(90 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a server and client software for displaying and managing images, with an interface to a separate CAD component. There is no mention of AI/ML within the description of the FirstView™ device itself.
No
The device is intended to display and manipulate x-ray images, acting as an interface to display information. It does not directly treat or diagnose a disease or condition in a patient.
No
The device is intended to display and manipulate x-ray images and acts as an interface for a CAD component. It does not perform a diagnosis itself, but rather provides tools for a trained professional to use in making a diagnosis.
No
The device description explicitly states that the FirstView™ consists of a dedicated server and client software loaded onto an existing workstation, indicating hardware components beyond just software.
Based on the provided information, the FirstView™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "display and manipulate x-ray images," specifically "chest x-ray images." This is a function related to medical imaging and image processing, not the analysis of biological samples (like blood, urine, or tissue) outside the body, which is the core of IVD devices.
- Device Description: The description focuses on a server and client software for managing and displaying medical images. It doesn't mention any components or processes related to analyzing biological specimens.
- Input: The input is "x-ray images" and "chest x-ray images," which are medical images, not biological samples.
- No mention of biological samples or analysis: The entire description revolves around image handling and display. There is no indication of any interaction with or analysis of biological materials.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The FirstView™ device's function is clearly within the realm of medical imaging and image management.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
Device Description
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.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, such as physicians, radiologists, and technicians.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/2 description: The image shows a signature or handwritten text that appears to read "KD71492". The text is written in a cursive style with varying stroke thicknesses, giving it a dynamic and personal feel. The background is plain white, which helps to emphasize the dark, bold strokes of the signature.
510(K) SUMMARY 3.0
| Submission Date: | AUG 28 2007
May 25, 2007 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | |
| Company Name: | Riverain Medical Group, LLC. |
| Company Address: | 3020 South Tech Blvd., Miamisburg, OH 45342-4860 |
| Contact Person: | Jennifer Steinke
Director, Regulatory Affairs and Quality Assurance
Riverain Medical
800.990.3387
937.425.6493
jsteinke@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, INC
Class II |
| | Centricity PACS System (K043415)
GE Medical Systems
Class II |
| | Platinum Reading, Review, and Analysis Workstation
(K981217)
GE Medical Systems
Class II |
| Device Description: | 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. |
| Intended Use: | The FirstView™ is intended to display and manipulate x-
ray images. |
| 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. |
1
Comparison to Predicate Device:
| | 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. |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | 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. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text, which appears to be in a non-English language, curves along the top and bottom edges of the circle. The central graphic consists of three curved lines that converge at the bottom, resembling a stylized bird in flight or a flowing water design. The logo has a simple, monochrome design.
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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Page 2 -
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
4
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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