(24 days)
No
The summary describes a standard X-ray image reader that digitizes images from a phosphor plate. The modifications focus on increasing processing speed through firmware changes to the mechanical feed sequence. There is no mention of AI or ML algorithms being used for image processing, analysis, or any other function of the device itself. The "Medical Image Processing Workstation" is mentioned as a separate, externally connected device.
No
The device is an X-ray image reader, which means it captures and processes diagnostic images, but it does not directly treat or manage a disease or condition. Its function is for image acquisition and transfer, which falls under diagnostic imaging rather than therapeutic intervention.
Yes
The device is an X-ray image reader that converts X-ray images into digital data for transfer to display and other devices, which is a process inherent to diagnostic imaging.
No
The device is a physical X-ray image reader with hardware components (reading unit, cassette, plate, laser, photoelectric method, LEDs) that reads images from a stimulable phosphor plate. While it includes firmware modifications, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Direct Digitizer, REGIUS SIGMA2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The REGIUS SIGMA2 is an X-ray image reader. It processes images recorded on a phosphor plate after the patient has been exposed to X-rays. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for reading X-ray images and transferring the data for display, printing, and filing. This is related to medical imaging, not laboratory testing of biological samples.
Therefore, the REGIUS SIGMA2 falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Direct Digitizer, REGIUS SIGMA2 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. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.
This device is not intended for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Direct Digitizer, REGIUS SIGMA2 is a compact X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this 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 device is comprised of a reading unit with cassette containing Plate.
Plates and cassette remain unchanged from the predicate device, REGIUS SIGMA.
The image data transfer 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 basic operations of REGIUS SIGMA2 and the predicate device, REGIUS SIGMA, such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the Medical Image Processing Workstation, ImagePilot (operator console) which is cleared 510(k), K071436.
The modification was made from the REGIUS SIGMA to the REGIUS SIGMA2 to increase processing capacity. To increase the processing capacity, the firmware (device mechanical control software) of the reading unit is modified. The outline is as follows.
The processing capacity is increased by controlling the feed sequence.
(1) Increasing the speed of removal of Plate from cassette and the sequence of storage into cassette
(2) Increasing the erasing speed by changing the erasing LED
The feed sequence related to Image Quality (Reading speed, Open/Close timing of sub-scanning nip) is not changed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.
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)
Performance data from non-clinical testing of the REGIUS SIGMA2 is compared with data from the predicate device, REGIUS SIGMA. This comparison showed that the REGIUS SIGMA2 performed as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.1680 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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510(k) Summary
FEB 1 0 2012
As required by 807.92
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Establishment Registration Number: 3004485675
2. Submitter's Name and Address
Shigeyuki Kojima Manager Regulations and Standards Section, Quality Assurance Center No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Telephone: 81-42-589-8429 Fax: 81-42-589-8053
3. Date of Submission
January 13, 2012
4. Device Trade Name
Direct Digitizer, REGIUS SIGMA2
5. Classification
Class II , 90 MQB, 21 CFR 892.1650.
6. Predicate Device
Direct Digitizer, REGIUS SIGMA, 510(k) number: K103703
7. Indications for Use
The Direct Digitizer, REGIUS SIGMA2 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. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.
This device is not intended for use in mammography.
8. Device Description
The Direct Digitizer, REGIUS SIGMA2 is a compact X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a
5-1
1
cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this 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 device is comprised of a reading unit with cassette containing Plate.
Plates and cassette remain unchanged from the predicate device, REGIUS SIGMA.
The image data transfer 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 basic operations of REGIUS SIGMA2 and the predicate device, REGIUS SIGMA, such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the Medical Image Processing Workstation, ImagePilot (operator console) which is cleared 510(k), K071436.
The modification was made from the REGIUS SIGMA to the REGIUS SIGMA2 to increase processing capacity. To increase the processing capacity, the firmware (device mechanical control software) of the reading unit is modified. The outline is as follows.
The processing capacity is increased by controlling the feed sequence.
(1) Increasing the speed of removal of Plate from cassette and the sequence of storage into cassette
(2) Increasing the erasing speed by changing the erasing LED
The feed sequence related to Image Quality (Reading speed, Open/Close timing of sub-scanning nip) is not changed.
9. Performance Testing
Performance data from non-clinical testing of the REGIUS SIGMA2 is compared with data from the predicate device, REGIUS SIGMA. This comparison showed that the REGIUS SIGMA2 performed as well as the predicate device.
10. Substantial Equivalence to Predicate Device
The predicate device and the REGIUS SIGMA2 are the X-ray image reader which use the same stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. The principals of operation and technological characteristics of the predicate device and the REGIUS SIGMA2 is the same. The performance test results show that there is no new safety and efficacy issue of the REGIUS SIGMA. The indications for use of REGIUS SIGMA remain unchanged from the predicate device. For details, please refer to Section 8, Device description.
$$\mathfrak{k}\cdot\mathfrak{k}$$
2
11. Safety Information
The REGIUS SIGMA2 has been tested and shown to meet the requirements of the following standards.
: IEC60601-1 Ed.2(1988)+ A1(1991)+A2(1995) Safety standard Electromagnetic Compatibility : IEC60601-1-2 Ed.3(2007) Radiation safety: 21 CFR 1040.10, IEC60825-1(1993)+A1(1997)+A2:2001 The Risk Analysis for the REGIUS SIGMA2 was conducted on the basis of ISO14971, "Medical devices - Application of risk management to medical devices". As a result of risk control measures, the risk associated with all of the identified hazards was reduced to an acceptable level.
12. Conclusion
Comprehensively, we judged that the REGIUS SIGMA2 has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings outstretched.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
KONICA MINOLTA MEDICAL & GRAPHIC, INC Mr. Russell D. Munves Consultant Storch Amini & Munves, P.C. Two Grand Central Tower, 25th Floor 140 East 45th Street NEW YORK NY 10017
FEB 1 0 2012
Re: K120131
Trade/Device Name: Direct Digitizer, REGIUS SIGMA2 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: January 13, 2012 Received: January 17, 2012
Dear Mr. Munves:
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
4
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 requirences as be form inrketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 809), please contact the Office 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 Division 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,
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known)
Device Name Direct Digitizer, REGIUS SIGMA2
Indications for Use:
The Direct Digitizer, REGIUS SIGMA2 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. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.
This device is not intended for use in mammography.
Prescription Use X (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 In Vitro Diagnostic Devices (OIVD)
Muthal D.K.
Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) hla0131