Reprocessed DecaNav Diagnostic Electrophysiology Catheter

K180710 · Innovative Health, LLC · NLH · Jun 19, 2018 · Cardiovascular

Device Facts

• Record ID: K180710
• Device Name: Reprocessed DecaNav Diagnostic Electrophysiology Catheter
• Applicant: Innovative Health, LLC
• Product Code: NLH · Cardiovascular
• Decision Date: Jun 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus. The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.

Device Story

Diagnostic electrophysiology catheter; high-torque shaft with deflectable tip; platinum/iridium electrode array. Used for cardiac electrical signal recording and stimulation; provides tip location data when connected to Carto 3 EP Navigation System. Operated by physicians in clinical electrophysiology labs. Interfaces with standard recording equipment and navigation systems via interface cables. Reprocessed device; includes cleaning, decontamination, inspection, and functional testing. Benefits patient by enabling cardiac mapping and navigation during EP procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility, cleaning validation, sterilization validation, functional testing (visual inspection, dimensional verification, electrical continuity/resistance, simulated use, mechanical characteristics), electrical safety testing (dielectric and current leakage), and packaging validation.

Technological Characteristics

7 French diagnostic EP catheter; platinum/iridium electrodes; deflectable tip with proximal hand piece; thumb-operated sliding piston. Compatible with Carto 3 magnetic field navigation system. Reprocessed device; limited to one reprocessing cycle. Materials and design identical to predicate.

Indications for Use

Indicated for electrophysiological mapping, recording, and stimulation of cardiac structures, including the Coronary Sinus, in patients requiring 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

• CS RefStar Catheter (K080425)

Submission Summary (Full Text)

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June 19, 2018

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

Re: K180710

Trade/Device Name: Reprocessed DecaNav Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 18, 2018 Received: May 21, 2018

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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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| Description | REF<br>Number | Item<br>Number | French<br>Size | Curve | Number of<br>Electrodes | Spacing<br>(mm) | Insertion<br>Length<br>(cm) |
|--------------------------------------|---------------|----------------|----------------|-------|-------------------------|-----------------|-----------------------------|
| DecaNav<br>Diagnostic EP<br>Catheter | R7D282CT | D-1285-01-S | 7 | D | 10 | 2-8-2 | 115 |
| DecaNav<br>Diagnostic EP<br>Catheter | R7F282CT | D-1285-02-S | 7 | F | 10 | 2-8-2 | 115 |

The item numbers in scope of this submission are as follows:

Table 1: Device Scope

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# Indications for Use

510(k) Number (if known)

#### K180710

Device Name

Reprocessed DecaNav Diagnostic Electrophysiology Catheter

Indications for Use (Describe)

The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.

The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# SECTION 5: 510(k) SUMMARY

As required by 21 CFR 807.92(c)

### Submitter's Name and Address:

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

### Contact Name and Information:

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

### Date prepared:

March 16, 2018

# Device Information:

Trade/Proprietary Name: Common or Usual Name: Classification Name: Classification Number: Product Code:

Reprocessed DecaNav Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Electrode Recording Catheter or Electrode Recording Probe Class II, 21 CFR 870.1220 NLH

## Predicate Device:

| 510(k) Number | 510(k) Title | Manufacturer |
|---------------|---------------------|------------------|
| K080425 | CS RefStar Catheter | Biosense Webster |

#### Device Description:

The Reprocessed DecaNav Catheter has been designed to be used with the Carto 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The catheter has a single proximal electrode that can be used for unipolar recording signals. The catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.

This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.

| Description | REF<br>Number | Item<br>Number | French<br>Size | Curve | Number of<br>Electrodes | Spacing<br>(mm) | Insertion<br>Length<br>(cm) |
|--------------------------------------|---------------|----------------|----------------|-------|-------------------------|-----------------|-----------------------------|
| DecaNav<br>Diagnostic EP<br>Catheter | R7D282CT | D-1285-01-S | 7 | D | 10 | 2-8-2 | 115 |
| DecaNav<br>Diagnostic EP<br>Catheter | R7F282CT | D-1285-02-S | 7 | F | 10 | 2-8-2 | 115 |

The item numbers in scope of this submission are as follows:

Table 5.1: Device Scope

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# Indications for Use:

The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus,

The catheter provides tip location information when used with the compatible Carto 3 EP Navigation Systems.

## Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed DecaNav Diagnostic EP Catheter are identical to the predicate devices. 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 Reprocessed Diagnostic EP Catheter. This included the following:

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

The Reprocessed DecaNav Diagnostic EP Catheter are reprocessed no more than one (1) time. Each device is marked 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 DecaNav Diagnostic EP Catheter is as safe and effective as the predicate devices described herein.