The Reprocessed Halo XP Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheters' preformed halo shape of the tip section is designed specifically for the tricuspid annulus.

Device Description

The Reprocessed Deflectable Tip Halo XP Diagnostic Electrophysiology (EP) Catheters have been designed for electrophysiological mapping of the heart, in particular, the tricuspid annulus. The catheters have a high-torque shaft with a halo-shaped tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The tip section also contains a radiopaque mark in the center of the electrode array. The halo-shaped tip section has a preformed curve which can be positioned around the atrial aspect of the tricuspid annulus. The catheters facilitate simultaneous local electrograms spanning the tricuspid annulus, from the midseptal to anterior to lateral to posterolateral. Recordings of the entire annulus can be obtained without repositioning the catheter tip.

A piston in the handpiece is attached to an internal puller wire which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the preformed loop is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section returns to the preformed shape. The high torque shaft allows the plane of the curve to be maneuvered in order to facilitate accurate positioning.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Reprocessed Halo XP Diagnostic Electrophysiology Catheters. This is a medical device, and the information focuses on demonstrating its substantial equivalence to legally marketed predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI performance, such as human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for training and test sets, are not applicable to this submission.

The "acceptance criteria" in this context refer to the demonstration of safety and effectiveness as a reprocessed device compared to its original and predicate devices.

Here's the information that can be extracted from the provided text, with an explanation of why other criteria are not applicable:

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

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Testing conducted (performance not detailed, but implied successful)
Cleaning Validation	Testing conducted (performance not detailed, but implied successful)
Sterilization Validation	Testing conducted (performance not detailed, but implied successful)
Functional Testing	Conducted, including:
- Visual Inspection	Performed
- Dimensional Verification	Performed
- Electrical Continuity and	Performed
Resistance
- Simulated Use	Performed
- Mechanical Characteristics	Performed
Electrical Safety Testing	Conducted, including:
- Dielectric and Current Leakage	Performed
Packaging Validation	Performed
Reprocessing Cycle Limit	Reprocessed no more than one (1) time
Reprocessing Restrictions	Only reprocessed by Innovative Health; excludes devices previously reprocessed by others

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for each test. The text mentions "Bench and laboratory testing," which would involve a sample of reprocessed devices, but the specific number is not provided.
Data Provenance: The "tests" were conducted internally by Innovative Health, LLC, as part of their submission to the FDA. The data is thus internally generated by the manufacturer.

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 a reprocessed medical device, not an AI diagnostic tool. "Ground truth" in this context would refer to established engineering and material science standards for device performance, integrity, and safety (e.g., electrical resistance within a spec, material strength meeting a threshold). These are typically verified by qualified engineers and technicians, not medical experts establishing a diagnostic ground truth.

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

Not Applicable. As mentioned above, this is not an AI diagnostic study requiring adjudication of expert interpretations. The testing involves objective measurements and validations against predefined specifications.

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 device is not an AI algorithm assisting human readers. It is a reprocessed physical medical catheter.

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

Not Applicable. This device is a physical medical instrument, not a standalone AI algorithm.

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

For the reprocessed device, the "ground truth" or reference points for testing are established engineering specifications, safety standards, and performance characteristics for the original device and similar predicate devices. For example:
- Biocompatibility: Likely tested against ISO standards for medical devices concerning patient contact.
- Cleaning/Sterilization: Validation against established microbiological and sterility assurance level (SAL) standards.
- Functional/Electrical/Mechanical: Comparison to the original device's specifications and performance using objective measurements (e.g., resistance values, tensile strength, deflection range, etc.).

8. The sample size for the training set:

Not Applicable. There is no AI model being trained for this device.

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

Not Applicable. There is no AI model being trained for this device.

Summary

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November 3, 2017

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

Re: K171788

Trade/Device Name: Reprocessed Halo XP Diagnostic Electrophysiology Catheters (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 25, 2017 Received: September 26, 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. Willehemen
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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The item numbers included in the scope of this submission are as follows:

Description	Item Number	Size(French)	Curve	Number ofElectrodes	Spacing(mm)	Length(cm)
Halo XPDiagnostic EPCatheter	116008RT	7	Tricuspid	20	2-18-2-8-2	110
	D7T20282RT	7	Tricuspid	20	(20)-2-8-2	110
	D7T20P15RT	7	Tricuspid	20	2-13-2	110

Table 1: Devices in Scope

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Indications for Use

510(k) Number (if known)

K171788

Device Name

Reprocessed Halo XP Diagnostic Electrophysiology (EP) Catheters

Indications for Use (Describe)

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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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:

June 14, 2017

Device Information:

Trade/Proprietary Name:

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

Reprocessed Halo XP Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K953768	Cordis Webster A20 DiagnosticDeflectable Tip Catheter	Cordis Webster, Inc.,Biosense Webster
K953663	Cordis Webster T20 DiagnosticDeflectable Tip Catheter	Cordis Webster, Inc.,Biosense Webster

Device Description:

A piston in the handpiece is attached to an internal puller wire which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the

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preformed loop is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section returns to the preformed shape. The high torque shaft allows the plane of the curve to be maneuvered in order to facilitate accurate positioning.

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

Description	Item Number	Size(French)	Curve	Number ofElectrodes	Spacing(mm)	Length(cm)
Halo XP	116008RT	7	Tricuspid	20	2-18-2-8-2	110
Diagnostic EPCatheter	D7T20282RT	7	Tricuspid	20	(20)-2-8-2	110
Catheter	D7T20P15RT	7	Tricuspid	20	2-13-2	110

Table 5.1: Item Numbers

Indications for Use:

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Halo XP 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 Halo XP Diagnostic EP Catheters.

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 Halo XP Diagnostic EP Catheters are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum

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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 Halo XP 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).