INQUIRY AFOCUS II DIAGNOSTIC CATHETER

K053582 · Irvine Biomedical, Inc. · DRF · Mar 21, 2006 · Cardiovascular

Device Facts

• Record ID: K053582
• Device Name: INQUIRY AFOCUS II DIAGNOSTIC CATHETER
• Applicant: Irvine Biomedical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions of the heart.

Device Story

Inquiry AFocusII™ Diagnostic Catheter is a flexible, radiopaque, steerable electrophysiology catheter; features distal loop with multiple platinum-iridium electrodes for recording cardiac potentials and stimulation. Used by electrophysiologists in clinical settings; catheter inserted via sheaths/introducers; distal loop resumes pre-formed shape upon extension. Steerable handle allows precise positioning of electrodes against cardiac structures; loop shape assists in fluoroscopic visualization. Connects to external electrogram recording devices via cable. Enables mapping of atrial regions without frequent repositioning; facilitates diagnostic electrophysiology procedures; single-use, sterile device.

Clinical Evidence

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

Technological Characteristics

Flexible, radiopaque catheter; platinum-iridium electrodes; Pebax (33 series) tubing. Features steerable handle (unidirectional or bidirectional), pulling wires, flat wire, and hypo tube (in bidirectional models). Distal loop configuration. Sterile, single-use. No software or electronic processing components.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiology 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™ AFocus™ Steerable Electrophysiology Catheter (K042775)
• Inquiry™ AFocusII™ Steerable Electrophysiology Catheter (K042775)
• Inquiry™ Optima™ Steerable Electrophysiology (K042775)

Submission Summary (Full Text)

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MAR 2 ] 2006

K05 3582
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## SUMMARY OF SAFETY AND EFFECTIVENESS

## 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.

- ﺎ . Submitter's name, address, telephone number, contact person, and date summary prepared:
Submitter: Irvine Biomedical, Inc.

2375 Morse Avenue Irvine, CA 92614 Tel. [phone]

Contact Person: Elvia Zavala Regulatory Affairs Associate Tel. [phone] Date Summary Prepared: December 22, 2005 (Revised February 24, 2006)

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

| Trade/Proprietary Name: | Inquiry™ AFocusII™ Diagnostic Catheter |
|-------------------------|----------------------------------------|
|-------------------------|----------------------------------------|

- b. Classification names: Catheter, Electrode Recording
- 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Company: | Irvine Biomedical, Inc. |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device: | Inquiry™ AFocus™ Steerable Electrophysiology Catheter,<br>Inquiry™ AFocusII™ Steerable Electrophysiology Catheter,<br>Inquiry™ Optima™ Steerable Electrophysiology |
| 510(k): | K042775 |

Date Cleared: November 4, 2004

- 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™ Bi-Directional Steerable Electrophysiology 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

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K053582
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predetermined distances. A connecting cable is used to connect the catheter to electrogram devices.

The catheter has a distal 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 and/or loop are 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: న్.
For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping 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™ (bi-directional) Steerable Electrophysiology Catheter and its predicate devices are intended for electrogram recording and stimulation during electrophysiological studies. The modifications 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 test plan for the Inquiry™ AFocus™, Inquiry AFocusII™, or Inquiry™ Optima™ Steerable Electrophysiology Catheter was based on the guidance document "Electrode Recording Catheter Preliminary Guidance, Draft Version", March 1995. Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product.

- Comparison characteristics of uni-directional and bi-directional. 8.
The table below compares the design of unilateral catheter and bi-directional catheter.

| No. | Design | Inquiry AFocusIIT TM (Uni-Directional) Diagnostic Catheter | Inquiry AFocus TM (Bi-Directional) Diagnostic Catheter |
|-----|----------------------|------------------------------------------------------------|--------------------------------------------------------|
| 1 | Curve Configurations | SM curve | SM curve (symmetrical in both directions) |
| 2 | Electrodes | Platinum-iridium | Platinum-iridium |
| 3 | Tubing | Pebax (33 series) | Pebax (33 series) |
| 4 | Handle | Moves only way for | Moves up and down to allow |

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Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K05-3582" on the first line. The second line reads "page 3 of 3", indicating this is the third page of a three-page document. The handwriting is in black ink and appears to be cursive.

| | unidirectional steering | bidirectional steering |
|-----------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>5</b> Pulling Wire | Contains one pulling wire<br>for unidirectional steering | Contains two pulling wires for<br>bidirectional steering |
| <b>7</b> Flat Wire | Contains a flat wire | Contains a flat wire with a tail |
| <b>8</b> Hypo tube | None | Contains a hypo tube that<br>contains two channels where<br>one of them supports the<br>pulling wire and the other<br>supports the flat wire and a<br>second pulling wire |

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a low-resolution image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 ] 2006

Irvine Biomedical, Inc. c/o Elvia Zavala Regulatory Affairs Specialist 2375 Morse Ave. Irvine, CA 92614

Re: K053582

K033762
Trade Name: Inquiry™ AFocus II™ Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Probe Regulatory Class: Class II (two) Product Code: DRF Dated: February 24, 2006 Received: February 27, 2006

## Dear Ms. Zavala:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 910(x) premainted in the interest of in the indications
referenced above and have determined the device is substantially interests a referenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule for tegally manatible to the Medical Device American be and Food. Days commerce prior to May 28, 1776, the encenters and of the provisions of the Federal Food, Drug, devices that have been reclassified in accordance "Hat a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmelle Act (Act) that to not require appro the general controls provisions of the Act. The You may, increfore, market the device, subject to the memor registration, listing of
general controls provisions of the Act include requirements for annual registered in and general controls provisions of the Fee neides >> ]
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), in If your device is classffred (see above) me etails and one allecting your device can
may be subject to such additional controls. Existing major and contribution EDA move may be subject to such adultional controller estisons. Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar regular regular in the Federal Register. publish furner announcents concerning your as not issues and more of the more of the Act Please be advised that FDA s issualled of a saconamial squirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Elvia Zavala

or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 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 prematted 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), please contact the Office of Compliance 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

B. Ammerman for

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): ___K053582

Device Name: Inquiry AFocus II™ Diagnostic Catheter

Indications for Use: For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping 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)

(Division Sign Off)
Division of Cardiovascular Device:
510(k) Number

Page 1 of 1

(Posted November 13, 2003)

B. Simmons

h Sign-Off Division of Cardiovascular Devices 510(k) Number