(15 days)
No
The document describes a Computed Radiography (CR) system for radiotherapy imaging and quality control. It mentions image processing and comparison but does not contain any terms or descriptions indicative of AI or ML technology.
No
This device is for producing simulation and quality control images for radiation therapy planning and quality control, not for directly treating a disease or condition.
No
The device is used for producing simulation and quality control images for radiation therapy planning and quality control, which are applications related to treatment planning and verification, not diagnosis of a medical condition.
No
The device description explicitly mentions "two different Portal Imaging Cassette types" and "acquisition of the images," indicating the involvement of hardware components (cassettes and potentially an acquisition device) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "producing simulation and quality control images for use in radiation therapy planning and quality control." This is a diagnostic imaging application used in vivo (on a living patient) to guide treatment, not an in vitro test performed on biological samples outside the body.
- Device Description: The description focuses on acquiring images under "typical Radiotherapy conditions" and supporting "low- and high-dose applications" for "Portal Imaging." This further reinforces its role in imaging the patient during or for radiotherapy.
- Input Imaging Modality: The input is Computed Radiography (CR), which is a method for acquiring radiographic images of the body.
- Care Setting: The intended user and care setting are a "Clinical radiotherapy department," which is where patients receive radiation therapy.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
N/A
Intended Use / Indications for Use
The Radiotherapy Solution Based on CR25.0 is indicated for producing simulation and quality control images for radiation therapy planning and quality control.
Product codes (comma separated list FDA assigned to the subject device)
90 IXK
Device Description
The Radiotherapy Solution Based on CR allows the application of Portal Imaging in a very wide dose range (1 MU - 400 MU's and higher) by using two different Portal Imaging Cassette types, which are optimised for image quality at their intended dose range. The Radiotherapy Solution Based on CR supports both low- and high-dose applications (sometimes called localisation and verification portal imaging).
Not only does the system enable the acquisition of the images under the typical Radiotherapy conditions, the specific requirements for these images are also met which allows their use by the typical "next-in-line" radiotherapy applications. Typical "next-in-line" applications for simulation imaging are, for instance, image comparison and bloc compensator/MLC calculations. For portal imaging, a typical "next-in-line" application is image comparison with a reference image (this can be a simulation image or DRR: comparisons are made between hardcopy prints or on a digital workstation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (Portal Imaging)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiotherapy department
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 Radiotherapy Solution Based on CR has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. Clinical performance has been tested in the typical environment of a clinical radiotherapy department, and sample clinical images have been provided in this 510(k).
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.
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
§ 892.1630 Electrostatic x-ray imaging system.
(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
OCT 2 1 2004
510(k) Summary
Radiotherapy Solution Based on CR
Computed Common/Classification Name: Radiotherapy Cassettes for Radiography, 21 CFR 892.1630
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: August 9, 2004
LEGALLY MARKETED (PREDICATE) DEVICES A.
The Radiotherapy Solution Based on CR is substantially equivalent to the PoRT Cassette (K032654) in regard to its indications for use and cassette characteristics, and to the CR25.0 in regard to the image acquisition and processing characteristics (K041701). The Radiotherapy Solution Based on CR should be considered as an accessory to the CR25.0, as was the case for the PoRT Cassette with respect to the PcCR device. K032654 was cleared by FDA as an accessory under regulation 21 CFR 892.1630 (product code IXK), so presumably this is the appropriate regulation and product code for the present product as well.
B. DEVICE DESCRIPTION
The Radiotherapy Solution Based on CR allows the application of Portal Imaging in a very wide dose range (1 MU - 400 MU's and higher) by using two different Portal Imaging Cassette types, which are optimised for image quality at their intended dose range. The Radiotherapy Solution Based on CR supports both low- and high-dose applications (sometimes called localisation and verification portal imaging).
Not only does the system enable the acquisition of the images under the typical Radiotherapy conditions, the specific requirements for these images are also met which allows their use by the typical "next-in-line" radiotherapy applications. Typical "next-in-line" applications for simulation imaging are, for instance, image comparison and bloc compensator/MLC calculations. For portal imaging, a typical "next-in-line" application is image comparison with a reference image (this can be a simulation image or DRR: comparisons are made between hardcopy prints or on a digital workstation).
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C. INTENDED USE
The Radiotherapy Solution Based on CR is substantially equivalent to the PoRT Cassette by Orex (K032654) in regard to its indications for use and cassette characteristics, and to the Agfa CR25.0 in regard to the image acquisition and processing characteristics (K041701). The Radiotherapy Solution Based on CR should be considered as an accessory to the CR25.0, as was the case for the PoRT Cassette with respect to the PcCR device (K003256). K032654 was cleared by FDA as an accessory under regulation 21 CFR 892.1630 (product code IXK), so presumably this is the appropriate regulation and product code for the present product as well.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Radiotherapy Solution Based on CR has a similar, but not identical, indications for use statement as the legally marketed predicate devices. However, the differences are minor and do not alter the fact that the devices clearly have the same intended use. The Radiotherapy Solution Based on CR has the same technological characteristics as the predicate devices. This premarket notification has described the characteristics of the device in sufficient detail to assure substantial equivalence. Sample clinical images are provided as confirmatory evidence that the device is equivalent to the legally marketed devices.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics are the same in the proposed and legally marketed predicate devices.
F. TESTING
The Radiotherapy Solution Based on CR has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. Clinical performance has been tested in the typical environment of a clinical radiotherapy department, and sample clinical images have been provided in this 510(k).
G. CONCLUSIONS
This 510(k) premarket notification 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of three stylized lines that resemble a bird or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2004
Agfa Corporation % Mr. William Sammons Project Engineer ·Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709 Re: K042779 Trade/Device Name: Radiotherapy Solution Based on CR25.0 Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II
Product Code: 90 IXK Dated: October 1, 2004 Received: October 6, 2004
Dear Mr. Sammons:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have it viewed your botten box(s) p
above and have determined the device is substantially equivalent (for the indications for use stated in above and have decemii... Parketed predicate devices marketed in interstate commerce prior to the enclosure) to regally maneted problem. Device Amendments, or to devices that have been May 20, 1770, the chacinent acto of the Federal Food, Drug, and Cosmetic Act (Act) that it classified in accordantes approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act device, subject to the general esting 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 (Premarket 11 your de rice is elassilied (200 2011 additional controls. Existing major regulations affecting your Apployally, It may or babyer to on Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device ban of round mouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease oe advisod that i by vion that your device complies with other requirements of the Act or any FDA has masternination and regulations administered by other Federal agencies. You must comply with all the I cacraf states and regulation but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, morating practice requirements as set forth in the quality systems (QS) (21 CFR Part 8017), good not if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarked notheation. The PDF mining of Cassification 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 Part 801), please II you desire specific acvice for your de roche following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, Tormation on your responsibilities under the Act from the 807.77). Tou may obtain careers, International and Consumer Assistance at its toll-free number (800) DVNSloll or (301) 443-6597 or at its Internet address http://www.fda.ggv/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. I Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 04 2779
Radiotherapy Solution Based on CR25.0 Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Radiotherapy Solution Based on CR25.0 is indicated for producing simulation and quality The Radiotherapy Solution Based on ORLO.6 In Indiation therapy planning and quality control.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Dyson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __
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