(29 days)
Not Found
No
The summary describes a standard ultrasound catheter and does not mention any AI or ML capabilities, image processing beyond basic ultrasound rendering, or performance metrics typically associated with AI/ML algorithms.
No
The device is strictly for imaging guidance and visualization, not for delivering treatment or therapy.
Yes
The device is described as providing "real-time three-dimensional ultrasound images of anatomical structures and devices" for "intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology." This visualization is used for "imaging guidance," which implies aiding in understanding the state of the patient's anatomy or physiology, a fundamental aspect of diagnosis.
No
The device description clearly states it is a 12.5F catheter with physical dimensions and steering capabilities, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states the device is a catheter intended for intracardiac and intra-luminal visualization of anatomy and other devices within the body. It uses ultrasound to create images in real-time.
- No Specimen Testing: There is no mention of collecting or analyzing any specimens from the patient. The device directly interacts with and images structures inside the body.
Therefore, based on the provided information, this device falls under the category of an in vivo (within the living body) diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheter is intended for intracardiac 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 (comma separated list FDA assigned to the subject device)
OBJ
Device Description
The ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time threedimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time two-dimensional images.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2021
Siemens Medical Solutions USA, Inc. Hyunjung Lee Regulatory Technical Specialist 22010 S.E. 51st Street Issaquah, Washington 98029
Re: K212959
Trade/Device Name: ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 13, 2021 Received: September 16, 2021
Dear Hyunjung Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212959
Device Name
ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter
Indications for Use (Describe)
The catheter is intended for intracardiac 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c).
SPONSOR'S NAME & ADDRESS
Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029, USA
OFFICIAL CORRESPONDENT
HyunJung Lee Regulatory Technical Specialist Phone: (425) 281-5061 Email: hyunjung.lee@siemens-healthineers.com
SUBMISSION DATE
September 13, 2021
TRADE NAME
ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter
COMMON NAME
Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Diagnostic Intravascular Catheter/ OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
#K203726, ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
DESCRIPTION OF MODIFIED DEVICE
The ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time threedimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time two-dimensional images.
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INDICATIONS FOR USE
The catheter is intended for intracardiac 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 ACUSON AcuNav Volume ICE catheter is substantially equivalent to the company's own previously cleared ACUSON AcuNav Volume Intracardiac Echocardiography catheter (K203726) with regard to both intended use and technological characteristics. Both the subject catheter and the predicate catheter function in the same manner as all diagnostic ultrasound catheters.
| ATTRIBUTES | ACUSON AcuNav Volume Intracardiac
Echocardiography Catheter
K203726 | ACUSON AcuNav Volume Intracardiac
Echocardiography (ICE) Catheter
K212959 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Predicate Device) | (Subject Device) |
| Indications for Use | The catheter is intended for intracardiac
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. | The catheter is intended for intracardiac
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. |
| Acoustic Array | 192 channel vector | 192 channel vector |
| Insertable Outer
Diameter | 12.5 French (4.17 mm) | 12.5 French (4.17 mm) |
| Insertable Length | Total Insertable Length: 90 cm
- Distal Tip: 36.8mm (1.45")
- Strain Relief: 45.7mm(1.80") | Total Insertable Length: 90 cm
- Distal Tip: 30.5mm (1.20")
- Strain Relief: 39.4mm(1.55") |
| Patient Contact
Material (Catheter
Body) | Pebax series
Comply with ISO 10993-1 | Pebax series
Comply with ISO 10993-1 |
| Heat Shrink
Tubing | MT 2000 | N/A |
| Minimum
Introducer Sheath
Requirement | 13 French | 13 French |
| Packaging | Tyvek/Polyester Pouch & Solid Un-
bleached Sulfate Box and Insert | Tyvek/Polyester Pouch & Solid Un-
bleached Sulfate Box and Insert |
| Sterilization
method | EtO sterilization | EtO sterilization |
| Single Use | Yes | Yes |
| Shelf Life | 1 Year | 1 Year |
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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 and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- = IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- = AIUM/NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound
- Safety and EMC Requirements for Medical Equipment .
- o EN/IEC 60601-1
- EN/IEC 60601-1-2 o
- ISO 10993-1 Biocompatibility
- ISO 11135, Sterilization of health-care products Ethylene oxide
- ISO 11607-1 and ISO 11607-2, Packaging for terminally sterilized medical devices
A SUMMARY DISCUSSION OF THE CLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE.
Because the ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) 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 13485:2016 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 opinion of Siemens Medical Solutions USA, Inc. that ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter is substantially equivalent with the respect to safety and effectiveness to the device currently cleared for market.