(434 days)
Not Found
No
The description mentions "computer-aided detection" and "computer-aided assessment" but does not use terms like AI, ML, deep learning, or neural networks. The focus is on quantitative analysis based on image processing techniques, which are not necessarily AI/ML.
No
The device aids in quantitative analysis of medical images for diagnosis and monitoring, but it does not directly treat or provide therapy to a patient.
Yes
The device aids in the quantitative analysis of vascular ultrasound images to determine vascular diameter and intima-media thickness, which are used to assess the state of the vascular system and, therefore, diagnose conditions.
Yes
The device is described as a "software program" and a "quantification software system" designed for installation on a personal computer. It processes existing ultrasound images and does not include any hardware components for image acquisition or other physical interactions.
Based on the provided information, "Vascular Tools 5" is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Vascular Tools 5's Function: The description clearly states that "Vascular Tools 5" analyzes ultrasound images of blood vessels (brachial and carotid arteries). It processes existing images to measure anatomical features (diameter and intima-media thickness).
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its input is image data, not biological samples.
Therefore, while "Vascular Tools 5" is a medical device used in the diagnostic process, it falls under the category of image analysis software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Vascular Tools 5" have been developed for the objective and reproducible analysis of vascular ultrasound images. The "Vascular Tools 5" data analysis program package components are intended to:
- Brachial Analyzer: Determine brachial artery diameter.
- Carotid Analyzer: Determine carotid artery diameter.
- Carotid Analyzer: Determine carotid artery intima-media thickness.
In each of the above listed intended use items, the Vascular Tools software aids the human expert to obtain quantitative information about the vascular morphology. Same as when using standard clinical methods, the human expert analyst is responsible for inspection and - if needed - editing of the identified vessel wall borders prior to their approval.
"Vascular Tools 5" software program has been developed to aid in quantitative analysis of longitudinal vascular ultrasound images, particularly to determine vascular diameter and intima-media thickness, as well as their changes as depicted in brachial and carotid arterial ultrasound images.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
"Vascular Tools 5" quantification software system is a state-of-the-art product for computer-aided assessment of vascular diameter, intima-media thickness derived from existing ultrasound images. Based on computer-aided detection of vessel wall borders within a region of interest of a single longitudinal ultrasound image or a sequence of longitudinal ultrasound images, vascular diameter and/or IMT are reported for each ultrasound image frame or a user-defined subset of image frames.
"Vascular Tools 5" is a proprietary software program for vascular ultrasound image quantification designed for installation on an IBM-PC-compatible personal computer and use with Windows 2000 r XP operating platform. It provides tools for display, selection, evaluation, and storage of multiple loops of vascular ultrasound image data. Furthermore, "Vascular Tools 5" facilitiate image import of complete studies in "Vascular Tools 5" format, and the export of results into general spread sheets, databases, or in ASCII formats for further statistical analysis of study results by the users.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound images
Anatomical Site
brachial artery, carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
human expert
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)
Test and validation results support the conclusion that the actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications. Detailed assessment of "Vascular Tools 5" performance is given in Appendix D.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
K033266 p.1/2
Medical Imaging Applications, LLC 832 Forest Hill Dr., Coralville IA 52241 phone: (319) 358-1529, fax: (319) 688-5296 e-mail: mia-llc@mia-llc.com URL: http://www.mia-llc.com
Medical Imaging Applications
DEC 1 € 2004
510(k) SUMMARY
Submission in accordance with the requirements of 21 CFR Part 807.87(h)
| 1) Submitter | Medical Imaging Applications LLC
832 Forest Hill Dr.
Coralville IA 52241
phone: (319) 358-1529
fax: (319) 688-5296
e-mail: mia-llc@mia-llc.com |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person
Prepared | Milan Sonka
October 10, 2004 |
| 2) Device Name: | "Vascular Tools 5" consisting of modules: "Brachial Analyzer 5"
"Carotid Analyzer 5" |
| Common name | Picture Archival and Communications System |
- Predicate Device: QLAB - Philips Ultrasound, Inc.
892.2050
4) Description of the device:
Classification name:
Regulation Number:
"Vascular Tools 5" quantification software system is a state-of-the-art product for computer-aided assessment of vascular diameter, intima-media thickness derived from existing ultrasound images. Based on computer-aided detection of vessel wall borders within a region of interest of a single longitudinal ultrasound image or a sequence of longitudinal ultrasound images, vascular diameter and/or IMT are reported for each ultrasound image frame or a user-defined subset of image frames.
Picture Archival and Communications System, Class II
"Vascular Tools 5" is a proprietary software program for vascular ultrasound image quantification designed for installation on an IBM-PC-compatible personal computer and use with Windows 2000 r XP operating platform. It provides tools for display, selection, evaluation, and storage of multiple loops of vascular ultrasound image data. Furthermore, "Vascular Tools 5" facilitate impge on namprt of complete studies in "Vascular Tools 5" format, and the export of results into general spread sheets, databases, or in ASCII formats for further statistical analysis of study results by the users,
5) Intended use:
"Vascular Tools 5" have been developed for the objective and reproducible analysis of vascular ultrasound images. The "Vascular Tools 5" data analysis program package components are intended to:
- Brachial Analyzer: Determine brachial artery diameter .
- Carotid Analyzer: Determine carotid artery diameter .
- Carotid Analyzer: Determine carotid artery intima-media thickness .
In each of the above listed intended use items, the Vascular Tools software aids the human expert to obtain quantitative information about the vascular morphology. Same as when using standard clinical
1
methods, the human expert analyst is responsible for inspection and - if needed - editing of the identified vessel wall borders prior to their approval.
6) Substantial equivalence Information:
The "Vascular Tools 5" software is believed substantially equivalent to the predicate devices of Philips Medical Systems' K040227"QLAB QUANTIFICATION SOFTWARE" by using the same technological characteristics and identical intended use.
Technological differences between the subject and predicate devices are minor and presented above. lt is concluded that the differences in technical characteristics between the two products are not significant in that there are no features in the subject device that raise new questions regarding safety nor that could result in a decrease of effectiveness as compared to the predicate device.
7) Conclusions respecting safety and performance - Level of Concern:
It is the opinion of Medical Imaging Applications LLC that "Vascular Tools 5" is a safe image quantification software and potential hazards are controlled by a risk management plan for the software development process (see Appendix B), including hazard analysis (see Appendix C), verification and validation tests (see Appendix D). In Medical Imaging Applications LLC's opinion, the level of concern for the stand-alone software to view images is moderate. The use of "Vascular Tools 5" quantification software neither changes the intended use of ultrasound scanners in practice, nor does the use of software result in any new potential hazards.
8) Validation and test conclusions
Test and validation results support the conclusion that the actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications. Detailed assessment of "Vascular Tools 5" performance is given in Appendix D.
9) Release version number
The software release described in this document has a release version number: Version 5.1.1, release date June 1, 2004
- Revision Level History No revisions were recorded to date.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2004
Medical Imaging Applications, LLC c/o Mr. Milan Sonka 832 Forest Hill Dr. Coralville, IA 52241
Re: K033266
Trade Name: Vascular Tools 5 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: II (two) Product Code: DQK Dated: October 10, 2004 Received: October 13, 2004
Dear Mr. Sonka:
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 10 mmerce 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 application (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 such 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.
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
3
Page 2 - Mr. Milan Sonka
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 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally proficated 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Brimmer for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K033266 |
|---|---|
| Device Name: | "Vascular Tools 5" consisting of modules: |
| "Brachial Analyzer 5", "Carotid Analyzer 5" | |
| Indications For Use: | "Vascular Tools 5" software program has been |
| developed to aid in quantitative analysis of | |
| longitudinal vascular ultrasound images, | |
| particularly to determine vascular diameter and | |
| intima-media thickness, as well as their | |
| changes as depicted in brachial and carotid | |
| arterial ultrasound images. |
X _ AND/OR Over-The-Counter Use ______________________________________________________________________________________________________________________________________________ Prescription Use __ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K23326
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