(118 days)
Not Found
No
The document describes standard 3D visualization software and does not mention AI, ML, or related concepts.
No.
The device is described as a software application for diagnostic image visualization, not for treatment or therapy.
No
The device is described as software that enables the display of 3D visualization of medical images for diagnostic quality image viewing, but it does not perform any diagnostic analysis itself. It simply presents the images for the user to interpret.
Yes
The device is described as a "software application comprised of a client module and a server module" and its function is the display and visualization of medical images. There is no mention of any accompanying hardware being part of the device itself.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Volumina's function: Volumina is described as software that enables the display of 3D visualizations of medical imaging studies (CT, PET, MR, etc.). It processes and presents existing image data.
- Lack of biological sample analysis: There is no mention of Volumina analyzing biological samples or performing any tests on materials taken from the human body. Its input is medical image data.
Therefore, Volumina falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.
Product codes
LLZ
Device Description
Volumina is a Class II software application comprised of a client module and a server module. Volumina is intended to provide a diagnostic quality image to a qualified health care professional to visualize multimodal medical image data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, and MR studies or other DICOM compliant images.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, technologists and clinicians.
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
The test data was retrieved from a PACS database containing actual patient Raw Data. Some synthetic data of known dimensions and values was also used for verification and validation.
Summary of Performance Studies
Verification and Validation was conducted according to written protocols and the test outcomes were documented with test reports including pass/fail determination. Verification was monitored and cross referenced in the traceability matrix to ensure all requirements are verified.
Tests were executed under various environments representing actual operating environments and included laptops, desktops, and servers running Microsoft Windows XP, Microsoft Windows XP x64,and Microsoft Windows Server 2003. The various test environments also included connections via a variety of internet and network connections, including DSL, and Cable.
Validation was undertaken to demonstrate that the Volumina Client and Server Modules together consistently fulfill the requirements within the intended use operates as intended under actual operating conditions by accepting the required parameters as input and by returning the expected output, and that the user interface provides a display that is consistent with the data that has been given.
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/1 description: The image shows the logo for KJAYA MEDICAL. The logo is in black and white and features the word "KJAYA" in large, outlined letters. Below the word "KJAYA" is the word "MEDICAL" in smaller, solid letters.
KJAYA MEDICAL, LLC One Stamford Plaza 263 Tresser Boulevard, 9th Floor, Stamford, CT 06901 Telephone: 203-653-5015. Fax: 203-653-2999
510(k) Summary (per 21 CFR 807.92)
AUG 2 6 2008
I. Applicant: KJAYA Medical, LLC One Stamford Plaza 263 Tresser Boulevard 9th Floor Stamford, CT 06901 USA
Contact Person: Kovalan Muniandy, Managing Member Tel: 203-653-3496 Fax: 203-653-2999 e-mail: kovalan.muniandy@kjaya.com
Date prepared: February 26, 2008
II. Device Name
Proprietary Name: Volumina Common/ Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological Regulation Number: 892.2050 Product Code: LLZ Classification; 2
III. Predicate Device
The Volumina is substantially equivalent to the following predicate devices:
- . Synapse 3D Visualization Software OBLIQUUS (K061672) from FUJIFILM Medical Systems USA Inc.
- Rtist for Fusion7D, (K033955) from Mirada Solutions, Ltd. .
IV. Indications for Use
Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.
V. Description of the Device
Volumina is a Class II software application comprised of a client module and a server module. Volumina is intended to provide a diagnostic quality image to a qualified health care professional to visualize multimodal medical image
1
Image /page/1/Picture/0 description: The image shows the text "KJAYA MEDICAL" in a stylized font. The word "KJAYA" is in a larger font size than the word "MEDICAL". The word "MEDICAL" is located directly below the word "KJAYA".
data.
For additional information refer to Section 11. Device Description
VI. Testing
Verification and Validation was conducted according to written protocols and the test outcomes were documented with test reports including pass/fail determination. Verification was monitored and cross referenced in the traceability matrix to ensure all requirements are verified.
Tests were executed under various environments representing actual operating environments and included laptops, desktops, and servers running Microsoft Windows XP, Microsoft Windows XP x64,and Microsoft Windows Server 2003. The various test environments also included connections via a variety of internet and network connections, including DSL, and Cable.
The test data was retrieved from a PACS database containing actual patient Raw Data. Some synthetic data of known dimensions and values was also used for verification and validation.
Due to the close relationship between the Client and Server modules, both were tested simultaneously.
Validation was undertaken to demonstrate that the Volumina Client and Server Modules together consistently fulfill the requirements within the intended use operates as intended under actual operating conditions by accepting the required parameters as input and by returning the expected output, and that the user interface provides a display that is consistent with the data that has been given.
A tabulation of Test Procedures, expected Results and Outcomes and are included in Appendix 16-C Traceability Matrix
For details please see Section 16. Software, Item 7. Verification & Validation Testing.
VII. Safety and Effectiveness
There are no substantial differences between the Volumina defined in this 510(k) submission and the stated predicate devices. They are similar to the technologies that are currently used in other similar medical devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and head, and three wavy lines forming its legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kjaya Medical, LLC % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
AUG 2 6 2008
Re: K081215
Trade/Device Name: Volumina Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2008 Received: August 11, 2008
Dear Mr. Lehtonen:
1
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 (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.
3
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.
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html J
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Page 2
Enclosure
4
510(k) Number (if known): K081215
Device Name: Volumina
Indications for Use:
Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.
Prescription Use × (Part 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 brodon
(Division Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of