The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Device Description

The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically, Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters. The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

For a reprocessed device, the substantiation often focuses on demonstrating that the reprocessing does not compromise the device's safety and effectiveness compared to new devices or already reprocessed predicate devices. The "study" mentioned in this context is a series of bench and laboratory tests rather than a clinical study.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics like a standalone AI performance evaluation would. Instead, it lists the types of testing performed to demonstrate that the reprocessed devices are "as safe and effective as the predicate devices." The "reported device performance" is essentially that the device passed these tests, implying they met internal or established industry standards for reprocessed devices.

Acceptance Criteria Type	Reported Device Performance
Biocompatibility	Passed
Cleaning Validation	Passed
Sterilization Validation	Passed
Functional Testing	Passed (includes Visual Inspection, Dimensional Verification, Electrical Continuity and Resistance, Simulated Use)
Mechanical Characteristics	Passed
Electrical Safety Testing	Passed (includes Dielectric and Current Leakage)
Packaging Validation	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each of the listed functional and safety tests (e.g., how many reprocessed catheters were tested for biocompatibility, cleaning, or functional checks). It only states that "Bench and laboratory testing was conducted."

Sample Size for Test Set: Not explicitly stated in the provided document.
Data Provenance: The testing was conducted in a laboratory setting by Innovative Health, LLC. The data is thus prospective, generated specifically for this submission. The "country of origin" would be the US, where Innovative Health is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is typically relevant for studies involving human interpretation or clinical endpoints, such as medical imaging AI. For this reprocessed device, the "ground truth" is established through engineering and laboratory standards.

No "experts" in the sense of clinical reviewers (e.g., radiologists) were used to establish a ground truth for a test set. The ground truth for functional and safety testing is based on established engineering specifications, material science, and regulatory standards for medical devices and reprocessing. The "observers" would be the engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers when establishing a clinical ground truth. For bench and laboratory testing, results are typically objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or therapeutic device. It is a reprocessed electrophysiology catheter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm, but a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device's performance is based on engineering specifications, material safety standards, and established regulatory requirements for medical device reprocessing. This includes demonstrating:

That the device is biocompatible after reprocessing.
That it can be effectively cleaned and sterilized.
That its functional and mechanical characteristics (e.g., electrical continuity, steerability, dimensions) remain within acceptable limits, comparable to the original new device specification or predicate device.
That electrical safety is maintained.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of a reprocessed medical device's physical and functional testing. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2016

Innovative Health, LLC Rafal Chudzik VP, R&D and Operations 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K161464

Trade/Device Name: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (Models per Table 1 in Enclosure) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: August 26, 2016 Received: August 29, 2016

Dear Rafal Chudzik:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mula Jellm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Item Number	Description	Electrodes	Spacing(mm)	Curve	FrenchSize	UsableLength(cm)
200131	Dynamic Tip SteerableDiagnostic EP Catheter	4	10	Large 4.0	6	110
200344	Dynamic Tip SteerableDiagnostic EP Catheter	4	5	Large 4.0	6	110
6DYNTP002	Dynamic Tip SteerableDiagnostic EP Catheter	4	2-5-2	Large 4.0	6	110
6DYNTP006	Dynamic Tip SteerableDiagnostic EP Catheter	8	2	Large 4.0	6	110
6DYNTP001	Dynamic Tip SteerableDiagnostic EP Catheter	10	2-5-2	Large 4.0	6	110

Table 1: Reprocessed Single-Use Devices Included in K161464 Clearance

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K161464

Device Name

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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:

Rafal Chudzik VP, R&D and Operations (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com

Date prepared:

May 25, 2016

Device Information:

Trade/Proprietary Name:	Reprocessed Dynamic Tip Steerable 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) Title	Manufacturer
K891908	Bard Tip Deflecting Electrode Catheter	C.R. Bard, Inc.

Device Description:

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

Description	Item Number	Number ofElectrodes	FrenchSize	ElectrodeSpacing(mm)	Curve	Length (cm)
Dynamic TipSteerableDiagnostic EPCatheter	200131	4	6	10	Large 4.0	110
	200344	4	6	5	Large 4.0	110
	6DYNTP002	4	6	2,5,2	Large 4.0	110
	6DYNTP006	8	6	2	Large 4.0	110
	6DYNTP001	10	6	2,5,2	Large 4.0	110

Table 5.1: Device Scope

{5}------------------------------------------------

Indications for Use:

The Reprocessed Dynamic Tip Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Dynamic Tip 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 Dynamic Tip 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 ●

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

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).