The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight right atrium, right ventricular apex, and HIS bundle.

Device Description

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.

AI/ML Overview

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter. It focuses on demonstrating substantial equivalence to predicate devices and detailing the reprocessing procedures and validation, rather than an AI/ML device or a comparative effectiveness study involving human readers.

Therefore, many of the requested categories for AI/ML device studies - such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set size, and ground truth for training set - are not applicable to this type of regulatory submission.

The document primarily describes the safety and functional testing performed to demonstrate that the reprocessed device performs as intended and is safe.

Here's the information available and a clear indication of what is not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Functional and Safety Testing Categories (Implicit Acceptance: Meets specifications for safe and effective use, equivalent to predicate)
Biocompatibility	Tested (Details not provided in this document)
Cleaning Validation	Validated (Details not provided in this document)
Sterilization Validation	Validated (Details not provided in this document)
Functional Testing
Visual Inspection	Performed (Details not provided in this document)
Dimensional Verification	Performed (Details not provided in this document)
Electrical Continuity and Resistance	Performed (Details not provided in this document)
Simulated Use	Performed (Details not provided in this document)
Mechanical Characteristics	Performed (Details not provided in this document)
Electrical Safety Testing
Dielectric and Current Leakage	Performed (Details not provided in this document)
Packaging Validation	Validated (Details not provided in this document)
Reprocessing Cycle Limit	Reprocessed no more than one (1) time
Exclusion of Other Reprocessors	Innovative Health restricts reprocessing to exclude devices previously reprocessed by other reprocessors.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of bench and laboratory tests described under "Functional and Safety Testing." These tests were conducted to demonstrate the performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in this document. The testing describes procedures like "cleaning validation," "sterilization validation," and various "functional testing" aspects (visual, dimensional, electrical, simulated use, mechanical, electrical safety, packaging). These tests would involve specific numbers of reprocessed units, but the exact sample sizes are not provided in this summary.
Data Provenance: Not applicable/not specified. This is a premarket notification for a reprocessed device, not a data-driven AI/ML study. The data arises from internal bench and laboratory testing conducted by Innovative Health, LLC.

3. 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. This is not an AI/ML device and does not involve establishing ground truth from expert consensus on medical images or clinical data. The "ground truth" for this device's performance comes from engineering and quality control specifications and tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device and does not involve clinical data adjudication.

5. 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 a conventional medical device (reprocessed catheter), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of typical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, validated test methods, and compliance with recognized standards for medical device safety and functionality (e.g., electrical safety standards, biocompatibility standards, cleaning efficacy standards). The control group for comparison is the original, new device and the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and therefore does not have a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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October 23, 2017

Innovative Health, LLC. Amy Stoklas-Oakes Director, Quality and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K171277

Trade/Device Name: Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter (See Enclosed Model List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 21, 2017 Received: September 22, 2017

Dear Amy Stoklas-Oakes:

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 device-related 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

M.A. Wilhelm

for __________________________________________________________________________________________________________________________________________________________________________ Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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The following device models are included in the scope of this 510(k) submission:
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ItemNumber	Number ofElectrodes	FrenchSize	ElectrodeSpacing (mm)	Curve	UsableLength (cm)
81530	10	4F	2	Medium	110
81531	10	4F	2.5-2	Medium	110
81532	10	4F	2.5-2	Large	110
81534	10	4F	5	Large	110
81537	10	4F	25	M(SC)(60)	60
81871	8	5F	2	Medium	110
81872	8	5F	2.5-2	Medium	110
81540	4	4F	2.5-2	Medium	110
81542	4	4F	5	Medium	110
81543	4	4F	2.5-2	Large	110
81472	4	5F	2.5-2	Medium	110
81473	4	5F	5	Medium	110
81474	4	5F	2.5-2	Large	110
81483	4	5F	5	E(HIS)	110
81402	4	6F	2.5-2	Medium	110
81403	4	6F	5	Medium	110
81404	4	6F	2.5-2	Large	110
81405	4	6F	5	Large	110
81417	4	6F	5	X-Large	110
81418	4	6F	2.5-2	X-Large	110
81102	10	6F	2.5-2	Medium	110
81104	10	6F	2.5-2	Large	110
81105	10	6F	2.5-2	X-Large	110
81107	10	6F	5	Large	110
81520	10	6F	2	X-Large	110
81524	10	6F	2	Large	110
81945	10	6F	2.5-2	Large	110
81947	10	6F	5	Medium/ Large	110
81504	10	6F	5	Medium	110
81801	8	6F	2	Medium	110
81802	8	6F	2.5-2	Medium	110
81807	8	6F	2	Large	110
81809	8	6F	2.5-2	Large	110
81516	8	6F	2.5-2	L1	110
81171	10	5F	2	Medium	110
81172	10	5F	2.5-2	Medium	110
81174	10	5F	2.5-2	Large	110
81223	10	5F	2.50-3	X-Large	110
81224	10	5F	2.30-3	Medium	110
81202	20	7F	2.10-2	XX-Large	110
81207	20	7F	5	Super Large	110
81209	20	7F	2.5-2	Super Large	110

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Indications for Use

510(k) Number (if known) K171277

Device Name

Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) 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)

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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:

Amy Stoklas-Oakes Innovative Health, LLC. Sr. Quality and Regulatory Manager (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com

Date prepared:

April 28, 2017

Device Information:

Trade/Proprietary Name:

Common Name: Classification Name: Classification Number: Product Code:

Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NEH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K982232	Modification of the IBI-1100 SteerableElectrophysiology Catheter System	Irvine Biomedical, Inc.
K961924	IBI-1100 Steerable ElectrophysiologyCatheter System	Irvine Biomedical, Inc.

Reference Device:

510(k) Number	510(k) Title	Reprocessor
K160496	Inquiry H-Curve Steerable Diagnostic EPCatheter	Innovative Health, LLC.

Device Description:

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Description	ItemNumber	Number ofElectrodes	FrenchSize	ElectrodeSpacing(mm)	Curve	UsableLength(cm)
InquirySteerableDiagnostic EPCatheter	81530	10	4F	2	Medium	110
	81531	10	4F	2-5-2	Medium	110
	81532	10	4F	2-5-2	Large	110
	81534	10	4F	5	Large	110
	81537	10	4F	25	M(SC)(60)	60
	81871	8	5F	2	Medium	110
	81872	8	5F	2-5-2	Medium	110
	81540	4	4F	2-5-2	Medium	110
	81542	4	4F	5	Medium	110
	81543	4	4F	2-5-2	Large	110
	81472	4	5F	2-5-2	Medium	110
	81473	4	5F	5	Medium	110
	81474	4	5F	2-5-2	Large	110
	81483	4	5F	5	E(HIS)	110
	81402	4	6F	2-5-2	Medium	110
	81403	4	6F	5	Medium	110
	81404	4	6F	2-5-2	Large	110
	81405	4	6F	5	Large	110
	81417	4	6F	5	X-Large	110
	81418	4	6F	2-5-2	X-Large	110
	81102	10	6F	2-5-2	Medium	110
	81104	10	6F	2-5-2	Large	110
	81105	10	6F	2-5-2	X-Large	110
	81107	10	6F	5	Large	110
	81520	10	6F	2	X-Large	110
	81524	10	6F	2	Large	110
	81945	10	6F	2-5-2	Large	110
	81947	10	6F	5	Medium/ Large	110
	81504	10	6F	5	Medium	110
	81801	8	6F	2	Medium	110
	81802	8	6F	2-5-2	Medium	110
	81807	8	6F	2	Large	110
	81809	8	6F	2-5-2	Large	110
	81516	8	6F	2-5-2	L1	110
	81171	10	5F	2	Medium	110
	81172	10	5F	2-5-2	Medium	110
	81174	10	5F	2-5-2	Large	110
	81223	10	5F	2-50-3	X-Large	110
	81224	10	5F	2-30-3	Medium	110
	81202	20	7F	2-10-2	XX-Large	110
	81207	20	7F	5	Super Large	110
	81209	20	7F	2-5-2	Super Large	110

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

Table 5.1: Item Numbers in Scope

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Indications for Use:

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Inquiry 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 Inquiry 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 Inquiry 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 Inquiry 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).