(174 days)
Not Found
No
The document describes a standard ultrasound catheter and its reprocessing. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies.
No
The device is described as a "Diagnostic Ultrasound Catheter" and its intended use is for "ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart," which points to a diagnostic rather than therapeutic purpose.
Yes
The intended use explicitly states "visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart," which is a diagnostic purpose. Additionally, the device is named "Diagnostic Ultrasound Catheters."
No
The device description clearly states it is a physical catheter with a transducer, handpiece, and flexible shaft, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart." This describes a device used in vivo (within the living body) for imaging, not for testing samples in vitro (outside the living body).
- Device Description: The description details a catheter with an ultrasound transducer at the tip, designed to be inserted into the body for imaging. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples outside the body, which are hallmarks of IVD devices.
Therefore, this device falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Reprocessed Diagnostic Ultrasound Catheters are intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. The device is intended for use in the right heart only.
Product codes
NLI
Device Description
Diagnostic Ultrasound Catheters are specially designed ultrasonic catheters that provide two-dimensional imaging using an ultrasound transducer. The ultrasound transducer is at the distal tip of the catheter and can be positioned for ultrasound imaging by a steering mechanism that rotates the catheter tip and variable deflection. Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer. The Ultrasound Catheter is 10 French with 90 cm insertion length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
intravascular or intracardiac, right heart
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters. This included the following tests:
- Biocompatibility .
- Validation of reprocessing ●
- Sterilization Validation
- . Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Ultrasound Catheters perform as originally intended.
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
K06a3076
..
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | MAR 2 9 2007 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Contact: | Jenn Selvey
Regulatory Affairs Specialist
(480) 763-6072 (o)
(480) 763-6089 (f)
jselvey@ascenths.com | |
| Date of preparation: | September 28, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Diagnostic Ultrasound
Catheter
Classification Name: Diagnostic Intravascular Catheter | |
| Predicate Device
K992631 | 510(k) Title
AcuNav™ Diagnostic Ultrasound
Catheter | Manufacturer
Acuson Corp. |
| Device description: | Diagnostic Ultrasound Catheters are specially designed
ultrasonic catheters that provide two-dimensional imaging using
an ultrasound transducer. The ultrasound transducer is at the
distal tip of the catheter and can be positioned for ultrasound
imaging by a steering mechanism that rotates the catheter tip
and variable deflection. Diagnostic Ultrasound Catheters
incorporate a handpiece, a flexible shaft and a distal tip section
containing an ultrasound transducer. The Ultrasound Catheter is
10 French with 90 cm insertion length. | |
| Indications for Use: | Reprocessed Diagnostic Ultrasound Catheters are intended for
intravascular or intracardiac ultrasound imaging in order to
provide visualization of vascular anatomy, cardiac and great
vessel anatomy and physiology, or other devices in the heart.
The device is intended for use in the right heart only. | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Diagnostic Ultrasound Catheters are identical to the predicate
devices. The mechanism of action of Reprocessed Diagnostic
Ultrasound Catheters is identical to the predicate devices in that
the same standard mechanical design, materials, and size are
utilized. There are no changes to the claims, intended use,
clinical applications, patient population, performance
specifications, or method of operation. In addition, Ascent
Healthcare Solutions's reprocessing of Ultrasound Catheters
includes removal of adherent visible soil and decontamination.
Each individual Ultrasound Catheter is tested for appropriate | |
| CONFIDENTIAL | Ascent Healthcare Solutions
Reprocessed Ultrasound Catheter
Traditional 510(k) | Page 11 |
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function of its components prior to packaging and labeling operations.
Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters. This included the following tests:
- Biocompatibility .
- Validation of reprocessing ●
- Sterilization Validation
- . Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Ultrasound Catheters perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Ultrasound Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
CONFIDENTIAL
Ascent Healthcare Solutions Reprocessed Ultrasound Catheter Traditional 510(k)
Page 12
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2007
Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044
Re: K063076
Trade Name: Reprocessed Diagnostic Ultrasound Catheter (See Enclosed Model) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: NLI Dated: March 2, 2007 Received: March 5, 2007
Dear Ms. Bray:
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 such 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. Katie Bray
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
B/himmerman for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reprocessed AcuNav Ultrasound Catheter
Indications For Use: Reprocessed Diagnostic Ultrasound Catheters are indicated for visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The Reprocessed Diagnostic Ultrasound Catheter is intended for use in the right side of the heart only.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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)
B. Hemmema
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K063076
CONFIDENTIAL
Ascent Healthcare Solutions Reprocessed Ultrasound Catheter Traditional 510(k)
Page 10
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