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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a reprocessed medical device, specifically a "Reprocessed Livewire Steerable Diagnostic EP Catheter." This type of document is focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study report for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text. The document describes bench and laboratory testing for a reprocessed physical catheter, not an AI or software algorithm.

Here's a breakdown of why each point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: This document lists "Functional and Safety Testing" categories (Biocompatibility, Cleaning Validation, Sterilization Validation, Functional Testing, Electrical Safety Testing, Packaging Validation), but it does not provide specific acceptance criteria values or detailed performance results for these tests. It broadly states that testing "was conducted to demonstrate performance (safety and effectiveness)."
Sample size used for the test set and the data provenance: Not applicable or provided. The testing relates to physical properties and reprocessing of the catheter, not a dataset for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or provided. Ground truth for AI models involves expert labeling of data, which is not relevant to testing a reprocessed physical catheter.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic tools, not a reprocessed physical catheter.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be established engineering standards and performance specifications for physical and material properties, which are not detailed here.
The sample size for the training set: Not applicable. There is no training set for a reprocessed physical catheter.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a reprocessed physical medical device and does not contain the information requested for evaluating an AI or software-based device.

Summary

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

May 10, 2016

Innovative Health, LLC Rafal Chudzik Director of Engineering 1435 North Hayden Road. Suite 100 Scottsdale, Arizona 85257

Re: K160242

Trade/Device Name: Reprocessed Livewire Steerable 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: April 5, 2016 Received: April 6, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

FDA

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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K160242

ITEM NUMBERS IN SCOPE

ItemNumber	Device	Electrodes	Spacing (mm)	Curve Type	FrenchSize	UsableLength (cm)
401582	Livewire Steerable Catheter	10	2-5-2	Med Sweep	7F	115
401932	Livewire Steerable Catheter	20	2-8-2-(60)-2-8-2	Super Lrg Curl	7F	95
401918	Livewire Steerable Catheter	20	2-20-2-2-2-2-2-2-2-2-2-2-2-25-2-25-2-25-2	Super Lrg Curl	7F	95
401580	Livewire Steerable Catheter	6	2-5-2	Med Sweep	7F	115
401581	Livewire Steerable Catheter	8	2-5-2	Med Sweep	7F	115
401938	Livewire Steerable Catheter	10	5-5-5	Med Sweep	5F	115
401939	Livewire Steerable Catheter	10	2-2-2	Med Sweep	5F	115
401940	Livewire Steerable Catheter	10	2-5-2	Med Sweep	5F	115
401941	Livewire Steerable Catheter	10	2-8-2	Extra Lrg Curl	5F	115
401990	Livewire Steerable Catheter	10	2-2-2	Extra Lrg Curl	5F	115
401991	Livewire Steerable Catheter	10	2-5-2	Extra Lrg Curl	5F	115
401575	Livewire Steerable Catheter	10	2-5-2	Med Sweep	6F	115
401915	Livewire Steerable Catheter	10	2-5-2	Extra Lrg Curl	6F	115
401923	Livewire Steerable Catheter	10	2-2-2	Extra Lrg Curl	6F	115
401926	Livewire Steerable Catheter	10	2-8-2	Extra LrgSweep CSL	6F	115
401904	Livewire Steerable Catheter	20	2-10-2	Super Lrg Curl	7F	95
401905	Livewire Steerable Catheter	20	5-5-5	Super Lrg Curl	7F	95
401914	Livewire Steerable Catheter	20	2-5-2	Super Lrg Curl	7F	95
401908	Livewire Steerable Catheter	20	2-2-2	Med Curl	7F	115
401917	Livewire Steerable Catheter	8	2-2-2	Med Sweep	6F	115
401949	Livewire Steerable Catheter	8	2-2-2	Lrg Sweep	6F	115
401600	Livewire Steerable Catheter	4	2-5-2	Med Sweep	6F	115
401603	Livewire Steerable Catheter	4	2-5-2	Med Curl	6F	115
401572	Livewire Steerable Catheter	4	2-5-2	Med Sweep	6F	115
401606	Livewire Steerable Catheter	4	2-5-2	Lrg Sweep	6F	115
401933	Livewire Steerable Catheter	4	5-5-5	Med Sweep	6F	115
401934	Livewire Steerable Catheter	4	5-5-5	Lrg Sweep	6F	115
401576	Livewire Steerable Catheter	4	2-5-2	Sml Sweep	7F	115
401577	Livewire Steerable Catheter	4	2-5-2	Med Sweep	7F	115
401578	Livewire Steerable Catheter	4	2-5-2	Lrg Sweep	7F	115
401586	Livewire Steerable Catheter	4	2-5-2	Sml Curl	7F	115
401587	Livewire Steerable Catheter	4	2-5-2	Med Curl	7F	115
401588	Livewire Steerable Catheter	4	2-5-2	Lrg Curl	7F	115

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Indications for Use

510(k) Number (if known) K160242

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.

Type of Use (Select one or both, as applicable)
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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:

Rafal Chudzik Director of Engineering (602) 326-7716 (cell) (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com

Date prepared:

January 28, 2016

Device Information:

Trade/Proprietary Name:	Reprocessed Livewire Steerable DiagnosticElectrophysiology 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
K102721	Livewire Electrophysiology Catheter	St. Jude Medical
K022380	Livewire Electrophysiology Catheter	St. Jude Medical

Reference Device:

510(k) Number	510(k) Title	Reprocessor
K052603	Reprocessed Daig LivewireElectrophysiology Catheters	Alliance Medical Corp.

Device Description:

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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.

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 ●

The Reprocessed Livewire 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 Livewire 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).