(73 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the physical manipulation of the catheter for visualization, not automated analysis or interpretation.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The catheter is intended for imaging guidance only, not treatment delivery." This indicates it is a diagnostic or guidance device, not a therapeutic one.
No
The device is described as an imaging guidance tool ("The catheter is intended for imaging guidance only, not treatment delivery"), which assists physicians in visualizing anatomy and other devices during procedures. While it provides visual information, its stated purpose is guidance for interventions rather than reaching a diagnosis based on the acquired images.
No
The device description clearly states it is a "catheter" which is a physical hardware component. The intended use also describes a physical device being maneuvered.
Based on the provided information, this device 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a catheter intended for intra-cardiac and intra-luminal visualization using ultrasound. It is used for imaging guidance during a procedure, not for analyzing samples taken from the body.
- Anatomical Site: The device operates directly within the heart and great vessels, not on external samples.
Therefore, the AcuNav V ultrasound catheter falls under the category of a medical device used for imaging and guidance during interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatic patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes
OBJ
Device Description
The AcuNav V ultrasound catheter is sterile, disposable, and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization.
The catheters are to be used only on systems with which they have been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intra-cardiac, intra-luminal (cardiac and great vessel anatomy)
Indicated Patient Age Range
Adult and pediatric patients
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
Because the AcuNav V catheter 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
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized wave or ribbon flowing beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Siemens Medical Solutions USA, Inc Shelly Pearce Director, Regulatory Affairs 685 East Middlefield Road Mountain View, California 94043
Re: K170992
Trade/Device Name: AcuNav V 10F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: March 10, 2017 Received: April 3, 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 of medical device
1
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.
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. Hilleman
for
for - Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170992
Device Name
AcuNav V 10F Diagnostic Ultrasound Catheter
Indications for Use (Describe)
The catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatic patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
| 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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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
March 10, 2017
TRADE NAME
AcuNav V 10F Diagnostic Ultrasound Catheter
COMMON NAME
Diagnostic Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Intravascular Ultrasound Catheter/OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
#K081808, ACUSON AcuNav V 10F Ultrasound Catheter
DESCRIPTION OF MODIFIED DEVICE
The AcuNav V ultrasound catheter is sterile, disposable, and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization.
The catheters are to be used only on systems with which they have been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.
4
INDICATIONS FOR USE
The catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
SUBSTANTIAL EQUIVALENCE CONCLUSION
The AcuNav V ultrasound catheter is substantially equivalent to the company's own previously cleared AcuNav V 10F Ultrasound Catheter (K081808) with regard to both intended use and technological characteristics. Both the subject catheters and the predicate catheters function in the same manner as all diagnostic ultrasound catheters.
| Feature/Characteristic | AcuNav V
This Submission | AcuNav V
K081808 |
|---------------------------|-----------------------------|---------------------|
| Indications for use: | | |
| Cardiac | | |
| Pediatric
। | | |
| Intra-luminal
-
| | |
| Intra-cardiac | | |
| Mode of operation: | | |
| 2D | | |
| C | | |
| D | | |
| Volume | | |
| 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.
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 l
- 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/EC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- ISO 10993-1 Biocompatibility I
Cleared patient contact materials and mechanical safety are unchanged.
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A SUMMARY DISCUSSION OF THE CLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE.
Because the AcuNav V catheter 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.
SUMMARY
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 AcuNav V Ultrasound Catheters are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.