Reprocessed Marinr Diagnostic EP Catheter

K181897 · Innovative Health, LLC · NLH · Nov 15, 2018 · Cardiovascular

Device Facts

• Record ID: K181897
• Device Name: Reprocessed Marinr Diagnostic EP Catheter
• Applicant: Innovative Health, LLC
• Product Code: NLH · Cardiovascular
• Decision Date: Nov 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reprocessed Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Device Story

Reprocessed Marinr Diagnostic EP Catheter is a steerable/deflectable tip electrode catheter used in clinical electrophysiology studies. Device inputs consist of intracardiac electrical signals; device outputs are recorded electrograms and temporary pacing stimulation. Operated by physicians in clinical settings, the catheter features a handle for precise tip placement within the heart. Construction involves extruded polymer over stainless steel braid. Device facilitates cardiac mapping and pacing to assist in diagnosing arrhythmias. Reprocessing by Innovative Health includes cleaning, decontamination, inspection, and functional testing to ensure performance equivalent to original predicate devices. Device is limited to one reprocessing cycle.

Clinical Evidence

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

Technological Characteristics

Steerable/deflectable tip electrode catheter; extruded polymer over stainless steel braid construction; radiopaque. Features 4 or 10 electrodes with varying spacing (2-8mm). Shaft size 7 French; usable length 90-110cm. Manual handle-actuated deflection. Sterilized device; single-use reprocessing cycle limit. No software or electronic processing algorithms.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiologic procedures requiring intracardiac electrogram recording and temporary pacing.

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

• Marinr Series EP Diagnostic Catheters (K951347)
• Marinr Series EP Diagnostic Catheters (K931794)

Submission Summary (Full Text)

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# November 15, 2018

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

Re: K181897

Trade/Device Name: Reprocessed Marinr Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: October 16, 2018 Received: October 17, 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. 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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 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,

for

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 | Item<br>Number | Shaft<br>Size<br>(French) | Curve<br>Reach<br>(mm) and<br>Curve Type | Number of<br>Electrodes | Electrode<br>Spacing<br>(mm) | Usable<br>Length<br>(cm) |
|-------------------------------------|----------------|---------------------------|------------------------------------------|-------------------------|------------------------------|--------------------------|
| Marinr<br>Diagnostic<br>EP Catheter | 072302 | 7 | 40-60, MC | 4 | 2-5-2 | 110 |
| | 072402 | 7 | 55-75,<br>MCXL | 4 | 2-5-2 | 110 |
| | 043302M | 7 | 55, CS | 10 | 2 | 90 |
| | 043325M | 7 | 55, CS | 10 | 2-5-2 | 90 |
| | 043328M | 7 | 55, CS | 10 | 2-8-2 | 90 |
| | 072322M | 7 | 65, SCXXL | 4 | 2-5-2 | 90 |

# The item numbers in scope of this submission (K181897) are as follows:

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# Indications for Use

510(k) Number (if known)

K181897

Device Name

Reprocessed Marinr Diagnostic Electrophysiology (EP) Catheter

Indications for Use (Describe)

The Reprocessed Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

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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### 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:

July 13, 2018

#### Device Information:

Trade/Proprietary Name: Reprocessed Marinr Diagnostic EP Catheter Common or Usual Name: Diagnostic Electrophysiology Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Classification: Class II, 21 CFR 870.1220 Product Code: NLH

#### Predicate Device:

| 510(k) Number | 510(k) Title | Manufacturer |
|---------------|---------------------------------------|--------------------------|
| K951347 | Marinr Series EP Diagnostic Catheters | Medtronic (CardioRhythm) |
| K931794 | Marinr Series EP Diagnostic Catheters | Medtronic (CardioRhythm) |

### Device Description:

The Reprocessed Marinr steerable/deflectable tip electrode catheter is a flexible, radiopaque catheter constructed of extruded polymer over stainless steel braid. The catheter is designed for intracardiac recording or stimulation. The Marinr catheter handle controls allow precise tip placement within the heart.

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

| Description | Item<br>Number | Shaft<br>Size<br>(French) | Curve<br>Reach<br>(mm) and<br>Curve Type | Number of<br>Electrodes | Electrode<br>Spacing<br>(mm) | Usable<br>Length<br>(cm) |
|-------------------------------------|----------------|---------------------------|------------------------------------------|-------------------------|------------------------------|--------------------------|
| Marinr<br>Diagnostic<br>EP Catheter | 072302 | 7 | 40-60, MC | 4 | 2-5-2 | 110 |
| | 072402 | 7 | 55-75,<br>MCXL | 4 | 2-5-2 | 110 |
| | 043302M | 7 | 55, CS | 10 | 2 | 90 |
| | 043325M | 7 | 55, CS | 10 | 2-5-2 | 90 |
| | 043328M | 7 | 55, CS | 10 | 2-8-2 | 90 |
| | 072322M | 7 | 65, SCXXL | 4 | 2-5-2 | 90 |

Table 5.1: Device Scope

Innovative Health Reprocessed Catheters

Page 1 Traditional 510(k) K181897

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## Indications for Use:

The Reprocessed Marinr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

## Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Marinr 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 packaqing and labeling.

## Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 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 Marinr Catheter is 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 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 Marinr Catheter is as safe and effective as the predicate devices described herein.

Innovative Health Reprocessed Catheters