(149 days)
No
The document describes standard digital radiology software functionalities (acquisition, processing, storage, viewing, DICOM communication) and explicitly states "Mentions AI, DNN, or ML: Not Found". There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as software for acquiring, processing, storing, and viewing digital radiology studies, which are diagnostic in nature, not therapeutic.
No
The device is described as software for the acquisition, processing, storage, and viewing of digital radiology studies (specifically digital x-ray images). It does not perform any diagnostic interpretation or analysis.
Yes
The device description explicitly states "The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images." and details its functions as interfacing with third-party hardware and providing a user interface for viewing and processing, indicating it is a software application that operates on existing hardware, not a hardware device itself.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ExamVue Duo's Function: ExamVue Duo is a software for acquiring, processing, storing, and viewing digital radiology studies (X-ray images). It works with external hardware (digital x-ray detectors) to capture images of the inside of the body.
- No Sample Analysis: The description clearly states that ExamVue Duo deals with digital radiology studies, which are images of the body, not samples taken from the body for laboratory analysis.
Therefore, ExamVue Duo falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Exam Vue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. Exam Vue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. Exam Vue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
Exam Vue Duo is not indicated for use in mammography.
Product codes
KPR
Device Description
The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors and (optionally) generators and manufacturer supplied software for the acquisition and storage of digital x-ray studies. The ExamVue Duo software then provides a user interface for the viewing, annotating, and other workstation functions. Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital x-ray images
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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)
Bench tests reports and clinical data have been provided, detailing the direct comparison of functions between the ExamVue Duo and predicate device.
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
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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February 18, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a seal with an eagle-like figure. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with the word 'ADMINISTRATION' written in a smaller font size below.
JPI Healthcare Co, Ltd. % William Little Senior Product Manager JPI Healthcare Solutions. Inc 52 Newtown Plaza PLAINVIEW NY 11803
Re: K213057
Trade/Device Name: ExamVue Duo Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: February 8, 2022 Received: February 10, 2022
Dear William Little:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213057
Device Name ExamVue Duo
Indications for Use (Describe)
Exam Vue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. Exam Vue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. Exam Vue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
Exam Vue Duo is not indicated for use in mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K213057 510 (k) Summary
April 12, 2021
1. Company and Correspondant Making the Submission:
Name: JPI Healthcare Co,. LTD Address: 608-ho, 28, Digital-ro 33-gil, Guro-gu, 08377 Seoul, Korea Telephone: +82-2-2108 - 2580 Fax: +82-2-2108-1180 Contact: Lee Jang Won Website: http://www.jpi.co.kr/
2. Identification of Device
| Classification Name: | Stationary x-ray system |
|---|---|
| Common Name: | Digital X-ray Acquisition Software |
| Trade/Proprietary Name: | ExamVue Duo |
3. Predicate Device
| Manufacturer: | JPI Healthcare Solutions, Inc |
|---|---|
| Device: | ExamVue DR |
| 510(k) Number: | K142930 |
| Classification Name: | Stationary x-ray system |
| Common Name: | Digital X-ray Acquisition Software |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 KPR |
Product Classification Names and Citations 4.
| Regulatory Number: | 21 CFR 892.1680 |
|---|---|
| Regulatory Class: | II |
| Product Code: | 90 KPR |
5. Description:
The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors and (optionally) generators and manufacturer supplied software for the acquisition and storage of digital x-ray studies. The ExamVue Duo software then provides a user interface for the viewing, annotating, and other workstation functions.
4
Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.
-
- Indication for use
ExamVue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. ExamVue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects.
- Indication for use
ExamVue Duo is indicated for use in general imaging, specialist imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
ExamVue Duo is not indicated for use in mammography.
-
- Comparison with Predicate Device:
JPI Healthcare Co., Ltd. believes that the ExamVue Duo software is substantially equivalent to the ExamVue DR software registered by JPI Healthcare Co. Ltd The ExamVue Duo software and the predicate device both -Provide a user interface for the registration, acquisition, and evaluation of x-ray studies. -Perform the functions of image transfer, image acquisition, image processing, and maintaining a patient database. -Use the DICOM 3.0 standard for medical imaging -Are intended for installation on Windows operating systems for use in a medical environment. -Interface with and process images from multiple models of hardware.
- Comparison with Predicate Device:
ExamVue Duo and the predicate device share the same essential functions of image acquisition, transfer, and processing; however they have different user interfaces and ExamVue Duo has some additional registration, annotation and imaging processing features. We believe this does not represent a substantial difference between the two devices, as the user interface presents the same essential data and supports similar workflow as the predicate device.
8. Safety, EMC and Performance Data
Bench tests reports and clinical data have been provided, detailing the direct comparison of functions between the ExamVue Duo and predicate device.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that the ExamVue PACS is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart.
5
EXHIBIT 1
SUBSTANTIAL EQUIVALENCE CHART
6
| Characteristics | Proposed
ExamVue Duo | Predicate 1
ExamVue DR |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | JPI Healthcare Solutions, Inc | JPI Healthcare Solutions, Inc |
| 510(k) Number | | K142930 |
| Intended use. | The ExamVue Duo software is
designed for use by radiologists
and radiology technicians for the
acquisition of digital x-ray images. It
interfaces with 3rd party digital x-ray
detectors or CR scanners and
manufacturer supplied software for
the acquisition and storage of digital
x-ray images. The ExamVue
Duo software then provides a user
interface for the viewing,
annotating, and other workstation
functions. ExamVue Duo software
includes the ability to receive
patient information and send x-ray
images to remote destinations
using the DICOM 3.0 protocol. | The ExamVue DR software is
designed for use by radiologists
and radiology technicians for
the acquisition of digital x-ray
images. It interfaces with 3rd
party digital x-ray detectors or
CR scanners and manufacturer
supplied software for the
acquisition and storage of digital
x-ray images. The ExamVue DR
software then provides a user
interface for the viewing,
annotating, and other
workstation functions. ExamVue
DR includes the ability to
receive patient information and
send x-ray images to remote
destinations using the DICOM
3.0 protocol. |
| Performance
Standard | 21 CFR 820
21 CFR 830 | SAME |
| Processor | Intel Core i5 or higher | Intel Core i5 or higher |
| RAM | 8GB or higher | Min. 4GB |
| Hard Disk | Min. 500GByte | Min. 500GByte |
| Network | 1GBit | 1GBit |
| Operating
System
Requirements | Windows 10 | Windows 7, Windows 8 or
Windows 10 |
| Resolution | Min. 1366 x 768 | 1920 x 1080 |
| Image
Transfer | DICOM 3.0 Standard | Same |
| Image
Acquisition | Yes | Yes |
| Image
Processing | Yes | Yes |
| Windowing | Yes | Yes |
| Image
Formatting | Yes (1x1, 1x2, 2x1, 2x2, 3x3) | Yes (1x1, 1x2, 2x1, 2x2, 3x3) |
| Annotations
and
Measurements | Yes | Yes |
| Image
Rotation | Yes | Yes |
| Zoom | Yes | Yes |
| Patient
Database | Yes | Yes |
| DICOM
Worklist | Yes | Yes |
| DICOM Store | Yes | Yes |
| DICOM Print | Yes | Yes |
| Detector
Specific | No | No |
| X-ray
Generator
Control | Yes | Yes |
| SW Ver. | ExamVue Duo – 1.0 | ExamVue DR - 1.0 |
| Added
Functions | - Auto Stitching
- Bone Suppression (option)
- Chiropractic measurement features (option)
- Podiatry measurement tools (option) | |
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8
Summary
- The pre / post image processing algorithm is the same for ExamVue DR and ExamVue Duo. -
- The measurement features for Chiropractic and Podiatry in ExamVue Duo are additional features. -However, they are similar to the measurement function of length and angle already incorporated in ExamVue DR (Ver 1.0). For the user convenience, a specific region of interest for chiropractic and podiatry was designated as a dedicated in ExamVue Duo (Ver 1.0).
- -In Conclusion, the intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. The differences do not introduce a fundamentally new scientific technology.
The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. For this reason, we believe it is substantially equivalent to the predicate devices.