(244 days)
Not Found
No
The summary describes a PACS system for capturing, archiving, and displaying medical images and video. There is no mention of AI or ML capabilities for analysis, interpretation, or any other function. The focus is on data management and viewing.
No.
The device is a PACS system for archiving and viewing audio/video sequences and patient data, explicitly stating that information is "for viewing and reference purposes only and are not intended for primary diagnosis." It does not provide any therapeutic function.
No
The "Intended Use / Indications for Use" section explicitly states that the information captured and stored by the system "are for viewing and reference purposes only and are not intended for primary diagnosis."
No
The device description explicitly mentions hardware components like the "mediCast Box" which is a video stream/image capture device. While there are software components, the system includes dedicated hardware.
Based on the provided information, the MedicVOD System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure." It explicitly says the information is for "viewing and reference purposes only and are not intended for primary diagnosis." IVD devices are specifically intended for use in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system for capturing, storing, and displaying audio/video and patient data from medical procedures. This aligns with a PACS system, not an IVD device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory results.
Therefore, the MedicVOD System, as described, functions as a medical image and data management system for procedural documentation and viewing, not as an IVD device.
N/A
Intended Use / Indications for Use
The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with videoconferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Orpheus Medical MedicVOD System is a picture archiving and communication system intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The MediVOD System contains the following modules/components:
- mediCast (ie mediCast Live) - a video stream / image capture device which is connected to a medical scope camera.
- mediCast App - real-time compression and archiving application displaying session from mediCast Box or from any USB attached camera and broadcast it in real time.
- mediCast Mobile App - a smart phone application for uploading medical images and videos.
- mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video.
- mediShow a viewer for real-time broadcasting from a mediCast System.
- mediSearch – a search utility application which allows the user to search for and view videos and still images previously captured by mediCast.
- mediWeb - a web based application that provides access to the mediSearch and mediShow applications.
The MedicVOD System key features include:
- Digital recording of medical procedures streamed directly to on-site server for storage and retrieval,
- Live broadcast of a medical procedure to an unlimited number of viewers,
- Archiving of video assets to a controlled storage resource,
- Data fetching with dynamic categories for statistical analysis and multiple report production, and
- Ability to view/review videos
The mediCAST box is capable of capturing and broadcasting a video stream in real time. MediCAST box captures and stores video and still images, and in parallel, uploads the captured images and video streams to the MedicVOD server. The mediCAST box uploads the videos and images when there is communication with the MedicVOD server.
The mediSearch application provides the ability to search within the MedicVOD archive. The mediSearch application allows users to perform searches for video recordings within a captured mediCAST session. Each session could be a combination of several recordings of various kinds. For example, a session could be a combination of several video recordings, several still images (snapshot taken) and several DICOM images that have been stored. MediSearch provides the ability to view the assets which were found, and provides certain editing capabilities.
The mediShow application automatically connects into the MedicVOD server and displays currently active sessions or procedures captured by any mediCAST station on the local network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laparoscopic images as well other audio/image/video outputs modalities
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical verification and validation of the Orpheus Medical Ltd. MedicVOD System was performed through extensive bench testing. Results of the testing demonstrated that the Orpheus Medical Ltd. MedicVOD System design met all specifications and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the Orpheus Medical Ltd. MedicVOD System to its predicate device.
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
§ 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 the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Orpheus Medical Ltd. % Mr. Ian Marsden Assistant Director Regulatory Affairs Dohmen Life Sciences Services, LLC 11925 W I-70 Frontage Road North, Suite 900 Wheat Ridge, Colorado 80033
Re: K151737
Trade/Device Name: MedicVOD System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 1, 2016 Received: February 2, 2016
Dear Mr. Marsden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151737
Device Name MedicVOD System
Indications for Use (Describe)
The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with videoconferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 07: 510(k) Summary
1. Introduction
- 1.1 This document contains the 510(k) summary for the modified Orpheus Medical Ltd. MedicVOD System (K151737). The content of this summary is based on the requirements of 21 CFR Section 807.92(c).
2. Applicant Name and Address
| Applicant Name: | Orpheus Medical Ltd. |
|---|---|
| Address: | PO Box 15140 |
| Haifa, 31905, Israel | |
| Phone: | Tel: +972-04-6968800 |
| Fax: | Fax: +972-77-4371228 |
| Official Contact: | Ian Marsden |
| Assistant Director of Regulatory Affairs | |
| Dohmen Life Science Services, LLC | |
| Address: | 11925 W. I-70 Frontage Rd. North |
| Suite 900 | |
| Wheat Ridge, CO 80033 | |
| Phone: | 303-832-8200 |
| Fax: | 303-832-6700 |
| E-mail: | ian.marsden@dlss.com |
Summary Preparation Date: February 24, 2016 3.
4. Device Name and Classification
| Trade Name | MedicVOD System |
|---|---|
| Common Name | Picture Archiving and Communication System |
| Classification Name | Picture Archiving and Communication System |
| Classification Regulation | 21 CFR 892.2050 |
| Product Code | LLZ |
5. Predicate Devices
- The modified Orpheus Medical Ltd. MedicVOD System is claimed to be substantially 5.1 equivalent to the following legally marketed predicate device:
- 5.1.1 Orpheus Medical Ltd. MedicVOD System (K123426)
6. Performance Standards
- 6.1 There are no mandatory performance standards for this device.
7. Device Description
- 7.1 Orpheus Medical MedicVOD System is a picture archiving and communication system intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The MediVOD System contains the following modules/components:
- 7.1.1 mediCast (ie mediCast Live) - a video stream / image capture device which is connected to a medical scope camera.
4
- 7.1.2 mediCast App - real-time compression and archiving application displaying session from mediCast Box or from any USB attached camera and broadcast it in real time.
- 7.1.3 mediCast Mobile App - a smart phone application for uploading medical images and videos.
- 7.1.4 mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video.
- mediShow a viewer for real-time broadcasting from a mediCast System. 7.1.5
- 7.1.6 mediSearch – a search utility application which allows the user to search for and view videos and still images previously captured by mediCast.
- 7.1.7 mediWeb - a web based application that provides access to the mediSearch and mediShow applications.
- 7.2 The MedicVOD System key features include:
- 7.2.1 Digital recording of medical procedures streamed directly to on-site server for storage and retrieval,
- 7.2.2 Live broadcast of a medical procedure to an unlimited number of viewers,
- 7.2.3 Archiving of video assets to a controlled storage resource,
- 7.2.4 Data fetching with dynamic categories for statistical analysis and multiple report production, and
- 7.2.5 Ability to view/review videos
- The mediCAST box is capable of capturing and broadcasting a video stream in real 7.3 time. MediCAST box captures and stores video and still images, and in parallel, uploads the captured images and video streams to the MedicVOD server. The mediCAST box uploads the videos and images when there is communication with the MedicVOD server.
- 7.4 The mediSearch application provides the ability to search within the Medic/OD archive. The mediSearch application allows users to perform searches for video recordings within a captured mediCAST session. Each session could be a combination of several recordings of various kinds. For example, a session could be a combination of several video recordings, several still images (snapshot taken) and several DICOM images that have been stored. MediSearch provides the ability to view the assets which were found, and provides certain editing capabilities.
- The mediShow application automatically connects into the MedicVOD server and 7.5 displays currently active sessions or procedures captured by any mediCAST station on the local network.
8. Comparison of Indications for Use to the Predicate Device
- 8.1 The modified MedicVOD System which is the subject of this submission has identical indications for use as identified in the original MedicVOD System cleared under K123426. The indications for use for the MedicVOD System are as follows:
- 8.1.1 The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with video-conferencing capability during the
5
broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.
9. Comparison of Technological Characteristics to the Predicate Device
- 9.1 The modified MedicVOD System is substantially equivalent to the original MedicVOD System cleared under K123426 with the addition to the following modules/components to the System:
- mediCast App real-time compression and archiving application displaying 9.1.1 session from mediCast Box or from any USB attached camera and broadcast it in real time.
- 9.1.2 mediCast Mobile App - a smart phone application for uploading medical images and videos.
- 9.1.3 mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video.
- 9.2 The table below provides a comparison of the modified MedicVOD System which is the subject of this 510(k), to the original MedicVOD System cleared under K123426.
| Specification | Modified Device | Unmodified MedicVOD
System K123426 | Comparison
to Predicate |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | MedicVOD System | MedicVOD System | Identical |
| System
Configuration | Video, still Image and audio
capturing workstation,
central archiving server and
view terminal/s | Video, still Image and audio
capturing workstation,
central archiving server and
view terminal/s | Identical |
| Clinical
Application | During and after surgical
procedures | During and after surgical
procedures | Identical |
| Hardware
Configuration | Touch panel PC, external
keyboard & mouse,
footswitch, mediCast Box,
Apple and Android based
tablets and phones | Touch panel PC, external
keyboard & mouse,
footswitch | Substantially
Equivalent |
| Data Storage | Internal storage and
transmission to external
central storage server | Internal storage and
transmission to external
central storage server | Identical |
| Operating
System | Windows, iOS, Android
based | Windows based | Substantially
Equivalent |
| Image
Sources | Laparoscopic images as well
other audio/image/video
outputs modalities | Laparoscopic images as well
other audio/image/video
outputs modalities | Identical |
| Signal
Encryption | Encrypted digital
transmission on session and
tier base + Various
authentication levels and
external LDAP integration | Encrypted digital
transmission on session and
tier base + Various
authentication levels and
external LDAP integration | Identical |
| Resolution | Supports up to high definition
:1920x1080 | Supports up to high definition
:1920x1080 | Identical |
| Audio
Compression | Mpeg2 Layer1 or AAC HE
LC | Mpeg2 Layer1 or AAC HE
LC | Identical |
| DICOM
Support | System Supports | System Supports | Identical |
6
10. Summary of Nonclinical Performance Testing
- 10.1 The following table summarizes the testing performed on the MedicVOD System to support this 510(k);
| | mediCast Box
(subject device) | mediCast Station
(predicate device –
K123426) | Comparison of
subject device
to predicate |
|---------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Software
Validation
Testing | Software testing at the unit
level | Software testing at the unit
level. Additional
nonclinical performance
testing used to support
K123426 | Identical |
| Electrical Safety
Testing | Testing performed to
ensure compliance to IEC
60601-1 3rd Edition | Testing performed to
ensure compliance to IEC
60601-1 3rd Edition | Identical |
| Electromagnetic
Compatibility
Testing | Testing performed to
ensure compliance to IEC
60601-1-2:2007 | Testing performed to
ensure compliance to IEC
60601-1-2:2007 | Identical |
| Emissions
Testing | Tested to comply with
FCC Part 15, Subpart B,
Class B | Tested to comply with
FCC Part 15, Subpart B,
Class B | Identical |
11. Summary of Clinical Performance Testing
- 11.1 No clinical testing was required to support the substantial equivalence to the predicate device.
12. Conclusion
- 12.1 Non-clinical verification and validation of the Orpheus Medical Ltd. MedicVOD System was performed through extensive bench testing. Results of the testing demonstrated that the Orpheus Medical Ltd. MedicVOD System design met all specifications and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the Orpheus Medical Ltd. MedicVOD System to its predicate device.
- 12.2 In conclusion, the Orpheus Medical Ltd. MedicVOD System is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the following legally marketed predicate device:
12.2.1 Orpheus Medical Ltd. MedicVOD System (K123426)