IntellaMap Orion High Resolution Mapping Catheter

K220796 · Boston Scientific Corporation · DRF · Jun 10, 2022 · Cardiovascular

Device Facts

• Record ID: K220796
• Device Name: IntellaMap Orion High Resolution Mapping Catheter
• Applicant: Boston Scientific Corporation
• Product Code: DRF · Cardiovascular
• Decision Date: Jun 10, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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

Device Story

IntellaMap Orion is an 8.5 French, 115 cm steerable catheter with a 64-electrode basket-shaped distal array. Used by electrophysiologists in clinical settings for cardiac mapping. Features bidirectional articulation and a deployment slider to expand the electrode array within the heart. Includes a flushing port for saline drip and an integrated sensor for spatial tracking when used with the RHYTHMIA HDx Mapping System. Device records or stimulates cardiac tissue to assist in electrophysiological assessment. Provides high-resolution mapping data to clinicians to guide clinical decision-making during cardiac procedures.

Clinical Evidence

No clinical data provided; not applicable for this Special 510(k) submission.

Technological Characteristics

8.5 French (2.82mm) diameter, 115 cm length, 64-electrode steerable catheter. Features basket-shaped distal array with 8 splines. Includes bidirectional articulation, deployment slider, and flushing port. Integrated sensor for spatial tracking. Sterilization and materials are identical to the predicate device.

Indications for Use

Indicated for electrophysiological mapping (recording or stimulating only) of cardiac structures. No specific patient population, age, or gender restrictions provided.

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

• IntellaMap Orion™ High Resolution Mapping Catheter (K192360)

Submission Summary (Full Text)

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June 10, 2022

Boston Scientific Corporation Melissa Schneider Senior Regulatory Affairs Specialist 4100 Hamline Ave North St. Paul, Minnesota 55112

Re: K220796

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: March 17, 2022 Received: March 18, 2022

Dear Melissa Schneider:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220796

Device Name

IntellaMap Orion™ High Resolution Mapping Catheter

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary for IntellaMap Orion™ High Resolution Mapping Catheter - K220796

#### 1. Submitter

Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112

#### Contact:

Melissa Schneider Regulatory Affairs Specialist Phone: [phone] E-mail: melissa.schneider(@bsci.com Oliver Buttleman Regulatory Affairs Specialist Phone: [phone] E-mail: [e-mail]

Date Prepared: March 17, 2022

#### 2. Device

Trade Name: IntellaMap Orion™ High Resolution Mapping Catheter Common Name: IntellaMap Orion Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220

#### 3.Predicate Device

Trade Name: IntellaMap Orion™ High Resolution Mapping Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K192360 Common Name: IntellaMap Orion Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220

### 4. Device Description

The IntellaMap Orion™ High Resolution Mapping Catheter (Orion catheter) is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter.

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The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bidirectional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.

## 5. Indications for Use

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

## 6. Technological Characteristics

The IntellaMap Orion catheter incorporates the identical design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device.

### 7. Substantial Equivalence

The proposed labeling modifications of the IntellaMap Orion catheter, including updated contraindications does not impact the device's substantial equivalence to the previously cleared version of this device. The device is as safe, as effective, and performs as well as the predicate device. The indications for use, intended use, classification, product functions, materials, configuration, and sterility are substantially equivalent to the predicate device.

### 8. Performance Data

Not applicable for the changes proposed in this Special 510(k).

### 8. Conclusion

The proposed IntellaMap Orion catheter is equivalent in indications for use, intended use, classification, product functions, materials, configuration, and sterility to the predicate device, the IntellaMap Orion catheter. Therefore, Boston Scientific believes the proposed IntellaMap Orion catheter to be substantially equivalent to the predicate IntellaMap Orion catheter.