(105 days)
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 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 operate with either the Carestream DRX-1 System Detector (GOS) or the DRX-2530C Detector (Csl) and can be configured to register and use both detectors. Images captured with the flat panel digital detector can be communicated to the operator console via tethered or wireless connection.
Here's a breakdown of the acceptance criteria and study information based on the provided text for K130464:
Please note that the provided 510(k) summary is for a device upgrade (new detector for an existing system) and focuses on demonstrating substantial equivalence to the predicate device. Therefore, a full-blown AI performance study with detailed metrics like sensitivity, specificity, or AUC for a diagnostic AI algorithm is not present, as the device itself is an imaging acquisition system, not an AI diagnostic tool. The "Reader Study" mentioned is a comparative effectiveness study to show that the new detector produces diagnostically equivalent images to the predicate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-clinical (bench) testing | "The performance characteristics and operation / usability of the Carestream DRX-1 System with DRX 2530C Detector were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. 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 Concurrence (Diagnostic Capability) | "A concurrence study of clinical image pairs was performed... to demonstrate the diagnostic capability of the Carestream DRX-1 System with DRX 2530C Detector. Results of the Reader Study indicated that the diagnostic capability of the Carestream DRX-1 System with DRX 2530C Detector is statistically equivalent to or better than that of the predicate device. These results support a substantial equivalence determination." |
Study Details
Detailed information regarding sample sizes, expert qualifications, and adjudication methods for the clinical study is very limited in this 510(k) summary. The document primarily states that a "concurrence study of clinical image pairs" and a "Reader Study" were conducted to demonstrate diagnostic equivalence.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided document. The text mentions "clinical image pairs."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study implicitly uses "clinical image pairs," suggesting prospective or retrospective collection of patient images. The nature of a "concurrence study" implies that images were acquired using both the new device and the predicate device (or comparable standard) for direct comparison.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated. The term "Reader Study" implies multiple readers.
- Qualifications of Experts: Not explicitly stated (e.g., specific experience or subspecialty).
-
Adjudication Method for the Test Set:
- Not explicitly stated. A "concurrence study" and "Reader Study" typically involve readers independently evaluating images, and then their findings are compared to each other, to predefined criteria, or to a ground truth. Common adjudication methods (like 2+1 or 3+1) are not detailed in this summary.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Yes, a "Reader Study" was performed. While not explicitly termed "MRMC," the description "Results of the Reader Study indicated that the diagnostic capability... is statistically equivalent to or better than that of the predicate device" strongly suggests a comparative study involving multiple readers assessing images. The purpose was to show diagnostic capability of the new detector in comparison to the predicate.
- Effect size of human readers improvement with AI vs without AI assistance: This information is not applicable as this study is not evaluating an AI diagnostic tool or AI assistance. It is evaluating the diagnostic equivalence of an imaging acquisition device (a new X-ray detector). The "improvement" is in the context of the new detector's image quality being diagnostically equivalent or better than the predicate detector, not AI assistance.
-
Standalone Performance (algorithm only without human-in-the-loop performance):
- Was it done? This is not applicable in the context of this 510(k). The device is an X-ray detector, which is an image acquisition component, not an standalone algorithm. Its performance is intrinsically linked to human interpretation of the images it produces.
-
Type of Ground Truth Used:
- The document implies that the ground truth for the "concurrence study" would have been established by expert interpretation of the images (either from the new device or the predicate) to determine if the new device's images offered equivalent diagnostic information. Pathology or outcomes data are not mentioned. It's likely based on expert consensus or comparison against established diagnostic images from the predicate.
-
Sample Size for the Training Set:
- Not applicable. This submission is for an imaging acquisition device (X-ray detector), not a machine learning algorithm. Therefore, there is no "training set" in the AI/ML sense. The device's performance is driven by its physical and electronic characteristics, and its "training" would be its design, engineering, and manufacturing process.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML algorithm.
{0}------------------------------------------------
K130464
Page 1 of 3
Carestream
JUN 0 7 2013
"510(k) Summary"
585 627-6543
585 454-1894
510(k) Owner Name: 510(k) Owner Address:
Carestream Health, Inc. 150 Verona Street Rochester, New York 14608
510(k) Owner Phone: 510(k) Owner Fax:
Contact Person & Info:
.
Carolyn Wagner Regulatory Affairs Manager, X-ray Solutions carolyn.wagner@carestream.com 585-627-6588
Carestream DRX-1 System w/ DRX 2530C Detector
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Date Summary Prepared:
Device Trade Name: Device Common Name: Classification Name:
Device Class: Device Code: Regulation Number: Class II MQB 21 CFR 892.1650
February 18, 2013
Flat Panel Digital Imager
Carestream DRX-1 System (w/ DRX-1 Detector) Manufactured by Carestream Health, Inc. 510(k) No. - K090318 (April 6. 2009)
Device Description:
Predicate Device:
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 operate with either the Carestream DRX-1 System Detector (GOS) or the DRX-2530C Detector (Csl) and can be configured to register and use both detectors. Images captured with the flat panel digital detector can be communicated to the operator console via tethered or wireless connection.
Indications for Use / Intended Use:
The Indications for Use for the device, as described in its labeling, are:
{1}------------------------------------------------
"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 2530C Detector 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 2530C Detector and the predicate device have the same intended use.
The Indications for Use for the subject device is different than the predicate device, but these differences do not alter the intended diagnostic use of the device. Differences are appropriately characterized as descriptive, 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 2530C Detector is substantially equivalent to the legally marketed Carestream DRX-1 System with DRX-1 System Detector (predicate device). Both the currently marketed DRX-1 Detector and the new DRX 2530C Detector 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. Both systems are used to directly capture and convert conventional projected x-ray images to generate digital images. An image can be displayed on a preview monitor for viewing with either detector. Both systems can transmit diagnostic images through a digital network for diagnostic viewing and printing.
The DRX 2530C Detector is a new component that can be used with the Carestream DRX-1 System. The DRX 2530C Detector is physically smaller than the Carestream DRX-1 System Detector and therefore has a smaller active image area. It is specifically designed to image smaller body parts and to function easily in confined locations. The DRX 2530C has functional and performance enhancements over the DRX-1 Detector such as a handle, a 16 bit dynamic range, and increased fluid resistance. These enhancements are designed to aid the user in achieving an efficient workflow.
The differences between the Carestream DRX-1 System with DRX 2530C Detector and the predicate device (Carestream DRX-1 System with DRX-1 System Detector) do not affect the intended use of the device or alter the fundamental scientific technology of the device.
Discussion of Testing
{2}------------------------------------------------
K130464
page 3 of 3
The performance characteristics and operation / usability of the Carestream DRX-1 System with DRX 2530C Detector were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. 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.
A concurrence study of clinical image pairs was performed in accordance with FDA guidance document "Guidance for the Submission of 510(k)'s for Solid State Imaging Devices" to demonstrate the diagnostic capability of the Carestream DRX-1 System with DRX 2530C Detector. Results of the Reader Study indicated that the diagnostic capability of the Carestream DRX-1 System with DRX 2530C Detector is statistically equivalent to or better than that of the predicate device. These results support a substantial equivalence determination.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
Carestream Health, Inc. % Ms. Carolyn L. Wagner Regulatory Affairs Manager 150 Verona Street ROCHESTER NY 14608
Re: K130464
Trade/Device Name: Carestream DRX-1 System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 8, 2013 Received: May 9, 2013
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, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Ms. Wagner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K130464
Device Name:
Carestream DRX-1 System
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEA'SE "DO "NOT"WRITE"BELOW"THIS"LINE-CONTINUE"ON"ANOTHER"PAGE"IF" NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K130464
Page 1 of 1
§ 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.