Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

• K Number: K191170
• Device Name: Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
• Manufacturer: Innovative Health, LLC.
• Date Cleared: 2019-10-30 ( 182 days)
• Product Code: NLH
• Regulation Number: 870.1220

Intended Use

The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.

Device Description

The Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Mapping Catheter (hereinafter Reflexion Spiral catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion Spiral catheter has a loop and a proximal handle that contains a shaft actuator mechanism for varying the bi-directional (90°/180° minimum) distal portion of the shaft, a loop actuator mechanism for varying the loop diameter from approximately 25 mm to approximately 15 mm, and an electrical connector.

Predicate Devices

K072012

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical electrophysiology catheter and its mechanical and electrical properties. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on physical and electrical characteristics, not algorithmic performance.

Therapeutic

No
The device is described as being used for recording signals and mapping, which are diagnostic purposes, not therapeutic.

Diagnostic

Yes
The device is used for "recording intracardiac signals and for cardiac stimulation during electrophysiology studies" and "to map the atrial regions of the heart," which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a flexible catheter constructed of a polymer shaft with platinum electrodes, a handle, and actuator mechanisms. The performance studies also include hardware-specific testing like mechanical characteristics, electrical safety, and dimensional verification.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "recording intracardiac signals and for cardiac stimulation during electrophysiology studies" and "to map the atrial regions of the heart." This describes a procedure performed within the body (in vivo) to gather electrical information and potentially stimulate the heart.
• Device Description: The description details a catheter designed to be inserted into the body, with electrodes for interacting directly with heart tissue.
• Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a patient's health. The description and intended use of this catheter do not involve the analysis of specimens outside the body.

Therefore, the Reprocessed Reflexion Spiral catheter is an invasive medical device used for electrophysiology procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.

Product codes (comma separated list FDA assigned to the subject device)

NLH

Device Description

The Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Mapping Catheter (hereinafter Reflexion Spiral catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion Spiral catheter has a loop and a proximal handle that contains a shaft actuator mechanism for varying the bi-directional (90°/180° minimum) distal portion of the shaft, a loop actuator mechanism for varying the loop diameter from approximately 25 mm to approximately 15 mm, and an electrical connector.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

atrial regions of the heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Reflexion Spiral 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072012

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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October 30, 2019

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

Re: K191170

Trade/Device Name: Reprocessed Reflexion Spiral Bi-Directional Variable Radius 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: September 30, 2019 Received: October 1, 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

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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Nicole Gillette Acting 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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K191170 - Amanda Babcock

| Description | Item
Number | Usable
Length
(cm.) | Number of
Electrodes | Electrode
Spacing
(mm) | Catheter
French
Size | Loop
Adjustment
(mm) | Distal
Reach |
|-----------------------------------------------------------------------------|----------------|---------------------------|-------------------------|------------------------------|----------------------------|----------------------------|-----------------|
| Reflexion
Spiral Bi-
Directional
Variable
Radius EP
Catheter | D402893 | 99 | 20 | 1-4-1 | 7 | 15 to 25 | Symmetric |
| | D402865 | 99 | 10 | 6.3 | 7 | 15 to 25 | Symmetric |
| | 402804 | 99 | 20 | 1-4-1 | 7 | 15 to 25 | Asymmetric |

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

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Indications for Use

510(k) Number (if known) K191170

Device Name

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology (EP) Catheter

Indications for Use (Describe)

The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.

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

Date prepared:

April 30, 2019

Device Information:

Trade/Proprietary Name:	Reprocessed Reflexion Spiral Bi-Directional Variable Radius
	EP Catheter
Common or Usual Name:	Diagnostic Electrophysiology Catheter
Classification Name:	Electrode Recording Catheter or Electrode Recording Probe
Classification Number:	Class II, 21 CFR 870.1220
Product Code:	NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K072012	Reflexion Spiral Variable Radius Catheter	St. Jude Medical

Device Description:

The Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Mapping Catheter (hereinafter Reflexion Spiral catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion Spiral catheter has a loop and a proximal handle that contains a shaft actuator mechanism for varying the bi-directional (90°/180° minimum) distal portion of the shaft, a loop actuator mechanism for varying the loop diameter from approximately 25 mm to approximately 15 mm, and an electrical connector.

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

| Description | Item
Number | Usable
Length
(cm.) | Number of
Electrodes | Electrode
Spacing
(mm) | Catheter
French
Size | Loop
Adjustment
(mm) | Distal
Reach |
|-----------------------------------------------------------------------------|----------------|---------------------------|-------------------------|------------------------------|----------------------------|----------------------------|-----------------|
| Reflexion
Spiral Bi-
Directional
Variable
Radius EP
Catheter | D402893 | 99 | 20 | 1-4-1 | 7 | 15 to 25 | Symmetric |
| | D402865 | 99 | 10 | 6.3 | 7 | 15 to 25 | Symmetric |
| | 402804 | 99 | 20 | 1-4-1 | 7 | 15 to 25 | Asymmetric |

Table 5.1: Device Scope

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Indications for Use:

The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Reflexion Spiral 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 Reflexion Spiral 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 Reflexion Spiral 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 Reflexion Spiral catheter is as safe and effective as the predicate devices described herein.