(350 days)
Not Found
No
The description mentions "proprietary algorithms" for detecting blood flow, but there is no mention of AI, ML, deep learning, or any related concepts. The technology described appears to be based on traditional signal processing and flow detection methods.
No
The device is described as a diagnostic tool used for imaging and fluid flow analysis, providing information about blood flow and velocity within the human body. There is no mention of treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The device description further elaborates on how it aids in diagnosis by providing "blood flow information" and a "two dimensional map of relative blood velocity" to assist in understanding the circulatory system.
No
The device description explicitly states it is an "internal option" for the Endosonics Oracle InVision Imaging System and involves "ultrahigh speed electronics" and "proprietary algorithms" to process ultrasound data from imaging catheters. This indicates it is a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "Endosonics ColorFlo Option for the Oracle Imaging System" used for "diagnostic ultrasound imaging or fluid flow analysis of the human body." It works by using ultrasound to visualize blood flow within the body (intra-luminal).
- No Specimen Analysis: The device does not analyze any specimens taken from the body. It directly interacts with and images the internal structures and fluids.
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
The Endosonics ColorFlo Option for the Oracle Imaging System is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide blood flow information. This additional flow information is provided as a color over the standard 2D echo image.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.
Product codes
90 IYO
Device Description
The Endosonics ColorFlo Option for the Oracle Intravascular Ultrasound Imaging System (the "ColorFlo Option") utilizes a novel patented technology to provide a visual depiction of blood flow through the vessel.
The ColorFlo technology can provide a two dimensional map of relative blood velocity which is overlayed onto the conventional black and white intravascular ultrasound image. Regions which contain faster moving red blood cells are signified by brighter colors, whereas regions of slow motion are less bright. Regions in which there is no or little motion perpendicular to the transducer are presented as clear, or non-colored. These regions appear in grey scale as in the standard display.
The ColorFlo processor detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. This is unlike conventional doppler imaging in which the blood must flow towards or away from the transducer. This is possible by utilizing ultrahigh speed electronics and Endosonics propritary algorithms.
The ColorFlo system can detect blood velocities in the following range:
The lower limit on particle detection is between 12 cm/sec and 5 cm/sec, depending on the intervening attenuation. (The higher limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The upper limit on particle detection is between 110 cm/sec and 107 cm/sec, depending on the intervening attenuation. (The lower limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The ColorFlo Option is available on the Endosonics Oracle InVision Imaging System. This option is an internal option, and no changes to the physical appearance of the system are made with the exception of an additional key on the keyboard.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
peripheral and coronary vasculature, intra-luminal use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Endosonic Cathscanner III Intravascular Imaging System, Endosonics Visions Five 64 3.5F model 84700 Intravascular Imaging Catheter, Endosonics Visions Five 64 F/X Model 82700 Intravascular Imaging Catheter, Millar Mikro-Tip Doppler Catheter Model DC-101, Small Vessel Balloon Angioplasty Catheter, ATL Ultramark 8 Ultrasound Imaging System, CVIS Insight System, Platinum System with the CVI Option
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary
(
(
| Submitted By:
AUG - 6 1997 | Endosonics Corporation
3078 B Prospect Park Drive
Rancho Cordova, CA 95670
916-638-8008
Contact: Adam Savakus |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | August 20, 1996 |
| Device: | Endosonics ColorFlo Option for the Oracle InVision
Intravascular Imaging System |
| Common or Usual Name: | Ultrasonic Imaging System |
| Predicate Devices: | Endosonic Cathscanner III Intravascular Imaging System
Endosonics Visions Five 64 3.5F model 84700 Intravascular
Imaging Catheter
Endosonics Visions Five 64 F/X Model 82700 Intravascular
Imaging Catheter
Millar Mikro-Tip Doppler Catheter Model DC-101
Millar Instruments Incorporated
Houston, TX
Small Vessel Balloon Angioplasty Catheter
Cook Incorporated
Bloomington, IN 47402
ATL Ultramark 8 Ultrasound Imaging System
Advanced Technology Labs
Bothell WA
CVIS Insight System
Cardiovascular Imaging Systems
Sunnyvale, CA
Platinum System with the CVI Option
Philips Imagings Systems |
1
510(k) Summary
The Endosonics ColorFlo Option for the Oracle Imaging System is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide blood flow information. This additional flow information is provided as a color over the standard 2D echo image.
The Endosonics Visions catheters and imaging system with the ColorFlo Option are substantially equivalent to existing devices such as the Endosonics Visions Microrail and Visions Model 54700 catheters with the Cathscanner II & III Imaging Systems, the Cook Small Vessel Balloon Angioplasty catheter, the ATL Ultramark 8 Imaging System, the Millar Mikro Tip Doppler catheter, the Philips Platinum Imaging System with the CVI Option, and the CVIS Insight imaging system and catheters.
The Endosonics ColorFlo Option for the Oracle Intravascular Ultrasound Imaging System (the "ColorFlo Option") utilizes a novel patented technology to provide a visual depiction of blood flow through the vessel.
The ColorFlo technology can provide a two dimensional map of relative blood velocity which is overlayed onto the conventional black and white intravascular ultrasound image. Regions which contain faster moving red blood cells are signified by brighter colors, whereas regions of slow motion are less bright. Regions in which there is no or little motion perpendicular to the transducer are presented as clear, or non-colored. These regions appear in grey scale as in the standard display.
The ColorFlo processor detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. This is unlike conventional doppler imaging in which the blood must flow towards or away from the transducer. This is possible by utilizing ultrahigh speed electronics and Endosonics propritary algorithms.
The ColorFlo system can detect blood velocities in the following range:
The lower limit on particle detection is between 12 cm/sec and 5 cm/sec, depending on the intervening attenuation. (The higher limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The upper limit on particle detection is between 110 cm/sec and 107 cm/sec, depending on the intervening attenuation. (The lower limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
2
The ColorFlo Option is available on the Endosonics Oracle InVision Imaging System. This option is an internal option, and no changes to the physical appearance of the system are made with the exception of an additional key on the keyboard.
The acoustic outputs for the 3.5F model 82700 and 84700 catheter when used with the Color Flo option were found to be:
= 5.89 mW/cm² I spta = 20.77 W/cm2
The acoustic outputs for the 2.9F model 82300 and model 84300 catheters in color mode operation were found to be:
= 1.13 mW/cm2 Ispia = 3.71 W/cm2
3
Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping shapes that resemble human profiles or abstract figures. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 1997
Adam Savakus Vice President Clinical and Regulatory Affairs Endosonics Corporation . . . . . . 3078-B Prospect Park Drive Rancho Cordova, CA 95670
Re: K963290 ColorFlo Option for the Oracle In-Vision Intravascular Ultrasound Imaging System
Dated: July 2, 1997 -----Received: July 3, 1997 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Mr. Savakus:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), it may be sished such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h.7) liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ultrasound Device Indications Statement Page _________________________________________________________________________________________________________________________________
510(k) Number (if known):__K963290
Sub (A) - Name - Oracle In-Vision Intravascular Ultrasound Imaging System with ColorFlo Option; Transducer Model 82700/84700
Fill out one form for each ultrasound system and each transducer.
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human body as follows:
Mode of Operation
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | X | | | | | | X | | |
| Peripheral
Vascular | | X | | | | | | X | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | X | | | | | | X | | |
Additional Comments :
This system is indicated for intra-luminal use in both peripheral and corozary applications. There is no This system is indicated for mults when used for coronary of peripheral vascular imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE aca of CDRH. Office of Device
Ra-Pell
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
510(k) Number
5
Ultrasound Device Indications Statement Page__________________________________________________________________________________________________________________________________
510(k) Number (if known): __K963290
Device Name : Oracle In-Vision Intravascular Ultrasound Imaging System with ColorFlo Option;
Transducer Model 82300/84300
Fill out one form for each ultrasound system and each transducer.
Intended Use ... Diaqnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | X | | | | | | X | | |
| Peripheral
Vascular | | X | | | | | | X | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | X | | | | | | X | | |
Mode of Operacion
Additional Comments:
This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF YESDED! Concurrence of CDRH. Office of Device Evaluation
Ru. Pales
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
510(k) Number K 96329