(350 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-Luminal, Peripheral Vascular, Other (Specify)
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.
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 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.
The provided 510(k) summary for the Endosonics ColorFlo Option for the Oracle InVision Intravascular Imaging System does not contain explicit acceptance criteria or a dedicated study section detailing performance metrics against such criteria.
The document focuses on substantiating substantial equivalence to predicate devices and describing the technology. However, it does report specific performance capabilities of the ColorFlo system regarding blood velocity detection. We can infer these reported capabilities act as implicit performance benchmarks.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not stated, we will use the reported performance characteristics as the "reported device performance."
| Category | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Blood Velocity Detection Range | Ability to detect a usable range of blood velocities in both low and high flow scenarios, considering attenuation. | Lower Limit: Between 12 cm/sec and 5 cm/sec (depending on intervening attenuation). |
| Upper Limit: Between 110 cm/sec and 107 cm/sec (depending on intervening attenuation). | ||
| Acoustic Output (3.5F catheters) | Keep acoustic output within safe limits for specific catheter models. | I_spta = 5.89 mW/cm², I_sppa = 20.77 W/cm² |
| Acoustic Output (2.9F catheters) | Keep acoustic output within safe limits for specific catheter models. | I_spta = 1.13 mW/cm², I_sppa = 3.71 W/cm² |
| Visual Depiction of Blood Flow | Provide a clear, two-dimensional, color-coded map of relative blood velocity overlaid on the standard 2D echo image. | Provides a two-dimensional map of relative blood velocity overlaid onto the conventional black and white intravascular ultrasound image. Regions with faster moving red blood cells are signified by brighter colors, and slow motion regions are less bright. |
| Flow Detection Perpendicular to Transducer | Detect blood flow perpendicular to the imaging plane/along the long axis of the catheter. | Detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. There is no mention of a specific test set, its sample size, or its provenance (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The document does not describe any expert involvement in establishing ground truth for a test set.
4. Adjudication Method
This information is not provided. There is no mention of an adjudication method, as no test set or expert review process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The summary focuses on the technical capabilities of the device itself rather than human-in-the-loop performance or comparison with human readers.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, in the sense of an algorithm-only evaluation against a ground truth, is implicitly described through the stated velocity detection ranges and acoustic outputs. The summary outlines the technical specifications and capabilities of the ColorFlo processor and associated catheters without human interaction as part of its core description (e.g., "The ColorFlo system can detect blood velocities in the following range..."). However, it's not presented as a formal "study" with a defined methodology, test set, and reported metrics in the way modern AI device submissions typically detail.
7. Type of Ground Truth Used
The ground truth used for verifying the reported velocity detection capabilities and other technical specifications is implied to be derived from physical measurements and engineering validation. For instance, the velocity detection ranges would likely be established in controlled laboratory settings using flow phantoms or calibrated flow systems. The acoustic outputs are typically measured using standardized hydrophones. The document does not refer to expert consensus, pathology, or outcomes data as ground truth for these specific performance claims.
8. Sample Size for the Training Set
This information is not provided. The ColorFlo option utilizes "Endosonics proprietary algorithms," but there is no mention of a training set size, suggesting the algorithms were likely developed based on engineering principles and signal processing, rather than machine learning requiring a distinct training dataset in the modern sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided for the same reasons as point 8. If "proprietary algorithms" were used, their development likely relied on theoretical models, simulations, and empirical testing in laboratory environments, rather than a "training set" with established ground truth as understood in contemporary machine learning.
{0}------------------------------------------------
510(k) Summary
(
(
| Submitted By:AUG - 6 1997 | Endosonics Corporation3078 B Prospect Park DriveRancho Cordova, CA 95670916-638-8008Contact: Adam Savakus |
|---|---|
| Summary Preparation: | August 20, 1996 |
| Device: | Endosonics ColorFlo Option for the Oracle InVisionIntravascular Imaging System |
| Common or Usual Name: | Ultrasonic Imaging System |
| Predicate Devices: | Endosonic Cathscanner III Intravascular Imaging SystemEndosonics Visions Five 64 3.5F model 84700 IntravascularImaging CatheterEndosonics Visions Five 64 F/X Model 82700 IntravascularImaging CatheterMillar Mikro-Tip Doppler Catheter Model DC-101Millar Instruments IncorporatedHouston, TXSmall Vessel Balloon Angioplasty CatheterCook IncorporatedBloomington, IN 47402ATL Ultramark 8 Ultrasound Imaging SystemAdvanced Technology LabsBothell WACVIS Insight SystemCardiovascular Imaging SystemsSunnyvale, CAPlatinum System with the CVI OptionPhilips 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
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | X | X | ||||||||
| PeripheralVascular | 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:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | X | X | ||||||||
| PeripheralVascular | 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
§ 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.