INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER

K060757 · Irvine Biomedical, Inc. · DRF · Apr 19, 2006 · Cardiovascular

Device Facts

• Record ID: K060757
• Device Name: INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
• Applicant: Irvine Biomedical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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

Device Story

Inquiry Optima PLUS is a steerable, radiopaque electrophysiology catheter used by electrophysiologists in clinical settings. It features a distal loop with 20 electrodes and a catheter shaft with 4 additional electrodes for recording cardiac potentials and stimulation. The device is inserted into the heart; the distal loop shape is adjustable via a handle-mounted rotating knob, while a push/pull mechanism controls distal deflection. The loop is flexible, allowing it to be straightened for insertion through sheaths and introducers, resuming its pre-formed shape upon exit. The catheter connects to external electrogram recording devices via a cable. By providing multi-electrode contact around cardiac structures, it enables mapping of atrial regions without requiring frequent repositioning of the catheter shaft. This facilitates diagnostic procedures, potentially reducing procedure time and improving signal acquisition for clinical decision-making.

Clinical Evidence

Bench testing only. Testing was conducted in accordance with the FDA guidance document 'Electrode Recording Catheter Preliminary Guidance, Draft Version' (March 1995). Results demonstrated reliable performance consistent with the predicate device.

Technological Characteristics

Flexible, radiopaque steerable catheter; 7Fr shaft (Pebax); distal loop with 20 Platinum/Iridium electrodes; 4 additional Platinum/Iridium electrodes on shaft; Copper/Nickel alloy conductor wires; uni-directional 0-180° deflectable distal end; adjustable loop diameter (15-25mm); handle with push/pull steering and loop adjustment knob; 24-pin connector; supplied sterile for single use.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiology studies requiring recording of intracardiac signals 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 Optima Steerable Electrophysiology Catheter (K042775)

Submission Summary (Full Text)

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K060757

## : | | | | 1 0 2006 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.

- Submitter's name, address, telephone number, contact person, and date summary l. prepared:
Submitter: Irvine Biomedical, Inc. 2375 Morse Avenue Irvine, CA 92614 Tel. [phone]

Contact: Dennis Hong Regulatory Affairs Manager Tel. [phone] March 18, 2006 Date:

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

| a. | Trade/Proprietary Name: | Inquiry™ Optima™ PLUS Steerable<br>Electrophysiology 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 Optima Steerable Electrophysiology Catheter 510(k): K042775 Date Cleared: November 4, 2004

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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 Optima PLUS 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 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 shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop and on the shaft of the catheter 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.

- 5. Statement of intended use:
The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima 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 Optima and Inquiry Optima PLUS Steerable Electrophysiology Catheters are intended for electrogram recording and stimulation during electrophysiological studies. The modification in additional electrodes on the shaft of the Inquiry Optima PLUS catheter does not affect the intended use or scientific technology of the device.

- 7. Brief summary of non-clinical tests and results:
The test plan for the Inquiry Optima PLUS Steerable Electrophysiology Catheter was based on the guidance document "Electrode Recording Catheter Preliminary Guidance, Draft Version", March 1995. The test results indicated reliable performance when the device was used in accordance with the Instructions for Use. The Inquiry Optima PLUS catheter does not raise new issues of safety, effectiveness, or performance of the product.

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8.

The Inquiry Optima Steerable EP Catheter and the Inquiry Optima PLUS Steerable EP catheter are both intended to be used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. In comparison to the Inquiry Optima Steerable EP Catheter, the Inquiry Optima PLUS Steerable EP Catheter has 4 additional electrodes. The similarities and differences between these catheters are tabularized below.

Choorg

| Product Description | Inquiry Optima Steerable EP<br>Catheter (K042775) | Inquiry Optima PLUS Steerable<br>EP Catheter |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Variable loop, steerable diagnostic<br>catheter | Same |
| Size | 7Fr Shaft, 4-5Fr Loop | Same |
| Usable Length | 110cm | Same |
| Electrode Number on<br>Loop | 10 - 20 electrodes | 20 electrodes |
| Size (width, diameter) of<br>Electrode on Loop | 0.6 mm - 1.0 mm width<br>4 Fr - 5 Fr diameter | 1.0 mm width<br>5 Fr diameter |
| Electrode Number on<br>Shaft | None | 4 electrodes |
| Size (width, diameter) of<br>Electrode on Shaft | None | 1 mm width<br>7 Fr diameter |
| Distal Tip Electrode<br>(length, diameter) | 1 mm - 2 mm length,<br>4 Fr - 5 Fr diameter | 1mm length<br>5 Fr diameter |
| Electrodes Material | Platinum / Iridium | Same |
| Electrode Profile | Each band has adhesive applied on<br>both ends of the electrode | Same |
| Type of Curve | The catheter has a uni-direction 0-<br>180° deflectable distal end, SM<br>curve and an adjustable loop | Same |
| Loop Size | Adjustable, minimum is 15mm<br>diameter, maximum is 25mm<br>diameter | Same |
| Type of Catheter Outer<br>Shaft | 7 Fr size, non braided on distal,<br>braided on proximal | Same |
| Material of Catheter<br>Outer Shaft | Pebax | Same |
| Handle and Connector | The handle has a push/pull<br>mechanism to steer the distal<br>deflection curve and a rotating<br>knob to adjust the distal loop<br>diameter. The handle has a<br>connector with 10 to 24 pins<br>attached at the back of the handle. | The handle has a push/pull<br>mechanism to steer the distal<br>deflection curve and a rotating<br>knob to adjust the distal loop<br>diameter. The handle has a<br>connector with 24 pins attached at<br>the back of the handle. |
| Type of Conductor Wire | Electrodes use a Copper / Nickel<br>Alloy | Same |
| Single Use or Usable | Single Use only | Same |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

Irvine Biomedical, Inc. c/o Mr. Dennis Hong Regulatory Affairs Manager 2375 Morse Avenue Irvine, CA 92614

Re: K060757

Trade Name: Inquiry™ Optima™ PLUS Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: March 20, 2006 Received: March 21, 2005

Dear Mr. Hong:

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. Ilisting 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 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 - Mr. Dennis Hong

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 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 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,

Bhimmar 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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## KO60757

## Indications for Use

KOBO757 510(k) Number: Inquiry Optima PLUS Steerable Electrophysiology Catheter Device Name: The Inquiry Optima Catheter is a steerable electrophysiology Indications for Use: catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima 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)

Blumina

(Division Sig
Division of Cardio vascular Devices
510(K) Number: K060757

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