IntellaMap Orion High Resolution Mapping Catheter

K143481 · Rhythmia Medical, Inc. · DRF · Jan 8, 2015 · Cardiovascular

Device Facts

• Record ID: K143481
• Device Name: IntellaMap Orion High Resolution Mapping Catheter
• Applicant: Rhythmia Medical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jan 8, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Device Story

The IntellaMap Orion™ is an 8.5 French, 115 cm, bidirectional, 64-electrode, basket-shaped diagnostic catheter. It is used by electrophysiologists in a clinical setting to acquire 64 simultaneous electrograms from cardiac tissue. The device features a polymer handle for steering and array deployment, a polymer shaft, and a distal mapping section with platinum/iridium electrodes. A flushing port provides continuous irrigation to the electrode array. The catheter is inserted percutaneously through an introducer sheath. By recording electrical signals from the heart, the device assists clinicians in mapping cardiac structures to guide clinical decision-making during electrophysiology procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing of the modified handle design to verify it meets the performance requirements of the predicate device.

Technological Characteristics

8.5 French (2.8mm) diameter, 115 cm length, bidirectional steering. 64-electrode non-linear basket array. Materials: polymer handle/shaft, platinum/iridium electrodes. Includes flushing port for continuous irrigation. Supplied sterile, single-use. Standalone diagnostic catheter.

Indications for Use

Indicated for electrophysiological mapping (recording or stimulating) of cardiac structures in patients requiring diagnostic cardiac electrophysiology procedures.

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

• Rhythmia Mapping Catheter (K122461)

Submission Summary (Full Text)

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

January 8, 2015

Rhythmia Medical, Inc Frank Jurczak Manager, Regulatory Affairs 111 South Bedford St Suite 205 Burlington, Massachusetts 01803

Re: K143481

> Trade/Device Name: IntellaMap Orion High Resolution Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: December 5, 2014 Received: December 9, 2014

Dear Frank Jurczak,

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

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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 yours,

Melissa A. Torres -S

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 Statement

| 510(k) Number (if known): | K143481 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | IntellaMap Orion™ High Resolution Mapping Catheter |
| Indications for Use: | The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. |

Prescription Use __X

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Rhythmia Medical. The logo features a cluster of blue hexagons on the left side, with the hexagons gradually fading to white as they move to the right. To the right of the hexagons, the word "RHYTHMIA" is written in a bold, dark blue font, and below it, the word "medical" is written in a lighter blue font.

## 510(k) Summary of Safety and Effectiveness

## Rhythmia Medical, Inc.

#### IntellaMap Orion™ High Resolution Mapping Catheter

#### General Information

- Date Compiled December 5, 2014
- Classification Class II, 21 CFR § 870.1220, Electrode Recording Catheter or Electrode Recording Probe, Product Code DRF (Catheter, Electrode Recording, or Probe, Electrode Recording)

Trade Name IntellaMap Orion™ High Resolution Mapping Catheter

- Submitter Rhythmia Medical, Inc. 111 South Bedford Street, Suite 205 Burlington, MA 01803
- Contact Frank Jurczak Sr. Manager, Regulatory Affairs Rhythmia Medical, Inc. 111 S Bedford St. Suite 205 Burlington, MA 01803 Phone: [phone] Fax: [phone] Email: [e-mail]

## Indications for Use

The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

## Predicate Device

Rhythmia Mapping Catheter, K122461, Manufactured by Rhythmia Medical, Inc.

#### Product Description

The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is

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Image /page/4/Picture/0 description: The image contains the logo for "Rhythmia medical". The logo features a cluster of blue hexagons on the left side, transitioning from dark blue to lighter shades, creating a gradient effect. To the right of the hexagons, the word "RHYTHMIA" is written in a bold, dark blue font. Below "RHYTHMIA", the word "medical" is written in a smaller, light blue font.

supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only.

The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

## Determination of Substantial Equivalence

Rhythmia Medical believes the proposed modification to the IntellaMap Orion™ High Resolution Mapping Catheter does not impact the device's substantial equivalence to the previously cleared version of this device and is as safe, as effective, and performs as well as the predicate device. The indications for use, intended use, product function, design and materials used, are either identical or substantially equivalent to previously cleared IntellaMap Orion™ High Resolution Mapping Catheter (formerly Rhythmia Mapping Catheter) predicate device.

## Conclusion

The proposed IntellaMap Orion™ High Resolution Mapping Catheter is equivalent in indications for use, intended use, product function, design and materials to the predicate device, the IntellaMap Orion™ High Resolution Mapping Catheter (formerly Rhythmia Mapping Catheter cleared in K122461).

Because of the similarities of indications for use, intended use, product function, design and materials, and verification testing, Rhythmia Medical, Inc. believes the IntellaMap Orion™ High Resolution Mapping Catheter to be substantially equivalent to the predicate device, the IntellaMap Orion™ High Resolution Mapping Catheter (formerly Rhythmia Mapping Catheter cleared in K122461).

## Summary of Non-Clinical Performance Data

Non Clinical performance of the modified IntellaMap Orion™ High Resolution Mapping Catheter has been fully evaluated based upon bench top testing referenced within this submission. The verification testing confirmed that the new handle design met the product performance requirements of the predicate device. Based on this result, the modified device can be considered substantially equivalent to the predicate.