(21 days)
The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.
The Saturn 9000-750 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 Xray 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 9000-750 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage 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 510(k) summary describes a digital X-ray system, the Saturn 9000-750, which is intended for general X-ray imaging (not mammography). However, the provided document does not contain acceptance criteria or study data demonstrating that the device meets such criteria.
The document primarily focuses on:
- Identification of the device and submitter information.
- Comparison to a predicate device (Saturn 9000). This comparison highlights technical specifications, noting that the proposed device (Saturn 9000-750) has a larger imaging area (17" x 17" vs. 14" x 17") and a different detector pixel size (168µm vs. 139µm) but maintains the same a-Se direct technology, Se layer thickness, image bit depth, and software as the predicate.
- Indications for use, stating it generates digital X-ray images for general X-ray systems and is intended for the same clinical applications as traditional film-screen based general radiography systems.
- An FDA letter confirming substantial equivalence to legally marketed predicate devices, implying that the safety and effectiveness are established by its similarity to an already approved device, rather than through new performance studies detailed in this summary.
Therefore, I cannot provide the requested information in the table or answer questions 2-9 because the provided text does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication for this specific submission.
The FDA's substantial equivalence determination for this device (K072983) is based on its comparison to the predicate device (K063710). This means that the regulatory pathway relied on demonstrating that the new device is as safe and effective as the predicate, rather than requiring extensive new clinical performance studies with defined acceptance criteria to be submitted within this specific 510(k) summary. The performance of the predicate device would have been previously evaluated.
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510(K) Summary
Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K072983". Below that, there is additional text that says "Page 2". The handwriting is somewhat cursive and appears to be on a document.
Image /page/0/Picture/2 description: The image shows a large, stylized letter 'N'. The letter is bold and appears to be slightly tilted to the right. The texture of the letter is somewhat rough or grainy, giving it a textured appearance. The background is plain and white, which makes the letter stand out.
October 7th 2007 1. Date Prepared:
NOV 1 3 2007
2. Submitter:
New Medical Co.,LTD. Company Name: Company Address: 4F, No.42, SingZhong Rd., NeiHu District Taipei 114, Taiwan Young-Hoon Shin, Diretor of R&D, yhshin@newmedical.com.tw Contact Person: +886-2-8791-6268 Phone number: +886-2-8791-6269 FAX number:
3. Proposed Device:
| Type of the Submission: | Special |
|---|---|
| Reason For 510(k): | Replacement of the component |
| Manufacturer: | New Medical Co.,LTD |
| Trade Name: | New Medical |
| Model Name: | Saturn 9000-750 |
| Regulatory Class: | II |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(K) Number: | To be assigned |
-
- Predicate Device:
| Manufacturer: | New Medical Co.,LTD. |
|---|---|
| Trade Name: | New Medical |
| Model Name: | Saturn 9000 |
| Regulatory Class: | II |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(K) Number: | K063710 |
- Device Description: The Saturn 9000-750 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 Xray 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 9000-750 includes acquisition workstation ("AWB") monitor,
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Koy Davis
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keyboard and mouse, computer, electronics, and accessory storage 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,
The Saturn 9000-750 is substantially equivalent to the Saturn 9000.
-
- Indications for Use: The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.
7. Comparison between Predicate Device and Proposed Device
| Predicate DeviceSaturn 9000 | Proposed DeviceSaturn 9000-750 | ||
|---|---|---|---|
| Detector | Technology | a-Se, Direct | a-Se, Direct |
| Thickness of Se layer | 450μm | 450μm | |
| Imaging Area | 14" X 17" | 17" X 17" | |
| Detector Pixel size | 139μm | 168μm | |
| Image Bit Depth | 14bits | 14bits | |
| Image Data Interface | Camera Link | Camera Link | |
| Control Box | Same as Saturn 9000 | ||
| Switch Box | Same as Saturn 9000 | ||
| Image Acquisition software | DxWorks | DxWorks(Same as Saturn 9000) | |
| Accessories | Same as Saturn 9000 |
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a flame.
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 NEIHU DISTRICT TAIPEI TAIWAN
Re: K072983
Trade/Device Name: Saturn 9000-750 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 19, 2007 Received: October 23, 2007
AUG 2 3 2013
Dear Mr. Shin:
This letter corrects our substantially equivalent letter of November 13, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the indication indication we have reviewed your Section 910(x) premation 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 encrosult, to tegary manates produced Device Amendments, or to commerce prior in May 28, 1970, the enactions and othe provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merelore, market the devices, secolor of the ments for annual registration, listing of general controls provisions of the rice 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 II your device is Classified (Sec above) into case (S) (S) = (S) = (S) = (S) = (S) = (S) = (S) = (S) = (S) = (S) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Sour of recents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a stablice complies with other requiremes of the Act that FDA has made a decorminations administered by other Federal agencies. You must of any Federal Statutes and regulations adminities on on limited to: registration and listing (21 Configure and an the Act 31equirements, art. 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 requirements as set form in the quality >>steam (<= ) regarder = ( = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = will allow you to begin marketing your device of your device to a legally marketed nothication. The FDA Image of Succember of Subscribe 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 for your device of our incenting and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device to premarket 5450. Also, please contact 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
under the MDR regulation (21 CFR Par 607), news good good good good good good on the CDRH's Office
http://www.fda.gov/MedicalDevices/Safety/Reportal/coo 1249.77WWW.Rda.go ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
You may obtain other general information on your responsibilities under the Act from the Y ou may other general informational on your responsessional 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
KC7298.3
Device Name: Saturn 9000-750
Indications For Use:
The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Prescription Use __ > (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _ (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)
Division Stb. Ofc
ductive, Abdominal and 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.