INQUIRY AFOCUSII DIAGNOSTIC CATHETER

K101623 · St Jude Medical · DRF · Aug 13, 2010 · Cardiovascular

Device Facts

• Record ID: K101623
• Device Name: INQUIRY AFOCUSII DIAGNOSTIC CATHETER
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.

Device Story

Flexible, steerable, radiopaque diagnostic catheter; features distal double-loop design for circumferential cardiac structure mapping. Operates by recording intracardiac electrical signals and delivering stimulation during electrophysiological studies. Used by electrophysiologists in clinical settings; catheter shaft manipulated via handle to position distal loop; loop shape facilitates fluoroscopic visualization and insertion through sheaths. Output consists of electrical signals transmitted via connecting cable to external electrogram recording equipment. Enables mapping of atrial regions without frequent repositioning; benefits patient by facilitating precise diagnostic electrophysiological assessment.

Clinical Evidence

Bench testing only. Testing performed in accordance with 'Electrode Recording Catheter Preliminary Guidance, Draft Version' (March 1995). Results demonstrated reliable performance.

Technological Characteristics

Flexible, radiopaque catheter with multiple band electrodes; steerable shaft with distal double-loop geometry. Single-use, sterile. Connects to external electrogram recording devices. No software or active electronic components within the catheter itself.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiological studies requiring intracardiac signal recording and cardiac stimulation, specifically for mapping atrial regions 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

• Inquiry™ AFocusII™ Steerable Electrophysiology Catheter (K042775)
• St. Jude Medical Reflexion HD™ High-Density Mapping Catheter (K080179)

Submission Summary (Full Text)

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K101623
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## Section 14

## Summary Of Safety And Effectiveness

AUG 1 3 2010

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.

- Submitter's name, address, telephone number, contact person, and date summary 1. prepared:

| a. | Submitter: | Irvine Biomedical, Inc.<br>a St. Jude Medical Company<br>2375 Morse Avenue<br>Irvine, CA 92614<br>Tel. [phone] |
|----|------------|-----------------------------------------------------------------------------------------------------------------------|
|----|------------|-----------------------------------------------------------------------------------------------------------------------|

- b. Contact Person: Quynh Phuong Le Regulatory Affairs Specialist II Tel. [phone]
- Date Summary Prepared: June 8, 2010 C.

#### 2. Name of device, including trade name and classification name:

- Trade/Proprietary Name: InquiryTM AFocusIITM Diagnostic Catheter a.
- Catheter, Electrode Recording b. Classification names:
- 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Company: | Irvine Biomedical, Inc<br>a St. Jude Medical Company |
|---------------|--------------------------------------------------------|
| Device: | Inquiry™ AFocusII™ Steerable Electrophysiology Cathete |
| 510(k): | K042775 |
| Date Cleared: | November 4, 2004 |

Company: St. Jude Medical Reflexion HDTM High-Density Mapping Catheter Device: 510(k): K080179 Date Cleared: January 7, 2009

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## A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

The Inquiry™ AFocusII™ Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices.

The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

#### Statement of intended use: 5.

The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic catheters are to be used to map the atrial regions of the heart.

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

The Inquiry™ AFocusII™ Diagnostic Catheter and its predicate devices are intended for electrogram recording and stimulation during electrophysiological studies. The encertifications do not affect the intended use or scientific technology of the device, as embodied in the catheter.

#### Brief summary of nonclinical tests and results: 7.

The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the The belieft tosument "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

100 13 WW

St. Jude Medical c/o Ms. Quynh Phuong Le Regulatory Affairs Specialist II Atrial Fibrillation Division 2375 Morse Avenue Irvine, CA 92614-6233

Re: K0101623

> Trade/Device Name: Inquiry AFocusII Diagnostic Catheter Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: II (two) Product Code: DRF Dated: June 08, 2010 Received: June 09, 2010

Dear Ms. Le:

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 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 - Ms. Quynh Phuong Le

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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W.W.S.

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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# Section 13

## Indications for Use

510(k) Number (if known): K101623

AUG 13 2010

Device Name: InquiryTM AFocusII™ Diagnostic Catheter

Indications for Use:

The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.

Prescription Use X (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)

W.M.S.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

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