The Reflexion Spiral™ catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral™ catheter is to be used to map the atrial regions of the heart.

Device Description

The St. Jude Medical (SJM) Reflexion Spiral™ Variable Radius Catheter (Reflexion Spiral catheter) is a flexible, asymmetric, bi-directional, radiopaque variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.

The Reflexion Spiral catheter has a proximal handle (ComfortGrip™) that contains: 1) A shaft actuator mechanism for varying the asymmetrical sweep (90° sweep) and curl (180° curl) of the distal portion of the shaft. 2) A loop actuator mechanism for varying the loop diameter from approximately 25mm to approximately 15mm. 3) An electrical connector fitted into the proximal end of the handle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance targets. Instead, it relies on demonstrating equivalence to a predicate device. The performance is described in a comparative manner rather than against pre-defined numerical thresholds.

Criterion Type	Acceptance Criteria (as implied)	Reported Device Performance
Intended Use	The device must be suitable for recording intracardiac signals and cardiac stimulation during electrophysiology studies, specifically for mapping atrial regions.	"The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart." (Matches intended use)
Equivalence to Predicate Device	Equivalent performance in loop radius control and sweep/curl positioning control compared to the predicate device.	"The different proximal handles show equivalent performance of the loop radius control and sweep/curl positioning control and does not affect the intended use or the scientific technology of the device."
Safety and Effectiveness	Does not raise new issues of safety, effectiveness, or performance.	"The Reflexion Spiral catheter does not raise any new issues of safety, effectiveness or performance of the device."
Conformance to Standards	Conformance to FDA Guidance "Electrode Recording Catheter Preliminary Guidance, Draft Version," March 1995 and ISO 10555-1.	"The test results indicate conformance to the standards and reliable performance when used in conformance with the device Instructions for Use."
Technological Characteristics	The technological characteristics should be comparable to the predicate device, not affecting intended use or scientific technology.	"The Reflexion Spiral catheter and the predicate IBI Inquiry™ Optima™ catheter are both intended for electrogram recording and stimulation during electrophysiological studies. The different proximal handles show equivalent performance...and does not affect the intended use or the scientific technology of the device." (Confirms comparability and functional equivalence despite design differences)

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

Sample Size for Test Set: The document does not specify a patient or clinical sample size for the test set. The testing described is primarily non-clinical (bench and animal data).
Data Provenance: The data comes from bench testing and animal studies conducted by St. Jude Medical. No information on country of origin of data or whether it was retrospective or prospective is provided for the non-clinical tests.

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

Number of Experts: This information is not provided in the document.
Qualifications of Experts: This information is not provided in the document.

Given that the studies were primarily non-clinical (bench and animal), "ground truth" would likely refer to engineering specifications or physiological measurements in the animal model, rather than expert interpretation of clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Adjudication Method: Not applicable/Not mentioned. Since the studies were non-clinical (bench and animal) and no expert review of clinical cases is described, there would be no need for a human adjudication method for establishing ground truth as would be relevant in a clinical imaging or diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device in question is a physical medical catheter, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: Not applicable/Not done in the context of an algorithm. The device is a physical catheter, not an algorithm. The "standalone performance" was demonstrated through bench testing and animal data to show its functional capabilities and safety, independent of human interpretive assistance (as it's a tool for direct physiological measurement/stimulation).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Ground Truth Type: For the non-clinical tests, the "ground truth" would be established by:
- Engineering Specifications: For bench testing of loop radius control, sweep/curl positioning, and electrical characteristics.
- Physiological Measurements/Observation: In animal studies, to ensure the catheter can record intracardiac signals and provide cardiac stimulation as intended, and to assess biocompatibility and safety.
- Compliance with Standards: Meeting the requirements outlined in FDA Guidance and ISO 10555-1.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set Establishment: Not applicable. There is no training set for this device.

Summary of Study and Device Performance:

The study described for the Reflexion Spiral™ Variable Radius Catheter is a non-clinical study primarily consisting of:

Bench Testing: To evaluate functional performance aspects like loop radius control and sweep/curl positioning, comparing them to the predicate device.
Animal Data: Likely to assess in-vivo performance, safety, and biocompatibility.

The purpose of these studies was to demonstrate substantial equivalence to a currently marketed predicate device (Irvine Biomedical, Inc., (IBI) Inquiry™ Optima™ Steerable Electrophysiology Catheter K042775) and conformance to relevant industry standards (FDA Guidance and ISO 10555-1). The document asserts that the device achieves functional equivalence to the predicate and does not introduce new safety or effectiveness concerns, thereby meeting the requirements for 510(k) clearance by the FDA.

Summary

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510(k) Summary

As required by 21 CFR 807.92(c)

KO62251 510(k) Number: _

OCT 2 0 2006

Date Prepared:

August 2, 2006

1. Submitter Information:

Submitter's Name/Address:	St. Jude Medical14901 DeVeau PlaceMinnetonka, MN 55345-2126
Contact Person:	Glenn JacquesRegulatory Affairs Manager

2. Device Information:

Trade Name:	Reflexion Spiral™ Variable Radius Catheter
Common Name:	Catheter, electrode recording
Classification Name:	Catheter, electrode recording or probe, electrode recording
Class:	Class II, 21 CFR 870.1220, Product Code DRF

Tel: 952-351-1356 Fax: 952-930-9481 gjacques@sjm.com

3. Predicate Device:

Irvine Biomedical, Inc., (IBI) Inquiry™ Optima™ Steerable Electrophysiology Catheter (K042775)

4. Device Description:

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5. Indications for Use:

The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:

The Reflexion Spiral catheter and the predicate IBI Inquiry™ Optima™ catheter are both intended for electrogram recording and stimulation during electrophysiological studies. The different proximal handles show equivalent performance of the loop radius control and sweep/curl positioning control and does not affect the intended use or the scientific technology of the device.

7. Brief summary of non-clinical tests and results:

The test plan for the Reflexion Spiral catheter was based on FDA Guidance "Electrode Recording Catheter Preliminary Guidance, Draft Version," March 1995 and ISO 10555-1, Sterile Single-Use Intravascular Catheters Part 1: General Requirements. The test results indicate conformance to the standards and reliable performance when used in conformance with the device Instructions for Use. The Reflexion Spiral catheter does not raise any new issues of safety, effectiveness or performance of the device.

8. Statement of Equivalence:

Through the comparison data, the equivalence evaluation, and supporting bench and animal data, SJM considers the Reflexion Spiral™ Variable Radius Catheter to be substantially equivalent to the Irvine Biomedical, Inc. Inquiry™ Optima™ Steerable Electrophysiology Catheter.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2006

St. Jude Medical Atrial Fibrillation Division c/o Mr. Glenn Jacques Regulatory Affairs Manager 14901 DeVeau Place Minnetonka MN 55345

Re: K062251

Trade/Device Name: Reflexion Spiral Variable Radius Catheter, Model 402804 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II Product Code: DRF Dated: August 2, 2006 Received: August 4, 2006

Dear Mr. Jacques:

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 market to in intristate 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, Dr ug 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, istin gof 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, IDA max 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); good manufacturing practice requirements as set

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Page 2 - Mr. Glenn Jacques

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 letter 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 varied to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 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/industry/support/index.html .

Sincerely yours,

Bhimmar for
Dr. D. Zochowski, M.D.

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): _K 06225 | _________________________________________________________________________________________________________________________________________

Device Name: Reflexion Spiral™ Variable Radius Catheter

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimnima

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Nu

Page 1 of 1

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).