(24 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for image quality or processing performance. Instead, it describes a comparative approach where the performance of the new device (REGIUS SIGMA2) is evaluated against a legally marketed predicate device (REGIUS SIGMA).
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Image Quality | Perform "as well as" the predicate device; no new safety and efficacy issues. | Performance data from non-clinical testing of REGIUS SIGMA2 compared favorably with the predicate device, REGIUS SIGMA, indicating it performed "as well as" the predicate device. |
| Processing Capacity | Increased processing capacity compared to the predicate device. | Processing capacity was increased by modifying firmware to control feed sequence, including faster Plate removal/storage and increased erasing speed. |
| Safety | Meet specified safety standards. | Met IEC60601-1, IEC60601-1-2, 21 CFR 1040.10, IEC60825-1, and ISO14971 standards. Risk analysis reduced identified risks to an acceptable level. |
| Technological Equivalence | Same technological characteristics and principle of operation as the predicate. | Principles of operation and technological characteristics are the same. Plates and cassettes remain unchanged from the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance data from non-clinical testing of the REGIUS SIGMA2 is compared with data from the predicate device, REGIUS SIGMA."
- Sample Size (Test Set): Not specified. The phrase "non-clinical testing" suggests laboratory/bench testing rather than human subject data.
- Data Provenance: Not specified, but likely internal Konica Minolta laboratory data, given it's "non-clinical testing." No indication of country of origin or whether it's retrospective or prospective in the traditional sense of human data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not specified. The testing described is "non-clinical" and focuses on device performance metrics rather than image interpretation by experts to establish a "ground truth" for clinical accuracy.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/none. As the testing is non-clinical, there wouldn't be an adjudication method for human interpretation. The comparison is based on technical performance metrics of the device itself.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an X-ray image reader, not an AI-assisted diagnostic tool for interpretation.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in a sense. The described "non-clinical testing" is inherently a standalone evaluation of the device's technical specifications and performance characteristics (e.g., image quality, processing speed) compared to the predicate, independent of human interaction for interpretation. It's evaluating the device's output, not its interpretative assistance to humans.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "non-clinical testing," the "ground truth" implicitly refers to the established technical performance specifications and acceptable output quality of the predicate device (REGIUS SIGMA), as well as adherence to relevant safety standards. The new device's performance metrics (e.g., image quality, speed) were compared directly against those of the predicate device to ensure equivalence or improvement. There's no mention of pathology, outcomes data, or expert consensus related to diagnostic accuracy from images as the ground truth.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable/not specified. This device is an X-ray digitizer/reader, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "firmware (device mechanical control software)" modifications are likely conventional programming changes to optimize mechanical sequences, not an AI model trained on data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As noted above, there's no indication of a "training set" for AI/ML in this context. The "ground truth" for developing the firmware modifications would be engineering specifications and desired operational parameters for mechanical control.
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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
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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.
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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
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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 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
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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
§ 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.