(545 days)
Yes
The device description mentions a "computer assisted boundary detection function" which is a common application of image processing techniques, often involving AI/ML for improved accuracy and automation. While not explicitly stating "AI" or "ML", the nature of the function suggests the use of such technologies.
No.
The device is described as being for "Diagnostic ultrasound imaging or fluid flow analysis" and provides "alternative 2D display of ultrasound information" and a "computer assisted boundary detection function," all of which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also refers to its use in "diagnostic ultrasound imaging".
No
The device description explicitly states it is an "option for the Oracle Imaging system" and is designed for use "in conjunction with imaging catheters." This indicates it is a component of a larger hardware system that includes ultrasound imaging hardware and catheters, not a standalone software 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 used for diagnostic ultrasound imaging or fluid flow analysis of the human body. It uses imaging catheters inserted into the peripheral and coronary vasculature to visualize structures and analyze flow within the body.
- No Sample Analysis: There is no mention of analyzing samples taken from the body. The device directly interacts with and gathers information from the living patient's internal structures.
Therefore, this device falls under the category of in vivo diagnostic imaging equipment, not in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The EndoSonics Resolve 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 an alternative 2D display of ultrasound information . This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.
Product codes
90 IYO
Device Description
The EndoSonics Resolve 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 an alternative 2D display of ultrasound information . This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging
Anatomical Site
peripheral and coronary vasculature
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)
Reference Device(s)
Millar Mikro-Tip Doppler Catheter Model DC-101, Echo-Scan System Tomtec Imaging System, ATL Ultramark 8& 9 Ultrasound Imaging System, CVIS Insight System Cardiovascular Imaging Systems A Boston Scientific Company, Philips DCI Angiographic Analysis System
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
EndoSonics Corporation
Oracle InVision Resolve Option
Summary Preparation:
Common or Usual Name:
Predicate Devices:
Submitted By:
Device:
JUN 2 9 1998
510(k) Summary
EndoSonics Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 916-638-8008 Contact: Adam Savakus
December 24, 1996
EndoSonics Resolve Option for the Oracle InVision Intravascular Imaging System
Ultrasonic Imaging System
EndoSonics 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
Echo-Scan System Tomtec Imaging System Boulder, CO
ATL Ultramark 8& 9 Ultrasound Imaging System Advanced Technology Labs Bothell WA
CVIS Insight System Cardiovascular Imaging Systems A Boston Scientific Company Sunnyvale, CA
Philips DCI Angiographic Analysis System Philips Incorporated
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Oracle InVision Resolv
510(k) Summary
The EndoSonics Resolve 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 an alternative 2D display of ultrasound information . This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.
The EndoSonics catheters and imaging system with the Resolve 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 Philips DCI Angiographic analysis system, and the CVIS Insight and Ultra Imaging systems and catheters
The acoustic outputs for all models remain unchanged due to the addition of the Resolve software option.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1998
Adam Savakus Vice President, Clinical and Regulatory Affairs Endosonics Corporation 2870 Kilgore Road Rancho Cordova, CA 95670
Re: K965223 Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System Regulatory Class: II Product Code: 90 IYO Dated: May 21, 1998 Received: May 22, 1998
Dear Mr. Savakus:
We have reviewed vour 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 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). 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.
This determination of substantial equivalence applies to the following catheters intended for use with the Oracle In Vision Intravascular Ultrasound Imaging System and the Endosonics Automatic Pull-Back Device (Model PBD-1), as described in your premarket notification:
Catheter Model Number
| Visions™ 2.9 F Model 84300 | Visions™ F/X 2.9 F Model 82300 |
|---|---|
| Visions™ 3.5 F Model 84700 | Visions™ F/X 3.5 F Model 82700 |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic OS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect ary obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Adam Savakus
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/edrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Sagers
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
Enclosures
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Ultrasound Device Indications Statement Page_ of
510(k) Number (if known): K965223 Device Name: RESOLVE Option for the ORACLE InVision System
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the 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 | | | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | X | | | | | | | | |
ring 8 THE 3
catheters use the same imaging mold
PLEASE DO NOT FRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED' of corry. 1008
David C. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 301.109)
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