(56 days)
The Carestream DRX-1 System is intended to capture for display radiographic images of human anatomy. It 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, tomography and angiography applications.
The Carestream DRX-1 System is a digital imaging system to be used with diagnostic x-ray systems. It includes a Carestream DRX-1 System Detector (flat panel digital detector), Carestream DRX-1 System Console (operator console) and Carestream DRX-1 System Interface Box (generator interface or Interface Box). Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection or wireless.
The provided document is limited in the detail it offers regarding acceptance criteria and the comprehensive study design. However, I can extract the information that is present.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Performance testing was conducted to verify the design input requirements and to validate the Carestream DRX-1 System conformed to the defined user needs and intended uses. Predefined acceptance criteria was met and demonstrated that the Carestream DRX-1 System is as safe, as effective, and performs as well as or better than the predicate device." And for clinical testing: "Results of clinical testing demonstrated there were no significant differences observed between the Kodak DirectView CR 850 System and Carestream DRX-1 System with respect to clinical acceptance or the ability to diagnose."
However, the specific "predefined acceptance criteria" (e.g., specific metrics like SNR, spatial resolution improvements, or diagnostic accuracy thresholds) and their corresponding numerical results for the Carestream DRX-1 System are not detailed in this document. The reported performance is a general statement of meeting criteria and no significant difference from the predicate.
| Acceptance Criteria (Specifics Not Provided) | Reported Device Performance |
|---|---|
| Safety | Met (as safe as predicate) |
| Effectiveness | Met (as effective as predicate) |
| Performance (bench testing) | Met (performs as well as or better than predicate) |
| Clinical Acceptance | No significant difference from predicate |
| Ability to Diagnose | No significant difference from predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "Clinical Testing" was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified. The term "clinical testing" implies expert evaluation, but the number or specific roles (e.g., radiologists) are not detailed.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Implied by the "no significant differences observed... with respect to clinical acceptance or the ability to diagnose" statement when comparing to the predicate, which suggests human readers evaluated both systems. However, a formal MRMC study design (e.g., number of readers, specific protocols) and its details are not explicitly described.
- Effect size of human readers with AI vs. without AI assistance: Not applicable/Not mentioned. This device is a digital radiography system, not an AI-assisted diagnostic tool. The comparison is between two digital imaging systems.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not applicable. The Carestream DRX-1 System is described as a complete digital imaging system (detector, console, interface). It's not an algorithm intended for standalone performance evaluation in the context of AI. The performance testing was for the integrated system.
7. Type of Ground Truth Used
- Type of Ground Truth: The document refers to "clinical acceptance" and "ability to diagnose," implying a clinical assessment by human experts (likely radiologists) as the ground truth for comparison. There is no mention of pathology or outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This device is a digital radiography system, not a machine learning algorithm that requires a separate training set. Performance was evaluated for its imaging capabilities.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. See point 8.
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Image /page/0/Picture/13 description: The image shows the logo for Carestream Health. The logo is in black and white and features the company name in a stylized font. The word "Carestream" is on the top line, and the word "Health" is on the bottom line.
K09C318
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Attachment 9
510(k): Carestream Health, Inc.
APR - 6 2009
Carestream DRX-1 System
510(k) Summary Prepared in accordance with 21 CFR Part 807.92(c)
| Submitter: | Carestream Health, Inc.150 Verona StreetRochester, New York 14608 |
|---|---|
| Contact Person: | Christine EhmannRegulatory Affairs DirectorTelephone: 585-627-6473; Fax: 585-454-1894 |
| Date Prepared: | February 6, 2009 |
| Device Name: | Carestream DRX-1 System21 CFR 892.1650 MOB |
Equivalent Device (currently marketed): Kodak DirectView CR 850 System, 510k number: K020635
- Device Description: The Carestream DRX-1 System is a digital imaging system to be used with diagnostic x-ray systems. It includes a Carestream DRX-1 System Detector (flat panel digital detector), Carestream DRX-1 System Console (operator console) and Carestream DRX-1 System Interface Box (generator interface or Interface Box). Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection or wireless.
- The Carestream DRX-1 System is intended to capture for display radiographic images of Indications for Use: human anatomy. It 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, tomography and angiography applications.
Comparison with Predicate Device: The Kodak DirectView CR 850 System (CR 850) and the Carestream DRX-1 System are digital imaging systems. Each device is used to acquire radiographic images digitally. The CR 850 system and the Carestream DRX-1 System, both, differ from traditional X-ray film systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image for viewing, a digital image is used to display and reviewing in electronic form. The digital data are then used to produce softcopy images to be sent to a hardcopy printing device or archive device. The CR 850 System reads the x-ray image captured on stimulated phosphor screens and converts it to a digital image. The Carestream DRX-1 System Detector is used to directly capture and conventional projected X-ray images to digital images. An image can be displayed on a preview monitor for viewing on both devices. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing using both devices.
Summary of Evaluation: Performance testing was conducted to verify the design input requirements and to validate the Carestream DRX-1 System conformed to the defined user needs and intended uses. Non-clinical testing was conducted use conditions. Predefined acceptance criteria was met and demonstrated that the Carestream DRX-1 System is as safe, as effective, and performs as well as or better than the predicate device. The Carestream DRX-1 System has been evaluated for product safety, electromagnetic compatibility and radiation safety. It conforms to applicable medical device safety standards.
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Image /page/1/Picture/0 description: The image shows the logo for Carestream Health. The logo is in black and white and features the company name in a stylized font. The word "Carestream" is written in a bold, sans-serif font, with each letter outlined in black. Below the word "Carestream" is the word "HEALTH" in a smaller, sans-serif font.
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Attachment 9
Clinical Testing: Results of clinical testing demonstrated there were no significant differences observed between the Kodak DirectView CR 850 System and Carestream DRX-1 System with respect to clinical acceptance or the ability to diagnose.
- Conclusion: The Carestream DRX-1 System is designed and will be manufactured in compliance with ISO 13485, the Quality System Regulations for Medical Devices and 21 CFR Part 820. The Carestream DRX-1 System is in conformance with applicable international and national safety standards. Based on the results of the clinical and bench testing, product comparison, product safety and electromagnetic compatibility testing, Carestream Health, Inc. concludes that the Carestream DRX-1 System is substantially equivalent to the current Kodak DirectView CR 850 System.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christine Ehmann Regulatory Affairs Manager Carestream Health. Inc. 150 Verona Street ROCHESTER NY 14608
Re: K090318
Trade/Device Name: Carestream DRX-1 System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 6, 2009 Received: February 9, 2009
Dear Ms. Ehmann:
This letter corrects our substantially equivalent letter of April 6, 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.
AUG 2 3 2013
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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ATTACHMENT 1 510(k): Carestream Health, Inc.
Statement of Indications for Use
510(k) Number (if known):
Device Name:
Carestream DRX-1 System
Indications for Use:
The Carestream DRX-1 System is intended to capture for display radiographic images of human anatomy. It 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, tomography and angiography applications.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (per 21 CFR 801.109)
OR
bdominal and
Over-the counter use
1
Laune K. Thoms
(Division Sign-Off)
Division of Reproductive, A
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.