(120 days)
Not Found
No
The summary describes a standard ultrasound imaging catheter with a location sensor. There is no mention of AI/ML in the device description, intended use, or performance studies. The performance studies focus on basic device functionality and safety, not algorithmic performance.
No
The 'Intended Use' section explicitly states the device is for 'visualization,' and its description as an 'imaging catheter' confirms its diagnostic, not therapeutic, purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "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." This indicates its use for diagnosing conditions through visualization.
No
The device description clearly states it is an "imaging catheter" with a physical ultrasound transducer and a steering mechanism, indicating it is a hardware device.
Based on the provided information, the Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that the device is an "imaging catheter" used for "intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology." This means it is used inside the body to visualize structures directly.
- Intended Use: The intended use is for visualization within the heart and great vessels, not for testing samples taken from the body.
Therefore, the Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
OWO, OWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy.
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles forming a single shape, resembling a bird in flight.
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
1
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 (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.
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
2
The following device models are included in this 510(k) submission:
| Item Number | Description | Sheath
Usable
Length
(cm) | French
Size | System Compatibility |
|-------------|------------------------------------------------|------------------------------------|----------------|---------------------------------------------|
| SNDSTR10 | SoundStar 3D Diagnostic Ultrasound
Catheter | 90 | 10F | Acuson/Siemens |
| SNDSTR10G | SoundStar 3D Diagnostic Ultrasound
Catheter | 90 | 10F | GE Vivid-i and Vivid-q
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)
| ☑ 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 Senior Quality and Regulatory Manager Innovative Health, LLC. (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com
Date prepared:
February 14, 2017
Device Information:
| Trade/Proprietary Name: | Reprocessed SoundStar 3D Diagnostic Ultrasound
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 | |
| Catheter | Biosense Webster, Inc. | |
| K091352 | SoundStar 3D Diagnostic Ultrasound | |
| 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
Usable
Length
(cm) | French
Size | System Compatibility |
|-------------|------------------------------------------------|------------------------------------|----------------|---------------------------------------------|
| SNDSTR10 | SoundStar 3D Diagnostic Ultrasound
Catheter | 90 | 10F | Acuson/Siemens |
| SNDSTR10G | SoundStar 3D Diagnostic Ultrasound
Catheter | 90 | 10F | GE Vivid-i and Vivid-q
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.