The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.

Device Description

The Reprocessed Inquiry H-Curve 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

The provided text is a 510(k) summary for a reprocessed medical device, specifically, the Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device or an AI/ML powered device.

Therefore, the information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML powered device is not available in this document. The document describes a traditional medical device (a catheter) and its reprocessing.

However, I can extract the safety and functional testing performed for this reprocessed device, which serves as its "demonstration of performance" to support its substantial equivalence claim.

Device Type: Reprocessed Steerable Diagnostic Electrophysiology Catheters (not an AI/ML powered device).

Summary of Device Performance and Testing (as described in the document):

The document lists "Functional and Safety Testing" conducted to demonstrate the performance, safety, and effectiveness of the reprocessed catheters. This is the closest equivalent to "proving the device meets acceptance criteria" for this type of device.

Acceptance Criteria Category	Reported Test Performed / Device Performance
Biocompatibility	Biocompatibility testing was performed.
Cleaning Validation	Cleaning validation was performed.
Sterilization Validation	Sterilization validation was performed.
Visual Inspection	Visual inspection was performed.
Dimensional Verification	Dimensional verification was performed.
Electrical Continuity and Resistance	Electrical continuity and resistance testing was performed.
Simulated Use	Simulated use testing was performed.
Mechanical Characteristics	Mechanical characteristics testing was performed.
Dielectric and Current Leakage	Dielectric and current leakage testing was performed.
Packaging Validation	Packaging validation was performed.

Additional Details from the Document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document only states that "Bench and laboratory testing was conducted."
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 for this type of device and testing. The testing is laboratory-based physical and electrical property assessment rather than expert evaluation of diagnostic output.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the tests performed (e.g., electrical continuity, mechanical characteristics), the "ground truth" would be established engineering specifications, performance standards, and established laboratory test methodologies for the predicate device.
The sample size for the training set: Not applicable. This is not an AI/ML powered device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.

Summary

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

June 10, 2016

Innovative Health, LLC. Rafal Chudzik Director of Engineering 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K160496

Trade/Device Name: Reprocessed Inquiry H-Curve Steerable Diagnostic EP 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: May 4, 2016 Received: May 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.

Mude Jellman
for

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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Item Number	Model/Description	Description	Electrodes	Spacing(mm)	Curve	FrenchSize	UsableLength(cm)
81120	1120-7-17-H	Inquiry SteerableDiagnostic EP Catheter	20	1-7-1	H-Curve	7	110
81130	1120-7-19-HL	Inquiry SteerableDiagnostic EP Catheter	20	1-9-1	H-Large	7	110
81136	1120-7-5-HL-UP	Inquiry SteerableDiagnostic EP Catheter	20	5	H-Large	7	110
81128	1121-7-5-H-UP	Inquiry SteerableDiagnostic EP Catheter	21	5	H-Curve	7	110
81124	1124-7-271-H	Inquiry SteerableDiagnostic EP Catheter	24	2-7-1	H-Curve	7	110
81134	1124-7-291-HL	Inquiry SteerableDiagnostic EP Catheter	24	2-9-1	H-Large	7	110

Reprocessed Single-Use Devices Included in K160496 Clearance

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Indications for Use

510(k) Number (if known) K160496

Device Name

Reprocessed Inquiry H-Curve 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 19, 2016

Device Information:

Trade/Proprietary Name:	Reprocessed Inquiry H-Curve Steerable DiagnosticElectrophysiology 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) Title	Manufacturer
K082061	Inquiry H-Curve TV Steerable DiagnosticCatheter	Irvine Biomedical, Inc.
K042775	Inquiry AFocus, Inquiry AFocus II andInquiry Optima SteerableElectrophysiology Catheter	Irvine Biomedical, Inc.
K961924	IBI-1100 Steerable ElectrophysiologyCatheter System	Irvine Biomedical, Inc.

Reference Device:

510(k) Number	510(k) Title	Reprocessor
K112232	Reprocessed ElectrophysiologyCatheters	Stryker SustainabilitySolutions

Device Description:

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Item Number	Model/Description	Description	Electrodes	Spacing(mm)	Curve	FrenchSize	UsableLength(cm)
81120	1120-7-17-H	Inquiry SteerableDiagnostic EP Catheter	20	1-7-1	H-Curve	7	110
81130	1120-7-19-HL	Inquiry SteerableDiagnostic EP Catheter	20	1-9-1	H-Large	7	110
81136	1120-7-5-HL-UP	Inquiry SteerableDiagnostic EP Catheter	20	5	H-Large	7	110
81128	1121-7-5-H-UP	Inquiry SteerableDiagnostic EP Catheter	21	5	H-Curve	7	110
81124	1124-7-271-H	Inquiry SteerableDiagnostic EP Catheter	24	2-7-1	H-Curve	7	110
81134	1124-7-291-HL	Inquiry SteerableDiagnostic EP Catheter	24	2-9-1	H-Large	7	110

Table 1: Models Included in Clearance

Indications for Use:

The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.

Technoloqical 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:

Biocompatibilitv
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

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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).