The St. Jude Medical (SJM) Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites when minimizing blood loss is essential.

Device Description

7F Unidirectional Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen is a catheter that will enable electrical mapping and pacing from endocardial and intravascular sites. Additionally, the Reflexion Cannulator™ with lumen can provide access to the vascular system by either over the wire, or by steerable access to the vasculature for guidewire positioning and contrast media injection through the lumen. The catheter includes a hemostasis valve, Cath-Lock and sideport with a 3-way stopcock, The catheters are provided sterile, and are intended for single-use only.

AI/ML Overview

The provided text is a 510(k) summary for the Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen. This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with proving the device meets specific performance criteria through a study with acceptance criteria in the way one would for a diagnostic or AI-driven device.

The entire summary {0}-{4} focuses on comparing technological characteristics and intended use to a predicate device. It explicitly states: "All technological characteristics of the Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling." {1}

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of submission.

Here's a breakdown of what can be answered and why other parts cannot:

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

Not Applicable. This document does not establish performance acceptance criteria in the typical sense for a diagnostic device, nor does it report performance against such criteria. The "performance" being demonstrated here is substantial equivalence to a predicate device based on technological characteristics and intended use.

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

Not Applicable. This is not a study reporting on specific diagnostic performance with a test set. This is a comparison of product specifications.

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)

Not Applicable. No ground truth for a "test set" was established, as this is a device comparison for substantial equivalence.

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 steerable electrophysiology catheter, not an AI-driven diagnostic tool or a device designed to assist human readers.

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

Not Applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

Not Applicable. No ground truth for device performance in a diagnostic sense is mentioned. Substantial equivalence is based on a comparison to the predicate device's characteristics and intended use.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. See point 8.

In summary: The provided text is a 510(k) summary for a medical device (a catheter) seeking substantial equivalence to a predicate device. It does not contain information about studies with acceptance criteria, test sets, ground truth establishment, or AI performance metrics as would be required for a diagnostic or AI-powered technology. The "proof" is the detailed comparison of the new device's technical specifications and intended use against a legally marketed predicate device.

Summary

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

Submitter Information A.

Submitter's Name:
Address:

Telephone Number:

Contact Person:

Date Submission Prepared:

B. Device Information

Common or Usual Name:

Classification Name:

Predicate Device:

Intended Use:

Device Description:

St. Jude Medical, Daig Division, Inc.

14901 DeVeau Place Minnetonka, Minnesota 55345-2126 U.S.A.

(952) 238-9356

$\left(x-y\right)^2$

Glenn Jacques

January 22, 2004

St. Jude Medical St. Davision, Inc. Daig Division, managements on Confidential and Proprietary
Confidential and Proprietary Confidential and Propriet O NOT COPY

Reflexion CannulatorTM Steerable Electrophysiology Catheter with Lumen

Steerable Catheter

6F Reflexion™ Bidirectional Electrophysiology Catheter St. Jude Medical, Daig Division, Inc

The Reflexion CannulatorTM Steerable Electrophysiology Catheter with Lumen can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites when minimizing blood loss is essential.

C. Comparison of Required Technological Characteristics

All technological characteristics of the Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling.

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Support of the Substantial Equivalence D.

St. Jude Medical, Daig Division, Inc. considers the Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen, to be substantially equivalent to the predicate device, Reflexion™ Bidirectional Electrophysiology catheter.

St. Jude Medical St. Juision, Inc. Daig Division, nr.

Confidential and Proprietary
Confidential and Proprietary
Posted NOT COPY DO NOT COPY

Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen St. Jude Medical, Daig Division, Inc. January, 2004 Confidential page 31 of 33

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Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

St. Jude Medical Daig Division, Inc. c/o Mr. Glenn Jacques Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345

Re: K040165

R040105
Trade Name: Reflexion Cannulator" Stecrable Electrophysiology Catheter with Lumen Regulation Number: 21 CFR 870.1280 Regulation Name: Stcerable Catheter Regulatory Class: Il (two) Product Code: DRA Dated: April 66, 2004 Received: April 08, 2004

Dear Mr. Jacques:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviouse your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninerou prior to may 20, 1978, its accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetor rear (ret) that as novice, subject to the general controls provisions of the Act. The Fourmal 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 may or day to 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. Glenn Jacques

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advised that I Dris issue that your device complies with other requirements of the Act that I DA has made a sond 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); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. production of allow you to begin marketing your device as described in your Section 510(k) 1 ms letter will anow you to ough inding of substantial equivalence of your device to a legally promatication: "The Presification 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), please If you desire specific at no 10 - 3 at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mich mation al 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,

R. Vochner

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

K040165 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen

Indications for Use:

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

Over-The-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lochner

Division Sign-Off) Jivision of Cardiovascular Devices

510(k) Number K0 40165

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Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).