(45 days)
Not Found
No
The description focuses on data capture, transport, and reporting automation, not on analytical or interpretive functions typically associated with AI/ML. There are no mentions of AI, ML, or related concepts like image processing or performance metrics that would suggest AI/ML is used.
No
The device is described as a clinical assessment tool and a system for capturing, transporting, and reporting patient cardiac study data. It automates data movement and facilitates reporting, but it does not directly treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
Yes
The device is described as a clinical assessment tool that facilitates the review and reporting of patient cardiac study data by physicians, which is a key component of diagnosing medical conditions.
No
The device description explicitly lists hardware components (Laptop, desktop, pole-mounted LCD screens, Computer tower) as part of the system, in addition to the software elements.
Based on the provided information, the CardioStream SonoAim is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The CardioStream SonoAim's intended use is to capture, transport, and report patient cardiac study data, which involves imaging and reporting on the heart itself, not analyzing biological samples.
- The device description focuses on data management and reporting of cardiac images and reports. It describes a system for handling clinical data from image capture devices, not for performing tests on biological specimens.
- The input modalities (S-video, composite, DICOM) are related to imaging, not laboratory analysis.
- The intended users (Sonographer, physician) and care setting (clinical setting) are consistent with a medical imaging workflow, not a laboratory setting where IVD tests are typically performed.
The CardioStream SonoAim appears to be a medical image management and reporting system used in the field of cardiology. Its function is to facilitate the workflow of cardiac imaging studies.
N/A
Intended Use / Indications for Use
The CardioStream SonoAim is intended for capturing, transporting, and reporting patient cardiac study data.
Product codes
LLZ
Device Description
The CardioStream SonoAim is a clinical assessment tool designed to automate the movement of clinical data through the clinical assessment process. The system is comprised of the following components:
Data Harvester (DH) - Laptop (variations - desktop, pole-mounted LCD screens) Data Packager (DP) - Computer (tower) AIM Server - Archive and Image Manager - located at secure off-site data center
Data and images are captured in the clinical setting via an image capture device (DH), and a preliminary report is completed by the Sonographer.
The preliminary report is immediately formatted (DP) and available on a secure webaccessed internet site.
The physician with secure user name and password will then access/review the clinical images and preliminary report, and edit or add commentary as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Sonographer, Physician
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
AUG 2 2 2005
Appendix E Page 1 of 2
cardiostreat_
510(k) Summary
Submitter Information:
CardioStream 3820 Medical Park Drive Suite 200 Austell, GA
Contact:
Mike Kingcaid Telephone: 770-948-2250 Fax: 770-948-7624
Date Prepared:
June 3, 2005
Product Name:
CFR Section: 892.2050 Product Code: LLZ Panel: Radiology
Description:
The CardioStream SonoAim is a clinical assessment tool designed to automate the movement of clinical data through the clinical assessment process. The system is comprised of the following components:
Data Harvester (DH) - Laptop (variations - desktop, pole-mounted LCD screens) Data Packager (DP) - Computer (tower) AIM Server - Archive and Image Manager - located at secure off-site data center
Data and images are captured in the clinical setting via an image capture device (DH), and a preliminary report is completed by the Sonographer.
The preliminary report is immediately formatted (DP) and available on a secure webaccessed internet site.
The physician with secure user name and password will then access/review the clinical images and preliminary report, and edit or add commentary as needed.
1
The final report is then electronically signed and returned to the referring physician. The information is available on any web-accessible device.
Substantial Equivalence:
This device is substantially equivalent to the Siemens KinetDX, marketed under K041029. :
| | CardioStream
SonoAim (Proposed Device) | KinetDx
WS3000 (Predicate Device) |
|---------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Image Format | Media Player v.9,
WMV, PNG, AVI
DICOM 3.0 | DICOM 3.0 |
| Compression-Video | Constant or variable bit rate | Dicom convertor - QV3000
For Non-Dicom Images |
| Compression - Dicom | Uncompressed
RLE Lossless Compression
JPEG Lossy Baseline
JPEG Lossless Non-Heirarchal | Uncompressed
RLE Lossless Compression
JPEG Lossy Baseline
JPEG Lossless Non-Heirarchal |
| Video Source | S-video, composite
DICOM | DICOM |
| Display | 15" — 21″
Flat Panel Color Monitor | 20" or 21"
Flat Panel Color Monitor |
| Operating System | Windows XP | Windows 2000 |
| User Interface | Keyboard
Mouse
Foot pedal | Keyboard
Mouse |
| Network | Fast Ethernet
10/100/1000 | Ethernet
100/1000 |
| Hardware | Standard Computer Hardware | Standard Computer Hardware |
| Image Storage Media | Internal Hard Disk
Built-in CD-Rom | Internal Hard Disk
Built-in CD-Rom |
| DICOM | Yes - Not required | Yes - Not required |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
::.
.
CardioStream, LLC % Mr. Ian P. Gordon Senior Vice President Emergo Group 2454 McMullen Booth Rd., Suite 427 CLEARWATER FL 33759
Re: K051853
Trade/Device Name: CarioStream SonoAim Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: July 7,, 2005 Received: July 13, 2005
Dear Mr. Gordon:
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 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) 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 (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 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 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
I has begin marketing for the support of equivalence of your device to a legally This letter will allow you to begin makeung your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your de premarket notification. The FDA Inding of substantial of 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 If you desire specific advice for your device on our lasting of the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general intonnation on your respections of its toll-free number (800) Division of Small 11 Small 11 - 11 its Internet address 058-2041 of (501) v/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) # (if known):
Device Name: CardioStream SonoAim
Indications for Use:
The CardioStream SonoAim is intended for capturing, transporting, and reporting patient cardiac study data.
Prescription Use x (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (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)
Nancy C. Broydon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________