(545 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular, Other (Specify) Intravascular
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.
This 510(k) summary for the EndoSonics Resolve Option for the Oracle InVision Intravascular Imaging System does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is the core requirement for 510(k) clearance.
However, based on the provided text, we can infer some aspects related to the device's function and potentially implied "acceptance criteria" through its description and comparison to predicate devices. It is crucial to understand that this is an interpretation based on limited information, and not explicit performance data.
Here's a breakdown of what can be extracted:
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission, explicit quantitative acceptance criteria for image analysis software are rarely presented in the summary itself. Instead, the focus is on functional equivalence and safety.
| Metric/Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Pertaining to Longitudinal Display: | |
| 1. Alternative 2D Display of Ultrasound Information | Provides an "alternative 2D display of ultrasound information" from uniform catheter withdrawal. |
| 2. Presentation of Longitudinal Information | Information collected during uniform withdrawal is "presented in a longitudinal display." This implies accurate spatial reconstruction along the catheter's pull-back path. |
| Pertaining to Computer-Assisted Boundary Detection: | |
| 3. Identification of Boundaries | Provides a "computer assisted boundary detection function which helps identify boundaries within the image." This implies the algorithm can highlight or delineate vessel walls or other structures. |
| 4. Operator Acceptance/Correction of Boundaries | The identified boundaries require the "operator must explicitly accept or correct before measurements can be performed." This indicates the system is a tool to aid, not replace, human judgment and that the accuracy is user-validated. The acceptance criteria here would implicitly be that the identified boundaries are sufficiently accurate to be useful to the operator, requiring minimal correction for typical cases. |
| Pertaining to Acoustic Output: | |
| 5. Acoustic Output Levels | The "acoustic outputs for all models remain unchanged due to the addition of the Resolve software option." This implies the device, with the new software, maintains acoustic output within previously cleared, safe limits. The post-clearance special report also requests "acoustic output measurements based on production line devices" to confirm this. |
| Pertaining to Substantial Equivalence: | |
| 6. Functional Equivalence to Predicate Devices | "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." This is the primary claim, implying that its performance (e.g., image quality, utility for diagnosis) is comparable to established market devices. |
Study Details (Based on the Provided Text)
Unfortunately, the provided 510(k) summary does not describe a specific scientific study with a defined test set, ground truth, or expert review process to demonstrate the performance of the "Resolve Option" software in terms of its longitudinal display or boundary detection capabilities.
The primary "study" or justification for clearance in a 510(k) is the demonstration of substantial equivalence to predicate devices. This typically involves:
- Comparison of Indications for Use: The Resolve option is for "diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display...", which is considered equivalent to existing systems.
- Comparison of Technological Characteristics: The software adds an "alternative 2D display" and "computer assisted boundary detection." The key argument is that the acoustic output remains unchanged.
- Performance Data (if applicable): For software features like "computer assisted boundary detection," robust clinical performance studies might be expected in more recent submissions, but this document (1998) does not detail one. The implicit 'performance' is that the operator can accept or correct the boundaries successfully.
Given this, the following points can be addressed with the available information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. There is no mention of a test set for evaluating the performance of the "Resolve Option" features (longitudinal display, boundary detection).
- Data Provenance: Not specified. No country of origin or whether data was retrospective/prospective is mentioned, as no specific performance study is detailed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment process for a test set is described. The "ground truth" for the identified boundaries is ultimately the operator's explicit acceptance or correction, transforming the computer-assisted function into a user-controlled measurement tool.
-
Adjudication method for the test set:
- Not applicable. No test set or adjudication process is described. The "adjudication" for boundary detection is the singular operator's decision to accept or correct.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study is not mentioned or described in the 510(k) summary. The "computer assisted boundary detection function" is presented as an aid that the operator validates, rather than a system designed to improve human reader performance through a comparative effectiveness study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The description explicitly states the "operator must explicitly accept or correct before measurements can be performed." This indicates the device is not intended for standalone use for final measurements. Its function is to "help identify boundaries," implying an assistance role.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for algorithm performance validation. As mentioned, for the boundary detection feature, the "ground truth" for measurement purposes is established by the operator's explicit acceptance or correction of the computer-identified boundaries. For the overall system, the ground truth for "substantial equivalence" is its clinical utility as perceived by comparison to predicate devices, rather than a specific pathological or outcomes benchmark for the added software features.
-
The sample size for the training set:
- Not specified. As no detailed algorithmic development or validation study is provided, the training set size for the boundary detection algorithm (if it was a machine learning algorithm, which is unlikely for 1998 in this context) is unknown.
-
How the ground truth for the training set was established:
- Not specified. As no training set or algorithm development details are provided, the method for establishing its ground truth is unknown.
Conclusion:
The provided 510(k) summary for the EndoSonics Resolve Option primarily serves to demonstrate substantial equivalence to existing devices for market clearance. It describes the new functional features (longitudinal display and computer-assisted boundary detection) but does not include a detailed scientific study with defined acceptance criteria, test sets, ground truth establishment, or expert reviews to quantify the performance of these features. The "acceptance criteria" are largely implicit in the claim of substantial equivalence and the design that requires operator validation for boundary detection.
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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
| 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 | ||||||||||
| PeripheralVascular | ||||||||||
| 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)
2
§ 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.