Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter

K190127 · Innovative Health, LLC · NLH · Aug 23, 2019 · Cardiovascular

Device Facts

• Record ID: K190127
• Device Name: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
• Applicant: Innovative Health, LLC
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Story

Flexible electrode catheter; polyurethane shaft; platinum electrodes. Used for endocardial and intravascular cardiac arrhythmia evaluation. Physician manipulates active tip via proximal remote control. Device records electrical signals from heart tissue; signals transmitted to external electrophysiology recording system for physician analysis. Facilitates diagnosis of cardiac arrhythmias. Reprocessed by Innovative Health; includes cleaning, decontamination, inspection, and functional testing. Maximum three reprocessing cycles; serialized and tracked. Used in clinical electrophysiology labs.

Clinical Evidence

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

Technological Characteristics

Polyurethane insulation/shaft; platinum electrodes. Steerable tip via proximal remote control. Dimensions: 5F-7F French size; 95-115 cm usable length. Connectivity: wired connection to external EP recording equipment. Reprocessing includes cleaning, decontamination, and functional testing. No software or electronic processing components.

Indications for Use

Indicated for the evaluation of cardiac arrhythmias from endocardial and intravascular sites in patients requiring electrophysiological diagnostic 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

• Reprocessed Livewire Steerable Diagnostic EP Catheter (K160242)
• Livewire Electrophysiology Catheter (K151622)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 23, 2019

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

Re: K190127

Trade/Device Name: Reprocessed Livewire Steerable 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: July 23, 2019 Received: July 24, 2019

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,

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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| | | The following device models are included in the scope of this 510(k) submission: | |
|--|--|----------------------------------------------------------------------------------|--|
| | | | |

| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French<br>Size | Usable<br>Length<br>(cm) |
|-------------|----------------------------------------------|------------|---------------------------------------------------|------------------------|----------------|--------------------------|
| 401582 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 7F | 115 |
| 401932 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-8-2-(60)-2-8-2 | Super Lrg Curl | 7F | 95 |
| 401918 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-20-2-2-2-2-2-<br>2-2-2-2-2-2-25-<br>2-25-2-25-2 | Super Lrg Curl | 7F | 95 |
| 401580 | Livewire Steerable<br>Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep | 7F | 115 |
| 401581 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-5-2 | Med Sweep | 7F | 115 |
| 401938 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 5-5-5 | Med Sweep | 5F | 115 |
| 401939 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-2-2 | Med Sweep | 5F | 115 |
| 401940 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 5F | 115 |
| 401941 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Curl | 5F | 115 |
| 401990 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 5F | 115 |
| 401991 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 5F | 115 |
| 401575 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 6F | 115 |
| 401915 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 6F | 115 |
| 401923 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 6F | 115 |
| 401926 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Sweep<br>CSL | 6F | 115 |
| 401904 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-10-2 | Super Lrg Curl | 7F | 95 |
| 401905 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 5-5-5 | Super Lrg Curl | 7F | 95 |
| 401914 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-5-2 | Super Lrg Curl | 7F | 95 |
| 401908 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-2-2 | Med Curl | 7F | 115 |
| 401917 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep | 6F | 115 |
| 401949 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-2-2 | Lrg Sweep | 6F | 115 |
| 401600 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401603 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 6F | 115 |
| 401572 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401606 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 6F | 115 |
| 401933 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 5-5-5 | Med Sweep | 6F | 115 |
| | | | | | | |
| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French<br>Size | Usable<br>Length<br>(cm) |
| 401934 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 5-5-5 | Lrg Sweep | 6F | 115 |
| 401576 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Sml Sweep | 7F | 115 |
| 401577 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 7F | 115 |
| 401578 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 7F | 115 |
| 401586 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Sml Curl | 7F | 115 |
| 401587 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 7F | 115 |
| 401588 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Curl | 7F | 115 |
| 401652 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep<br>CRD-2 | 5F | 115 |
| 401653 | Livewire Steerable<br>Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep<br>CRD2 | 5F | 115 |
| 401654 | Livewire Steerable<br>Diagnostic EP Catheter | 6 | 5 | Med Sweep<br>CRD-2 | 5F | 115 |

(Continued on the following page)

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The following device models are included in the scope of this 510(k) submission (continued):

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# Indications for Use

510(k) Number (if known) K190127

#### Device Name

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter

Indications for Use (Describe)

The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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

#### Date prepared:

January 25, 2019

#### Device Information:

Trade/Proprietary Name:

Common Name: Classification Name: Classification Number: Product Code:

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH

### Predicate Device:

| 510(k) Number | 510(k) Device | Manufacturer |
|---------------|----------------------------------------------------------|-------------------------|
| K160242 | Reprocessed Livewire Steerable<br>Diagnostic EP Catheter | Innovative Health, LLC. |
| K151622 | Livewire Electrophysiology Catheter | St. Jude Medical |

#### Device Description:

The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by remote means located at the proximal end of the catheter.

#### Indications for Use:

The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French<br>Size | Usable<br>Length<br>(cm) |
|-------------|----------------------------------------------|------------|-------------------------------------------------|------------------------|----------------|--------------------------|
| 401582 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 7F | 115 |
| 401932 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-8-2-(60)-2-8-2 | Super Lrg Curl | 7F | 95 |
| 401918 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-20-2-2-2-2-2-<br>2-2-2-2-2-25-<br>2-25-2-25-2 | Super Lrg Curl | 7F | 95 |
| 401580 | Livewire Steerable<br>Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep | 7F | 115 |
| 401581 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-5-2 | Med Sweep | 7F | 115 |
| 401938 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 5-5-5 | Med Sweep | 5F | 115 |
| 401939 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-2-2 | Med Sweep | 5F | 115 |
| 401940 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 5F | 115 |
| 401941 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Curl | 5F | 115 |
| 401990 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 5F | 115 |
| 401991 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 5F | 115 |
| 401575 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 6F | 115 |
| 401915 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 6F | 115 |
| 401923 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 6F | 115 |
| 401926 | Livewire Steerable<br>Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Sweep<br>CSL | 6F | 115 |
| 401904 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-10-2 | Super Lrg Curl | 7F | 95 |
| 401905 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 5-5-5 | Super Lrg Curl | 7F | 95 |
| 401914 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-5-2 | Super Lrg Curl | 7F | 95 |
| 401908 | Livewire Steerable<br>Diagnostic EP Catheter | 20 | 2-2-2 | Med Curl | 7F | 115 |
| 401917 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep | 6F | 115 |
| 401949 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-2-2 | Lrg Sweep | 6F | 115 |
| 401600 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401603 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 6F | 115 |
| 401572 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401606 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 6F | 115 |
| 401933 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 5-5-5 | Med Sweep | 6F | 115 |
| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French<br>Size | Usable<br>Length<br>(cm) |
| 401934 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 5-5-5 | Lrg Sweep | 6F | 115 |
| 401576 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Sml Sweep | 7F | 115 |
| 401577 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 7F | 115 |
| 401578 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 7F | 115 |
| 401586 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Sml Curl | 7F | 115 |
| 401587 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 7F | 115 |
| 401588 | Livewire Steerable<br>Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Curl | 7F | 115 |
| 401652 | Livewire Steerable<br>Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep<br>CRD-2 | 5F | 115 |
| 401653 | Livewire Steerable<br>Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep<br>CRD2 | 5F | 115 |
| 401654 | Livewire Steerable<br>Diagnostic EP Catheter | 6 | 5 | Med Sweep<br>CRD-2 | 5F | 115 |

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

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Table 5.1: Device Scope

## Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Livewire Steerable Diagnostic Electrophysiology (EP) Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices 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 Livewire Steerable 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

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The Reprocessed Livewire Steerable Diagnostic EP Catheters are 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 Livewire Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.