(26 days)
Intended for use by a qualified/trained doctor on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
The Insight Essentials™ DRF Digital Imaging System is designed to replace the video camera and user interface on the following FDA cleared R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The x-ray generator, beam-limiting device and patient positioner. necessary for a full fluoroscopy system are not part of the subject device.
The Insight Essentials™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Essentials™ DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a fluoroscopic video camera, monitors, and an image processor PC.
This document describes a 510(k) submission for the Insight Essentials™ DRF Digital Imaging System, comparing it to a predicate device, the FluoroPRO RF Digital Imaging System (K070390). The submission focuses on demonstrating substantial equivalence rather than proving clinical performance against specific acceptance criteria for an AI algorithm.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not directly applicable to this submission, as it is a device modification submission for digital imaging system components, not an AI/ML medical device.
However, I can extract information regarding non-clinical tests performed to demonstrate substantial equivalence, which serves as the "study" for compliance in this context.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission for hardware/software components, the "acceptance criteria" are implied by the comparison to the predicate device. The goal is to show the new device is "as safe and effective as" the predicate. Performance is assessed through non-clinical bench testing.
| Characteristic | Predicate Device Performance (FluoroPro RF Digital Imaging System - K070390) | Subject Device Performance (Insight Essentials™ DRF Digital Imaging System - K191310) | Acceptance Criterion (Implied) | Outcome |
|---|---|---|---|---|
| Intended Use | As described in document | SAME | Identical to Predicate | Met |
| Power Source | 120 VAC 50/60 HZ, 2.5 amps | SAME | Identical to Predicate | Met |
| Image Acquisition | Up to 15 FPS (spot), up to 30 fps (fluoro) | SAME | Identical to Predicate | Met |
| File Compatibility | DICOM | SAME | Identical to Predicate | Met |
| Digital Video Camera | Thales TH 8740 - 020 CCD | Basler acA1920-50gm CMOS | Substantially Equivalent | Met |
| Digital Resolution | 1000 x 1000 12-bit | 1k x 1k 12 bit | Substantially Equivalent | Met |
| Electrical Safety | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3 | SAME | Conformance to Standards | Met |
| Image Output Characteristics (Bench Test) | (Implied standard based on predicate) | Substantially equivalent to predicate | Substantially Equivalent | Met |
| Doses Used (Bench Test) | (Implied standard based on predicate) | Analyzed and compared to predicate | Substantially Equivalent | Met |
The Study:
The study conducted to demonstrate the device meets these (implied) criteria is a non-clinical bench testing study.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated as a number of distinct "cases" or "images" in the way an AI study would define a test set. The document mentions "phantom images" were acquired. The quantity of phantom images is not specified.
- Data Provenance: The images were acquired from a "GE Legacy R&F system" with the subject device installed and compared to images from a "GE Advantx 1 R&F system" with the predicate device installed. This indicates prospective acquisition for the purpose of the comparison. The country of origin is not specified but implicitly within the context of the submitter's (Imaging Engineering, LLC in Florida, USA) operations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable in the context of this submission. The "ground truth" for this engineering bench test is objective measurement and comparison of technical parameters and image quality, not expert clinical interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. This was a technical comparison, not a clinical interpretation study requiring adjudication. The analysis was based on direct comparison of acquired images and doses.
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:
- No. This is not an AI-assisted device, nor is it a clinical efficacy study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a digital imaging system component, not an autonomous algorithm.
7. The Type of Ground Truth Used:
- The ground truth in this context is objective technical performance measurements (e.g., image output characteristics, resolution, doses, adherence to safety standards) derived from the phantom images acquired during bench testing, compared against the known specifications and performance of the predicate device.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware/software upgrade to an existing imaging system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for an AI/ML model.
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June 10, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Imaging Engineering, LLC % Mr. George Jachode President 1318 NW 7th Avenue CAPE CORAL FL 33993
Re: K191310
Trade/Device Name: Insight Essentials™ DRF Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, LLZ Dated: May 10, 2019 Received: May 15, 2019
Dear Mr. Jachode:
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/cfpmp/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 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
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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.
For
Thalia T. Mills, Ph.D. Director 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)
Device Name
Insight Essentials™ DRF Digital Imaging System
Indications for Use (Describe)
Intended for use by a qualified/trained doctor on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Imaging Engineering, LLC. The logo consists of two overlapping squares, one blue and one orange, each made up of smaller squares. The text "Imaging Engineering, LLC" is written in a simple, sans-serif font below the squares.
1. Traditional 510(k) SUMMARY
This summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.
Date 510K summary prepared: May 10, 2019
| Submitter's Name: | Imaging Engineering, LLC |
|---|---|
| Submitter's Address: | 1318 NW 7th Ave, Cape Coral, Florida 33993 |
| Submitter's Telephone: | (239) 223-1371 |
Contact person: George Jachode/President
| Official Correspondent: George Jachode (jachode@aol.com) | |
|---|---|
| Address: | 1318 NW 7th Ave, Cape Coral, Florida 33993 |
| Telephone: | (239) 223-1371 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| 510K Number: | K191310Trade/proprietary name: Insight Essentials™ DRF Digital Imaging System |
|---|---|
| Model Number: | ES-1000-00 |
| Regulation Name: | lmage-Intensified Fluoroscopic X-ray System |
| Regulation Number: | 21 CFR 892. 1650 |
| Regulatory Class: | Class II |
| Product Code: | JAA and LLZ |
Predicate Device
| Trade Name: | FluoroPRO RF Digital Imaging System |
|---|---|
| 510(k) Clearance #: | K070390 |
| Clearance date: | 02/02/2007 |
| Classification Name: | Image Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21CFR 892.1650 (Produce Code; JAA and LLZ) |
| Device Class: | Class II |
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2. Device Description
The Insight Essentials™ DRF Digital Imaging System is designed to replace the video camera and user interface on the following FDA cleared R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The x-ray generator, beam-limiting device and patient positioner. necessary for a full fluoroscopy system are not part of the subject device.
The Insight Essentials™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Essentials™ DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a fluoroscopic video camera, monitors, and an image processor PC.
3. Indications for Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
4. Summary of Design Control Risk Management
The Insight Essentials™ DRF Digital Imaging System has been developed to provide medical professionals optimized workflow when imaging patients while meeting critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design and production were successfully mitigated and accepted.
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5. Substantial Equivalence
The Insight Essentials™ DRF Digital Imaging System conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to the electro-, mechanical, software-, clinical-and risk management, it's the sponsor's opinion that the subject device is a safe and effective device.
| Characteristic | FluoroPro RF DigitalImaging System(K070390) | Insight EssentialsDRF DigitalImaging System(K191310) |
|---|---|---|
| Intended Use: | Intended for use by aqualified/trained doctor ortechnician on both adultand pediatric subjects forobtaining fluoroscopicradiographic images of theskull, spinal column, chest,abdomen, extremities, andother body parts. | SAME |
| Power source | 120 VAC 50/60 HZ2.5 amps | 120 VAC 50/60 HZ2.5 amps |
| Image acquisition | Up to 15 FPS (spot), up to30 fps (fluoro) | SAME |
| File compatibility | DICOM | SAME |
| Digital Video Camera | Thales TH 8740 - 020CCD | Basler acA1920-50gmCMOS |
| Digital Resolution | 1000 x 1000 12-bit | 1k x 1k 12 bit |
| Electrical safety | IEC 60601-1:IEC 60601-1-2IEC 60601-1-3 | SAME |
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6. Difference Discussion
There are four primary differences between the two systems are due to the amount of time that has passed (and the technological advancements made) since the predicate device was first cleared in 2007.
- a. The CCD camera in the predicate device has been replaced with a CMOS camera with substantially equivalent features.
- b. The personal computer (pc) used in the predicate device uses Windows XP operating system. The subject device has a pc that uses Windows 10 Professional operating system.
- c. The Digital Interface Board (DIB) was updated to incorporate a modern microcontroller.
- d. The predicate device did not have a Dose Area Product (DAP) meter to record and display patient exposure dose. The subject device includes a DAP meter.
7. Summary of the technological characteristics of the device compared to the predicate device
Both the subject device and the predicate device have the identical software program that provides a Graphical User Interface (GUI), image processing and patient workflow functions.
The CCD camera in the predicate device is replaced with a CMOS camera. The image output characteristics of both cameras are substantially equivalent. The CCD camera technology used in the predicate device is at the end of its life.
The DIB has been updated with a modern microcontroller as the predicate device microcontroller is no longer in production.
The pc used in the predicate device has a Windows XP operating system that is obsolete and no longer in production. The pc of the subject device has a Windows 10 Professional operating system that includes modern cybersecurity protection and is compliant with recently established guidelines.
The subject device includes a DAP meter to record and provide DAP and Air Kerma measurements that are displayed and stored in the DICOM header of patient studies. The fluoro exam time and timer are maintained by the host R&F system.
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Image /page/7/Picture/0 description: The image shows the logo for Imaging Engineering, LLC. The logo consists of two overlapping squares made up of smaller squares. The top right square is orange, and the bottom left square is blue. The text "Imaging Engineering, LLC" is located below the logo.
8. Description of non-clinical tests.
Bench testing was performed on the subject device installed on a GE Legacy R&F system to assess substantial equivalence of the device. Phantom images were acquired with the subject device and compared to the predicate device, installed on a GE Advantx 1 R&F system. These images and the doses used to acquire them were analyzed and compared. In conclusion, the tests obtained demonstrated substantial equivalence to the predicate device.
9. Description of clinical tests.
No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness.
10. Conclusion as to Substantial Equivalence.
The Insight Essentials™ DRF Digital Imaging System, the subject device is substantially equivalent to the predicate (K070390). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate device. The performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that the subject device appears to be as safe and effective as the predicate device.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.