(26 days)
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projections. It consists of a high frequency x-ray generator, overhead tube crane (with x-ray tube assembly), elevating 4-way float radiographic table with detector tray, tilting Bucky receptor on an upright Wall Stand, and x-ray controls containing a power distribution unit and operator PC.
Due to the nature of the submitted document, which is a 510(k) summary for a diagnostic X-ray system, the information typically found in a study demonstrating how a device meets acceptance criteria for an AI/CADe (Computer-Aided Detection/Diagnosis) system is not present.
This document describes a conventional diagnostic X-ray system (DRX-Evolution) and its substantial equivalence to predicate devices, focusing on hardware components and intended use. It is not an AI/CADe device, and therefore, the concepts of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as defined in the prompt for AI/CADe are not applicable here.
The "Discussion of Testing" mentions "Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, these acceptance criteria relate to the performance of an X-ray system (e.g., image quality, radiation output, mechanical safety, software functionality), not the diagnostic performance of an AI algorithm based on sensitivity, specificity, or other metrics typically used for AI/CADe.
Therefore, I cannot provide the requested information regarding AI/CADe specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this device does not appear to incorporate such AI technology requiring these types of evaluations.
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Special 510(k) for DRX-Evolution
KC091889
Image /page/0/Picture/2 description: The image shows the logo for Carestream Health. The logo consists of the word "Carestream" in a sans-serif font, with the word "HEALTH" in a smaller font below it. To the right of the word "Carestream" is a stylized graphic that appears to be a circle with some internal shapes.
JUL 2 0 2009
"510(k) Summary"
510(k) Owner Name: 510(k) Owner Address:
510(k) Owner Phone: 510(k) Owner Fax:
Contact Person & Info:
Carestream Health, Inc. 150 Verona Street Rochester, New York 14608
585 627-6543 585 454-1894
Carolyn Wagner Regulatory Affairs Manager, Medical Imaging carolyn.wagner@carestreamhealth.com 585-627-6588
Date Summary Prepared:
Device Trade Name: Device Common Name: Classification Name:
Device Class: Device Code: Regulation Number:
Predicate Devices:
May 20, 2009
DRX-Evolution diagnostic x-ray system Stationary x-ray system
Class II 90 KPR 21 CFR 892,1680
Kodak DirectView DR 7500 Manufactured by Carestream Health, Inc. 510(k) No. - K051258 (June 1, 2005) AND Carestream DRX-1 System Manufactured by CarestreamHealth, Inc. . 510(k) No. - K090318 (April 6, 2009)
Device Description:
The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projections. It consists of a high frequency x-ray generator, overhead tube crane (with x-ray tube assembly), elevating 4-way float radiographic table with detector tray, tilting Bucky receptor on an upright Wall Stand, and x-ray controls containing a power distribution unit and operator PC. The DRX-Evolution incorporates the following new features:
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- Add the wireless Carestream DRX-1 System detector option as a component of 하 the x-ray system
- Include a different model CPI generator ■
- Add a Toshiba x-ray tube option (tube used in predicate device (K051258) still . available)
- Include Carestream- designed motion control software that functions the same as 트 the OEM-designed motion control software used in the predicate device (K051258).
Intended Use:
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Comparison of Technological Characteristics:
The DRX-Evolution has the same technological characteristics as the predicate device, the Kodak DirectView DR 7500 System. The DRX-Evolution System incorporates various configurations with the following standard components: radiographic table, flat panel detector, x-ray generator, x-ray tube housing, and beam-limiting device. The device modifications raise no new issues of safety or effectiveness.
Discussion of Testing
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
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Substantial Equivalence Comparison with Predicate Devices
:
| Kodak DirectView DR 5100 | Kodak DirectView DR 7100 | Kodak DirectView DR 7500 | DRX-Evolution | |
|---|---|---|---|---|
| DR System | K001341 | K001341 | K051258 (SE to Kodak DirectView DR 5100/7100) | SE to Kodak DirectView DR (K051258) and Carestream DRX-1 System (K090318) |
| Image ProcessingSoftware | K925344 | K925344 | K925344, K060137 | K060137 |
| Long Length ImagingSoftware | No | No | K081836 | K081836 |
| Intended Use &Indications for Use | Permanently installed diagnostic x-raysystem for generation of x-rays forexaminations of various anatomicalregions. | Permanently installed diagnostic x-raysystem for generation of x-rays forexaminations of various anatomicalregions. | Permanently installed diagnostic x-raysystem for generation of x-rays forexaminations of various anatomicalregions. | Permanently installed diagnostic x-raysystem for generation of x-rays forexaminations of various anatomicalregions. |
| X-ray Generator | Communication Power IndustriesIndico 100 Series X-ray Generator | Communication Power IndustriesIndico 100 Series X-ray Generator | Communication Power IndustriesIndico 100 Series X-ray Generator | Communication Power IndustriesCMP200DR X-ray Generator |
| X-ray Tube | Varian X-ray Tube (RAD-60 w/ B-130 housing) | Varian X-ray Tube (RAD-60 w/ B-130 housing) | Varian X-ray Tube (RAD-60 w/ B-130 housing) | Varian X-ray Tube (RAD-60 w/ B-130 housing) / Alternate: ToshibaE7254GX with XH-157 Housing |
| Beam Limiting Device | Collimator: Huestis Medical Model150 PBL | Collimator: Huestis Medical Model150 PBL | Collimator: Ralco, Model 302 ACS.Collimator K / Alternate: Ralco R302DACS/A | Ralco R302 DACS/A |
| Detector(X-ray Operator Console) | DirectRay Digital Array & Controller(Solid State Digital Device, K973206) | DirectRay Digital Array & Controller(Solid State Digital Device, K973206) | DirectRay Digital Array & Controller(Solid State Digital Device, K973206)/ Carestream DRX-1 Digital Detector(K090318)/ Alternate: Trixell Pixium 4600 DigitalDetector | Carestream DRX-1 Digital Detector(K090318) / Alternate: Trixell Pixium4600 Digital Detector |
| Operator Console (X-raycontrol) | Diagnostic Operator ConsoleSystem software w/ imageprocessing capabilityComputer w/ touch screenmonitorBarcode Scanner | Diagnostic Operator ConsoleSystem software w/ imageprocessing capabilityComputer w/ touch screenmonitorBarcode Scanner | Diagnostic Operator ConsoleSystem software w/ imageprocessing capabilityComputer w/ touch screenmonitorBarcode Scanner | Diagnostic Operator ConsoleSystem software w/ imageprocessing capabilityComputer w/ touch screenmonitorBarcode Scanner |
| Timing Distribution Unit(X-ray control) | Timing and Distribution Unit: BestPower Fortress 750 UPS | Timing and Distribution Unit: BestPower Fortress 750 UPS | Timing and Distribution Unit (providesgenerator interface & powerdistribution): Best Power Fortress 750UPS/Alternate: APC 1500 VA UPS | Power Distribution Unit (providespower distribution & generatorinterface): Optional APC 1500 VAUPS |
| Overhead Tube Crane /Tube StandWall Stand | Tube Stand w/ manual and automatedray tube assembly movementYes, contains Bucky w/ Detector | Overhead Tube Crane w/ manual x-raytube assembly movementNo | x-Overhead Tube Crane w/ manual andautomated x-ray tube assemblymovementYes, contains Bucky w/ Detector | Overhead Tube Crane w/ manual andautomated x-ray tube assemblymovementYes, contains Bucky w/ Detector |
.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2009
Ms. Carolyn L. Wagner, RAC Regulatory Affairs Manager Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608
Re: K091889
Trade/Device Name: DRX-Evolution Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 23, 2009 Received: June 24, 2009
Dear Ms. Wagner:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k): Carestream Health, Inc.
Statement of Intended Use
510(k) Number (if known):
Device Name:
DRX-Evolution
Indications for Use:
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Prescription Use_ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi Reem
(Division Sign-Off) Division 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.