(214 days)
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.
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,
The provided 510(k) summary for the New Medical Co., LTD. Saturn 9000 focuses on demonstrating substantial equivalence to a predicate device for general X-ray imaging, excluding mammography. It relies heavily on non-clinical testing and a "concurrence study" but provides very limited detail about the clinical study design or its results in terms of specific performance metrics or acceptance criteria related to a specific product.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not available in the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Effectiveness | "Compatible with predicate device" and "concurrence study is preferred for proving the clinical effectiveness" | "Device performance is compatible with predicate device." "Compliance was verified through independent clinical trial." |
| Technical Characteristic Values | Based on IEC 62220-1, "conformed that the device performance is compatible with predicate device." | Measured and computed values were "conformed that the device performance is compatible with predicate device." |
Limitations: The document does not provide specific numerical acceptance criteria (e.g., minimum AUC, sensitivity, specificity) or specific numerical performance results for the Saturn 9000. It relies on a general statement of "compatibility" and "concurrence."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions a "concurrence study" and an "independent clinical trial" but does not specify how many patients or images were included.
- Data Provenance: Not explicitly stated. The context implies the study was conducted to support a submission in the US (FDA), but the country of origin of the actual patient data is not mentioned. It is also not specified whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The abstract nature of the clinical study description means there is no detail on who established ground truth or their qualifications.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study involving AI assistance was not done. The device being described is a digital X-ray image capture device (hardware), not an AI algorithm. The study described is a "concurrence study" aimed at showing the device produces images comparable to a predicate device, which is a film-screen system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the Saturn 9000 is a hardware device (digital X-ray system), not an AI algorithm. Its performance is inherent in its ability to capture images.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- This information is not explicitly stated. Given it's a "concurrence study" comparing a new digital system to a traditional film-screen system, the "ground truth" likely revolved around comparing image quality and diagnostic utility as interpreted by human readers, possibly against the findings on the predicate device's images (e.g., if a lesion was visible on film, was it also visible on the digital image?). However, the specific methodology for establishing this "ground truth" (e.g., expert consensus on specific clinical findings) is not detailed.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Saturn 9000 is a hardware device, not an AI model that requires a training set of images in the typical sense. Any "training" would be related to calibrating the hardware itself, not an algorithm's learning.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reasons as point 8.
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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.4F, No.42, SingZhong Rd., NeiHu DistrictTaipei 114, Taiwan |
|---|---|
| Contact Person: | Young-Hoon Shin, Ph.D.R&D Manageryhshin@newmedical.com.twTelephone: +886-2-8791-6268 |
| Date Prepared: | December 11th 2006 |
Saturn 9000
- Device Name:
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- Marketd Device: new submission
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- 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,
- 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.
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- 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,
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- 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.
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- 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
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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 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 (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 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 (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): 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
Page 1 of 1
vision of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.