(29 days)
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 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.
This document is a 510(k) Premarket Notification from Siemens Medical Solutions USA, Inc. for their ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter. The FDA has reviewed the submission and determined that the device is substantially equivalent to a legally marketed predicate device (K203726, also an ACUSON AcuNav Volume Intracardiac Echocardiography Catheter).
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to an AI/ML algorithm.
Instead, this submission is for a medical device (an ultrasound catheter) that:
- Provides real-time three-dimensional ultrasound images.
- Is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as other devices in the heart, for adult and pediatric patients.
- Is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The 510(k) summary explicitly states: "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."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as the document states such a study was not required or provided for this specific 510(k) submission. The FDA clearance is based on substantial equivalence to a predicate device, and compliance with general medical device safety and quality standards (e.g., UL, IEC, ISO standards for safety, EMC, biocompatibility, sterilization, and packaging).
In summary, there is no discussion of an AI/ML component, clinical performance study, or specific acceptance criteria for performance metrics (like sensitivity, specificity, AUC, etc.) in the provided text.
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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 IntracardiacEchocardiography CatheterK203726 | ACUSON AcuNav Volume IntracardiacEchocardiography (ICE) CatheterK212959 |
|---|---|---|
| (Predicate Device) | (Subject Device) | |
| Indications for Use | The catheter is intended for intracardiacand intra-luminal visualization ofcardiac and great vessel anatomy andphysiology as well as visualization ofother devices in the heart of adult andpediatric patients.The catheter is intended for imagingguidance only, not treatment delivery,during cardiac interventionalpercutaneous procedures. | The catheter is intended for intracardiacand intra-luminal visualization ofcardiac and great vessel anatomy andphysiology as well as visualization ofother devices in the heart of adult andpediatric patients.The catheter is intended for imagingguidance only, not treatment delivery,during cardiac interventionalpercutaneous procedures. |
| Acoustic Array | 192 channel vector | 192 channel vector |
| Insertable OuterDiameter | 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 ContactMaterial (CatheterBody) | Pebax seriesComply with ISO 10993-1 | Pebax seriesComply with ISO 10993-1 |
| Heat ShrinkTubing | MT 2000 | N/A |
| MinimumIntroducer SheathRequirement | 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 |
| Sterilizationmethod | 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.
§ 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).