(29 days)
Not Found
No
The summary describes a standard ultrasound catheter for visualization and guidance, with no mention of AI, ML, or related concepts like image processing beyond basic visualization. The substantial equivalence argument is based on the predicate device's technology, which is also a standard ultrasound catheter.
No
The device is explicitly stated to be "for imaging guidance only, not treatment delivery," indicating it is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The device is described as an "Imaging guidance" device for "intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology." Visualization of anatomy and physiology is a diagnostic function, even if it's for guiding procedures. The predicate device's name "AcuNav Diagnostic Ultrasound Catheter" further supports this.
No
The device description explicitly states it is a "catheter," which is a physical hardware component. The 510(k) summary focuses on the hardware aspects of the device.
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 intracardiac and intra-luminal visualization using ultrasound. It is used for imaging guidance during a procedure, not for analyzing samples taken from the body.
- Intended Use: The intended use is for visualization of anatomy and physiology within the heart and great vessels, and for imaging guidance during procedures. This is a direct imaging and procedural guidance tool, not a diagnostic test performed on a sample.
Therefore, the AcuNav Crystal Ultrasound catheter falls under the category of a medical device used for imaging and procedural guidance, 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 pediatic patients. The cather is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes
OBJ
Device Description
The AcuNav Crystal Ultrasound catheter is 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 catheter is to be used only on systems with which they have been tested and found compatible.
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, sterilization, packaging, shelf life 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:
- ISO 14971 risk management to medical devices
- ANSI/AAMI ES 60601-1 Safety Requirements for Medical Equipment
- IEC 60601-1-2 EMC requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 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
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
October 28, 2023
Siemens Medical Solutions USA, Inc. Bongsoo Cho Regulatory Technical Specialist 22010 S.E. 51st Street Issaquah, Washington 98029
Re: K233270
Trade/Device Name: AcuNav Crystal Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 28, 2023 Received: September 29, 2023
Dear Bongsoo Cho:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233270
Device Name AcuNav Crystal Ultrasound 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 pediatic patients. The cather 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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510k 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
Bongsoo Cho Regulatory Affairs Professional Phone: (425) 606-9346 Email: bongsoo.cho@siemens-healthineers.com
SUBMISSION DATE
September 28, 2023
TRADE NAME
AcuNav Crystal Ultrasound Catheter
COMMON NAME
Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Diagnostic Intravascular Catheter/ OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
#K170263, AcuNav Diagnostic Ultrasound Catheter 8F, 10F
DESCRIPTION OF MODIFIED DEVICE
The AcuNav Crystal Ultrasound catheter is 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 catheter is to be used only on systems with which they have been tested and found compatible.
5
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 AcuNav Crystal Ultrasound catheter is substantially equivalent to the company's own previously cleared AcuNav Diagnostic Ultrasound Catheter 8F, 10F (K170263) with regard to both intended use and technological characteristics. The Indications for Use and Intended Uses of the submission device remain unchanged from the predicate catheter device as cleared under K170263. Both the subject catheter and the predicate catheter function in the same manner as all diagnostic ultrasound catheters.
| ATTRIBUTES | AcuNav Crystal Ultrasound Catheter
This Submission | AcuNav Diagnostic Ultrasound
Catheter
Predicate (K170263) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BACKGROUND | | |
| Device name | AcuNav Crystal Ultrasound Catheter | AcuNav Diagnostic Ultrasound Catheter
8F/10F |
| 510(k) | Subject of this 510(k) submission | K170263 |
| Manufacturer | Siemens Medical Solutions USA, Inc.
22010 S.E. 51st Street
Issaquah, WA 98029, USA | Siemens Medical Solutions USA, Inc.
22010 S.E. 51st Street
Issaquah, WA 98029, USA |
| Manufacturing
Facility | Siemens Healthineers Ltd.
2nd & 3rd Venture Bld.,
Pohang Technopark,
394, Jigok-ro, Nam-gu,
Pohang-si, Gyeongsangbuk-Do,
Republic of Korea | Siemens Healthineers Ltd.
2nd & 3rd Venture Bld.,
Pohang Technopark,
394, Jigok-ro, Nam-gu,
Pohang-si, Gyeongsangbuk-Do,
Republic of Korea |
| 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. |
| INDICATIONS FOR USE | | |
| Cardiac | X | X |
| Pediatric | X | X |
| Intra-luminal | X | X |
| Intra-Cardiac | X | X |
| MODE OF OPERATION | | |
| 2D | X | X |
| M | X | X |
| C | X | X |
| D | X | X |
| CW | X | X |
| PRINCIPLE OF OPERATION | | |
| Mechanism of
Distal tip
Orientation | Manual Control knobs on the handle
provide bidirectional steering capabilities | Manual Control knobs on the handle
provide bidirectional steering capabilities |
6
| ATTRIBUTES | AcuNav Crystal Ultrasound Catheter
This Submission | AcuNav Diagnostic Ultrasound
Catheter
Predicate (K170263) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| (steering
control) | /anterior. | /anterior. |
| MECHANICAL DESIGN CHARACTERISTICS | | |
| Tip
Dimensions | 9F | 8F, 10F |
| Insertable
Length | 90 cm | 90 cm |
| Function of
handle | The handle houses the steering
mechanism that enables deflection of the
distal tip | The handle houses the steering
mechanism that enables deflection of the
distal tip |
| OTHER DESIGN CHARACTERISTICS | | |
| Radiopacity | Yes | Yes |
| Biocompatibility | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 |
| Adhesives | N/A - no patient contacting materials
have adhesives associated. Internal sub-
assemblies inside the handle are bonded
using adhesives | N/A - no patient contacting materials
have adhesives associated. Internal sub-
assemblies inside the handle are bonded
using adhesives |
| Sterilization
Method | EtO | EtO |
| Single Use | Yes | Yes |
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, sterilization, packaging, shelf life 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:
- ISO 14971 risk management to medical devices
- ANSI/AAMI ES 60601-1 Safety Requirements for Medical Equipment
- IEC 60601-1-2 EMC requirements for Medical Equipment
- = IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- · 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 AcuNav Crystal Ultrasound catheter in this submission uses the same intended use, technology 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
7
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 AcuNav Crystal Ultrasound catheter is substantially equivalent with the respect to safety and effectiveness to the device currently cleared for market.