This device is intended for use when there is a need to convert endoscopic and microscopic surgical video to a digital video format for subsequent review and archiving. This device will also transfer the digital video over digital networks and/or digital communication lines.

Device Description

fyreLINK VL (formerly echoLINK) now provides the endoscopy and surgical market a real-time solution for dealing with video data in a complete image management system. There are three major components that make up the fyreLINK VL product line; an image acquisition unit, a review station (either the fyreLINK station or a third party product), and a DVD library system or other archive device. The telemedicine system uses the same components except for the DVD library system. Appendix D shows an example of how an image acquisition unit can be arranged to provide a particular customer solution.

The fyreLINK VL Image Acquisition Unit (IAU) is the key component of the fyreLINK VL device. It uses a hardware video converter to convert analog video coming from a surgical video system to streaming digital video in real time. This streaming digital video is then compressed using MPEG 2 technology and stored on its local hard drive as a MPEG2 file. The IAU can store up to 1000 minutes of digital video data on its internal hard disk. The data is available for immediate review on the IAU, or can be exported to another application or another workstation or archive. Each acquired recording is an individual file. Exams can consist of a single continuous recording of the entire procedure, or a collection of shorter recordings of areas of interest. Still images may also be captured and saved as bitmap or JPEG files. The IAU is built on a Windows 2000 platform, and is network-ready for transferring patient data to a local or central archive system and/or to a physician's review station. The IAU's compact size allows it to be a direct replacement for existing VCR's used in endoscopic and microscopic surgical procedures. The IAU platform can consist of either a laptop or desktop type computer. The device has an electronic report generator that will allow the user to enter exam information as part of a paperless reporting system. The IAU, when configured as part of a WAN environment, can be a part of a remote access telemedicine system. The IAU is controlled by MPACS proprietary software.

fyreLINK VL offers two review station solutions. Acquired images can be reviewed at the IAU, or the image files can be exported for use with another application. THE REVIEW FUNCTION OF FYRELINK VL SOFTWARE LABELS ALL RECALLED IMAGES WITH THE TYPE OF COMPRESSION USED AND THE COMPRESSION RATIO.

fyreLINK VL used in a network environment can integrate with a mass archive solution already in place. As an alternative, the IAU includes a DVD recorder built in, to permit immediate local archival of endoscopic or microscopic surgical procedures.

MPACS can supply network solutions for integrating the fyreLINK VL components. In a network configuration, the image acquisition unit moves patient studies directly to a server. The networked review station is able to review both on-line and near-line studies. Network solutions can also include telecommunication links such as T1, DSL, and cable modem connections for telemedicine.

AI/ML Overview

The provided documentation (K030728) is a 510(k) Summary for the fyreLINK VL device, which is a Picture Archiving and Communications System (PACS). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the fyreLINK VL itself.

Therefore, many of the requested sections about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, and reader studies are not applicable as this type of information is not typically included in a 510(k) summary for a PACS device demonstrating substantial equivalence. The FDA submission for this type of device primarily relies on demonstrating that its technological characteristics and intended use are similar to a legally marketed predicate device.

Here's an analysis based on the available information:

Acceptance Criteria and Study for fyreLINK VL (K030728)

The submission for the fyreLINK VL device is a 510(k) Premarket Notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, the Dyonics Vision 635 Digital Capture System (K011944). For this type of submission, the "acceptance criteria" are generally met by demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Specific quantitative performance metrics with pre-defined acceptance criteria, as would be seen in a clinical trial or performance study for a diagnostic algorithm, are not typically provided or required in such a submission for a PACS system.

1. Table of Acceptance Criteria and Reported Device Performance

As a substantial equivalence submission for a PACS device, the "acceptance criteria" are implicitly met by demonstrating technological equivalence and equivalent intended use with the predicate device. There are no explicit quantitative performance metrics or a table of acceptance criteria presented in this 510(k) Summary.

The key reported performance claims are:

Acquisition/Digitization: Converts analog video to streaming digital video (MPEG 2) in real-time (30 frames per second).
Storage: Stores up to 1000 minutes of digital video data on its local hard drive.
Playback: Plays back stored digital video in real-time.
Export: Exports data files in DICOM format and still images as bitmap or JPEG files.
Compression Labeling: The review function of fyreLINK VL software labels all recalled images with the type of compression used and the compression ratio.

The "study that proves the device meets the acceptance criteria" is the comparison of technological characteristics and intended use to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) submission does not describe a clinical performance study with a test set of data. The submission focuses on technical specifications and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth establishment by experts for a test set is described in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is described. The device is a PACS system for managing video data, not a diagnostic AI algorithm that would typically undergo such a study to assess human-AI collaboration.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The fyreLINK VL is a hardware and software system for video acquisition, storage, and review, not an AI algorithm for standalone diagnostic performance. Its functionality is described in terms of its ability to process and manage video data effectively, mirroring the predicate device.

7. Type of Ground Truth Used

Not applicable. The submission does not involve ground truth in the context of diagnostic accuracy. The "truth" for this device lies in its ability to accurately digitize, store, and playback video as described by its technical specifications and demonstrated by its equivalence to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense for a diagnostic model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for an AI/ML model.

Summary

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MPACS

MAY 2 3 2003

Ko30728

7601 Ganser Way Madison, WI 53719 (608) 827-7111

510(K) SUMMARY (As Required by 21 CFR 807.92(c))

A. Submitter's Name and Address

MPACS, LLC 7601 Ganser Way Madison, WI 53719

Phone: (608) 827-7111 Fax:

B. Contact Person

Greg Sopotnick Phone: (608) 827-7111 Fax: (608) 827-0162

C. Date of Submission: March 6, 2003

D. Device Name

D.1. Device Trade or Proprietary name: fyreLINK VL™

D.2. Device Common or Usual Name: Picture Archiving and Communications Systems (PACS)

D.3. Classifications: Image Processing System

D.4. Product Code: LLZ

D.5. Class: Class II

D.6. Classification Panel: Radiology

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E. Equivalent Device

The equivalent legally marketed device is the Dyonics Vision 635 Digital Capture System (K011944) from Smith & Nephew, Inc., Endoscopy Division.

F. Device Description

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G. Intended Use

H. Substantial Equivalency Comparison

fyreLINK VL and Dyonics Vision 635 Digital Capture System are technologically equivalent in their capture of video images. Both convert an analog video signal to digital data, and then use the MPEG compression standard to create a file for storage and playback. In addition, both devices are capable of exporting data files in DICOM format, and both devices also capture still images in bitmap and JPEG format.

Data files on both devices are initially stored to a large internal hard drive. Both devices also can export to a network storage device via an Ethernet connection.

I. Conclusions

fyreLINK VL's performance is the same as the equivalent marketed device. Both devices are required to acquire or digitize full-motion (30 frames per second) analog video in real time. Likewise, both devices can playback the stored digital video in realtime.

Based on the intended use and the comparisons between the fyreLINK VL device and the legally marketed device, there are all the indications that the fyreLINK VL device is substantially equivalent to the Dyonics Vision 635 Digital Capture System device.

(End of 510(k) Summary)

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2003

Mr. Greg Sopotnick OA Manager MPACS, LLC 7601 Ganser Way MADISON WI 53719 Re: K030728

Trade/Device Name: fyreLINK VL Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: March 6, 2003 Received: March 7, 2003

Dear Mr. Sopotnick:

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 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, 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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Page 1 of

ڊيسٽمبر

510(k) Number (if known):

fyreLINK VL Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Leppmm

Prescription Use

(Posted July 1, 1998)

(Optional Format 3-10-98)

Regulation Number and Section

§ 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).