(9 days)
Not Found
No
The summary describes hardware improvements and basic operational principles, with no mention of AI, ML, or related concepts.
No.
The device is used for diagnostic imaging to aid in physician diagnosis, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use to provide diagnostic quality images to aid in physician diagnosis."
No
The device description explicitly mentions hardware components like a laser, detector, and electronics, indicating it is a physical device, not software-only.
Based on the provided information, the ADC Compact Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- ADC Compact Plus Function: The ADC Compact Plus is an X-ray imaging device. It uses X-rays to create images of internal structures within the body (in vivo). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it provides "diagnostic quality images to aid in physician diagnosis" for chest, skeletal, and gastro-intestinal applications. This is consistent with the function of an imaging device, not an IVD.
Therefore, the ADC Compact Plus falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADC Compact Plus is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Compact Plus is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
Product codes
MOB
Device Description
The ADC Compact Plus is similar to the ADC Compact, but it has a different laser and smaller spot size for improved resolution and higher An improved detector improves the sensitivity. throughout. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. The components that implement these principles of operation are simply being upgraded with better components that are now available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
chest, skeletal, and gastro-intestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician diagnosis
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
The ADC Compact Plus has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. The device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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SEP 2 8 2001
510(k) Summary
ADC Compact Plus
K013138
Page 1 of 2
Common/Classification Name: Computed Radiography, 21 CFR 892.
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeff Jedlicka, Prepared: September 18, 2001
LEGALLY MARKETED PREDICATE DEVICES A.
The predicate device is the previous version of the same device, namely the ADC Compact, which was cleared by FDA on 09 March 1998 as K974597.
B. DEVICE DESCRIPTION
The ADC Compact, the predicate device, is a computed radiology Instead of screens and photographic film for imaging system. producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.
The ADC Compact Plus is similar to the ADC Compact, but it has a different laser and smaller spot size for improved resolution and higher An improved detector improves the sensitivity. throughout. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. The components that implement these principles of operation are simply being upgraded with better components that are now available.
C. INTENDED USE
The ADC Compact Plus is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Compact Plus is intended
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to be used mainly in chest, skeletal, and gastro-intestinal x-ray imag applications.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The ADC Compact Plus has the same indications for use as the legally marketed predicate device, so the first decision point in the 510(k) Decision Algorithm is straight-forward. The ADC Compact Plus has the same technological characteristics as the predicate device. This premarket notification has described most of the characteristics of the Compact Plus in sufficient detail to assure substantial ADC equivalence. For the few characteristics that may not be precise enough to ensure equivalence, performance data was collected, and this data demonstrates substantial equivalence. In keeping with the format of a Special 510(k) for Device Modification, performance data were not included in the submission, but the declarations in Section IV provide certification that the data demonstrate equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
The ADC Compact Plus has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. The device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.
G. CONCLUSIONS
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure. The text is in a bold, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Agfa Corporation % T. Whit Athey, Ph.D. Senior Consultant C L McIntosh 12300 Twinbrook Parkway, Suite 625 ROCKVILLE MD 20852
AUG 2 3 2013
Re: K013138
Trade/Device Name: ADC Compact Plus Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 19, 2001 Received: September 19, 2001
Dear Dr. Athey:
This letter corrects our substantially equivalent letter of September 28, 2001.
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ADC Compact Plus is indicated for use to provide diagnostic quality images for aid in physician diagnosis. The ADC Compact Plus is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Harriet Townsend
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