The Digital X-ray Capture Device Saturn 8000-GS Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).

Device Description

The "Digital X-ray Capture Device (Saturn 8000-GS System)" (as Saturn 8000-GS System) is equipped with digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create 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 can be triggered by detector, which initiate the exposure signal to the generator; or the exposure signal is triggered by the generator itself and the detector is acted as bucky receptor. The connection between generator and detector is via the hardware interface box (HB), which can also connect the hand switch. The Saturn 8000-GS System contains the operation workstation software, which is installed on acquisition ("AWS"), which contains 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.

AI/ML Overview

The provided text describes a 510(k) submission for the "Saturn 8000-GS System" (a Digital X-ray Capture Device). It indicates that the device has been found substantially equivalent to a predicate device, the "New Medical Saturn 9000 system." However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical performance studies.

The document primarily focuses on:

General information about the device and company.
The device's description and indications for use.
Claim of substantial equivalence to a predicate device (New Medical Saturn 9000 system).
Mention of bench testing and electrical safety testing to substantiate equivalence.
Confirmation of satisfactory results for various safety and EMC standards (EN/IEC 60601 series).
A conclusion that the device does not raise new issues of safety or effectiveness compared to predicate devices.

Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, or MRMC studies for the Saturn 8000-GS System.

The document states: "Bench testing and electrical safety further substantiate equivalence to the predicate." and "Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory."

However, these are general safety and performance tests, not specifically a clinical study evaluating diagnostic accuracy or performance against specific acceptance criteria for image quality or clinical efficacy in the way your request implies for AI/ML device studies. The document claims equivalence based on these engineering/safety tests and comparison to a predicate device's technology (different flat panel detector, but similar overall system intended use).

In summary, the provided text does not contain the detailed clinical study information you requested.

Summary

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Doc. NO.
Rev. NO.	1.0
Issued date	Page
2011.01.12	15 of 75

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This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 APR 2 0 2011

Initial Importer/Distributor Address:

Phone number: Fax number:

New Medical Co., Ltd. 2F, No. 35, Lane 513, Ruiguang Rd. Neihu District, Taipei 114, Taiwan +886-2-8751-6289 +886-2-8751-9623

Contact Person Email: Phone: Cell: Fax:

Manufacturer

HARRY-KUO harryk@newmedical.com.tw +886-2-8751-6289

+886-2-8751-9623

New Medical Co., Ltd. 2F, No. 35, Lane 513, Ruiguang Rd. Neihu District, Taipei 114, Taiwan Tel: +886-2-8751-6289 Fax: +886-2-8751-9623

Device Name and

Classification

Trade name/Product Name: Classification name: Common name: Product Code: MQB Regulation Number 892.1650

Saturn 8000-GS System Stationary X-ray System General purpose diagnostic X-ray System

Date Prepared

2011.01.12

Substantial Equivalence claimed to:

New Medical Saturn 9000 System

New Medical Co., Ltd. Confidential

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Device Description

Indications for Use

The Saturn 8000-GS system generates digital X-ray images that can be used for general X-ray system except fluoroscopic, and mammographic applications. The Saturn 8000-GS system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 8000-GS is intended to be used in same clinical application as traditional film-screen based general radiography system.

Substantial Equivalence

The Saturn 8000-GS System is substantially equivalent to the commercially available New Medical Saturn 9000 system cleared on December 11, 2006 via 510k K063710. Bench testing and electrical safety further substantiate equivalence to the predicate. The Saturn 8000-GS System utilizes the Varian PaxScan 4336R panel while the New Medical Saturn 9000 System utilizes the DRTech FDXD1417 panel to acquire image.

General Safety and Effectiveness Concerns

Electrical, mechanical safety and performance testing according to standard ENVIEC 60601-1, ENVIEC 60601-1-1, EN/IEC 60601-1-3 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory.

New Medical Co., Ltd. Confidential

16/75

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Image /page/2/Picture/0 description: The image shows a logo with two stylized letters, 'N' and 'M', overlapping each other. The 'N' is larger and bolder, with a slightly jagged or distressed appearance. The 'M' is smaller and positioned to the right of the 'N', with a more streamlined and modern design. The logo is black against a white background.

Conclusion

The results of all testing demonstrate that the Saturn 8000-GS does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.

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New Medical Co., Ltd. Confidential

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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure within a circle, representing the department's focus on health and well-being.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Jun-Hstung Lin Manager New Medical Co., Ltd. 1460 Atterbury Drive WALNUT CA 91789

AUG 2 3 2013

Re: K110210

Trade/Device Name: Saturn 8000-GS System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 12, 2011 Received: January 25, 2011

Dear Mr. Lin:

This letter corrects our substantially equivalent letter of April 20, 2011.

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 Cosmatic 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 modion do roo rolated as rites quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality of the as described in your Section 510(k) premarket will anow you to began maninal equivalence of your device to a legally marketed nothication. The FDF imany si fication 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 II you desire specific antile for your as not is the career 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 Tou may 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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510(k) Number (if known): K110210

Device Name: Saturn 8000-GS System

Indications For Use:

Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Bevice-Evaluation (QDE) - OT

Mary S Pastl
(Division Sign-Off)

Division of Radiological Devices New Medical Objical Objice Viro Diagnostic Device Evaluation and Salety13775 Confidential

510K.

Regulation Number and Section

§ 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.