™ Steerable Electrophysiology Catheter can beused in the evaluation of a variety of cardiac arrhythmias fromendocardial and intravascular sites.
Comparison toPredicate Devices	The Livewire Steerable Electrophysiology Catheter that is thesubject of this application remains substantially equivalent to thepredicate device. The changes made to the buckle force requirementdo not alter the fundamental design, packaging, biocompatibility,sterilization or labeling.
Summary on Non-Clinical Testing	Historical bench test data for buckle force was evaluated to set theproposed buckle force specifications.
Statement ofEquivalence	The Livewire Steerable Electrophysiology Catheter that is thesubject of this application has the same indications for use andtechnological characteristics as the predicate device. Based on thisand the data provided in this pre-market notification, the subjectdevice remains substantially equivalent to the predicate device.

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Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).