Reprocessed Supreme Diagnostic Electrophysiology Catheter

K182386 · Innovative Health, LLC · DRF · Apr 23, 2019 · Cardiovascular

Device Facts

• Record ID: K182386
• Device Name: Reprocessed Supreme Diagnostic Electrophysiology Catheter
• Applicant: Innovative Health, LLC
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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

Device Story

Diagnostic electrophysiology (EP) catheters; used for mapping cardiac arrhythmias from endocardial and intravascular sites. Device consists of multi-electrode catheter with fixed curves; inserted by physician in clinical EP lab setting. Electrodes capture intracardiac electrical signals; signals transmitted to external recording system for physician analysis. Output enables identification of arrhythmia origin; guides clinical decision-making for ablation or other interventions. Reprocessed device; undergoes cleaning, decontamination, inspection, and functional testing to ensure performance equivalent to original device. Maximum of three reprocessing cycles permitted; tracked via marking system.

Clinical Evidence

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

Technological Characteristics

Multi-electrode diagnostic EP catheter; 6 French size; various fixed curves (CSL, CRD, JSN, DAO) and electrode spacings. Sensing principle: electrode-based electrical signal recording. Connectivity: connects to external EP recording system. Reprocessing includes cleaning, decontamination, and functional testing. Maximum 3-cycle limit.

Indications for Use

Indicated for patients requiring evaluation of cardiac arrhythmias via endocardial and intravascular sites.

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

• Supreme Electrophysiology Catheter (K151622)
• Reprocessed Supreme Diagnostic Electrophysiology Catheter (K161769)

Submission Summary (Full Text)

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# Indications for Use

510(k) Number (if known)

### K182386

Device Name

Reprocessed Supreme Diagnostic Electrophysiology (EP) Catheters

Indications for Use (Describe)

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

| 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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April 23, 2019

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

Re: K182386

Trade/Device Name: Reprocessed Supreme Diagnostic Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: March 15, 2019 Received: March 18, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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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The item numbers included in the scope of this submission (K182386):

| Description | Item<br>Number | French<br>Size | Electrode<br>Spacing<br>(mm) | Curve<br>Type | Usable<br>Length<br>(cm) | Number of<br>Electrodes |
|-----------------------------------------------|----------------|--------------------------------------------------------|------------------------------|---------------|--------------------------|-------------------------|
| Supreme<br>Fixed<br>Diagnostic<br>EP Catheter | 401978 | 6 | 2-2-2 | CSL | 65 | 20 |
| 402033 | 6 | 2-2-2-2-2-2-2-<br>2-2-45-2-2-2-<br>2-2-2-2-2 | CSL | 120 | 20 | |
| 402020 | 6 | 2-5-2-5-2-5-2-<br>5-2-60-2-10-2-<br>10-2-10-2-10-<br>2 | CRD | 120 | 20 | |
| | 401956 | 6 | 10 | CRD | 120 | 2 |
| | 402010 | 6 | 2-5-2 | CRD-2 | 120 | 6 |
| | 402011 | 6 | 5-5-5 | CRD-2 | 120 | 6 |
| | 401876 | 6 | 5-5-5-175-175 | CRD-1 | 120 | 6 |
| | 401877 | 6 | 5-5-5-175-175 | JSN | 120 | 6 |
| | 401434 | 6 | 10 | CRD | 120 | 4 |
| | 401436 | 6 | 10 | JSN | 120 | 4 |
| | 401438 | 6 | 10 | DAO | 120 | 4 |
| | 401442 | 6 | 5 | CRD | 120 | 4 |
| | 401474 | 6 | 5 | CRD-1 | 120 | 4 |
| | 402004 | 6 | 5 | CRD-2 | 120 | 4 |
| | 401430 | 6 | 5 | JSN | 120 | 4 |
| | 401475 | 6 | 5 | JSN-1 | 120 | 4 |
| | 401445 | 6 | 5 | DAO | 120 | 4 |
| | 401449 | 6 | 2-5-2 | CRD | 120 | 4 |
| | 401451 | 6 | 2-5-2 | JSN | 120 | 4 |
| | 401453 | 6 | 2-5-2 | DAO | 120 | 4 |
| | 401950 | 6 | 5 | CRD | 120 | 4 |
| | 401951 | 6 | 5 | JSN | 120 | 4 |
| | 401952 | 6 | 10 | CRD | 120 | 4 |

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

# Date prepared:

August 30, 2018

# Device Information:

| Trade/Proprietary Name: | Reprocessed Supreme Diagnostic Electrophysiology Catheters |
|-------------------------|------------------------------------------------------------|
| Common Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Catheter, Recording, Electrode, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |

# Predicate Device:

| 510(k) Number | 510(k) Device | Manufacturer |
|---------------|--------------------------------------------------------------|-------------------------|
| K151622 | Supreme Electrophysiology Catheter | St. Jude Medical |
| K161769 | Reprocessed Supreme Diagnostic<br>Electrophysiology Catheter | Innovative Health, LLC. |

#### Device Description:

The Reprocessed Supreme Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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

| Description | Item<br>Number | French<br>Size | Electrode<br>Spacing<br>(mm) | Curve<br>Type | Usable<br>Length<br>(cm) | Number of<br>Electrodes |
|-----------------------------------------------|----------------|----------------|--------------------------------------------------------|---------------|--------------------------|-------------------------|
| Supreme<br>Fixed<br>Diagnostic<br>EP Catheter | 401978 | 6 | 2-2-2 | CSL | 65 | 20 |
| | 402033 | 6 | 2-2-2-2-2-2-2-<br>2-2-45-2-2-2-<br>2-2-2-2-2-2 | CSL | 120 | 20 |
| | 402020 | 6 | 2-5-2-5-2-5-2-<br>5-2-60-2-10-2-<br>10-2-10-2-10-<br>2 | CRD | 120 | 20 |
| | 401956 | 6 | 10 | CRD | 120 | 2 |
| | 402010 | 6 | 2-5-2 | CRD-2 | 120 | 6 |
| | 402011 | 6 | 5-5-5 | CRD-2 | 120 | 6 |

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| 401876 | 6 | 5-5-5-175-175 | CRD-1 | 120 | 6 |
|--------|---|---------------|-------|-----|---|
| 401877 | 6 | 5-5-5-175-175 | JSN | 120 | 6 |
| 401434 | 6 | 10 | CRD | 120 | 4 |
| 401436 | 6 | 10 | JSN | 120 | 4 |
| 401438 | 6 | 10 | DAO | 120 | 4 |
| 401442 | 6 | 5 | CRD | 120 | 4 |
| 401474 | 6 | 5 | CRD-1 | 120 | 4 |
| 402004 | 6 | 5 | CRD-2 | 120 | 4 |
| 401430 | 6 | 5 | JSN | 120 | 4 |
| 401475 | 6 | 5 | JSN-1 | 120 | 4 |
| 401445 | 6 | 5 | DAO | 120 | 4 |
| 401449 | 6 | 2-5-2 | CRD | 120 | 4 |
| 401451 | 6 | 2-5-2 | JSN | 120 | 4 |
| 401453 | 6 | 2-5-2 | DAO | 120 | 4 |
| 401950 | 6 | 5 | CRD | 120 | 4 |
| 401951 | 6 | 5 | JSN | 120 | 4 |
| 401952 | 6 | 10 | CRD | 120 | 4 |

Table 5.1: Device Scope

# Indications for Use:

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

### Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Supreme 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 Supreme 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 Supreme Diagnostic EP Catheters are reprocessed no more than three (3) times. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing.

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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 Supreme Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.