(50 days)
The indications for use of the VIEWSEND Medical System, as described in its labeling, are the same as the previously cleared devices marketed and distributed by KLT telecom, Inc. (K-962225). The VIEWSEND Medical System has the same intended use as the originally cleared device.
When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to comnare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security.
Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA
The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The system may also utilize some or all of the following components: (1) DICOM, (2) Zydacron, (3) Canon Communication Camera, (4) COHERENT Call Port Display Audio Conferencing System, (5) Canon RE-650 MKH Video Visualizer Document Camera.
This document appears to be a 510(k) premarket notification for the VIEWSEND Medical System. It focuses on demonstrating substantial equivalence to a predicate device and discussing software development and safety, rather than presenting a study specifically designed to establish acceptance criteria for device performance. As such, much of the requested information regarding acceptance criteria, study methodologies, and performance metrics is not directly available in this text.
However, I can extract information related to the device's technical specifications and safety evaluation.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study. Instead, it describes compliance with industry standards and internal software development policies, as well as the technical specifications of the integrated components.
| Acceptance Criteria (Implied / Stated Compliance) | Reported Device Performance (as described) |
|---|---|
| DICOM Compliance | Image file format complies with industry standard DICOM 3.0 protocols. Query, retrieve, send, receive, DICOM Direct, and DICOM print all conform with DICOM 3.0 protocols. |
| Compression Standard | Complies with ACR Standard for Digital Image Data Management, 1998 Res.15: "Data compression...may be used under the direction of a qualified physician, with no reduction in clinical diagnostic image quality." Lossy compression will be apparent to the reader, showing compression mechanism and ratio (e.g., DICOM JPEG LOSSY 12-bits, 14.8:1). |
| Monitor Resolution for Diagnostic Purposes | Conforms to "current industry standard recommendations for clinical and diagnostic display - currently minimum 1.5K x 2.0K resolution for diagnostic purposes." Specifically, Diagnostic Display requires "Medical Grayscale monitor(s) at 1.5 x 2.0k resolution with medical grade graphics board". |
| Software Functional Requirements | "Testing results demonstrated that the software functional requirements were met, and that the software specifications were fulfilled." (No specific metrics provided). |
| Safety (for incremental software revisions) | Each incremental revision was evaluated for potential hazards (e.g., threat to patient's life, irreversible illness, obscuring information, inaccurate diagnostic information). All listed revisions were assigned a "Minor" hazard level, except for JPEG2000 compression which was "Moderate" and 128-bit encryption which was "Minor". |
| Verification and Validation (for incremental software revisions) | For all listed incremental software revisions: "Were software specifications, requirements, and design set forth for this revision?" - Yes. "Was this revision verified and validated through KLT testing criteria?" - Yes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a specific "test set" in the context of a performance study with a defined sample size (e.g., number of images, patients). The testing mentioned is for software verification and validation of incremental revisions, not for image analysis performance. There is no information regarding data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document primarily discusses the technical capabilities and software development process of the system. While it mentions that "healthcare professionals shall exercise their own judgment when using the displayed information for diagnosis" and radiologists require specific monitors, it doesn't describe a process of establishing ground truth by medical experts for a test set to evaluate the device's diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as there is no described test set or study involving expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. The VIEWSEND Medical System is described as a modular software for telemedicine, teleradiology, and videoconferencing, focusing on image transmission, storage, and viewing capabilities. It is not an AI-assisted diagnostic device designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm without human-in-the-loop was not performed. The device is a system for medical professionals to use for "compare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis." It explicitly states that it "does NOT...Provide a diagnosis recommendation or statement (such as an expert system)".
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify a type of ground truth used, as it doesn't describe a study to evaluate diagnostic accuracy. The safety evaluation matrix uses criteria like "Could software errors in this revision potentially lead to diagnostic or monitoring information to be missed or inaccurate?", but the "Hazard Level of Concern" for these is determined based on software analysis, not a comparison to a clinical ground truth.
8. The sample size for the training set
This information is not applicable/not provided. The VIEWSEND Medical System is not an AI/ML device that requires a training set. It's a software system built upon existing medical software (Osiris 2.5) and integrated components (DICOM routines from Merge Technologies, JPEG 2000 routines from Pegasus).
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the text "KOJI586" written in a handwritten style. The letters and numbers are all connected, and the text is written in black ink. The text appears to be a code or a name.
AUG 4 - 2005
SECTION 3
SECTION 510(k) SUMMARY
The following information was completed on May 31, 2005. It is submitted in compliance with the provisions of 21 CFR 807.92:
807.92 (a)(1)
-
Submitter's Name: (a)
Kenei Co., Ltd 5-13-9 Higashi Ueno Taito-ku Tokyo, Japan 110-0005 -
Contact Person: (b)
Jennifer Li 6899 Churchill Road McLean, Virginia 22102 Telephone: 703-905-8038 Facsimile: 703-905-8038 Email: jennli@viewsend.com
807.92 (a)(2)
-
Device Name: (a)
VIEWSEND Medical System -
Trade/Proprietary/Common Name: (b)
VIEWSEND Medical VIEWSEND Medical 7 (Plus and Lite) VIEWSEND Medical 7.5 (Plus and Lite) VIEWSEND Telemed DICOM Server VIEWSEND RAD Plus and Lite; Client Station, Viewing Station -
Classification Name: System, Image Processing, Radiological (c)
Identification of Legally Marketed Device to Which Kenei Claims Equivalence 807.92 (a)(3)
The VIEWSEND Medical System is equivalent to a legally marketed predicate system; specifically, VIEWSEND Medical Products marketed by KLT Telecom, Inc. ("KLT") pursuant to an authorization issued by CDRH on October 25, 1996 (K-962225).
Identification of Device That is Subject of this Premarket Notification Submission 807.92 (a)(4)
The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The system may also utilize some or all of the following components:
(1) DICOM
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· Image file format complies with industry standard DICOM 3.0 protocols; and
- · Query, retrieve, send, receive, DICOM Direct, and DICOM print all conform with DICOM 3.0 protocols.
- (2) Zydacron
• Features:
User Interface:
Full feature video teleconferencing application
Audio:
Standards: G.711, G.722, and G.728 One line level input/output Balanced microphone input Amplified speaker output RJ-11 jack to connect to standard POTS telephone or fax machine Hook and DTMF detection for dialing Automatic gain control Full duplex echo cancellation Noise suppression
Video:
Standards: H.261 Two video inputs S-video or composite NTSC or PAL Analog VGA input from VGA board, no feature connector VGA output CIF/QIF resolution PIP window
Data:
Built in file transfer and messaging commands Serial port emulation supports popular groupware applications Optional network emulation supports TCP/IP applications
Comm Board Options - Signaling Standards: H 320, H.221, H.230, H.242, H.243
ISDN-BRI/PRI Ethernet Iso-Ethernet V 35 Interface MVIP compatible boards
Customization Options:
ZDK for custom application development Installation kits for custom install disk and manuals Call control development kit for integrating new communication systems Host comm. development kit for integrating host bus based communication system
(3) Canon Communication Camera
- Features:
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| Video Signal: | TCC video signal |
|---|---|
| Image Sensor: | 1/3-inch CCD |
| Total # of Pixels: | 410,000 pixels |
| Synchronization: | Internal |
| Horizontal Resolution: | 450 TV lines |
| Vertical Resolution: | 350 TV lines |
| S/N ratio: | 43dB |
| Scanning Method: | 2 : 1 interlace |
| Pan Mechanism: | Rotation angle: RT-LT (+ or -) 50 degress.Rotation speed: Maximum of 38 degress/second |
| Tilt Mechanism: | Rotation angle: RT-LT (+ or -) 20 degress.Rotation speed: Maximum of 35 degress/second |
| Input Terminal: | MIC IN mini-jack x 1 (input impedance approx. 5k ohms) |
| Output Terminal: | Audio Out: pin jack x 1 (O/P impedance approx. 1k ohms)Video Out: pin jack x 1 (O/P impedance approx. 75 ohms)S Video Out: S-video jack x 1 (O/P impedance approx. 75 ohms) |
| Control Terminal: | RS-232C: Mini DIN x 1Communication Standards: RS-232C levelData Bit: 8 bitParity: NoneStop Bit: 2 bitHandshake: RTS/CTS control |
| Focusing: | Auto/Manual |
| Iris Adjustment: | Auto iris servo system |
| Lens: | f/1/8 -2.6 8x power zoom 6-48 mm focal length |
| White Balance: | TTL system, full auto white balance |
| Power Supply/Other: | Pwr Source: Commercial power supply 120V AC, 60HzPwr. Consumption: Max. 17W (AC adapter included)Weight: Approx. 2.2 lbs. (1kg)Dimensions: 4 15/16 x 6 1/4 x4 1/16"(125 x 158 x 103 mm)Temp. Hum.: 41 F-95 F (5C-35C), 20% - 85 |
.
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| Wireless Controller: | Angle: (+ or -) 30 degrees from a hoz. position |
|---|---|
| Type :System:Pwr. Supply:Dimensions: | WL-V1Infrared pulse systemDC 3V (Two R6/AA batteries)1 13/16 x 6 11/16 x 11/16 inches(45 x 169.5 x 19 mm) |
| AC adapter: | Type:Input Level:Output Level:Polarity:Dimensions:Weight: |
| PA -V6120 V AC 60Hx 27VA12 V DC 1.5 A (max)Outside (-)2 1/4 x 3 15/16 x 1 7/8 inches(58 x 100 x 49 mm)Approx. 1.4lbs (690g) |
COHERENT Call Port Display Audio Conferencing System (4)
• FEATURES:
Frequency Response (1 kHz reference)
| Transmit: | 200 Hz to 3.4 kHz (+ or - 1dB) | |
|---|---|---|
| Receive: | 200 Hz to 3.4 kHz (+ or - 1dB) | |
| Harmonic Distortion: | Microphone to audio output: | 0.5% maximum |
| Audio Input to Loudspeaker: | 0.1% maximum at 1 watt output (1kHz | |
| Audio Power: | 3 watts peak to loudspeaker | |
| Dynamic Range: | 70 dB minimum | |
| Echo Control: | Acoustic Tail Circuit Delay: | 68 mS |
| Center Clipper (NLP): | Adaptive | |
| AERL Enhancement: | 65 dB min. with NLP enabledContinuously adaptive echo cancellation during normal speech | |
| Input/Output Impedance: | Input: | Headphone 10 k ohmsLine 50 k ohms |
| Output: | Microphone 100 ohmsLine 50 ohms | |
| Normal Levels: | Input: | Headphone -25 dBmLine -33 dBm |
| Output: | Microphone -58 dBmLine -27 dBm | |
| Power Requirements: | Power is derived using the 120 VAC power supply included with the Call Port |
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Canon RE-650 MKH Video Visualizer Document Camera (5)
• FEATURES:
. .
.
| Video Signal: | Conforms to NTSC color Format | |
|---|---|---|
| Pick-up Element: | 1/3 - inch CCD | |
| Total # of Pixels: | 410,000 (811H X 508V) | |
| Synchronization: | Internal | |
| Horizontal Resolution: | 450 TV Line | |
| Vertical Resolution: | 350 TV Lines | |
| S/N: | 46dB | |
| White Balance: | Automatically adjusted | |
| Negative/PositiveConversion: | Possible | |
| Input Source: | Camera head and two (2) other sources | |
| Input/OutputTerminals: | Video InVideo OutS-Video OutAudio InAudio OutMic InAC outlet | Pin jack x 2Pin jack x 2S-Video jack x 1Pin jack x 2Pin jack x 2Mini-jack x 1120VAC, 5A max. |
| ExternalInputMicrophone | Input Impedance: 450 to 1,200 ohms (mini jack) | |
| Lens (for RearPosition) | Zoom Lens, 5.2 62.4 mm f/1.8 - 2.8 (8 - group 10 - group) | |
| Document tableLens: | 500 mm close-up lens (1 - group 2 - clement) | |
| Ranges: | 16 - 7/32" x 12 - 13/32" to 1 - 13/32" x 1 - 1/16"(412 x 315 mm to 35.5 x 27mm) NORMAL position12 -5/8' x 9- 29/64" to 1 -13/64" x 7/8"(320 x 240 mm to 30.5 x 22.5 mm) in CLOSE UP position | |
| Zoom: | Power Zoom | |
| Focusing: | Auto/Manual | |
| IrisAdjustment: | Automatically adjusted (fine-adjustable) | |
| ZoomPositionMemory: | Zoom position setting saved when power turned off | |
| ElectronicShutter: | Two (2) settings, 1/60 and 1/100 | |
| CameraHeadPositions: | NORMAL, CLOSE-UP, REAR | |
| Illumination: | 6W fluorescent lamp (FL6W) x 2, angle-adjustable | |
| OutsideDimension: | 26 - 1/16" (W) x 26- 3/4: (H) x 21 - 3/4" (D)(662 (W) x 680 (H) x 553 (D) mm) | |
| StoredDimension: | 15 -3/4" (W) x 8 -1/16" (H) x 21 -3/4" (D)(400 (W) x 205 (H) x 553 (D) mm) | |
| Weight: | Approx. 22lbs (10kg) | |
| PowerSource: | 120VAC 60Hz | |
| PowerConsumption: | 25 W | |
| 807.92 (a)(5) | Intended Uses and Indications. | |
| See Section 2 above | ||
| 807.92 (a) (6) | Technological Characteristics |
:
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Introduction (i)
The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The software can be installed and tellediedle, telefonderstogy and of these capabilities as shown in Table 3-1.
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| VIEWSENDMedicalVersion | Telemedicine | Videoconferencing | Collaboration | DICOM | Communications | Viewer | Storage | Customizable DB | Stand Alone | Client/Server | Web-based | Compression | Security |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Plus/Lite | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| RAD Workstation | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| RAD Viewer | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| MDOffice | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||||
| RIX | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||||
| Web-RIX | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Server | ✓ | ✓ | ✓ |
Table 3-1
. .
Version names for common VIEWSEND Medical installation options
- System Specifications (ii)
The following minimum hardware and software components have been qualified for use with the VIEWSEND Medical System (not all items listed are required for install or use):
| (b) | Operating SystemsWindows 2000 Workstation |
|---|---|
| Window XP Professional (Service Pack 2) | |
| Windows NetMeeting 2.1, 3.x | |
| (c) | Hardware |
| Pentium IV - 1.8 GHz processor | |
| 512 MB Ram | |
| 80 GB Hard disk drive | |
| Zydacron Z350, Z360 Video Codec | |
| VCON Escort, Cruiser Video Codec | |
| ISDN Telecommunication Board | |
| Video capture card | |
| 56K Modem | |
| Network Interface Card | |
| Mouse/Keyboard | |
| Video Camera | |
| Mic & Speaker combination | |
| (ત) | |
| (c) | Displays |
The medical professional will follow their current industry standard recommendations for clinical and diagnostic display - currently minimum 1.5K x 2.0K resolution for diagnostic purposes.
Clinical display - 17" SVGA monitor at 1024x768 screen resolution
Diagnostic Display - Medical Grayscale monitor(s) at 1.5 x 2.0k resolution with medical grade graphics board
(f) Compression
The VIEWSEND Medical System complies with the following standard adopted by the American College of Radiology (ACR Standard for Digital Image Data Management, 1998 Res.15):
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"Data compression may be performed to facilitate transmission and storage. Several methods, including both reversible and irreversible techniques, may be used under the direction of a qualified physician, with no reduction in clinical diagnostic image quality. The types and ratios of compression used for different imaging studies transmitted and stored by the system should be selected and periodically reviewed by the responsible physician to ensure appropriate clinical image quality."
Diagnostic wet reads can be made according to radiologist industry standard recommendations. Currently radiologists require medical grade grayscale monitors and uncompressed iccommendations: "Currenty factoregion required and used according to ACR's guidelines mage tornator's discretion. VIEWSEND Medical is compliant with these requirements.
Lossy compression will be apparent to the reader when using the VIEWSEND Medical System. As shown in Figure 3-1 below, the compression applied to an image can be displayed. In this way, both the compression mechanism and the ratio can be seen.
| Patient | DOE JOHN |
|---|---|
| Anatomy | CHEST |
| Birthdate: | 1954.12.31 |
| Series Date: | 2002.01.03 |
| Series Time: | 13:56:21 |
| FileType: | DICOM JPEG LOSSY 12-bits |
| Modality: | CR |
| Compression Ratio | 14.8 : 1 |
| Bit Depth: | 16-bit |
| Image Pixel Size: | 880 x 1068 |
| Series File Size (KB) | 127 |
| No. of Images: | 1 |
Figure 3-1 Image Compression Information
- Checklist (d)
The Section 510(k) Summary Checklist follows immediately after this Section 3.
Incremental Technological Improvements to Predicate Device 807.92 (a)(6)
The VIEWSEND Medical System includes incremental technological features which have been added to the predicate device as indicated in Section 1, 807.87(g) and Chart 1-1 above
Other Information - Safety and Effectiveness. 807.92 (d)
The following information will provide certification as to the subject of safety and effectiveness analysis.
The VIEWSEND Medical System is comprised of modular software that provides telemedicine, teleradiology and videoconferencing capabilities. This system is desail in Section 1 above. Further, the software has been evaluated in accordance with CDRH's "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review". Based on this review, a Our level of concern was assigned to the software. Provided below is a discussion of the software's development process.
VIEWSEND Medical was developed based on an off-the-shelf medical software product known as Osiris 2.5. The Osiris 2.5, a Windows-based radiology package, was developed by University of Geneva Medical Center as part of its PACS system. The Osiris software is built upon C++ object oriented methodology with well-defined interface for each software module. C++ exception handling is built in to minimize system malfunction and to provide a graceful system exit without data loss. All DICOM routines are from Merge Technologies. JPEG 2000 routines are from Pegasus.
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VIEWSEND Medical provides image transmission and storage. TCP/IP protocol is used to guarantee reliable image transmissions among VIEWSEND Medical workstations in local and wide arca networks. Zmodem and FTP protocols are used as well for direct modem-to-modem connections.
As established with the unmodified device, and as stated as the intended use of both the unmodified and the modified device, VIEWSEND Medical System software does NOT:
- Threaten the patient's life �
- Cause irreversible illness or injury �
- Directly control delivery of energy �
- Administration of parental drugs �
- Perform life-sustaining functions �
- Provide alarms for life threatening conditions �
- Provide a diagnosis recommendation or statement (such as an expert system) �
In addition, it has always been maintained, and supported by ACR, that healthcare professionals shall exercise their own judgment when using the displayed information for diagnosis.
Standard software development policy/procedures were followed by Kenei's predecessor in order to provide quality assurance. Test plans were developed in the process and used for testing, vertication and validation tasks. Testing results demonstrated that the software functional requirements were met, and that the software specifications were fulfilled.
The following matrix is provided as a summary to demonstrate that Kenei's predecessor has sufficiently analyzed the safety of each incremental software revision, established the basis for appropriate development, and implemented safety/performance requirements.
| Incremental SoftwareRevisions | A | B | C | D | E | F | G | Comment | HazardLevel ofConcern | |
|---|---|---|---|---|---|---|---|---|---|---|
| User Interface Updates | ||||||||||
| 1 | Added Patient Work List withread/unread status indicators | N | N | N | N | Y | Y | N | Minor | |
| 2 | Added user preferences tool | N | N | N | N | Y | Y | N | Minor | |
| 3 | Added floating toolbar | N | N | N | N | Y | Y | N | Minor | |
| 4 | Single address book is usedfor systems configured withboth H.320 and H.323standards | N | N | Y | N | Y | Y | N | Minor | |
| 5 | Revised the toolbar to flatbarstandard with support forvarious screen resolutions | N | N | N | N | Y | Y | Y | Minor | |
| 6 | Added window width/levelpresets | N | N | Y | N | Y | Y | Y | Minor | |
| 7 | Added Japanese localization | N | N | N | N | Y | Y | Y | Localizationcompleted by AkiraTanaka, MelonSystem, Inc.,Japan | Minor |
| Incremental SoftwareRevisions | A | B | C | D | E | F | G | Comment | HazardLevel ofConcern | |
| User Interface Updates | ||||||||||
| 8 | Viewer now follows radiologyworkflow more closely | N | N | N | N | Y | Y | Y | Minor | |
| Feature Additions | ||||||||||
| 9 | Enable or disable theautomatic forwardingcapability of patientinformation received byVIEWSEND Medical stationto another DICOM station | N | N | N | N | Y | Y | N | Minor | |
| 10 | Enable or disable the losslesscompression capability foreach transfer item in thetransfer list queue | N | N | N | N | Y | Y | Y | Minor | |
| 11 | Enable or disable the FTPtransfer capability beforeeach consultation session. IfFTP transfer is enabledbefore the connectionprocess occurs, VIEWSENDMedical station will attemptto establish an FTP link to beused for all the file transferactivities during thesubsequent consultationsession | N | N | N | N | Y | Y | Y | Minor | |
| 12 | Added VIEWSEND log file todetail the actions performedduring use | N | N | N | N | Y | Y | N | Minor | |
| 13 | Added DICOM interface toinclude query, retrieve, send,receive, print, and DICOMDir | N | N | N | N | Y | Y | Y | DICOM toolkitprovided by Mergefor all datatransfer | Minor |
| 14 | Added store and forward e-mail send capability | N | N | N | N | Y | Y | Y | Minor | |
| 15 | Added dual video sourceswitching | N | N | N | N | Y | Y | N | Minor | |
| 16 | Added capability of savingvideo captured images andscan images into DICOMsecondary capture imageformat | N | N | N | Y* | Y | Y | N | * Used samealgorithm as withfilm images in theunmodified device | Minor |
| Incremental SoftwareRevisions | A | B | C | D | E | F | G | Comment | HazardLevel ofConcern | |
| 17 | Added the capability toautomatically forward studyinformation received fromDICOM modalities usingDICOM Send. In addition,study information receivedfrom another VIEWSENDMedical station duringcollaboration can beautomatically forwardedusing DICOM Send | N | N | N | N | Y | Y | N | Minor | |
| 18 | Application sharing is nowavailable for VIEWSENDMedical systems configuredwith H.320 standard- | N | N | N | N | Y | Y | Y | Minor | |
| Software/HardwareSupport | ||||||||||
| 19 | VIEWSEND is now a 32-bitapplication | N | N | N | N | Y | Y | N | NT/Win2K 32-bitsupport providedby C++development code | Minor |
| 20 | Added industry standardJPEG2000 compressionoption - ISO InternationalStandard, IS 15444 Part 1.The 'Joint' in JointPhotographic Experts Grouprefers to the link with ITU-T,and IS 15444-1 will also bean ITU-T Recommendation,T.800 | N | N | N | Y* | Y | Y | Y | * Used ISOinternationalstandard in toolkitfrom Pegasus | Moderate |
| 21 | Added capability to printoverlays and image to laserprinter | N | N | N | N | Y | Y | N | Minor | |
| 22 | Added industry standard128-bit encryption option.The encryption algorithm isbased on the standardRijndael algorithm, asspecified in the AdvancedEncryption Standard (AES)developed by the U.S.National Institute ofStandards and Technology(NIST). The AES is a blockcypher that uses long keys(128-, 192-, 256-bit) for dataencryption | N | N | N | Y* | Y | Y | N | * Used industrystandard 128-bitalgorithm providedby Microsoft (MS) | Minor |
| 23 | Added support for Zydacron350, 360 and VCON escort, | N | N | N | N | Y | Y | Y | Minor | |
| Incremental SoftwareRevisions | A | B | C | D | E | F | G | Comment | HazardLevel ofConcern | |
| 24 | Added support for CannonVCC4 camera | N | N | N | N | Y | Y | N | Minor | |
| 25 | Added MS SQL client/serversupport | N | N | N | N | Y | Y | Y | Minor | |
| 26 | Added PowerPointPresentation support invideoconferencing | N | N | N | N | Y | Y | Y | Minor | |
| 27 | Added MPEG4 video formatsupport | N | N | N | N | Y | Y | Y | Minor |
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- A Could the failure or latent design flaw in this revision immediately threaten the patient's life under plausible conditions?
- B Could the failure or latent design flaw in this revision directly cause irreversible illness or permanent injury under plausible conditions?
- C Does the failure or latent design flaw in this revision consolidate or obscure information or data that is available to the user in the unmodified device?
- D Could software errors in this revision potentially lead to diagnostic or monitoring information to be missed or inaccurate?
- E Were software specifications, requirements, and design set forth for this revision?
- F Was this revision verified and validated through KLT testing criteria?
- G Was regression testing required to maintain this revision?
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Image /page/12/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 - 2005
Kenei, Co., Ltd. % Ms. Jennifer Li United States Agent Vanguard Solutions Technology, LLC 6899 Churchill Road MCLEAN VA 22101
Re: K051586
Trade/Device Name: VIEWSEND Medical System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: June 2, 2005 Received: June 16, 2005
Dear Ms. Li:
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.
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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, primits wourderice 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 one of the following numbers, based on the regulation punther 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 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/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051586
Device Name: VIEWSEND Medical System
Indications For Use:
The indications for use of the VIEWSEND Medical System, as described in its labeling, are the same as the previously cleared devices marketed and distributed by KLT telecom, Inc. (K-962225). The VIEWSEND Medical System has the same intended use as the originally cleared device.
When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to comnare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security.
Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA
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)
R051586
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K05/9
Page 1 of 1
§ 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).