(505 days)
Not Found
No
The summary describes a reprocessed ultrasound catheter and its intended use for imaging. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of such technologies. The performance studies focus on reprocessing validation and basic functional tests.
No
The device is intended for diagnostic imaging and visualization of anatomy and blood flow, not for treating a disease or condition.
Yes
The device is explicitly named "Diagnostic Ultrasound Catheters" and its intended use is to "provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart" as well as "measurement of blood flow," all of which are diagnostic functions.
No
The device description clearly outlines physical components like a catheter, handpiece, shaft, and transducer, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Diagnostic Ultrasound Catheter" used for "intravascular or intracardiac ultrasound imaging." It provides "visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart."
- Method of Operation: The device uses ultrasound technology to create images inside the body. It does not analyze samples taken from the body.
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.
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.
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, vascular anatomy, cardiac and great vessel anatomy, right heart only, right side of the heart only.
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 the Reprocessed Ultrasound Catheters.
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- Function test(s) .
- Packaqing Validation
Performance testing demonstrates that Reprocessed Ultrasound Catheters perform as originally intended.
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
KO33436 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MAR 1 6 2005
Alliance Medical Corporation
Submitter:
Image /page/0/Picture/2 description: The image shows a logo with three curved lines above the word "ALLIANCE". The lines are thick and black, and they curve upwards and to the right. The word "ALLIANCE" is written in a simple sans-serif font, and it is located directly below the curved lines. The logo is simple and modern, and it is likely used to represent a company or organization.
ALLIANCE
SECTION B: 510(k) SUMMARY
10232 South 5 Ist Street Phoenix, Arizona 85044
ILL 480.763.5300
FAX 480.763.5310 Tالا Free 888.888.3433 www.alliance-medical.com
| Submitter: | Alliance Medical Corporation
10232 South 51 st Street
Phoenix, Arizona 85044 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton
Regulatory Affairs Manager
(480) 763-5350 (o)
(480) 763-5310 (f)
mbarton@alliance-medical.com |
| Date of preparation: | October 3, 2003 |
| Name of device: | Trade/Proprietary Name: Reprocessed Ultrasound Catheter
Common or Usual Name: Diagnostic Ultrasound Transducer Catheter
Classification Name: Catheter, Intravascular, Diagnostic |
| Predicate device: | AcuNav™ Diagnostic Ultrasound Catheter |
| K992631 | |
| 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. |
| Intended 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. |
| Indications statement: | 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. |
| Technological characteristics: | The design, materials, and intended use of Reprocessed
Ultrasound Catheters are identical to the predicate devices. The |
Alliance Medical Corporation
Reprocessed Ultrasound Catheters
Traditional 510(k)10
1
mechanism of action of Reprocessed Ultrasound Catheters is mechanism of dotion of dotion of that the same standard luentical to the prodicate cals and sizes are utilized. There are mochaniour doolig intended use, clinical applications, no changes to the claim ance specifications, or method of operation.
Alliance Medical Corporation's reprocessing of ultrasound Allianoo Moules removal of adherent visible soil and catheters indiados rom individual ultrasound catheter is tested for appropriate function of its components prior to packaging and labeling operations.
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Ultrasound Catheters.
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- Function test(s) .
- Packaqing Validation ●
Performance testing demonstrates that Reprocessed Ultrasound Catheters perform as originally intended.
Conclusion:
Alliance Medical Corporation concludes that the modified device (the Reprocessed Ultrasound Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
SEP - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044
Re: K033436
Trade/Device Name: Reprocessed Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (Two) Product Code: NLI Dated: January 19, 2004 Received: January 21, 2005
Dear Ms. Barton:
This letter corrects our substantially equivalent letter of March 16, 2005.
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 (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. Moira Barton
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 continue 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/dsma/dsmamain.html
Sincerely yours,
B. Bimiena for
Bram D. Zuckerman, M.D. Director Divison of Cardioascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (2)
4
Page 3 - Ms. Moira Barton
| Original model found to be SE | |
|---|---|
| AccuNavTM Diagnostic Ultrasound Catheter, Model | |
| 08255790 |
:
5
Indications for Use Statement 2.
510(k) Number (if known): KO33434
Device Name: Alliance Medical Corporation Reprocessed Ultrasound Catheter
Indications for Use: Reprocessed Diagnostic Ultrasound Catheters are Indications for Use: Replocessed Diagnosus Cardiac and great vessel anatomy
indicated for visualization of vascular anatomy, cardiac mazurement of blood indicated for visualization of vascular analy, barantes, as well as measurement of blood
and physiology, or other devices in the heart, as well as measurement of blood and physiology, or other devices in the nearly as well as work in the first in the right side of the heart only.
Prescription Use _ (per 21 CFR 801.109) ਾ
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Cardiovascular Devices 510(k) Numbər _