(26 days)
Not Found
No
The summary describes a digital radiography system with image processing software but does not mention AI, ML, or any related concepts. The performance studies focus on traditional imaging metrics and bench testing.
No
Explanation: The device is described as a diagnostic imaging system (DRX-1 System) intended to capture diagnostic images of human anatomy using digital radiography (DR) technology. Its purpose is to aid in diagnosis, not to provide therapy or treatment.
Yes
The device is explicitly described as a "diagnostic imaging system" in the "Device Description" section, and its "Intended Use / Indications for Use" states it's intended to capture "radiographic images of human anatomy." These images are then used for diagnostic purposes.
No
The device description explicitly states that the system consists of hardware components including an operator console, flat panel digital imager (detector), and optional tether interface box. The performance studies also mention evaluating both hardware and software requirements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "diagnostic imaging system utilizing digital radiography (DR) technology" intended to "capture for disgraphic images of human anatomy." It works by using X-rays to create images of the inside of the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is solely focused on capturing images of the body itself.
Therefore, based on the provided information, the Carestream DRX-1 System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to capture for disgraphic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projections wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
MOB, MQB
Device Description
The Carestream DRX-1 System is a diagnostic imaging system utilizing digital radiography (DR) technology that is used with diagnostic x-ray systems. The system consists of the Carestream DRX-1 System Console (operator console), flat panel digital imager (detector), and optional tether interface box. The system can be configured to register and use any of the two new DRX-Plus 4343 and DRX Plus 4343C Detectors. Images captured with a flat panel digital detector can be communicated to the operator console via tethered or wireless connection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics and operation / usability of the Carestream DRX-1 System with DRX Plus 4343 and DRX Plus 4343C Detectors were evaluated in non-clinical (bench) testing in accordance with FDA guidance document "Guidance for the Submission of 510(k)'s for Solid State Imaging Devices".
Non-clinical test results have demonstrated that the device conforms to its specifications. Acceptance criteria were determined based on desired performance with respect to image quality, intended use, workflow related performance, shipping performance, and general functionality and reliability, including both hardware and software requirements. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device; therefore supporting a substantial equivalence determination. Acceptance criteria were identified for weight, pixel size, resolution, pixel pitch, total pixel area, usable pixel area, MTF (at various spatial resolutions), DQE (at various spatial resolutions), sensitivity, ghosting, boot-up time, operating temperature, exposure latitude, signal uniformity, and dark noise (ADC). Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
Clinical studies were not submitted because the non-clinical data was sufficient to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Carestream Health, Inc. % Ms. Victoria Wheeler Sr. Regulatory Affairs Manager, US&C 150 Verona Street ROCHESTER NY 14608
Re: K153142
Trade/Device Name: Carestream DRX-1 System with DRX Plus 4343 Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: November 5, 2015 Received: November 6, 2015
Dear Ms. Wheeler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153142
Device Name
Carestream DRX-1 System
Indications for Use (Describe)
The device is intended to capture for disgraphic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projections wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Carestream
"510(k) Summary"
| 510(k) Owner Name: | Carestream Health, Inc. |
|---|---|
| 510(k) Owner Address: | 150 Verona Street |
| Rochester, New York 14608 | |
| 510(k) Owner Phone: | 585 627-8706 |
| 510(k) Owner Fax: | 585 627-8802 |
| Contact Person & Info: | Victoria Wheeler |
| Sr. Regulatory Affairs Manager, US&C | |
| victoria.wheeler@carestream.com | |
| 585-627-8706 | |
| Date Summary Prepared: | October 21, 2015 |
| Device Trade Name: | Carestream DRX-1 System w/ DRX Plus 4343 |
| Detectors | |
| Device Common Name: | Flat Panel Digital Imager |
| Classification Name: | Stationary x-ray system |
| Device Class: | Class II |
| Device Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Predicate Device: | Carestream DRX-1 System (with DRX Plus |
| 3543 Detectors) | |
| Manufactured by: Carestream Health, Inc. | |
| 510(k) No.: K150766 (June 24, 2015) | |
| Classification Regulation: 21 CFR 892.1680 | |
| Classification Name: Stationary x-ray system | |
| Primary Product Code: MQB |
Device Description:
The Carestream DRX-1 System is a diagnostic imaging system utilizing digital radiography (DR) technology that is used with diagnostic x-ray systems. The system consists of the Carestream DRX-1 System Console (operator console), flat panel digital imager (detector), and optional tether interface box. The system can be configured to register and use any of the two new DRX-Plus 4343 and DRX Plus 4343C Detectors. Images captured with a flat panel digital detector can be communicated to the operator console via tethered or wireless connection.
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Indications for Use / Intended Use:
The Indications for Use for the device, as described in its labeling, are:
"The device is intended to capture for display radiographic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications."
The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. The Carestream DRX-1 System with DRX Plus 4343 and DRX Plus 4343C Detectors is a diagnostic imaging system utilizing digital radiography (DR) technology that is used to capture x-rays for diagnostic procedures. We believe that the Carestream DRX-1 System with DRX Plus 4343 and DRX Plus 4343C Detectors and the predicate device have the same intended use.
The Indications for Use for the subject device is the same as for the predicate device and the intended use remains unchanged. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.
Comparison of Technological Characteristics:
Based upon information provided within this submission. we believe that the Carestream DRX-1 System with DRX Plus 4343 and DRX Plus 4343C Detectors is substantially equivalent to the legally marketed Carestream DRX-1 System with the DRX Plus 3543 Detectors (predicate device). Both the currently marketed DRX Plus 3543 Detectors and the new DRX Plus 4343 and DRX Plus 4343C Detectors are used in combination with the image processing software and user interface resident on the DRX-1 System Console component of the Carestream DRX-1 System. The system is used to directly capture conventional projected x-rays to generate digital images, regardless of which detector is being used. An image can be displayed on a preview monitor for viewing with any of the detectors. The system can transmit diagnostic images through a digital network for diagnostic viewing and printing regardless of which detector is used.
The predicate (DRX Plus 3543/3543C) Detectors share synonymous design specifications except the larger physical size of the detector (43cmX43cm).
Discussion of Testing:
The performance characteristics and operation / usability of the Carestream DRX-1 System with DRX Plus 4343 and DRX Plus 4343C Detectors were evaluated in non-clinical (bench) testing in accordance with FDA guidance document "Guidance for the Submission of 510(k)'s for Solid State Imaging Devices".
Non-clinical test results have demonstrated that the device conforms to its specifications. Acceptance criteria were determined based on desired performance with respect to image quality, intended use, workflow related performance, shipping performance, and general
Document No. 9J9088
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functionality and reliability, including both hardware and software requirements. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device; therefore supporting a substantial equivalence determination. Acceptance criteria were identified for weight, pixel size, resolution, pixel pitch, total pixel area, usable pixel area, MTF (at various spatial resolutions), DQE (at various spatial resolutions), sensitivity, ghosting, boot-up time, operating temperature, exposure latitude, signal uniformity, and dark noise (ADC). Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
Clinical studies were not submitted because the non-clinical data was sufficient to demonstrate substantial equivalence to the predicate device.
Consensus Standards:
The device conforms to ISO 14971:2012. Digital Imaging and Communications in Medicine (DICOM) Set, IEC 60601-1+Amd 1 - 3td Edition 2005, CFR 47 part 15, ANSI C95.1, and IEC 60601-1-2:2007.
Compatibility:
Carestream has a documented validation and verification process for integrating the Carestream DRX-1 System and DRX Plus 4343 and DRX Plus 4343C Detectors with OEM x-ray consoles that were originally installed by other manufacturers as analog or computed radiography x-ray systems. The modifications made to the existing x-ray system are limited to integration between the hand-switch and its connector to the x-ray system console. Sales and service personnel are qualified to determine whether the Carestream DRX-1 System can be integrated with a particular x-ray system. Once installed, proper operation is verified before the system is turned over for use on patients.
As of March 21, 2013, the systems listed in the Compatibility List (Table 1) have been found compatible with the Carestream DRX-1 System. This list may be updated in the future to include additional compatible systems.
| CARESTREAM DRX-1 System Compatibility List | ||
|---|---|---|
| Bennett Model HFQ-12050P | Philips Diagnost 94 | DEL ATC 525 |
| CPI CMP | Philips Easy Diagnost Eleva | DEL ATC 725 |
| CPI Indico 100 | Odyssey | Dyna RAD |
| CPI Indico 100 RAD | Quantum (Odyssey HF Series) | GE AMX4 |
| DEL AXR | Quantum Q-Vision | GE MPG 50 |
| Fischer RMS Digital 425HF | Rontgenwerk Editor Mp | GE MPG 65 |
| GE 500D | Sedecal Shf-330 | GE MPS 64 |
| GE Advantx | Shimadzu Gsc | GE MVP 80 |
| GE MPG | Siemens Axiom Dr | GE Silhouette VR |
| GE MPH | Siemens Fluorospot Compact | Gendex Reliance ATC525 |
| GE MVP | Philips Optimus | Gendex Reliance ATC725 |
| GE Precision RXi | Philips Super Cp | Medira 2000 |
| GE Prestige II | Picker Mtx | Philips Medio CP |
CARESTREAM DRX-1 System Compatibility List
6
| GE Prestilix 1600X | Picker Rad 65 | Picker Clinx-R |
|---|---|---|
| GE Proteus | Primax Go | Quantum Quest |
| GENDEX APG500 | Primax/Mecal Challenger | Reliance ATC725 |
| GMM Opera | Siemens Polydoros | Sedecal Global |
| KODAK DIRECTVIEW DR 5100 | Siemens Polydoros 80s | Sedecal Ideal |
| KODAK DIRECTVIEW DR 7100 | Siemens Polydoros Gen It55 | Sedecal SHF |
| KODAK DIRECTVIEW DR 3500 | Siemens Polydoros Lx | Sedecal Touchscreen |
| KODAK DIRECTVIEW DR 7500 | Siemens Polydoros Sx | Shimadzu Evolution |
| KODAK DIRECTVIEW DR 9000 | Stephanix Trophy N500 | Siemens Mobile XP Hybrid |
| KODAK DIRECTVIEW DR 9500 | Suinsa Hercules | Siemens Mobilette |
| Quantum | Toshiba Kalare | Stadler Electonik AG SE 4500 |
| Philips Diagnost 93 | Toshiba Kxo |
Table 1
The Beam Detect Mode allows integration with OEM systems where there is no access to intercept the Prep/Expose signal. The user commands the detector to get prepared for an exposure on the Carestream DRX-1 System Console and separately asserts the "expose" command to the x-ray generator when the Console indicates the detector is ready. The detector determines when an exposure has arrived and captures the image.
Conclusion:
In conclusion, the new detectors are equivalent to the DRX Plus 3543 Detectors in all applicable parameters recommended by the Guidance for the Submission of 510(k)'s for Solid State Imaging Devices. Image quality parameters such as DQE, sensitivity, and MTF of the DRX Plus 4343 and DRX Plus 4343C Detectors demonstrate this. The tests used to determine these parameters were performed using industry standards.
The new detectors have been tested to conform to applicable existing specifications of the predicate DRX Plus 3543 Detectors. Quality Assurance tests with traceable links to design inputs were performed to verify conformance to specifications. In addition, tests were included to confirm mitigation of risks identified in an extensive product hazard risk analysis based on results of a Failure Mode Effects Analysis.