(59 days)
Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.
The provided text is a 510(k) summary for the RALCO srl Model R302DACS/A Automatic X-RAY Collimator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the comprehensive completion of the requested table and study information.
The document primarily focuses on establishing substantial equivalence based on safety and effectiveness compared to predicate devices, rather than presenting a performance study with defined acceptance criteria and quantitative results for the new device.
Therefore, I cannot populate the table or provide the requested study details as the information is not present in the provided text.
Here is an explanation of why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: The document states, "The results of bench, safety test laboratory and user testing indicates that the new device is as safe and effective as the predicate device." It also mentions "analyzing both bench and safety testing data." However, it does not define what these "results" or "data" actually are, what specific performance metrics were measured (e.g., accuracy of collimation, field size precision), nor what the predefined "acceptance criteria" for these metrics were.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone, Training Set Details: None of this information is available in the provided text. The submission focuses on regulatory compliance and comparison to predicate devices, not on a detailed clinical or technical performance study with these elements.
- Type of Ground Truth: While it mentions "bench, safety test laboratory and user testing," it doesn't specify if this involved expert consensus, pathology, or other forms of "ground truth" as typically understood in a performance study for AI/diagnostic devices. For an X-ray collimator, ground truth would likely relate to the actual dimensions and alignment of the X-ray field versus the device's output, but this is not detailed.
In summary, the provided 510(k) pertains to a hardware device (X-ray collimator) and emphasizes regulatory equivalence based on general safety and effectiveness. It does not include the type of detailed performance study data, acceptance criteria, or ground truth establishment typically found for AI/software-based diagnostic devices.
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510(k) Summary: K072780 RALCO srl Via dei Tigli 13/G 20046 Biassono (mi) Italy Tel. +39.039.249.7925 Fax: +39.039.249.7799 email: ralco@ralco.it August 14, 2007 Contact person: Vincenzo Velardi, President and CEO
NOV 2 6 2007
1. Identification of the Device:
Proprietary-Trade Name: Model R302DACS/A Automatic X-RAY Collimator Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator.
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- Equivalent legally marketed devices: Ralco Collimator, Automatic Radiographic, Tecnomed, Inc. K820306 and K827124 (Manufactured by Ralco but sold in the US by Tecnomed); Advantech Model R600/800 series collimators manufactured by Ralco SRL under K904182; Omega Medical Imaging Model R605FACS, K050092.
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- Indications for Use (intended use): Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
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- Description of the Device: Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.
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- Safety and Effectiveness, comparison to predicate device. The results of bench, safety test laboratory and user testing indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards and is CSA Listed to US Standards for safety for medical devices.
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- Conclusion: After analyzing both bench and safety testing data, it is the conclusion of Ralco that the Model R302DACS/A is as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ralco SRL % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K072780
Trade/Device Name: Model R302DACS/A Automatic X-RAY Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: September 26, 2007 Received: September 28, 2007
Dear Mr. Kamm:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. 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
K072780 510(k) Number (if known):_
Device Name: Model R302DACS/A Automatic X-RAY Collimator
Indications For Use: Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
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)
Aomi hin Whing
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.