Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

K212776 · Innovative Health, LLC · NLG · Dec 20, 2021 · Cardiovascular

Device Facts

• Record ID: K212776
• Device Name: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
• Applicant: Innovative Health, LLC
• Product Code: NLG · Cardiovascular
• Decision Date: Dec 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Device Story

Irrigated, steerable, flexible electrophysiology catheter; used for mapping cardiac structures. Input: electrical signals from heart tissue via 16 noble metal electrodes. Operation: physician manipulates handle-based control mechanism to deflect catheter shaft; catheter records electrograms or provides stimulation. Output: electrograms displayed on compatible EnSite Velocity or EnSite Precision cardiac mapping systems. Used in clinical electrophysiology labs by physicians. Reprocessed device; intended to provide diagnostic mapping data to assist in clinical decision-making for cardiac arrhythmias; benefits patient by enabling precise localization of cardiac electrical activity.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, cleaning and sterilization validation, visual inspection, dimensional verification, electrical continuity, simulated use, mechanical characteristics, and electrical safety (dielectric and current leakage).

Technological Characteristics

Thermoplastic elastomer construction; 16 noble metal electrodes; 8F French size; 110cm usable length. Steerable shaft with handle-based control. Compatible with EnSite Velocity and EnSite Precision systems. Reprocessed device (max 3 cycles).

Indications for Use

Indicated for patients requiring electrophysiological mapping of cardiac structures, specifically for recording or stimulation in atrial and ventricular regions.

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

• Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K200212)
• Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393)

Reference Devices

• Reprocessed Advisor FL, Sensor Enabled, Circular Mapping Catheter (K181458)
• Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K190785)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

December 20, 2021

Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K212776

Trade/Device Name: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLG Dated: August 31, 2021 Received: September 1, 2021

Dear Amanda Babcock:

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,

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

Enclosure

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The item number included in the scope of this submission is as follows:

The item number included in the scope of this submission is as follows:

| Item Number | Description | Usable<br>Length<br>(cm) | French<br>Size | Curve | Spacing<br>(mm) | Electrodes | System<br>Compatibility |
|-------------|-----------------------------------------------------------------------|--------------------------|----------------|-------|-----------------|------------|--------------------------------------------------------------------------------|
| D-AVHD-DF16 | Reprocessed<br>Advisor HD Grid<br>Mapping Catheter,<br>Sensor Enabled | 110 | 8F | DF | 3 | 16 | EnSite<br>Velocity and<br>EnSite<br>Precision<br>Cardiac<br>Mapping<br>Systems |

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# Indications for Use

510(k) Number (if known) K212776

#### Device Name

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Indications for Use (Describe)

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

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

| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) SUMMARY

As required by 21 CFR 807.92

#### Submitter's Name and Address:

Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

### Contact Name and Information:

Amanda Babcock Requlatory Affairs Manager Innovative Health, LLC. [phone] (office) [phone] (fax) [e-mail]

## Date prepared:

August 31, 2021

#### Device Information:

| Trade/Proprietary Name: | Reprocessed Advisor HD Grid Mapping Catheter,<br>Sensor Enabled |
|-------------------------|-----------------------------------------------------------------|
| Common or Usual Name: | Diagnostic Electrophysiology Mapping Catheter |
| Classification Name: | Electrode Recording Catheter or Electrode Recording<br>Probe |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLG |

#### Predicate Device:

| 510(k) Number | Device | Manufacturer |
|---------------|-----------------------------------------------------------------|-------------------------|
| K200212 | Reprocessed Advisor HD Grid Mapping<br>Catheter, Sensor Enabled | Innovative Health, LLC. |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor<br>Enabled | St. Jude Medical |

#### Reference Device:

| 510(k) Number | Device | Manufacturer |
|---------------|----------------------------------------------------------------------|-------------------------|
| K181458 | Reprocessed Advisor FL, Sensor Enabled,<br>Circular Mapping Catheter | Innovative Health, LLC. |
| K190785 | Reprocessed PentaRay Nav eco High-<br>Density Mapping Catheter | Innovative Health, LLC. |

#### Device Description:

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

The item number in scope of this submission is as follows:

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| ltem Number | Description | Usable<br>Length<br>(cm) | French<br>Size | Curve | Spacing<br>(mm) | Electrodes | System Compatibility |
|-------------|-----------------------------------------------------------------------|--------------------------|----------------|-------|-----------------|------------|-----------------------------------------------------------------------|
| D-AVHD-DF16 | Reprocessed<br>Advisor HD Grid<br>Mapping Catheter,<br>Sensor Enabled | 110 | 8F | DF | 3 | 16 | EnSite Velocity and<br>EnSite Precision<br>Cardiac Mapping<br>Systems |

Table 5.1: Device Scope

# Indications for Use:

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

# Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Advisor HD Grid Mapping Catheter (Sensor Enabled) are identical to the predicate device. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Catheter includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.

# Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. This included the following:

- Biocompatibility .
- . Cleaning Validation
- Sterilization Validation ●
- Functional testing ●
- . Visual Inspection
- . Dimensional Verification
- Electrical Continuity .
- . Simulated Use
- = Mechanical Characteristics
- . Electrical Safety Testing
- · Dielectric and Current Leakage
- . Packaging Validation

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is reprocessed no more than three (3) times. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

# Conclusion:

Innovative Health concludes that the Reprocessed Advisor HD Grid Mapping Catheter. Sensor Enabled, is substantially equivalent to the predicate devices described herein.

Page 2 of 2 Traditional 510(k) K212776