(120 days)
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.
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.
This document is a 510(k) premarket notification for a reprocessed medical device, specifically a Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter. It is not an AI/ML-enabled device, and therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided text, focusing on the available information regarding the reprocessed device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Functional & Safety | Biocompatibility | Not explicitly stated (implied to meet standards for initial device) | Not detailed, but "bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness)" |
| Cleaning Validation | Not explicitly stated (implied to ensure removal of visible soil and decontamination) | "includes removal of visible soil and decontamination" | |
| Sterilization Validation | Not explicitly stated (implied to ensure sterility) | "Sterilization Validation" was conducted | |
| Visual Inspection | Not explicitly stated (implied to ensure no visible defects) | "Each device is inspected" | |
| Dimensional Verification | Not explicitly stated (implied to match original specifications) | "Dimensional Verification" was conducted | |
| Ultrasound Transducer Testing | Not explicitly stated (implied to meet original performance specifications) | "Ultrasound Transducer Testing" was conducted | |
| Simulated Use | Not explicitly stated (implied to function correctly in a simulated environment) | "Simulated Use" was conducted | |
| Mechanical Characteristics | Not explicitly stated (implied to meet original mechanical strength/integrity) | "Mechanical Characteristics" were tested | |
| Electrical Safety Testing | Not explicitly stated (implied to meet electrical safety standards) | Conducted, includes Dielectric and Current Leakage | |
| Packaging Validation | Not explicitly stated (implied to maintain sterility and integrity) | "Packaging Validation" was conducted | |
| Reprocessing Limits | Maximum Reprocessing Cycles | No more than one (1) time | "The Reprocessed Diagnostic Ultrasound Catheters are reprocessed no more than one (1) time." |
| Material/Design Identity | Purpose, Design, Materials, Function, Intended Use | Identical to predicate devices | "The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices." |
Study Proving Device Meets Acceptance Criteria:
The document broadly states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters."
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify the sample size for any of the tests. It only lists the types of tests performed.
- Data Provenance: Not applicable in the context of reprocessed physical devices. The testing was conducted by Innovative Health, LLC as part of their reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This is not a study involving human interpretation of data where "ground truth" needs to be established by experts. The "ground truth" for a reprocessed device's acceptance is its adherence to predefined engineering, safety, and functional specifications, compared to the original device.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method described as it's not a performance study requiring human interpretation or consensus.
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:
- No. This is a reprocessed medical device, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a reprocessed medical device, not an AI/ML device.
7. The Type of Ground Truth Used:
- The "ground truth" for this reprocessed device is its ability to meet the original device's specifications and performance characteristics after reprocessing, along with ensuring safety (biocompatibility, sterility, electrical safety) and functional integrity. This is established through the various functional, safety, and sterilization validation tests mentioned.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" as it is not an AI/ML system.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device does not involve a "training set."
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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 (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
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The following device models are included in this 510(k) submission:
| Item Number | Description | SheathUsableLength(cm) | FrenchSize | System Compatibility |
|---|---|---|---|---|
| SNDSTR10 | SoundStar 3D Diagnostic UltrasoundCatheter | 90 | 10F | Acuson/Siemens |
| SNDSTR10G | SoundStar 3D Diagnostic UltrasoundCatheter | 90 | 10F | GE Vivid-i and Vivid-qUltrasound 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 UltrasoundCatheters |
|---|---|
| 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 UltrasoundCatheter | Biosense Webster, Inc. |
| K091352 | SoundStar 3D Diagnostic UltrasoundCatheter | 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 | SheathUsableLength(cm) | FrenchSize | System Compatibility |
|---|---|---|---|---|
| SNDSTR10 | SoundStar 3D Diagnostic UltrasoundCatheter | 90 | 10F | Acuson/Siemens |
| SNDSTR10G | SoundStar 3D Diagnostic UltrasoundCatheter | 90 | 10F | GE Vivid-i and Vivid-qUltrasound 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.
§ 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).