FIRMap Catheter

K163709 · Abbott Electrophysiology · MTD · Feb 28, 2017 · Cardiovascular

Device Facts

• Record ID: K163709
• Device Name: FIRMap Catheter
• Applicant: Abbott Electrophysiology
• Product Code: MTD · Cardiovascular
• Decision Date: Feb 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.

Device Story

FIRMap Catheter is a sterile, single-use intravascular device for cardiac electrophysiology. It features a distal, expandable 3D basket assembly with 64 electrodes across 8 splines. Delivered via sheath to heart chambers; sheath withdrawal allows basket expansion and electrode-to-wall contact. Device detects/records intracardiac electrical potentials and delivers pacing stimuli. Used by physicians in clinical electrophysiology settings. Radiopaque markers (platinum-iridium) assist in spline identification and orientation under fluoroscopy. Output consists of electrical signals used by mapping systems to assist in arrhythmia diagnosis. Benefits include improved diagnostic capability for arrhythmias difficult to identify with conventional linear catheters.

Clinical Evidence

Bench testing only. No clinical or animal data were conducted. Performance testing included radial strength, lateral strength, insertion/withdrawal cycling, torque, and pancake atrium tests to demonstrate substantial equivalence.

Technological Characteristics

Distal expandable 3D basket assembly with 64 electrodes on 8 splines. Electrodes spaced equally along splines. Radiopaque markers (platinum-iridium alloy) for orientation. Basket tip made of stainless steel. Single-use, EO gas sterilized. Complies with ISO 14971:2012, ISO 10555-1:2012, IEC 60601-1 (3rd Ed), and IEC 60601-1-2:2007.

Indications for Use

Indicated for patients undergoing cardiac electrophysiology procedures requiring diagnosis of complex arrhythmias and delivery of pacing stimuli.

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

• FIRMap Catheter (K153093)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## February 28, 2017

Abbott Electrophysiology Dennis Pozzo Senior Regulatory Affairs Specialist 3668 S. Geyer Road Suite 365 St. Louis, Missouri 63127

Re: K163709

Trade/Device Name: FIRMap Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: January 17, 2017 Received: January 18, 2017

Dear Dennis Pozzo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Yellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known)

K163709

#### Device Name

FIRMap Catheter

Indications for Use (Describe)

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Section 5: 510(k) Summary per 21CFR §807.92

| Submitter's<br>information | Abbott Electrophysiology<br>3668 S. Geyer Road, Suite 365, St. Louis, MO 63127<br>Contact: Dennis Pozzo<br>Phone [phone] |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/<br>classification<br>name | • Device Trade Name: FIRMap Catheter<br>• Classification/Common name: Electrode recording catheter or electrode<br>recording probe<br>• Product Code/Classification No.: MTD/21 CFR 870.1220<br>• The marketed device(s) to which substantial equivalence is claimed:<br>FIRMap Catheter. K153093, cleared April 7, 2016 |
| Device<br>description | The FIRMap Catheter is a sterile, single use device used to detect and record<br>intracardiac electrical potentials and to deliver externally generated pacing<br>stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may<br>also be used for delivery of externally generated pacing stimuli.<br>The FIRMap catheter is delivered to the heart chamber via an intravascular<br>sheath. After the catheter is positioned the sheath is withdrawn enough to<br>allow the basket to expand and the electrodes to contact the heart wall. |
| Indications for<br>use | For use in cardiac electrophysiology procedures to assist in the diagnosis of<br>arrhythmias that may be difficult to identify using conventional mapping<br>systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also<br>be used for delivery of externally generated pacing stimuli. |
| Technological<br>characteristics | The distal, expandable basket assembly is arranged into a three dimensional<br>"basket" shape. The basket assembly contains an array of 64 electrodes<br>mounted onto eight support structures called splines. Each spline has 8<br>electrodes spaced at an equal distance along the length of the spline.<br>The eight splines are fixed at an equal distance labeled A through H in a<br>clockwise direction if viewed from the catheter/basket's distal tip. The array<br>orientation is displayed by use of radiopaque markers. To distinguish splines<br>under fluoroscopy, Spline A has a larger radiopaque marker next to electrode<br>8, Spline B has a larger marker next to electrode 7, Spline C has an additional<br>marker next to electrode 6, and so onwards in progression to Spline G. |

Continued on next page

{4}------------------------------------------------

## Section 5: 510(k) Summary per 21CFR §807.92, Continued

| Device Characteristic | Predicate RhythmView<br>Workstation | Proposed RhythmView<br>Workstation |
|---------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Device Characteristic | Predicate FIRMap<br>Catheter (K153093) | Proposed FIRMap<br>Catheter |
| Intended Use | Intracardiac<br>electrophysiological<br>mapping and pacing. | Intracardiac<br>electrophysiological<br>mapping and pacing. |
| Splines expand | Yes | Yes |
| No. of Splines | 8 | 8 |
| No. of electrodes | 64 | 64 |
| Sterile | Yes | Yes |
| Method of sterilization | EO gas | EO gas |
| Single use | Yes | Yes |
| Radiopaque markers | Yes | Yes |
| Spline radiopaque material | platinum-iridium alloy | platinum-iridium alloy |
| Basket diameter/ Electrode<br>spacing | 50mm/ 9.0mm<br>60mm/ 11.2mm<br>70mm/13.5mm | 50mm/ 9.0mm<br>60mm/ 11.2mm<br>70mm/13.5mm |
| Basket Tip | Two Piece - Tip Dome<br>and Cap | Single Piece |
| Basket Tip Material | Stainless Steel | Stainless Steel |

Applicable standards

- ISO 14971: 2012, Medical Devices - Application of risk management to medical devices
- ISO 10555-1: 2012 Intravascular catheters Sterile and single-use ● catheters - Part 1: General requirements

Since there are no electrical updates, the EMC and Electrical Safety reports referenced in K153093 still apply.

- IEC 60601-1, 3rd Edition, Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Continued on next page

{5}------------------------------------------------

# Section 5: 510(k) Summary per 21CFR §807.92, Continued

| Performance<br>data | The following is a list of the tests conducted: Radial Strength, Lateral<br>Strength, Insertion/Withdrawal cycling, Torque and Pancake Atrium.<br>P q'animal or clinical testing was conducted. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The testing has demonstrated that the FIRMap catheter provides<br>reasonable assurance that the proposed device conforms to the<br>appropriate requirements for its intended use. Therefore, it is<br>substantially equivalent to the predicate device, safe and effective for<br>its intended use. |