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 cardiac arrhythmia evaluation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies listed are standard tests for medical devices, not AI/ML model validation.

Therapeutic

No
The device is described as a "Diagnostic Electrophysiology Catheter" used for "evaluation of a variety of cardiac arrhythmias" and "electrophysiological mapping". Its purpose is diagnostic (identifying a condition) rather than therapeutic (treating a condition).

Diagnostic

Yes

The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is used for "electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias." Evaluation of a condition falls under the definition of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Reprocessed Supreme Diagnostic Electrophysiology Catheter," which is a physical medical device used for electrophysiological mapping. 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 involves using the catheter within the body to record electrical signals from the heart.
Device Description: The device is described as a catheter used for "electrophysiological mapping." This is a procedure performed in vivo (within a living organism).
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not process or analyze biological specimens in vitro.

The device is clearly intended for a diagnostic procedure performed directly on the patient's heart, which is not the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

NLH

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.

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

Description	Item Number	French Size	Electrode Spacing (mm)	Curve Type	Usable Length (cm)	Number of Electrodes
Supreme Fixed Diagnostic EP Catheter	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	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
	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
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

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 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

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.

K151622, K161769

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

Indications for Use

510(k) Number (if known)

K182386

Device Name

Reprocessed Supreme Diagnostic Electrophysiology (EP) Catheters

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)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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April 23, 2019

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

Re: K182386

Trade/Device Name: Reprocessed Supreme Diagnostic Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: March 15, 2019 Received: March 18, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

2

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Enclosure

3

The item numbers included in the scope of this submission (K182386):

| Description Number | French
Size | Spacing
(mm) | Curve
Type | Usable
Length
(cm) | Number of
Electrodes |
|-----------------------------------------------|------- | Supreme
Fixed
Diagnostic
EP Catheter | 401978 | 6 | 402033 | 6 2-2-45-2-2-2-
2-2-2-2-2 | CSL | 120 | 402020 | 6 5-2-60-2-10-2-
10-2-10-2-10-
2 | CRD | 120 | 20 | | 401956 | | 402010 | | 402011 | | 401876 | | 401877 | | 401434 | | 401436 | | 401438 | | 401442 | | 401474 | | 402004 | | 401430 | | 401475 | | 401445 | | 401449 | | 401451 | | 401453 | | 401950 | | 401951 | | 401952 | Item
Electrode
---------|--------------------------------------------------------|------------------------------|---------------|--------------------------|-------------------------|
| 2-2-2 | CSL | 65 | 20 |
| 2-2-2-2-2-2-2-
| 20 | |
| 2-5-2-5-2-5-2-
| |
| 6 | 10 | CRD | 120 | 2 |
| 6 | 2-5-2 | CRD-2 | 120 | 6 |
| 6 | 5-5-5 | CRD-2 | 120 | 6 |
| 6 | 5-5-5-175-175 | CRD-1 | 120 | 6 |
| 6 | 5-5-5-175-175 | JSN | 120 | 6 |
| 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 | CRD-2 | 120 | 4 |
| 6 | 5 | JSN | 120 | 4 |
| 6 | 5 | JSN-1 | 120 | 4 |
| 6 | 5 | DAO | 120 | 4 |
| 6 | 2-5-2 | CRD | 120 | 4 |
| 6 | 2-5-2 | JSN | 120 | 4 |
| 6 | 2-5-2 | DAO | 120 | 4 |
| 6 | 5 | CRD | 120 | 4 |
| 6 | 5 | JSN | 120 | 4 |
| 6 | 10 | CRD | 120 | 4 |

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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 Principal Regulatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com

Date prepared:

August 30, 2018

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
K151622	Supreme Electrophysiology Catheter	St. Jude Medical
K161769	Reprocessed Supreme Diagnostic
Electrophysiology Catheter	Innovative Health, LLC.

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.

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

| Description | Item
Number | French
Size | Electrode
Spacing
(mm) | Curve
Type | Usable
Length
(cm) | Number of
Electrodes |
|-----------------------------------------------|----------------|----------------|--------------------------------------------------------|---------------|--------------------------|-------------------------|
| Supreme
Fixed
Diagnostic
EP Catheter | 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 |
| | 402010 | 6 | 2-5-2 | CRD-2 | 120 | 6 |
| | 402011 | 6 | 5-5-5 | CRD-2 | 120 | 6 |

5

401876	6	5-5-5-175-175	CRD-1	120	6
401877	6	5-5-5-175-175	JSN	120	6
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

Table 5.1: Device Scope

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 three (3) times. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing.

6

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.