Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reprocessed diagnostic electrophysiology catheter and its intended use for mapping cardiac arrhythmias. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on standard medical device testing like biocompatibility, sterilization, and functional testing.

Therapeutic

No
The device is described as diagnostic, used for evaluation and mapping of cardiac arrhythmias rather than treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the device "can be used in the evaluation of a variety of cardiac arrhythmias." and the "Device Description" states it is for "electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias." This indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Reprocessed Response Diagnostic Electrophysiology Catheter," which is a physical medical device used for mapping cardiac arrhythmias. The performance studies also focus on hardware-related testing like biocompatibility, sterilization, and electrical safety.

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 "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This describes a procedure performed within the body (in vivo) to gather electrical signals from the heart.
Device Description: The description confirms it's a catheter used for "electrophysiological mapping." This is a technique that involves inserting the catheter into the heart to record electrical activity directly.
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. This device does not process or analyze biological specimens in this manner.

The device is clearly an in vivo diagnostic device used for electrophysiological studies of the heart.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

NLH

Device Description

The Reprocessed Response 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

endocardial and intravascular sites

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 the Reprocessed Response 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
Innovative Health concludes that the Reprocessed Response Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.

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.

K002976, K894500

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

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right, representing health and well-being.

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

December 8, 2016

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

Re: K161827

Trade/Device Name: Reprocessed Response Diagnostic Electrophysiology Catheters (see list of models 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: November 8, 2016 Received: November 9, 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,

for

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

Enclosure

2

| Description Number | Number of
Electrodes | French
Size | Electrode
Spacing (mm) | Curve
Type | Usable
Length (cm) |
|---------------------------------------------------------|------- | Response
Diagnostic
Electrophysiology
Catheter | 401381 | 10 | 6 | | 401353 | | 401392 | | 401399 | | 401400 | | 401360 | | 401317 | | 401318 | | 401305 | | 401306 | | 401308 | | 401309 | | 401310 | | 401311 | | 401312 | | 401150 | | 401271 | | 401275 | | 401276 | | 401278 | | 401281 | | 401282 | | 401425 | | 401386 | | 401206 | | 401207 | | 401222 | | 401223 | | 401210 | | 401211 | | 401212 | | 401226 | | 401356 | | 401227 | | 401357 | | 401228 | | 401329 | | 401260 | | 401261 | | 401154 | | 401155 | | 401156 | | 401158 | Item
---------|-------------------------|----------------|---------------------------|---------------|-----------------------|
| 2-8-2 | CSL | 120 |
| 10 | 6 | 2-8-2 | CSL | 65 |
| 10 | 6 | 2-2-2 | CSL | 120 |
| 10 | 6 | 5-5-5 | CSL | 120 |
| 10 | 6 | 5-5-5 | CSL | 65 |
| 6 | 5 | 2-5-2 | JSN | 120 |
| 2 | 6 | 10 | CRD | 120 |
| 2 | 6 | 10 | JSN | 120 |
| 10 | 6 | 2-5-2 | CRD | 120 |
| 10 | 6 | 2-5-2 | JSN | 120 |
| 10 | 6 | 2-5-2 | CRD | 65 |
| 10 | 6 | 2-5-2 | JSN | 65 |
| 10 | 6 | 2-5-2 | DAO | 65 |
| 10 | 6 | 2-2-2 | CRD | 120 |
| 10 | 6 | 2-2-2 | JSN | 120 |
| 10 | 6 | 2-1-1-10-1-1-1-1-1 | CRD | 120 |
| 6 | 6 | 2-5-2 | JSN | 120 |
| 6 | 6 | 2-2-2 | CRD | 120 |
| 6 | 6 | 2-2-2 | JSN | 120 |
| 6 | 6 | 2-2-2 | CRD | 65 |
| 6 | 6 | 5-5-5 | CRD | 120 |
| 6 | 6 | 5-5-5 | JSN | 120 |
| 6 | 6 | 5-5-5-150-5 | CRD | 120 |
| 6 | 6 | 5-5-5 | CSL | 120 |
| 4 | 5 | 10 | CRD | 120 |
| 4 | 5 | 10 | JSN | 120 |
| 4 | 5 | 5 | CRD | 120 |
| 4 | 5 | 5 | JSN | 120 |
| 4 | 6 | 10 | CRD | 120 |
| 4 | 6 | 10 | JSN | 120 |
| 4 | 6 | 10 | DAO | 120 |
| 4 | 6 | 5 | CRD | 120 |
| 4 | 6 | 5 | CRD-1 | 120 |
| 4 | 6 | 5 | JSN | 120 |
| 4 | 6 | 5 | JSN-1 | 120 |
| 4 | 6 | 5 | DAO | 120 |
| 4 | 6 | 5 | DAO-1 | 120 |
| 4 | 6 | 2-5-2 | CRD | 120 |
| 4 | 6 | 2-5-2 | JSN | 120 |
| 4 | 6 | 5 | CRD | 120 |
| 4 | 6 | 5 | JSN | 120 |
| 4 | 6 | 5 | DAO-1 | 120 |
| 4 | 6 | 10 | CRD | 120 |

The following item numbers are included in the scope of this submission (K161827):

3

Indications for Use

510(k) Number (if known) K161827

Device Name

Reprocessed Response Diagnostic Electrophysiology Catheter

Indications for Use (Describe)

The Reprocessed Response 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)
-------------------------------------------------	--

X 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 Innovative Health, LLC. (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com

Date prepared:

June 30, 2016

Device Information:

| Trade/Proprietary Name: | Reprocessed Response 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, Daig
Division
K894500	Daig Electrophysiology Catheter	Daig Corp.

Device Description:

The Reprocessed Response 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.

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

5

Description	Item Number	Number of Electrodes	French Size	Electrode Spacing (mm)	Curve Type	Usable Length (cm)
Response Diagnostic
Electrophysiology
Catheter	401381	10	6	2-8-2	CSL	120
	401353	10	6	2-8-2	CSL	65
	401392	10	6	2-2-2	CSL	120
	401399	10	6	5-5-5	CSL	120
	401400	10	6	5-5-5	CSL	65
	401360	6	5	2-5-2	JSN	120
	401317	2	6	10	CRD	120
	401318	2	6	10	JSN	120
	401305	10	6	2-5-2	CRD	120
	401306	10	6	2-5-2	JSN	120
	401308	10	6	2-5-2	CRD	65
	401309	10	6	2-5-2	JSN	65
	401310	10	6	2-5-2	DAO	65
	401311	10	6	2-2-2	CRD	120
	401312	10	6	2-2-2	JSN	120
	401150	10	6	2-1-1-10-1-1-1-1-1	CRD	120
	401271	6	6	2-5-2	JSN	120
	401275	6	6	2-2-2	CRD	120
	401276	6	6	2-2-2	JSN	120
	401278	6	6	2-2-2	CRD	65
	401281	6	6	5-5-5	CRD	120
	401282	6	6	5-5-5	JSN	120
	401425	6	6	5-5-5-150-5	CRD	120
	401386	6	6	5-5-5	CSL	120
	401206	4	5	10	CRD	120
	401207	4	5	10	JSN	120
	401222	4	5	5	CRD	120
	401223	4	5	5	JSN	120
	401210	4	6	10	CRD	120
	401211	4	6	10	JSN	120
	401212	4	6	10	DAO	120
	401226	4	6	5	CRD	120
	401356	4	6	5	CRD-1	120
	401227	4	6	5	JSN	120
	401357	4	6	5	JSN-1	120
	401228	4	6	5	DAO	120
	401329	4	6	5	DAO-1	120
	401260	4	6	2-5-2	CRD	120
	401261	4	6	2-5-2	JSN	120
	401154	4	6	5	CRD	120
	401155	4	6	5	JSN	120
	401156	4	6	5	DAO-1	120
	401158	4	6	10	CRD	120

Table 5.1: Device Scope

6

Indications for Use:

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