SATURN 9000

K063710 · New Medical Co., Ltd. · MQB · Jul 16, 2007 · Radiology

Device Facts

• Record ID: K063710
• Device Name: SATURN 9000
• Applicant: New Medical Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Jul 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

The Saturn 9000 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000 is intended to be used in same clinical application as traditional film-screen based general radiography system.

Device Story

Saturn 9000 is a digital X-ray imaging system consisting of an amorphous selenium (a-Se) flat panel detector, X-ray generator interface, and acquisition workstation (AWS). The detector absorbs X-ray photons, converting them into electrical charges, which are read out as modulated electrical signals. The AWS, operated by clinical staff, manages image acquisition, processing, display, database management, and transmission to remote viewing or archiving sites. The system interfaces with traditional X-ray generators to provide digital images, replacing film-screen radiography. It supports clinical decision-making by providing digital diagnostic images for general radiography.

Clinical Evidence

Clinical effectiveness was verified through a concurrence study conducted in accordance with MED/2.7/R1 guidelines, establishing the system as a Class II X-ray digital image capture device.

Technological Characteristics

Amorphous selenium (a-Se) flat panel detector; X-ray generator interface; acquisition workstation (monitor, keyboard, mouse, computer). Complies with IEC 62220-1 industrial standards for performance. Connectivity includes image transmission to remote viewing sites and electronic storage.

Indications for Use

Indicated for general radiographic imaging applications, excluding mammography. Intended for use as a digital replacement for traditional film-screen radiography systems.

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

• StingRay (INFIMED, Inc)

Submission Summary (Full Text)

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Kola8710

510(k) Premarket Notification New Medical Co.,LTD. - Saturn 9000 December 11", 2006

JUL 16 2007

## 510 (K) Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92 9 (c)

Image /page/0/Picture/5 description: The image shows a bold, black letter N. The letter is slightly tilted to the left. The right side of the letter has some pixelation, giving it a slightly rough or degraded appearance.

| 1. Submitter: | New Medical Co.,LTD.<br>4F, No.42, SingZhong Rd., NeiHu District<br>Taipei 114, Taiwan |
|-----------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Young-Hoon Shin, Ph.D.<br>R&D Manager<br>[e-mail]<br>Telephone: [phone] |
| Date Prepared: | December 11th 2006 |

Saturn 9000

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2. Device Name:

- 3. Marketd Device: new submission
- 4. Device Description: The Saturn 9000 Is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000 includes acquisition workstation ("AWS") monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites. and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming,

5. Indications for Use: The Saturn 9000 system generates digital X-ray images that can be used for general X-ray system except mammography. The Saturn 9000 system can

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interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000 is intended to be used in same clinical application as traditional film-screen based general radiography system.

- 6. Companison with Predicate Device: The Saturn 9000 is of a comparable type and substantially equivalent to solid state X-ray imaging devices. It has the same technological characteristic and is comparable in key safety and effectiveness features. It uitiizes similar design, construction, and interface scheme. It has same intended uses and basic operation modes as the predicate device,
- 7. Non-clinical Tests: The performance of the device has been evaluated and has been founded to confirm with applicable medical device performance and safety standards. Based on industrial standard, IEC 62220-1, many technical characteristic values were measured and computed and it is conformed that the device performance is compatible with predicate device.
- 8. Clinical Tests: Concurrence study is preferred for proving the clinical effectiveness of Saturn 9000 system as "X-ray digital image capture device" which is classified as "Class II" device according to the guideline of MED/2.7/R1. StingRay manufactured by INFIMED, Inc is assigned as approved predicate device
- 9. Conclusion: Intended uses and other key features are consistent with previously cleared solid state X-ray imaging devices. The device conforms to applicable medical device safety standards and compliance was verified through independent clinical trial. Saturn 9000 is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services USA. The logo consists of a stylized depiction of a human figure, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure. The image is in black and white.

## 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

Mr. Young-Hoon Shin Director of R&D New Medical Company, Ltd. 4F, No. 42, SingZhong Road HEIHU DISTRICT TAIPEI 114 TAIWAN

Re: K063710 Trade/Device Name: Saturn 9000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 11, 2007 Received: June 11, 2007

AUG 23 2013

Dear Mr. Shin:

This letter corrects our substantially equivalent letter of July 16, 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premison is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroom's to trgans) the enactment date of the Medical Device Amendments, or to connineres phor to May 20, 1976, the occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 r ou may, dicrorolo, manel 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, additional controls. Existing mayor 19gats 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 I least of acrised that I Drivedantly or our device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 coord statutes and regulanents, 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 pactice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as so forth in the quality of evice as described in your Section 510(k) premarket will anow you to ogen finding of substantial equivalence of your device to a legally marketed predication. The FDF Imanis ssification 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 CFF) Parts 801 and II you desire specific advice 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 muer the MDK regulation (2) "OFF Pur 007) promo goblem/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 Tour inay 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,

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): K 063710

Device Name: Saturn 9000

Indications For Use:

The Saturn 9000 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000 is intended to be used in same clinical application as traditional film-screen based general radiography system.

V Prescription Use_ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CIONTINUE ON ANOTHER PAGE IF needed)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Riemer

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vision of Reproductive, Abdominal and Radiological Devices 510(k) Number