(75 days)
Not Found
No
The description focuses on standard ultrasound imaging and location sensing technology, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions. The signal processing mentioned is for calculating position and orientation, which is typical for navigation systems and does not necessarily imply AI/ML.
No
The device is described as a "Diagnostic Ultrasound Catheter" and its intended use is for "visualization of cardiac and great vessel anatomy and physiology," which indicates a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "3D Diagnostic Ultrasound Catheter." It is used for "intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology," which is a diagnostic purpose.
No
The device description clearly states it is a catheter with a physical ultrasound transducer and location sensor at the distal tip, indicating it is a hardware 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.
- Device Function: The description clearly states that this device is a catheter used for intracardiac and intraluminal visualization using ultrasound. It is inserted directly into the body to image internal structures.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from the patient. Its function is based on real-time imaging within the body.
Therefore, this device falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.
Product codes
NLI
Device Description
3D Diagnostic Ultrasound Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip and variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer and a location sensor. The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter 3-D location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is 10 French with a 90 cm insertion length.
The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is a 90cm 10F IntraCardiac diagnostic ultrasound catheter with an acoustic array identical to the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter. The catheter has a location sensor (providing location information to the CARTO® Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip. It also has a pre-amplifier circuit board inside the handle that amplifies the signals from the location sensor. The location sensor consists of a set of three micro-machined coils that act as pick up coils when placed in an external electromagnetic field created by external field generator coils. The sensor coils are positioned orthogonal to each other inside the sensor assembly. The coils pick up signals from the field in response to their position and orientation with respect to a frame of reference. The signals are processed by a system to calculate the position and orientation of the tip of the catheter. The associated circuitry for the sensor consists of pre-amplifier circuits for each coil.
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
Not Found
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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 3D Diagnostic Ultrasound Catheters. This included the following tests: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation.
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
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Contact: | Amanda Babcock
Regulatory Affairs Specialist
(480) 763-5300 (o)
(863) 904-2312 (f)
ababcock@ascenths.com | OCT 21 2009 |
| Date of preparation: | August 5, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed 3D Diagnostic
Ultrasound Catheters
Classification Name: Catheter, Angiography, Reprocessed | |
| Predicate Device
K070242 | 510(k) Title
SOUNDSTAR™ 3D Ultrasound
Catheter, Model M-5723-05 | Manufacturer
Biosense Webster, Inc. |
| Device description: | 3D Diagnostic Ultrasound Catheters are specially designed
catheters that provide two-dimensional imaging using an
ultrasound transducer and three-dimensional location
information using a location sensor. The ultrasound transducer
and location sensor are at the distal tip of the catheter and can
be positioned for ultrasound imaging and 3D mapping by a
steering mechanism that rotates the catheter tip and variable
deflection. 3D Diagnostic Ultrasound Catheters incorporate a
handpiece, a flexible shaft and a distal tip section containing an
ultrasound transducer and a location sensor. The SOUNDSTAR™
3D Diagnostic Ultrasound Catheter 3-D location sensor provides
location information to the CARTO® XP EP Navigation System
(mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound
Catheter is 10 French with a 90 cm insertion length. | |
| Indications for Use: | Reprocessed 3D Diagnostic Ultrasound Catheters are indicated
for intracardiac and intraluminal visualization of cardiac and
great vessel anatomy and physiology as well as visualization of
other devices in the heart. The 3D Diagnostic Ultrasound
Catheter provides location information when used with the
CARTO® XP EP Navigation System Version 9 or greater. | |
| Technological
characteristics: | The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is a
90cm 10F IntraCardiac diagnostic ultrasound catheter with an
acoustic array identical to the ACUSON AcuNav 10F Diagnostic
Ultrasound Catheter. The catheter has a location sensor
(providing location information to the CARTO® | EP XP |
Ascent Healthcare Solutions
Reprocessed 3D Diagnostic Ultrasound Catheters
Reprocessed 3D Diagnostic Ultrasound Catheters
Traditional 510(k)
Page 18 OF2
1
Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip. It also has a pre-amplifier circuit board inside the handle that amplifies the signals from the location sensor. The location sensor consists of a set of three micro-machined coils that act as pick up coils when placed in an external electromagnetic field created by external field generator coils. The sensor coils are positioned orthogonal to each other inside the sensor assembly. The coils pick up signals from the field in response to their position and orientation with respect to a frame of reference. The signals are processed by a system to calculate the position and orientation of the tip of the catheter. The associated circuitry for the sensor consists of pre-amplifier circuits for each coil.
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 3D Diagnostic Ultrasound Catheters. This included the following tests:
- Biocompatibility .
- Validation of reprocessing ●
- Sterilization Validation .
- · Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed 3D Diagnostic Ultrasound Catheters perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed 3D Diagnostic Ultrasound Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
Ascent Healthcare Solutions Reprocessed 3D Diagnostic Ultrasound Catheters Traditional 510(k)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the perimeter, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. In the center of the seal is a stylized depiction of a bird-like symbol, which is the department's official logo. The logo is a modern representation of a human figure embracing a bird, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ascent Healthcare Solutions c/o Ms. Amanda Babcock Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044
OCT 21 2009
Re: K092425
Trade/Device Name: Reprocessed 3D Ultrasound Catheter (See Enclosed Model) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: NLI Dated: August 5, 2009 Received: August 7, 2009
Dear Ms. Babcock:
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.
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.
3
Page 2 - Ms. Amanda Babcock
Please bé 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Duna R. Richter
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Ms. Amanda Babcock
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Original model found to be SE SE SE SE SOUNDSTAR™ 3D Ultrasound Catheter, Model M-5723-05
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reprocessed 3D Diagnostic Ultrasound Catheters
Indications For Use:
Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
· Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.P.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K092425
CONFIDENTIAL
Ascent Healthcare Solutions Reprocessed 3D Diagnostic Uitrasound Catheters Traditional 510(k)