K Number
K171788
Device Name
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
Date Cleared
2017-11-03

(141 days)

Product Code
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

Not Found

No
The description focuses on the mechanical and electrical properties of a diagnostic catheter for electrophysiological mapping, with no mention of AI or ML for data analysis, interpretation, or device control.

No
The device is indicated for electrophysiological mapping and recording, which are diagnostic purposes, not therapeutic interventions.

Yes
The "Intended Use / Indications for Use" states that the device is "indicated for electrophysiological mapping of cardiac structures" and also refers to it as a "Diagnostic EP Catheter." The "Device Description" section further reiterates its purpose for "electrophysiological mapping of the heart." These functions are inherently diagnostic as they aim to identify or characterize physiological conditions.

No

The device description clearly details a physical catheter with electrodes, a shaft, a handpiece, and a puller wire, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
  • Device Function: The Reprocessed Halo XP Diagnostic EP Catheter is used inside the body to directly map electrical activity within the heart. It is a diagnostic tool, but it operates in vivo (within a living organism), not in vitro (in glass/outside the body).
  • Intended Use: The intended use clearly states "electrophysiological mapping of cardiac structures, i.e. stimulation and recording only." This is a procedure performed directly on the patient's heart.
  • Device Description: The description details the physical characteristics and how it is manipulated within the heart to obtain electrical signals.

Therefore, based on the provided information, this device is an in vivo diagnostic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

NLH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

cardiac structures, the heart, tricuspid annulus

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 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

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.

K953768, K953663

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

§ 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).

0

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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 of
Electrodes | Spacing
(mm) | Length
(cm) |
|--------------------------------------|-------------|------------------|-----------|-------------------------|-----------------|----------------|
| Halo XP
Diagnostic EP
Catheter | 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)

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.

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) Number510(k) TitleManufacturer
K953768Cordis Webster A20 Diagnostic
Deflectable Tip CatheterCordis Webster, Inc.,
Biosense Webster
K953663Cordis Webster T20 Diagnostic
Deflectable Tip CatheterCordis Webster, Inc.,
Biosense Webster

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

5

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 of
Electrodes | Spacing
(mm) | Length
(cm) |
|---------------------------|-------------|------------------|-----------|-------------------------|-----------------|----------------|
| Halo XP | 116008RT | 7 | Tricuspid | 20 | 2-18-2-8-2 | 110 |
| Diagnostic EP
Catheter | 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:

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.

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

6

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.