(100 days)
The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-810 is intended to be used in same clinical application as traditional film-screen based general radiography system.
The Saturn 9000-810 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 9000-810 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.
This document pertains to the Saturn 9000-810, a digital X-ray system. The information provided is from a 510(k) Premarket Notification.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it relies on the comparison to a predicate device and conformance to industry standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | - Same intended uses | Yes, same intended uses as Saturn 9000. |
| - Comparable in key safety and effectiveness features | Yes, comparable to Saturn 9000. | |
| - Similar design, construction, and interface scheme | Yes, similar to Saturn 9000. | |
| Technological Characteristics | Conformance to applicable medical device performance and safety standards (e.g., IEC 62220-1) | Measured and computed technical characteristic values confirm device performance is compatible with predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not report any clinical test data, including sample size or data provenance for a test set. It explicitly states: "Clinical Tests: Not applicable for special 510(k) procedure." This suggests conformance was primarily based on non-clinical engineering tests and comparison to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Given that no clinical tests were reported for this specific 510(k) procedure, there is no information provided regarding experts or ground truth establishment for a clinical test set.
4. Adjudication Method for the Test Set:
No information is provided as no clinical test set was reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done or reported in this document. The submission explicitly states "Clinical Tests: Not applicable."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
This device is an X-ray imaging system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study as described would not be applicable in this context. The document focuses on the performance of the imaging system itself.
7. The Type of Ground Truth Used:
As no clinical tests were performed or reported, there is no mention of ground truth types (e.g., expert consensus, pathology, outcomes data) for clinical evaluation. The primary "ground truth" for evaluating this device appears to be comparison to the predicate device and conformance to non-clinical engineering standards.
8. The Sample Size for the Training Set:
This document describes a medical imaging device (hardware and software for image acquisition and processing), not a machine learning algorithm that typically requires a training set. Therefore, the concept of a "training set sample size" as it applies to AI/ML is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established:
As the device described is not an AI/ML algorithm requiring a training set, this question is not applicable.
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510(k) Premarket Notification New Medical Co.,LTD. - Saturn 9000-810 January 3d, 2008
Koross.9
JUN 1 1 2008
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 stylized letter N in bold, sans-serif font. The letter is predominantly black, with a subtle gradient effect that gives it a three-dimensional appearance. The right side of the N has a textured pattern, resembling vertical lines or ridges, adding depth and visual interest to the design.
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Submitter: New Medical Co.,LTD. 4F, No.42, SingZhong Rd., NeiHu District Taipei 114, Taiwan Contact Person: Young-Hoon Shin, Ph.D. R&D Manager yhshin@newmedical.com.tw Telephone: +886-2-8791-6268 January 30 2008 Date Prepared:
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Device Name: Saturn 9000-810
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- Market Device: new submission
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- Device Description: The Saturn 9000-810 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 9000-810 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.
- Indications for Use: The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can
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interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-810 is intended to be used in same clinical application as traditional filmscreen based general radiography system.
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- Comparison with Predicate Device: The Saturn 9000-810 Is substantially equivalent to the Saturn 9000. It has the same technological characteristic and is comparable in key safety and effectiveness features. It utilizes similar design, construction, and interface scheme. The only difference is the pixel size and imaging area of the detector. It has same intended uses and basic operation modes as the predicate device.
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- Non-cilnical 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.
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- Clinical Tests: Not applicable for special 510(k) procedure.
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- 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. Saturn 9000-810 is substantially equivalent to currently marketed devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 3 2013
Mr. Young-Hoon Shin Director of R&D New Medical Company, Ltd. 4F. No. 42. SingZhong Road NEIHU DISTRICT TAIPEI 114 TAIWAN
Re: K080589 Trade/Device Name: Saturn 9000-810 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 15, 2008 Received: May 16, 2008
Dear Mr. Shin:
This letter corrects our substantially equivalent letter of June 11, 2008.
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 mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirents as set forth in the quality 2) vice as described in your Section 510(k) premarket witi anow you to ocgin finding of substantial equivalence of your device to a legally marketed notheation. The I Dri imanig of Succion 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 If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-007), product on 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 ulder the MDA regulation (27 °CF RT at 005); produced/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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Indications for Use
510(k) Number (if Known): To be assigned
Device Name: Satum 9000-810
Indications For Use:
The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-810 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CIONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tonth Whang
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 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.