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

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.

AI/ML Overview

This document is a 510(k) Summary for Reprocessed Supreme Diagnostic Electrophysiology Catheters, outlining their substantial equivalence to predicate devices. It describes the device, its indications for use, and a summary of testing conducted to demonstrate safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Functional and Safety Testing" section. The document states that testing was conducted "to demonstrate performance (safety and effectiveness)". However, specific quantitative acceptance criteria or detailed reported device performance values are not provided in this summary document. The summary only lists the types of tests performed and generally states that the device is "as safe and effective as the predicate devices".

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compatible with biological systems for intended use	Demonstrated as safe and effective (specific results not provided)
Cleaning Validation	Meets cleanliness standards for reprocessed devices	Demonstrated as safe and effective (specific results not provided)
Sterilization Validation	Meets sterilization standards for reprocessed devices	Demonstrated as safe and effective (specific results not provided)
Visual Inspection	Meets visual quality and integrity standards	Demonstrated as safe and effective (specific results not provided)
Dimensional Verification	Meets specified dimensional requirements	Demonstrated as safe and effective (specific results not provided)
Electrical Continuity & Resistance	Meets electrical specifications	Demonstrated as safe and effective (specific results not provided)
Simulated Use	Performs as intended during simulated clinical use	Demonstrated as safe and effective (specific results not provided)
Mechanical Characteristics	Meets mechanical strength and functional requirements	Demonstrated as safe and effective (specific results not provided)
Electrical Safety Testing (Dielectric & Current Leakage)	Meets electrical safety standards	Demonstrated as safe and effective (specific results not provided)
Packaging Validation	Maintains device integrity and sterility until use	Demonstrated as safe and effective (specific results not provided)

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

The document does not specify the sample sizes used for the functional and safety testing. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. It implies that "bench and laboratory testing" were conducted by Innovative Health, LLC.

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

This type of information is not provided in the document. The testing described focuses on physical and electrical device performance rather than interpretation of data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable to the type of device and testing described. The tests are objective measurements of the device's physical and electrical properties.

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

This information is not applicable. The device is a reprocessed electrophysiology catheter, which is a physical medical device, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable as the device is a physical medical device and not an algorithm or software.

7. The Type of Ground Truth Used

For the functional and safety testing, the "ground truth" would be the engineering and performance specifications for the original, new device, and relevant regulatory standards (e.g., for biocompatibility, sterility, electrical safety). The reprocessed devices are tested to ensure they meet these established specifications.

8. The Sample Size for the Training Set

This information is not applicable as this is a reprocessing of a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with three wave-like lines below them.

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

December 6, 2016

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

Re: K161769

Trade/Device Name: Reprocessed Supreme Diagnostic Electrophysiology Catheters (see attached list of models) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: November 4, 2016 Received: November 7, 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

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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.

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	ItemNumber	FrenchSize	Electrode Spacing(mm)	CurveType	UsableLength(cm)	Number ofElectrodes
SupremeDiagnostic EPCatheter	401957	5	10	CRD	120	2
	401978	6	2-2-2	CSL	65	20
	402033	6	2-2-2-2-2-2-2-2-2-45-2-2-2-2-2-2-2-2-2	CSL	120	20
	402020	6	2-5-2-5-2-5-2-5-2-60-2-10-2-10-2-10-2-10-2	CRD	120	20
	401956	6	10	CRD	120	2	401893	4	2-8-2	CSL	65	10	401979	4	2-5-2	CSL	65	10	401863	5	2-8-2	CSL	120	10	401864	5	2-8-2	CSL	65	10	401865	5	5-5-5	CSL	120	10	401966	4	5-5-5	CRD-2	120	6	401967	4	2-2-2	CRD-2	120	6	401968	4	2-5-2	CRD-2	120	6	401872	5	2-2-2	CRD-1	120	6	402008	5	2-5-2	CRD-2	120	6	402009	5	5-5-5	CRD-2	120	6	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	401891	4	5-5-5	CRD	120	4	401890	4	5-5-5	JSN	120	4	401892	4	5-5-5	DAO	120	4	401993	4	2-2-2	JSN	120	4	401994	4	2-5-2	JSN	120	4	401996	4	2-5-2	CRD	120	4	402012	4	5-5-5	CRD-2	120	4	401433	5	10	CRD	120	4	401859	5	10	CRD-2	120	4	401435	5	10	JSN	120	4	401441	5	5	CRD	120	4	401860	5	5	CRD-2	120	4	401443	5	5	JSN	120	4	401444	5	5	DAO	120	4	401466	5	5	DAO-1	120	4	401448	5	2-5-2	CRD	120	4	401450	5	2-5-2	JSN	120	4	401468	5	2-5-2	DAO-1	120	4	401871	5	2	CRD-1	120	4	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
	401956	6	10	CRD	120	2
	401893	4	2-8-2	CSL	65	10
	401979	4	2-5-2	CSL	65	10
	401863	5	2-8-2	CSL	120	10
	401864	5	2-8-2	CSL	65	10
	401865	5	5-5-5	CSL	120	10
	401966	4	5-5-5	CRD-2	120	6
	401967	4	2-2-2	CRD-2	120	6
	401968	4	2-5-2	CRD-2	120	6
	401872	5	2-2-2	CRD-1	120	6
	402008	5	2-5-2	CRD-2	120	6
	402009	5	5-5-5	CRD-2	120	6
	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
	401891	4	5-5-5	CRD	120	4
	401890	4	5-5-5	JSN	120	4
	401892	4	5-5-5	DAO	120	4
	401993	4	2-2-2	JSN	120	4
	401994	4	2-5-2	JSN	120	4
	401996	4	2-5-2	CRD	120	4
	402012	4	5-5-5	CRD-2	120	4
	401433	5	10	CRD	120	4
	401859	5	10	CRD-2	120	4
	401435	5	10	JSN	120	4
	401441	5	5	CRD	120	4
	401860	5	5	CRD-2	120	4
	401443	5	5	JSN	120	4
	401444	5	5	DAO	120	4
	401466	5	5	DAO-1	120	4
	401448	5	2-5-2	CRD	120	4
	401450	5	2-5-2	JSN	120	4
	401468	5	2-5-2	DAO-1	120	4
	401871	5	2	CRD-1	120	4
	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

The model numbers included in the scope of this submission (K161769) are as follows:

Table 1: Device Scope

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Indications for Use

510(k) Number (if known) K161769

Device Name

Reprocessed Supreme Diagnostic Electrophysiology Catheter

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

Date prepared:

June 24, 2016

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
K002976	Response Electrophysiology Catheter,Supreme Electrophysiology Catheter	St. Jude Medical, DaigDivision
K894500	Daig Electrophysiology Catheter	Daig Corp.

Device Description:

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

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Description	ItemNumber	FrenchSize	Electrode Spacing(mm)	CurveType	UsableLength(cm)	Number ofElectrodes
SupremeDiagnostic EP	401957	5	10	CRD	120	2
	401978	6	2-2-2	CSL	65	20
Catheter	402033	6	2-2-2-2-2-2-2-2-2-45-2-2-2-2-2-2-2-2-2	CSL	120	20
	402020	6	2-5-2-5-2-5-2-5-2-60-2-10-2-10-2-10-2-10-2	CRD	120	20
	401956	6	10	CRD	120	2
	401893	4	2-8-2	CSL	65	10
	401979	4	2-5-2	CSL	65	10
	401863	5	2-8-2	CSL	120	10
	401864	5	2-8-2	CSL	65	10
	401865	5	5-5-5	CSL	120	10
	401966	4	5-5-5	CRD-2	120	6
	401967	4	2-2-2	CRD-2	120	6
	401968	4	2-5-2	CRD-2	120	6
	401872	5	2-2-2	CRD-1	120	6
	402008	5	2-5-2	CRD-2	120	6
	402009	5	5-5-5	CRD-2	120	6
	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
	401891	4	5-5-5	CRD	120	4
	401890	4	5-5-5	JSN	120	4
	401892	4	5-5-5	DAO	120	4
	401993	4	2-2-2	JSN	120	4
	401994	4	2-5-2	JSN	120	4
	401996	4	2-5-2	CRD	120	4
	402012	4	5-5-5	CRD-2	120	4
	401433	5	10	CRD	120	4
	401859	5	10	CRD-2	120	4
	401435	5	10	JSN	120	4
	401441	5	5	CRD	120	4
	401860	5	5	CRD-2	120	4
	401443	5	5	JSN	120	4
	401444	5	5	DAO	120	4
	401466	5	5	DAO-1	120	4
	401448	5	2-5-2	CRD	120	4
	401450	5	2-5-2	JSN	120	4
	401468	5	2-5-2	DAO-1	120	4
	401871	5	2	CRD-1	120	4
	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

Table 5.1: Device Scope

Page 2
Traditional 510(k)
K161769

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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 one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is reiected 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 Supreme 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).