(38 days)
Not Found
No
The summary describes a software device for digitizing and communicating medical images in DICOM format. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The focus is on image communication and archiving, not analysis or interpretation using AI/ML.
No
The device is described as software for digitizing and communicating cardiac images, not for treating any condition.
No
The device is described as software for digitizing and communicating cardiac and cardiovascular images in DICOM format for visualization and archiving. It does not perform any analysis or interpretation of the images to determine a diagnosis or aid in one.
Yes
The device is explicitly described as a "Software Device" in both the Intended Use and Device Description sections, and there is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to digitize and communicate cardiac and cardiovascular images. This is related to medical imaging and data management, not to the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description reinforces the intended use of handling medical images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide diagnostic information. This device deals with medical images, which are acquired from within or on the body.
N/A
Intended Use / Indications for Use
The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.
Such Digitized Images will be visualized and archivied by independent DICOM entities.
Product codes
90LLZ
Device Description
The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.
Such Digitized Images will be visualized and archivied by independent DICOM entities.
Mentions image processing
No
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Cardiac and Cardiovascular
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
Not required for determination of substancial equivalence for this class of device.
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logo for Electromed International. The logo consists of a black circle on the left, with a white design inside that resembles a stylized medical symbol. To the right of the circle are the words "ELECTROMED INTERNATIONAL" in black, sans-serif font. There are two horizontal lines above the text.
Electromed International 310 Boul. Industriel, St-Eustace, Québec, Canada, J7R 5R4 Tél.: (450) 491-2100 Fax: (450) 491-4138
APR 15 193
510(k) SUMMARY
K 990759
-
1 DATE PREPARED
March 2, 1999 -
2 CONTACT PERSON
Pascal M. Kaufmann Quality Assurance Director
3 DEVICE NAME
| Proprietary Name: | VIEW COM |
|---|---|
| Common Name: | Image Digitizer and Communication System; |
| Radiology Panel; 90LLZ - System, Image Processing | |
| Classification Name: | Picture Archiving and Communications Systems (PACS) |
| 21CFR892.2050 | |
| (Federal Register / Vol. 63, No. 82 / April 29, 1998) |
4 DEVICE DESCRIPTION AND INTENDED USE
The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.
Such Digitized Images will be visualized and archivied by independent DICOM entities.
1
K_
SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE(S) 5
| Specifications | VIEW COM
(This 510(k)) | View Archiving Station
(VAS) | Video Plus with
Analytical Workstation |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Manufacturer | Electromed | Electromed | Camtronics |
| 510(k) Number | --- | K971176 | K941979 |
| Classification | 892.2050; Class II | 892.1600; Class II | 892.1600; Class II |
| Operating System | Windows NT | Windows 3.11 | Unknow, not essential for
Substantial Equivalence |
| Archiving | • Hard Disk
• SCP DICOM; External
on other DICOM
Entity
• CD-R; External on
other DICOM Entities | CRV; Internal | • Hard disk
• CD-R |
| Video: | | | |
| - Analogic Input | 525, 625, 1023, 1049,
1249; interlaced or
progressive | 525, 625, 1023, 1049,
1249; interlaced or
progressive | 525, 625, 1023, 1049,
1249; interlaced or
progressive |
| - Display | No diagnosis,
display only | Diagnosis | Diagnosis |
| - Image Compression | JPEG - Lossless | JPEG - Lossless | JPEG - Lossless |
| | JPEG - Lossy | JPEG - Lossy | JPEG - Lossy |
| - Image Processing | No | Yes | Yes |
| - Frame rate | ≤30 fps | 25 or 30 fps | ≤60 fps |
| Acquisition: | | | |
| - Input Acquisition | Video | Video | Video |
| - Stored Image Matrix | 512 x 512 | 512 x 512 | 512 x 512 or higher |
| - Gray Scale Resolution | 8 bits, 256 levels | 8 bits, 256 levels | 8 bits, 256 levels |
| - Output | DICOM | DICOM | DICOM |
| Communication: | | | |
| - Networking | Yes | Yes | Yes |
| - Transfer Mode | TCP/IP | TCP/IP | TCP/IP |
| - Exchange Format | DICOM | DICOM | DICOM |
Substantial Equivalence Comparaison
2
K
SAFETY AND EFFECTIVENESS STATEMENT 6
The intended use and technological characteristic of the VIEW COM Software Device are similar or equivalent to the Predicate Device(s). Any differences between the VIEW COM Software Device and the Predicate Device(s) have no significant influence on the safety and/or effectiveness of the Device
CLINICAL PERFORMANCE DATA 7
Not required for determination of substancial equivalence for this class of device.
8 CONCLUSION DRAWN FROM CLINICAL AND NONCLINICAL TEST DATA
Not required for determination of substancial equivalence for this class of device.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1999
Pascal M. Kaufmann Quality Assurance Director Electromed International 310 Boul Industriel St-Eustace, Quebec Canada J7R 5R4
Re:
K990759 View COM, Digitizer and Communications Device Dated: March 4, 1999 Received: March 8, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Kaufmann:
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 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.
If your device is classified (see above) into either 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 Current Good Manufacturing Practice requirements, 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 the Electronic Product 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation 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/dsma/dsmamain.html".
Sincerely yours,
BART Daniel C. Sjolund, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image is a black and white logo. The logo is a circle with a design inside of it. The design appears to be a stylized image of a railroad track with an overhead line.
ELECTROMED INTERNATIONAL
Electromed International 310 Boul. Industriel, St-Eustace, Québec, Canada, J7R 5R4 Tél.: (450) 491-2100 Fax: (450) 491-4138
Indication for Use Statement
510(k) Number (if known):
Device Name:
VIEW COM
Indications for Use:
The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.
Such Digitized Images will be visualized and archivied by independent DICOM entities.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Szyrm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
Prescription
Use
OR
Over-the-Counter Use
(per 21CFR801.109)