REGUIS SIGMA

K103703 · Konica Minolta Medical & Graphic, Inc. · MQB · Jun 2, 2011 · Radiology

Device Facts

• Record ID: K103703
• Device Name: REGUIS SIGMA
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Direct Digitizer, REGIUS SIGMA 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.

Device Story

Compact X-ray image reader; utilizes stimulable phosphor plate (Plate) in cassette as X-ray detector. Device reads latent X-ray images via laser scan and photoelectric method; converts data to digital format. Operated by trained medical personnel in clinics/hospitals. Basic operations (start, shutdown, patient registration, condition setting) managed via external Medical Image Processing Workstation (ImagePilot, K071436). Digital output transferred to host computers, displays, printers, or filing systems. Facilitates diagnostic imaging workflow; enables digital reproduction of X-ray data.

Clinical Evidence

Bench testing only. Device met IEC60601-1, IEC60601-1-2, and radiation safety standards (21 CFR 1040.10, IEC60825-1). Risk analysis performed per ISO14971.

Technological Characteristics

Compact X-ray image reader; stimulable phosphor plate detector; laser scan and photoelectric reading mechanism. Connectivity: external interface to host workstation/peripherals. Standards: IEC60601-1 (safety), IEC60601-1-2 (EMC), 21 CFR 1040.10/IEC60825-1 (radiation).

Indications for Use

Indicated for use by trained medical personnel in clinics, hospitals, and medical facilities to read X-ray images from stimulable phosphor plates. Not intended for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Direct Digitizer, REGIUS Model 110 (K071181)
• Point-of-Care CR360 (K073630)

Reference Devices

• ImagePilot (K071436)

Submission Summary (Full Text)

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K103703

# 510(k) Summarv

As required by 807.92

# JUN - 2 2011

### 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: [phone] Fax: [phone]

### 3. Date of Submission

April 14, 2011

#### 4. Device Trade Name

Direct Digitizer, REGIUS SIGMA

### 5. Classification

Class II , 90 MQB, 21 CFR 892.1630.

#### 6. Predicate Device

Direct Digitizer, REGIUS Model 110, 510(k) number: K071181 Point-of-Care CR360, 510(k) number: K073630

### 7. Indications for Use

The Direct Digitizer, REGIUS SIGMA 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 SIGMA is a compact X-ray image reader which

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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.

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 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.

### 9. Substantial Equivalence to Predicate Device

The predicate devices and the REGIUS SIGMA are the same X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. The principals of operation and technological characteristics of predicate devices and the REGIUS SIGMA are similar. 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 is almost the same as that of predicate devices. In details, please refer to Tab Number 5, Device description with Substantial Equivalence Comparison Table.

### 10. Safety Information

The REGIUS SIGMA has been tested and shown to meet the requirements of the following standards.

Safety standard : IEC60601-1 Ed.2(1988)+ A1(1991)+A2(1995) 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 SIGMA 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.

### 11. Conclusion

Comprehensively, we judged that the REGIUS SIGMA has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.

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### 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 Medcial & Graphic, Inc. % Mr. Russell Munves Official Correspondent Storch, Amini, & Munves, P.C. 140 East 45th Street NEW YORK NY 10017

JUN - 2 2011

Re: K103703

Trade/Device Name: Direct Digitizer, REGIUS SIGMA Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: April 14, 2011 Received: April 15, 201-1

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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone] or [phone] 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 SIGMA

Indications for Use;

The Direct Digitizer, REGIUS SIGMA 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 Device Evaluation (ODE)

Minu Patel

Page 1 of

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103703