Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

K170474 · Innovative Health, LLC · OWQ · Jun 16, 2017 · Cardiovascular

Device Facts

• Record ID: K170474
• Device Name: Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
• Applicant: Innovative Health, LLC
• Product Code: OWQ · Cardiovascular
• Decision Date: Jun 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The SoundStar 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO EP Navigation Systems.

Device Story

Imaging catheter for intra-cardiac and intra-luminal visualization; features distal ultrasound transducer for 2D imaging and 3D location sensor for integration with CARTO EP Navigation Systems. Steering mechanism allows operator to control image plane orientation by rotating catheter tip. Used in clinical settings by physicians to visualize cardiac anatomy, physiology, and other devices; provides real-time location data to navigation systems. Reprocessed version of original device; undergoes cleaning, decontamination, inspection, and functional testing. Benefits include visualization of heart structures and device positioning during procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility, cleaning validation, sterilization validation, functional testing (visual inspection, dimensional verification, ultrasound transducer testing, simulated use, mechanical characteristics), electrical safety testing (dielectric and current leakage), and packaging validation.

Technological Characteristics

10F diagnostic ultrasound catheter with 90cm usable length. Features distal ultrasound transducer and 3D location sensor. Compatible with Acuson/Siemens or GE Vivid-i/Vivid-q systems. Reprocessed via cleaning and decontamination; limited to one reprocessing cycle. Includes steering mechanism for image plane orientation.

Indications for Use

Indicated for patients requiring intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy, physiology, and other devices within the heart.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• SoundStar 3D Diagnostic Ultrasound Catheter (K101138)
• SoundStar 3D Diagnostic Ultrasound Catheter (K091352)

Submission Summary (Full Text)

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Public Health Service

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

June 16, 2017

Innovative Health, LLC. Amv Stoklas-Oakes Sr. Ouality and Regulatory Manager 1435 North Havden Road. Suite 100 Scottsdale, Arizona 85257

Re: K170474

Trade/Device Name: Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter (see list of models enclosed) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: May 11, 2017 Received: May 12, 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

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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 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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hillebrand

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 following device models are included in this 510(k) submission:

| Item Number | Description | Sheath<br>Usable<br>Length<br>(cm) | French<br>Size | System Compatibility |
|-------------|------------------------------------------------|------------------------------------|----------------|---------------------------------------------|
| SNDSTR10 | SoundStar 3D Diagnostic Ultrasound<br>Catheter | 90 | 10F | Acuson/Siemens |
| SNDSTR10G | SoundStar 3D Diagnostic Ultrasound<br>Catheter | 90 | 10F | GE Vivid-i and Vivid-q<br>Ultrasound System |

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# Indications for Use

510(k) Number (if known) K170474

Device Name

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

Indications for Use (Describe)

The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

The SoundStar 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO EP Navigation Systems.

Type of Use (Select one or both, as applicable)

| <span style="font-size:100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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 Senior Quality and Regulatory Manager Innovative Health, LLC. [phone] (office) [phone] (fax) [e-mail]

### Date prepared:

February 14, 2017

### Device Information:

| Trade/Proprietary Name: | Reprocessed SoundStar 3D Diagnostic Ultrasound<br>Catheters |
|-------------------------|-------------------------------------------------------------|
| Classification Name: | Reprocessed Intravascular Ultrasound Catheter |
| Classification Number: | Class II, 21 CFR 870.1200 |
| Product Code: | OWQ |

#### Predicate Device:

| 510(k) Number | 510(k) Title | Manufacturer |
|---------------|------------------------------------------------|------------------------|
| K101138 | SoundStar 3D Diagnostic Ultrasound<br>Catheter | Biosense Webster, Inc. |
| K091352 | SoundStar 3D Diagnostic Ultrasound<br>Catheter | Biosense Webster, Inc. |

#### Device Description:

The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheters (hereinafter Catheter) is an imaging catheter. The distal end of the catheter has an ultrasound transducer providing two-dimensional imaging and a three-dimensional location sensor providing location information to compatible CARTO EP Navigation Systems with ultrasound capability. A steering mechanism controls the image plane orientation by rotating both the catheter tip and the variable direction.

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

| Item Number | Description | Sheath<br>Usable<br>Length<br>(cm) | French<br>Size | System Compatibility |
|-------------|------------------------------------------------|------------------------------------|----------------|---------------------------------------------|
| SNDSTR10 | SoundStar 3D Diagnostic Ultrasound<br>Catheter | 90 | 10F | Acuson/Siemens |
| SNDSTR10G | SoundStar 3D Diagnostic Ultrasound<br>Catheter | 90 | 10F | GE Vivid-i and Vivid-q<br>Ultrasound System |

Table 5.1: Device Scope

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# Indications for Use:

The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is indicated for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

The SoundStar 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO EP Navigation Systems.

# Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Diagnostic Ultrasound Catheter 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 Reprocessed Diagnostic Ultrasound Catheters. This included the following:

- Biocompatibility .
- Cleaning Validation .
- Sterilization Validation ●
- Functional testing ●
- . Visual Inspection
- . Dimensional Verification
- . Ultrasound Transducer Testing
- . Simulated Use
- . Mechanical Characteristics
- . Electrical Safety Testing
- · Dielectric and Current Leakage
- Packaging Validation

The Reprocessed Diagnostic Ultrasound 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 Diagnostic Ultrasound Catheter is as safe and effective as the predicate devices described herein.