(101 days)
The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
REGIUS MODEL 170 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.
REGIUS MODEL 170 is also used to obtain image data to verify the position for a radiotherapy location.
It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.
It is not intended for use with digital mammography system.
The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of the REGIUS MODEL 170. By means of laser scan and photoelectric method, the device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection. Then the REGIUS MODEL 170 is capable of transferring the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
The modifications are 1) Applicable cassette size is increased. 2) Read-Only cassettes are added, 3) Exposure-Only cassettes are added, and 4) Function of a reader console is upgraded.
The purpose of modification is to enable to use of multiple cassettes to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature), and to obtain images to verify the position for a radiotherapy location.
This 510(k) summary describes a device modification to the Direct Digitizer REGIUS MODEL 170, and as such, it focuses on the changes and their intended use rather than a comprehensive study to establish its primary performance characteristics. The document explicitly states that the "Risk analysis is the same as our current REGIUS MODEL 170, K023061" and "Software information is also the same as current REGIUS MODEL 170, K023061." This suggests that the fundamental performance characteristics established for the original device are considered applicable, and no new studies are presented to re-evaluate those core metrics for the modified device.
However, based on the provided text, we can infer some aspects related to acceptance criteria for the new functionalities:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a device modification submission, the document doesn't present new quantitative performance metrics for the device as a whole. Instead, the "acceptance criteria" are implicitly met by demonstrating the device's ability to implement the new functionalities as intended and ensuring consistency with the predicate device.
| Acceptance Criteria (Inferred from New Features) | Reported Device Performance (Inferred from Description) |
|---|---|
| Long Length Imaging Feature: | |
| Ability to combine multiple phosphor plates for large anatomical areas (e.g., whole spine, whole lower leg). | "enable to use of multiple cassettes to obtain images of long areas of anatomy and then to present the images as a single composite image" |
| Support for specified long length cassette sizes (14x42in, 11x28in, 10x36in). | "14x42in, 11x28in, 10x36in sizes are required for the exposure size" |
| Mechanism for reading images from combined plates, including use of Read-Only and Exposure-Only cassettes. | "the plates are removed from the Exposure-Only Cassette and loaded to Read-Only Cassettes" to be fed into the device. |
| Radiotherapy Localization (Linac Graphy) Feature: | |
| Ability to obtain image data for verifying radiotherapy position. | "used to obtain image data to verify the position for a radiotherapy location." |
| Compatibility with specialized cassettes containing a metal plate for Linac Graphy. | "exposure cassette containing metal plate to prevent over exposure problem" |
| Mechanism for reading images from these specialized cassettes, including use of Read-Only and Exposure-Only cassettes. | "Exposure-Only cassettes incorporating a metal plate and Read-Only cassettes with photostimulable phosphor plates processed in the device after exposure, enable image reading identical to ordinary X-ray exposure by replacement of the photostimulable phosphor plate after exposure." |
| Safety and Compatibility: | |
| Maintenance of safety standards (UL60601-1, IEC60601-1, FCC, IEC60601-1-2, 21 CFR 1040.10). | "The Direct Digitizer, REGIUS MODEL 170 complies with the following standards." (listed in section 11) |
| No new risks introduced by the modifications. | "Risk analysis is the same as our current REGIUS MODEL 170, K023061. (We consider no new risk will arise and therefore we did not conduct a new risk analysis.)" |
| Software functionality remains consistent with the predicate device. | "Software information is also the same as current REGIUS MODEL 170, K023061." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a clinical study or a specific test set with a defined sample size for the evaluation of the device modifications. The submission relies on the established performance of the predicate device and the design documentation for the new features. It is therefore implicitly assumed that standard engineering and quality assurance practices for device functionality testing were conducted during development, but no specific data or provenance is detailed in this regulatory document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No information is provided regarding experts or ground truth establishment for a test set. This type of detail is typically found in clinical validation studies, which are not described here given the nature of this submission focused on device modification and substantial equivalence.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated test set or clinical study requiring expert adjudication is described in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study is mentioned or implied. The submission is based on modifications to an existing device, and the focus is on maintaining equivalence and functionality of the new features rather than demonstrating improved human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is an X-ray image reader. Its function is to digitize X-ray images for subsequent viewing by human operators, not to provide diagnostic algorithms or standalone interpretations. Therefore, a standalone algorithm performance study is not relevant to this device.
7. The Type of Ground Truth Used
Not applicable. As described in points 2 and 3, there's no mention of a clinical or expert-reviewed test set for this modification. The device's performance is demonstrated through its ability to accurately digitize images, a technical rather than interpretative function. The implicit ground truth for the core device functionality would be the accurate digital representation of the analog X-ray image on the phosphor plate.
8. The Sample Size for the Training Set
Not applicable. This device is an image digitizer and does not employ AI or machine learning algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used by this device.
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510(k) Summary : Device Modification
as required by 807.92
1. Company Identification NOV - 3 2005
KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 Ishikawa-machi Hachioji-shi, Tokyo 192-8505. Japan Tel: +81-426-60-9607 Fax: +81-426-60-9588
2. Official Correspondent
Masafumi Saito(Mr.) Department TS Advanced Technology Division R & D Center
3. Date of Submission
July 11th, 2005
4. Device Trade Name
Direct Digitizer REGIUS MODEL 170
5. Common Name
Direct Digitizer
6. Classification
Medical image digitizers were reviewed by the Radiology Panel and are classified in Class II per 21 CFR 892. 1650.
7. Predicate Device
Modified Direct Digitizer REGIUS MODEL 170 is substantially equivalent to our current Direct Digitizer, MODEL 170, 510(k) number: K023061.
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8. Description of Device
The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of the REGIUS MODEL 170. By means of laser scan and photoelectric method, the device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection. Then the REGIUS MODEL 170 is capable of transferring the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
The modifications are 1) Applicable cassette size is increased. 2) Read-Only cassettes are added, 3) Exposure-Only cassettes are added, and 4) Function of a reader console is upgraded.
The purpose of modification is to enable to use of multiple cassettes to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature), and to obtain images to verify the position for a radiotherapy location.
· Long Length Imaging feature
This is suitable for ordinary exposure of the skeletal system such as the whole spine or the whole lower leg, and is used for measurement purposes, such as measurement of skeletal deformation. 14x42in, 11x28in, 10x36in sizes are required for the exposure size, and the exposure is made onto a photostimulable phosphor plate formed by joining a number of photostimulable phosphor plates (Plate) of regular size.
Read-Only Cassettes and Exposure-Only Cassettes used for Long Length . Imaging feature.
Exposure-Only Cassette can not be set to REGIUS MODEL 170, because size does not match.
Read-Only Cassette can be set to REGIUS MODEL 170.
In order to set to REGIUS MODEL 170, the plates are removed from the Exposure-Only Cassette and loaded to Read-Only Cassettes.
When the image is read onto REGIUS MODEL 170, the cassette is fed into the device, the photostimulable phosphor plate contained in the cassette uncovered and the image information recorded on the plate scanned and read out.
REGIUS MODEL 170, using Exposure-Only cassettes that incorporate multiple
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plates (joined) for exposure and Read-Only cassettes that incorporate a single plate so that the cassette size is small enough to be accepted by the device, enable image reading similar to ordinary X-ray exposure by replacement of the photostimulable phosphor plates.
· Radiotherapy localization for Linac Graphy
Linac Graphy is used as part of linac (Linear Accelerator) treatment, a kind of radiotherapy (in cases of external radiation radiotherapy).
First of all, design a treatment plan including the irradiation field size and irradiation amount so that the dose to which the patient is exposed during radiotherapy is minimized.
To make a test exposure in order to design the treatment plan, expose the body part positioned as it would be during actual treatment using a CT, etc., and develop the treatment plan based on the information thus obtained.
Then, mark the treatment-target area of the body part that is actually positioned on the treatment table for linac, and, after checking the treatment position using the photo for position verification by linac graphy technology, initiate the treatment.
One method of photographic procedure to produce images used to verify the position is the method using REGIUS MODEL 170, Photostimulable Phosphor Plate and exposure cassette containing metal plate to prevent over exposure problem where all of the exposed images are recorded on the photostimulable phosphor plate exactly as for general X-ray exposures.
- · Read-Only Cassettes and Exposure-Only Cassettes used for Radiotherapy localization
When the image is read on REGIUS MODEL 170, the cassette is fed into the device, the photostimulable phosphor plate contained in the cassette uncovered and the image information recorded on the plate scanned and read out.
Because the above mentioned cassette for linac graphy contains a metal plate, it is difficult to feed such a cassette into the device due to its weight that is relatively greater than that of a normal X-ray cassette. Therefore, REGIUS MODEL 170, using Exposure-Only cassettes incorporating a metal plate and Read-Only cassettes with photostimulable phosphor plates processed in the device after exposure, enable image reading identical to ordinary X-ray exposure by replacement of the photostimulable phosphor plate after exposure.
Risk analysis is the same as our current REGIUS MODEL 170, K023061.
(We consider no new risk will arise and therefore we did not conduct a new risk analysis.)
Software information is also the same as current REGIUS MODEL 170, K023061.
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Labeling (User operation manual) is added to current REGIUS MODEL 170. Additional part of Labeling from the current REGIUS MODEL 170 is attached. For more information, please refer to the attachments.
9. Intended Use
The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
REGIUS MODEL 170 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.
REGIUS MODEL 170 is also used to obtain image data to verify the position for a radiotherapy location.
It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.
lt is not intended for use with digital mammography system.
10. Substantial Equivalence to Predicate Device
The Direct Digitizer, REGIUS MODEL 170 is substantially equivalent to our current Direct Digitizer REGIUS MODEL170, 510(k) number: K023061. Comparison of the principal characteristics of the two devices is shown in the attachments.
11. Compliance standards
The Direct Digitizer, REGIUS MODEL 170 complies with the following standards:
| Safety standard | :UL60601-1, IEC60601-1 |
|---|---|
| Electromagnetic Compatibility | : FCC, IEC60601-1-2 |
| Radiation safety | : 21 CFR 1040,10 |
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure with outstretched arms, and the text is in a serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Masafumi Saito Manager, Department TS Konica Minolta Medical & Graphic, Inc. 2970 Ishkawa-cho HACHIOJI-SHI TOKYO 192-8505 JAPAN
AUG 2 3 2013
Re: K051998
Trade/Device Name: Direct Digitizer REGIUS Model 170 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 20, 2005 Received: September 30, 2005
Dear Mr. Saito:
This letter corrects our substantially equivalent letter of November 3, 2005.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket witification. 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 Parts 801 and 11 you desire specific acrise of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Totalliary of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
: K051998
..
Device Name
Direct Digitizer, REGIUS Model 170
Indications For Use:
The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.
REGIUS MODEL 170 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.
REGIUS MODEL 170 is also used to obtain image data to verify the position for a radiotherapy location.
It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.
It is not intended for use with digital mammography system.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K031998 |
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.