(139 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the physical manipulation and imaging capabilities of the catheter.
No
The intended use explicitly states, "The catheter is intended for imaging guidance only, not treatment delivery." This indicates it's a diagnostic tool, not a therapeutic one.
Yes
The device is explicitly referred to as a "DIAGNOSTIC ULTRASOUND CATHETER" in the predicate device information, and its intended use is for visualization to aid in imaging guidance rather than for treatment.
No
The device description explicitly states it is a "catheter" which is a physical hardware component. The summary focuses on the physical manipulation and imaging capabilities of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intra-cardiac and intra-luminal visualization" and "imaging guidance only". This describes a device used within the body for imaging purposes, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description focuses on the physical characteristics and maneuverability of a catheter designed for internal scanning.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is an imaging catheter used directly within the body.
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 pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes
OBJ
Device Description
The AcuNav catheters are, 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, 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/EC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- I ISO 10993-1 Biocompatibility
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).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.
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: K170263
Trade/Device Name: AcuNav Diagnostic Ultrasound Catheter 8F, 10F Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: May 2, 2017 Received: May 23, 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 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,
MA. Hillebrand
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)
Device Name
AcuNav Diagnostic Ultrasound Catheter 8F, 10F
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 pediatric 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
Mav 2, 2017
TRADE NAME
AcuNav Diagnostic Ultrasound Catheter 8F, 10F
COMMON NAME
Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Intravascular Ultrasound Catheter/OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
#K071234, ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10
DESCRIPTION OF MODIFIED DEVICE
The AcuNav catheters are, 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 8F, 10F ultrasound catheters are substantially equivalent to the company's own previously cleared AcuNav Diagnostic Ultrasound Catheter 8F, 10F (K071234) 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 8F, 10F
This Submission | AcuNav 8F, 10F
K071234 |
|---------------------------|-----------------------------------|---------------------------|
| Indications for use: | | |
| - Cardiac | √ | √ |
| - Pediatric | √ | √ |
| - Intra-luminal | √ | √ |
| - Intra-cardiac | √ | √ |
| Mode of operation: | | |
| - 2D | √ | √ |
| - C | √ | √ |
| - D | √ | √ |
| - CW | √ | √ |
| 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, electrical, 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/EC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- I ISO 10993-1 Biocompatibility
5
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 catheters 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 Diagnostic Ultrasound Catheters are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.