EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

K033050 · Medtronic Vascular · DRF · Mar 26, 2004 · Cardiovascular

Device Facts

• Record ID: K033050
• Device Name: EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
• Applicant: Medtronic Vascular
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Encirclr AL catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.

Device Story

Diagnostic catheter with control handle and 7F shaft transitioning to 5F distal tip; features adjustable loop with 10 radiopaque electrodes and non-active distal tip. Nickel/titanium forming wire provides memory/elasticity for loop diameter adjustment (14-28mm) to fit ostial anatomy. Used by physicians in clinical EP settings to map/pace atrial tissue. Connects via 10-pin cable to standard EP recording systems. Input: intracardiac electrical signals; Output: electrograms displayed on external recording system. Enables physician to identify cardiac electrical activity and perform temporary pacing to support diagnosis and treatment of arrhythmias.

Clinical Evidence

Bench testing only. Electrical and mechanical testing performed to demonstrate functional equivalence to the predicate device. No clinical data provided.

Technological Characteristics

7F to 5F catheter shaft; nickel/titanium forming wire; 10 radiopaque electrodes (.75-1.3mm width). Adjustable loop diameter (14-28mm). Connects to standard EP recording systems via 10-pin connector. Sterile, single-use. No software or active electronic components within the catheter itself.

Indications for Use

Indicated for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.

Regulatory Classification

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.

Predicate Devices

• StableMapr (K981642)

Submission Summary (Full Text)

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MAR 2 6 2004

Special 510(k) Exhibits

Encirclr™ AL Diagnostic Catheter

## Exhibit l

| Submitter: | Medtronic, EP Systems Inc.<br>CRM East Facility<br>7000 Central Avenue<br>Fridley, MN 55432 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mac McKeen, RAC<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Cell: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 17, 2003 |
| Trade Name: | Encirclr™ AL |
| Classification Name and Number: | 21 CFR 870.1220 |
| Product 1642: | DRF |
| Predicate Device Name and 510(k)<br>Number | StableMapr<br>K981642<br>Cleared August 5, 1998 |
| Device Description: | DEVICE DESCRIPTION<br>The device consists of a control handle and a<br>closed lumen 7 French catheter shaft that<br>transitions to a 5 French distal tip section. The<br>distal tip section has an adjustable loop with 10<br>evenly spaced radiopaque active electrodes that<br>are .75 to 1.3 mm in width, and a non-active 5<br>French distal tip. The catheter contains two<br>control wires, insulated recording wires, and a<br>nickel/titanium forming wire which has memory<br>and elasticity that allows for adjustability of the<br>loop. The control handle enables the user to steer<br>the device, and adjust the diameter of the loop at<br>the distal end of the catheter in order to fit<br>various ostial anatomy. These catheters are<br>available in four models (1045AL1, 1045AL2,<br>1060AL1, 1060AL2) with a usable length of 110<br>cm measuring from the strain relief to the center<br>of the distal loop. They have curve reaches that |
| | range from 45 to 60 mm, and adjustable loop<br>diameters that range from 14 to 28 mm (AL1's<br>range is14-22mm and AL2's range is 18-28mm).<br>The catheter connects to a cable that serves as the<br>interface between the catheter and a standard EP<br>recording system using a Medtronic 10-pin<br>connector cable. The catheter is supplied sterile<br>and is intended for single-use. |
| Indication for Use: | The Encirclr AL catheter is intended for<br>electrophysiologic mapping, recording<br>intracardiac electrograms, and temporary pacing<br>in the atria of the heart. |
| Statement of Technological<br>Comparison | Representative samples of the device underwent<br>electrical and mechanical testing to demonstrate<br>comparable functional and performance<br>characteristics to the predicate device. The<br>patient contact materials of the Encirclr AL are<br>identical to those used in other legally marketed<br>predicate devices from Medtronic that have<br>undergone appropriate biocompatibility testing.<br>Therefore biocompatibility testing of the Encirclr<br>has been fulfilled by analogy to those catheters. |
| Conclusion: (statement of<br>equivalence) | The Encirclr AL is substantially equivalent to the<br>StableMapr EP catheter. This conclusion is based<br>upon the fact that this device is substantially<br>equivalent to the predicate device in terms of<br>functional design, materials, intended use, and<br>principles of operation. |

## 510(k) Summary

C Confidential

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KO33050
p.2012

## Special 510(k) Exhibits

Encirclr™ AL Diagnostic Catheter

Image /page/1/Picture/4 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image of a person inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Medtronic, Inc. c/o Mr. Mac McKeen, RAC Principal Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432

Re: K033050

. Trade Name: Encirclr™ AL Adjustable Loop Mapping Catheter Regulation Number: 21 CFR 870 1220 Regulation Name: 21 CFR 878 1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: January 14, 2004 Received: January 15, 2004

Dear Mr. McKeen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your section 310(t) presidentially equivalent (for the indications for use stated in the enclosure) the are are are are are are as marketed in interstate for use stated in the encrosule) to regard the Medical Device Amendments, or (or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug, devices mat have been recuired in wore approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, merclore, market the do rec, nolude requirements for annual registration, listing of general controls provisions of the riot rest 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 If your device is classified (500 abs. 9) ins. Existing major regulations affecting your device can may be subject to such additional controller Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of I cases oncerning your device in the Federal Register.

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Page 2 -- Mr. Mac McKeen, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast oc advised that I Dr is assum that your device complies with other requirements of the Act that I D. I has made a aved regulations administered by other Federal agencies. You must or any I coclar batated and regisments, including, but not limited to: registration and listing (21 Comply with an the 11et 31equirements,01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) see as described in your Section 510(k) This letter with anow you to begin mailing of substantial equivalence of your device to a legally prematicated predicated on "The stassification 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 advice for your at [phone]. 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 international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincercly yours,

Duna R. la lunel

QLBram 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):_ K033050

Device Name: Encirclr™ AL Adjustable Loop Mapping Catheter

Models 1045AL1, 1045AL2, 1060AL1, 1060AL2

Indications For Use:

The Encirclr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Duma R-Vichner

Division Sign-Off) ivision of Cardiovascu'a Devices

10/k) Number_K033050

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