(90 days)
The FirstView™ is intended to display and manipulate x-ray images.
The FirstView™ is indicated for displaying and manipulating chest x-ray images. It acts as an interface with the CAD component, if installed or available at the clinical site, and provides display of information contained within the DICOM header of the images. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians.
The FirstView™ consists of a dedicated server that has been programmed with a database and server software, as well as client software that is loaded onto an existing workstation. New images, which may be a chest x-ray or CAD result, are sent to the FirstView™ server from a Digital or from the PACS network, prompting FirstView to query the PACS for additional images related to that study. The FirstView™ server manages the images within its Riverain proprietary database.
The provided text concerns the 510(k) summary for the FirstView™ device, a system for displaying and manipulating chest x-ray images. However, the document does not contain information related to specific acceptance criteria, formal study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that would typically be described as "proving the device meets the acceptance criteria."
Instead, the document focuses on the device's substantial equivalence to predicate devices for its intended use as a "Picture archiving and communications system" (PACS). The 510(k) process primarily evaluates whether a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to meet novel performance criteria in the way a PMA (Premarket Approval) might.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be filled from the provided text. The information available is presented below within the constraints of the provided document.
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format typically used for demonstrating performance against such criteria (e.g., sensitivity, specificity, accuracy).
Instead, the "acceptance criteria" in this context appear to be met by demonstrating substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices for Intended Use | "FirstViewTM is substantially equivalent to the cited predicate devices. Differences in the design and performance from the cited predicate devices do not affect either the safety or effectiveness of the FirstViewTM for its intended use.""FirstViewTM has the same intended use and technology as the legally-marketed predicate devices. Riverain Medical Group, LLC, has determined that the FirstViewTM is as safe and effective as the predicate devices that have been identified in this submission." |
| Ability to display and manipulate chest x-ray images | The device description states: "The FirstView™ is intended to display and manipulate x-ray images." and "The FirstView™ is indicated for displaying and manipulating chest x-ray images." The "Conclusion" section reinforces that the device has the "same intended use and technology" as predicate devices, implying it effectively performs these functions. |
| Interface with CAD component (if installed/available) | "It acts as an interface with the CAD component, if installed or available at the clinical site, and provides display of information contained within the DICOM header of the images." This is a stated indication for use, implying the device is designed and functions to meet this. |
| Used by trained professionals (physicians, radiologists, technicians) | "This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians." This indicates the device's operational design and user interface are suitable for these professional users, consistent with predicate PACS systems. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- The document does not report any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) submission primarily relies on comparison to predicate devices, not independent performance testing against a specific dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention a test set with ground truth established by experts.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method for a test set.
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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:
- The document does not describe an MRMC comparative effectiveness study. The FirstView™ is described as an image display and manipulation system, potentially interfacing with CAD, but not inherently as an AI-powered diagnostic aid that would typically undergo such a study to evaluate human reader improvement.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document does not describe any standalone algorithm performance study.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" for a specific performance evaluation test set is not mentioned in the document.
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The sample size for the training set:
- The document does not report any training set sample size.
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How the ground truth for the training set was established:
- The document does not report how ground truth for a training set was established, as it does not mention a training set.
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510(K) SUMMARY 3.0
| Submission Date: | AUG 28 2007May 25, 2007 |
|---|---|
| Submitter Information: | |
| Company Name: | Riverain Medical Group, LLC. |
| Company Address: | 3020 South Tech Blvd., Miamisburg, OH 45342-4860 |
| Contact Person: | Jennifer SteinkeDirector, Regulatory Affairs and Quality AssuranceRiverain Medical800.990.3387937.425.6493jsteinke@riverainmedical.com |
| Device Information: | |
| Trade Name: | FirstView™ |
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | Picture archiving and communications system |
| Device Class: | Class II, 21 CFR §892.2050 |
| Predicate Devices: | R2 Breast Imaging Workstation (K051743)R2 TECHNOLOGY, INCClass II |
| Centricity PACS System (K043415)GE Medical SystemsClass II | |
| Platinum Reading, Review, and Analysis Workstation(K981217)GE Medical SystemsClass II | |
| Device Description: | The FirstView™ consists of a dedicated server that hasbeen programmed with a database and server software, aswell as client software that is loaded onto an existingworkstation. New images, which may be a chest x-ray orCAD result, are sent to the FirstView™ server from a |
| Digital or from the PACS network, prompting FirstView toquery the PACS for additional images related to that study.The FirstView™ server manages the images within itsRiverain proprietary database. | |
| Intended Use: | The FirstView™ is intended to display and manipulate x-ray images. |
| Indications for Use: | The FirstView™ is indicated for displaying andmanipulating chest x-ray images. It acts as an interfacewith the CAD component, if installed or available at theclinical site, and provides display of information containedwithin the DICOM header of the images. This device isintended to be used by trained professionals, such asphysicians, radiologists, and technicians. |
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Comparison to Predicate Device:
| FirstViewTM is substantially equivalent to the citedpredicate devices. Differences in the design andperformance from the cited predicate devices do not affecteither the safety or effectiveness of the FirstViewTM for itsintended use. | |
|---|---|
| Conclusion: | FirstViewTM has the same intended use and technology asthe legally-marketed predicate devices. Riverain MedicalGroup, LLC, has determined that the FirstViewTM is as safeand effective as the predicate devices that have beenidentified in this submission. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Jennifer Steinke Director, Regulatory Affairs and Quality Assurance Riverain Medical Group, LLC 3020 South Tech Blvd. MIAMISBURG OH 45342-4860
AUG 2 8 2007
Re: K071492
Trade/Device Name: FirstView™M Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2007 Received: August 2, 2007
Dear Ms. Steinke:
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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "PA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged in a horizontal line beneath the word "Centennial".
cling and Promoting Public Shoath
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT 2.0
510(k) Number (if known): K071492
FirstView™ Device Name:
Indications for Use:
The FirstView™ is indicated for displaying and manipulating chest x-ray images. It acts as an interface with the CAD component, if installed or available at the clinical site, and provides display of information contained within the DICOM header of the images. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
TWhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 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).