(59 days)
Not Found
No
The summary describes a real-time 3D ultrasound catheter and its features, but there is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the hardware and its imaging capabilities.
No
The device is intended for imaging guidance and visualization, not for treatment delivery.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for imaging guidance" and "intraluminal visualization" and "intracardiac visualization." This is diagnostic in nature, providing information about anatomy and physiology rather than delivering treatment. Furthermore, the predicate device is explicitly described as a "diagnostic ultrasound catheter."
No
The device description explicitly states it is a "12.5F catheter with 90 cm of usable length and four-way steering," which is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "imaging guidance," "intraluminal visualization," and "intracardiac visualization" of anatomical structures and devices within the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The device is described as a catheter that provides real-time ultrasound images from within the body. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
- Anatomical Site: The anatomical sites are cardiac and great vessels, which are internal structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with IVD testing.
Therefore, the AcuNav Volume is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.
Product codes
OBJ
Device Description
The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, great vessel
Indicated Patient Age Range
Adult or a pediatric patient.
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)
To support the design change of the catheter, Design Verification Testing was performed on the modified ACUNAV VOLUME CATHETER.
Safety and Electromagnetic Cpmpliance testing was also performed to support the design changes on the predicate device. The Safety and Electromagnetic compliance testing validates the use of the modified device.
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards:
- I UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards I
- I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- I ISO 10993-1 Biocompatibility
Cleared patient contact materials and mechanical safety are unchanged.
Because the AcuNav Volume in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure in profile, with three overlapping heads suggesting community and connection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Siemens Medical Solutions USA, Inc. Shelly Pearce Director, Regulatory Affairs 685 East Middlefield Road Mountain View, California 94043
Re: K163478
Trade/Device Name: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: January 19, 2017 Received: January 27, 2017
Dear Shelly Pearce:
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 (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.
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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 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.
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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Indications for Use
510(k) Number (if known) K163478
Device Name
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
Indications for Use (Describe)
The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.
| 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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14 510(k) Summary
SPONSOR'S NAME & ADDRESS
Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mt. View, CA 94043
OFFICIAL CORRESPONDENT
Shelly Pearce Director, Regulatory Affairs Phone: 650-279-0134 Email: shelly.pearce@siemens.com
SUBMISSION DATE
November 18, 2016
TRADE NAME
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
COMMON NAME
Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Intravascular Ultrasound Catheter/OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
The AcuNav Volume is substantially equivalent to the AcuNav V diagnostic ultrasound catheter.
DESCRIPTION OF MODIFIED DEVICE
The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images.
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INDICATIONS FOR USE
The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.
DESCRIPTION OF MODIFICATION
This is the initial release of the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
SUMMARY OF NONCLINICAL TESTS
To support the design change of the catheter, Design Verification Testing was performed on the modified ACUNAV VOLUME CATHETER.
Safety and Electromagnetic Compliance testing was also performed to support the design changes on the predicate device. The Safety and Electromagnetic compliance testing validates the use of the modified device.
SUBSTANTIAL EQUIVALENCE CONCLUSION
The AcuNav Volume diagnostic ultrasound catheter is substantially equivalent to the company's own previously cleared Acuson AcuNav V diagnostic ultrasound catheter (K081808) with regard to both intended use and technological characteristics. Both the subject catheter and the predicate catheter functions in the same manner as all diagnostic ultrasound catheters.
| Feature / Characteristic | AcuNav Volume
This Submission | AcuNav V
K081808 |
|-----------------------------|----------------------------------|---------------------|
| Indications for Use: | | |
| ■ Cardiac | √ | √ |
| ■ Pediatric | √ | √ |
| ■ Intraluminal | √ | √ |
| ■ Intraoperative | √ | √ |
| ■ Intra-cardiac | √ | √ |
| Patient Contact Materials | ISO 10993-1 | ISO 10993-1 |
A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
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The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards:
- I UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards I
- I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- I ISO 10993-1 Biocompatibility
Cleared patient contact materials and mechanical safety are unchanged.
A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Because the AcuNav Volume in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence.
Intended use and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the ACUSON AcuNav Volume ICE Catheter is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
SIMILARITIES TO THE PREDICATE DEVICES
a) The modified ACUNAV VOLUME is identical to the currently cleared ACUNAV V in the following aspects:
- Have the same intended use .
- Use the same operating principle •
- Are manufactured in the same manufacturing facility .
- Use the same fundamental scientific technology .
- . Incorporate the same materials and construction
- Have the same deflection mechanism .
- Catheter body & strain relief have identical assembly process .
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- . Have the same acoustic array location and connection
- Are packaged using the same materials and processes .
- Have the same Electronics; the PCB is inside the Hypertronic connector . and Extension Cable
- Identical magnetic sensor location (not connected to the Printed Circuit . Board (PCB))
- Have the same handle material •
- . Have the same Steering mechanism
- Have identical Hypertronic connector .
- Most of the manufacturing processes are identical .
- . Have the same shelf life
- Use the same sterilization method (EtO sterilization) .
- Are single use devices .
DIFFERENCES FROM THE PREDICATE DEVICES
Some of the differences between the modified ACUNAV VOLUME CATHETER and the currently cleared ACUNAV V CATHETER are:
- a) Tip dimensions
- b) Distal shaft dimension
- c) Electrical connector
- d) Packaging
| AcuNav V | AcuNav Volume | |
|---|---|---|
| Tip Dimensions | 10F | 12.5F |
| Distal Shaft | ||
| Dimensions | 10F | 12.5F |
| Electrical | ||
| Connector | Twist and lock mechanism | Push and lock mechanism |
| Packaging | Paper board tray | Paper board tray |
| Double Pouch | Single Pouch | |
| Telescoping two-piece CCSBS unit | ||
| carton | Non-telescoping one-piece CCSBS unit | |
| carton |