The electrophysiology catheters are manufactured in various fixed and deflectable curve profiles and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

AI/ML Overview

This 510(k) submission (K022380) for the St. Jude Medical, DAIG Division Livewire Electrophysiology Catheter does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way a modern AI/ML device submission would.

Instead, this submission from 2002 relies on the concept of substantial equivalence to a predicate device. The performance data section explicitly states: "Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites." This indicates that the safety and effectiveness of the type of device (electrophysiology diagnostic catheters) were established by previously reviewed literature, and the current device is deemed substantially equivalent to a predicate.

Therefore, many of the requested categories for a contemporary AI/ML device study are not applicable here.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified. The submission relies on substantial equivalence to a predicate device, meaning its performance is considered equivalent to the predicate's known performance.	Not specified as quantitative metrics. The device is stated to have "all technological characteristics... substantially equivalent to the predicate SJM-Daig Electrophysiology Catheter including product design, materials, packaging, and sterilization."

2. Sample size used for the test set and the data provenance

Not applicable. No specific test set data is presented for this device. The submission relies on previously established safety and effectiveness of electrophysiology catheters as a class of devices, as cited in a previous submission (K002976).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No specific test set with ground truth established by experts is described for this device in this submission.

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

Not applicable. No test set or adjudication method is described.

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

Not applicable. This device is a diagnostic electrophysiology catheter, not an AI/ML algorithm. There is no human-in-the-loop performance or AI assistance involved.

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

Not applicable. This is a hardware device, not a standalone algorithm.

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

Not applicable. No specific ground truth data is presented for this device. The safety and effectiveness are inferred from the class of devices and previous literature, likely based on clinical outcomes and expert understanding of cardiac electrophysiology from prior studies.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm that undergoes a "training" process with a dataset.

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

Not applicable. No training set or ground truth establishment relevant to an AI/ML context is described.

Summary of the Study Proving Acceptance Criteria:

The "study" or justification for the Livewire Electrophysiology Catheter meeting its intended purpose is based on the substantial equivalence paradigm prevalent for 510(k) submissions. The submission states:

"Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites." (Section D)
"All technological characteristics of the SJM-Daig Livewire Electrophysiology Catheters are substantially equivalent to the predicate SJM-Daig Electrophysiology Catheter including product design, materials, packaging, and sterilization." (Section C)

This means that the device is considered safe and effective because:

The general class of devices (diagnostic electrophysiology catheters) has established safety and effectiveness through previous studies and clinical use (referenced by K002976).
The Livewire Electrophysiology Catheter is technologically identical or very similar in design, materials, and function to a previously cleared predicate device, implying it will perform equivalently.

Therefore, no new clinical study specific to the Livewire device, with acceptance criteria and performance metrics, was required or presented in this 510(k) submission.

Summary

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K022380
page 1 of 2

OCT 01 2002

510(k) Summary (as required by 21 CFR 807.92)

Submitter Information A.

Submitter's Name:	St. Jude Medical, DAIG Division
Address:	14900 Minnetonka Industrial BlvdMinnetonka, Minnesota 55345-2126 U.S.A.
Telephone Number:	(952) 933-4700
Contact Person:	Jim M. Taufen
Date Submission Prepared:	19-July-2002

B. Device Information

Common or usual Name:	Diagnostic Electrophysiology Catheter
Classification Name:	Catheter, Electrode Recording
Predicate Device:	Electrophysiology CatheterDAIG Corporation
Device Description/Intended Use:	The electrophysiology catheters are manufactured in variousfixed and deflectable curve profiles and electrode spacingsfor electrophysiological mapping for the evaluation of avariety of cardiac arrhythmias from endocardial andintravacular sites.
Indications for Use:	SJM-Daig Electrophysiology Catheters can be used in theevaluation of a variety of cardiac arrhythmias fromendocardial and intravascular sites.

C. Comparison of Required Technological Characteristics

All technological characteristics of the SJM-Daig Livewire Electrophysiology Catheters are substantially equivalent to the predicate SJM-Daig Electrophysiology Catheter including product design, materials, packaging, and sterilization.

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D. Performance Data

Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites.

E. Conclusion

In accordance with the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device,' issued January 10, 1997; the new labeling is being submitted to FDA as part of a new 510(k) Change Being Effected. SJM-Daig intends to continue to market the Livewire device with the amended labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three distinct lines forming the body and wings. The bird is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 01 2002

St. Jude Medical c/o Mr. Jim M. Taufen Sr. Regulatory Affairs Specialist Daig Division 14901 DeVeau Place Minnetonka, MN 55345

Re: K022380

Trade Name: Livewire™ Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: July 19, 2002 Received: July 22, 2002

Dear Mr. Taufen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Jim M. Taufen

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); 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. This Jetter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kala Teth

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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2380

Page

510(k) Number (if known):	K022380
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St. Jude Medical, Daig Division™ Electrophysiology Catheter (Livewire™) Device Name:

Indications for Use:

SJM-Daig electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022380

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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).