The Reprocessed Inquiry Optima and Inquiry Optima Plus Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic studies. The reprocessed Inquiry Optima catheters are to be used to map the atrial regions of the heart.

Device Description

The Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic Electrophysiology (EP) Catheter incorporates both a distal end with a variable loop diameter, which allows selection of diameters within a specific range, and a deflectable shaft steering mechanism. The diameter of the distal loop may be contracted or expanded by turning the rotating knob. The distal shaft may be deflected by pushing and pulling the thumb control.

AI/ML Overview

The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable in the context of this regulatory filing for a reprocessed medical device.

The "acceptance criteria" here refer to the tests and validations performed to ensure the reprocessed device maintains the same safety and effectiveness as the original predicate device. The "study" proving this involves a series of bench and laboratory tests.

Here's the information that can be extracted and a clear indication of what is not applicable:

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

The document lists the types of tests performed rather than specific quantitative acceptance criteria or performance metrics in a table. The "reported device performance" is implicitly that the reprocessed device meets the standards of the predicate device.

Acceptance Criteria Category	Reported Device Performance (as demonstrated by testing)
Biocompatibility	Demonstrated equivalent biocompatibility.
Cleaning Validation	Demonstrated effective cleaning.
Sterilization Validation	Demonstrated effective sterilization.
Functional Testing (Visual)	Passed visual inspection.
Functional Testing (Dimensional)	Passed dimensional verification.
Functional Testing (Electrical)	Passed electrical continuity and resistance tests.
Functional Testing (Simulated Use)	Performed equivalently during simulated use.
Functional Testing (Mechanical)	Maintained mechanical characteristics.
Electrical Safety Testing	Passed dielectric and current leakage tests.
Packaging Validation	Passed packaging validation.

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

Not applicable for a reprocessing submission in this format. The device is reprocessed; the tests are laboratory/bench-based, not clinical studies with patient data.

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 pertains to diagnostic accuracy studies, which are not described here.

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

Not applicable. This pertains to diagnostic accuracy studies, which are not described here.

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 medical device reprocessing submission, not an AI or diagnostic imaging study.

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. Ground truth generation is relevant for diagnostic performance assessments. For this device, the "ground truth" for comparison is the performance and safety profile of the original, new predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

Summary

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

November 2, 2016

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

Re: K160421

Trade/Device Name: Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic 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: October 4, 2016

Received: October 5, 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 yours.

Mache Jellson

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	Number ofElectrodes	ElectrodeSpacing(mm)	FrenchSize	Loop Diameter(mm)	CatheterLength(cm)
Inquiry Optima PlusDiagnostic EPCatheter	81717	24	1-4.5-1	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81683	20	1-4.5-1	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81659	20	1-4.5-1	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81687	10	7	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81767	10	7	7	15-25	110

Table 1: K160421 List of Models in Scope

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Indications for Use

510(k) Number (if known) K160421

Device Name

Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic Electrophysiology 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:

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

Date prepared:

February 12, 2016

Device Information:

Trade/Proprietary Name:

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

Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH

Predicate Device:

510(k)Number	510(k) Title	Manufacturer
K060757	Inquiry Optima Plus Steerable ElectrophysiologyCatheter	Irvine Biomedical, Inc.
K042775	Inquiry AFocus, Inquiry AFocus II and InquiryOptima Steerable Electrophysiology Catheter	Irvine Biomedical, Inc.
K961924	IBI-1100 Steerable Electrophysiology CatheterSystem	Irvine Biomedical, Inc.

Reference Device:

510(k)Number	510(k) Title	Reprocessor
K112232	Reprocessed Electrophysiology Catheters	Stryker SustainabilitySolutions

De vice De scription:

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shaft steering mechanism. The diameter of the distal loop may be contracted or expanded by turning the rotating knob. The distal shaft may be deflected by pushing and pulling the thumb control.

Description	ItemNumber	Number ofElectrodes	ElectrodeSpacing(mm)	FrenchSize	Loop Diameter(mm)	CatheterLength(cm)
Inquiry Optima PlusDiagnostic EPCatheter	81717	24	1-4.5-1	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81683	20	1-4.5-1	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81659	20	1-4.5-1	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81687	10	7	7	15-25	110
Inquiry OptimaDiagnostic EPCatheter	81767	10	7	7	15-25	110

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

Table 5.1:Device Scope

Indications for Use:

The Reprocessed Inquiry Optima and Inquiry Optima Plus Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiologic studies. The reprocessed Inquiry Optima catheters are to be used to map the atrial regions of the heart.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic 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 Optima and Inquiry Optima Plus 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

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Electrical Safety Testing .
- · Dielectric and Current Leakage
. Packaging Validation

The Reprocessed Inquiry Optima and Inquiry Optima Plus 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 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 Optima and Inquiry Optima Plus 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).