IntellaMap Orion High Resolution Mapping Catheter

K192360 · Boston Scientific Corporation · DRF · Oct 25, 2019 · Cardiovascular

Device Facts

• Record ID: K192360
• Device Name: IntellaMap Orion High Resolution Mapping Catheter
• Applicant: Boston Scientific Corporation
• Product Code: DRF · Cardiovascular
• Decision Date: Oct 25, 2019
• Decision: SESE
• Submission Type: Traditional
• 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

IntellaMap Orion is an 8.5 French, 64-electrode steerable catheter with a basket-shaped distal array (8 splines). Used for electrophysiological mapping (recording/stimulating) of cardiac structures. Operated by physicians in clinical settings. Features bi-directional articulation and deployment slider to expand basket array within the heart. Includes flushing port for saline drip. Integrated sensor enables spatial tracking when used with RHYTHMIA HDx™ Mapping System. Provides high-resolution electrical data to assist clinicians in identifying cardiac arrhythmias; facilitates targeted therapy delivery.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included electrical testing, reliability, joint strength, tip buckle, visual/dimensional inspections, and simulated use. Biocompatibility testing performed per ISO 10993-1:2018, including cytotoxicity, hemolysis, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and complement activation. All tests passed.

Technological Characteristics

8.5F (2.82mm) diameter, 115cm length, 64-electrode basket array. Steerable design with bi-directional articulation. Includes integrated sensor for spatial tracking. Materials evaluated per ISO 10993-1. Sterilization method not specified. Connectivity via cable/connector to RHYTHMIA HDx Mapping System.

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 (K143481)

Submission Summary (Full Text)

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October 25,2019

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

Re: K192360

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: August 29, 2019 Received: August 30, 2019

Dear Nicole Lyden:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K192360

#### Device Name

IntellaMap Orion™ High Resolution Mapping Catheter

Indications for Use (Describe)

The IntellaMap Orion™ High Resolution Mapping 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) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size:20px">☒</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div><span style="font-size:20px">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

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Image /page/3/Picture/0 description: The image contains the logo for Boston Scientific. The logo is in blue and features the words "Boston" and "Scientific" stacked on top of each other. The font is a serif typeface, and the overall design is simple and professional.

Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 [phone]

www.bostonscientific.com

#### 510(k) Summary for IntellaMap Orion™ High Resolution Mapping Catheter K192360

#### 1. Submitter

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

#### Contact:

Benjamin Dollins, JD Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone] E-mail: [e-mail]

Nicole Lyden Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date Prepared: August 29, 2019

## 2. Device

Trade Name: IntellaMap Orion™ Common Name: IntellaMap Orion High Resolution Mapping 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™ Manufacturer: Boston Scientific Corporation Clearance Number: K143481 Common Name: IntellaMap Orion High Resolution Mapping Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF

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Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220

# 4. Device Description

The IntellaMap Orion High Resolution Mapping Catheter is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. 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 bi-directional 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 High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

## 6. Technological Characteristics

The IntellaMap Orion High Resolution Mapping Catheter incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device.

## 7. Substantial Equivalence

The proposed modifications to the IntellaMap Orion High Resolution Mapping Catheter flexible printed circuit assembly, feeder tube, feed tube strain relief, and insertion sleeve do not impact the device's substantial equivalence to the previously cleared version of this device. The modified 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

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and design verification tests to provide evidence of substantial equivalence for the IntellaMap Orion High Resolution Mapping Catheter. The device has been verified through the following:

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Design Verification Bench Testing The Design Verification Bench Testing included:

| Test | Results |
|-----------------------------------|---------|
| Electrical Testing | Pass |
| Reliability Testing | Pass |
| Catheter Joint Strength | Pass |
| Tip Buckle | Pass |
| Visual Inspections and Dimensions | Pass |
| Simulated Use | Pass |

Biocompatibility Testing

The following Biocompatibility Testing was completed on the IntellaMap Orion High Resolution Mapping Catheter in compliance with the requirements of ISO 10993-1: 2018 - Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.

| Test | Results |
|----------------------------------------------|---------|
| Cytotoxicity | Pass |
| Hemolysis Direct Contact and Extract Methods | Pass |
| Sensitization Maximization | Pass |
| Intracutaneous Irritation | Pass |
| Acute Systemic Toxicity | Pass |
| Materials Mediated Rabbit Pyrogen | Pass |
| Partial Thromboplastin Time | Pass |
| In Vitro Hemocompatibility | Pass |
| Complement Activation | Pass |
| USP Physicochemical Test | Pass |
| Latex Assay | Pass |

The test results demonstrate that the IntellaMap Orion High Resolution Mapping Catheter is considered safe and effective for its intended use.

## 9. Conclusion

The proposed IntellaMap Orion High Resolution Mapping Catheter is equivalent in indications for use, intended use, classification, product functions, materials, configuration, and sterility to the predicate device. Therefore, Boston Scientific asserts the proposed

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IntellaMap Orion High Resolution Mapping Catheter to be substantially equivalent to the predicate IntellaMap Orion High Resolution Mapping Catheter (cleared in K143481).