(77 days)
The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
The RadStar Digital Imaging System consists of two components, a solid state x-ray imager and software for viewing the captured images on a Windows-based computer. The device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings.
This document is a 510(k) summary for the RadStar Digital Imaging System, describing its substantial equivalence to previously marketed devices. It does not contain the typical elements of a study proving a device meets specific acceptance criteria as it would for an algorithm or AI-powered device.
For medical devices that generate images, "acceptance criteria" are usually related to image quality metrics, safety, and performance against predicate devices. The study involved in such a submission primarily aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against pre-defined quantitative acceptance criteria for a new and innovative function.
Based on the provided text, here's an analysis:
1. A table of acceptance criteria and the reported device performance
The provided text does not define specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or image quality scores. This submission is for a conventional digital X-ray detector, and its performance demonstration focuses on substantial equivalence rather than novel algorithm performance.
The submission states:
- "The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings."
- "The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology."
- "There are no significant differences between the RadStar Digital Imaging System and the predicate devices and therefore, the RadStar Digital Imaging System does not raise any questions regarding safety and effectiveness."
- "The RadStar Digital Imaging System, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."
These statements serve as the "performance" claim, but they are qualitative and comparative to existing technology, not quantitative against specific, pre-defined acceptance criteria for diagnostic efficacy.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a digital X-ray imager, not an AI or algorithm-based diagnostic tool requiring a test set of patient data with ground truth. The "test" for this device would involve engineering and physical performance evaluations (e.g., image resolution, DQE, MTF, dose response) rather than a clinical study with patient images to evaluate diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as there is no mention of a "test set" of medical images requiring expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there is no mention of a "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device. The submission focuses on the digital imaging system itself replacing film/screen systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a hardware imaging system with associated viewing software. Its performance is inherent to its image acquisition capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the clinical sense for this type of device submission. Performance is assessed through technical specifications and comparison to predicate devices.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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K083645
Traditional 510(k)
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RadStar
SECTION 5. 510(K) SUMMARY
| Submission Correspondent: | 5-Star Medical, Inc. |
|---|---|
| Phone: (504) 952-9729 | |
| Email: terry@pvmed.net | |
| Contact: Terry L. Ancar | |
| FEB 2 4 2009 | |
| Submission Sponsor: | 5-Star Medical, Inc. |
| 11515 Prosperous Dr. | |
| Odessa, FL. 33556 | |
| Phone: (727) 753-0410 | |
| Fax: (727) 376-2868 | |
| Email: terry@pvmed.net | |
| Contact: Terry L. Ancar | |
| Date summary prepared: | October 30, 2008 |
| Device trade name: | RadStar Digital Imaging System |
| Device common name: | Solid State X-ray Imager (Flat Panel/Digital Imager) |
| Device classification name: | MQB at 21 CFR Part 892.1650 |
| Legally marketed devices to which the device is substantially equivalent: | K081648 |
| Canon CXDI-60G | |
| K024147 | |
| Varian PaxScan 4030 | |
| Description of the device: | The RadStar Digital Imaging System consists of two components, a solid state x-ray imager and software for viewing the captured images on a Windows-based computer. The device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings. |
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| Intended use of the device: | The RadStar DDR Digital Imaging System is intended for use ingenerating radiographic images of human anatomy. This device isintended to replace film/screen systems in all general purposediagnostic procedures. The device is intended for incorporation intoa complete x-ray system by qualified x-ray service personnel. Thisdevice is not intended for mammography applications. This deviceis intended for use by qualified medical personnel and iscontraindicated when, in the judgment of the physician, procedureswould be contrary to the best interest of the patient. |
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| Technologicalcharacteristics: | The technological characteristics between the predicate and proposeddevices are identical. There is no difference in fundamental scientifictechnology. |
| Conclusions: | There are no significant differences between the RadStar Digital ImagingSystem and the predicate devices and therefore, the RadStar DigitalImaging System does not raise any questions regarding safety andeffectiveness. |
| The RadStar Digital Imaging System, as designed, is as safe and effectiveas the predicate device, and the device is determined to be substantiallyequivalent to the referenced predicate device currently on the market. |
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized depiction of a human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
5 Star Medical, Inc. % Mr. Terry L. Ancar President Porta Vision Medical P.O. Box 641606 KENNER LA 70065
AUG 2 3 2013
Re: K083645
Trade/Device Name: RadStar DDR Digital Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 12, 2009 Received: January 21, 2009
Dear Mr. Ancar:
This letter corrects our substantially equivalent letter of February 24, 2009.
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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 809), please contact the Office 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 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 Division 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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SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indications for Use:
is83645
RadStar DDR Digital Imaging System
The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
Prescription Use × (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulk Pein
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
5-Star Medical
§ 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.