(56 days)
Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..
This document is a 510(k) summary for the Ralco Model R605DASM Automatic X-RAY Collimator. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Here's the breakdown regarding acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, precision, error rates) for the device. Instead, the "acceptance criteria" are implied to be adherence to general safety and effectiveness standards, and substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective | "The new device conforms to US Performance Standards and is CSA Listed to US Standards for safety for medical devices." |
| Substantially Equivalent to Predicate Device | "The results of bench, safety test, and laboratory testing indicates that the new device is as safe and effective as the press, and The predicate device was made for Omega Medical Imaging and in fact carries virtually the same model name as the new Ralco device. The predicate employs a round field, same as our new device." |
| Identical Indications for Use | "has identical indications for use" (compared to predicate) |
| Few Technological Differences | "has few technological differences" (compared to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench, safety test, and laboratory testing" but does not provide details on the sample size used for any test sets or the data provenance (e.g., country of origin, retrospective/prospective nature). It focuses on the physical characteristics and control mechanisms of the collimator.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The device described is an automatic X-ray collimator, a hardware component that limits the X-ray beam. Its performance is assessed through engineering and safety tests, not through clinical interpretation requiring expert consensus on ground truth (like in image analysis AI).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As mentioned above, the assessment is based on physical and functional testing, not on clinical adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for devices that provide diagnostic interpretations or assist human readers in making decisions (e.g., AI for image analysis). The Ralco Model R605DASM is a hardware device for controlling X-ray beams.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not directly applicable in the typical sense of an "algorithm only" standalone performance study for an AI device. The device itself is an automatic collimator, meaning it operates autonomously to control the X-ray beam based on its internal programming and external signals. The "tests" performed would assess its standalone mechanical and electronic performance, in that sense, it is "standalone." However, this is not a standalone AI algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established engineering specifications, safety standards, and the physical accuracy of the collimator's movements and beam-limiting capabilities. For example:
- Engineering Specifications: Whether the 5 stepping motors accurately position the shutters.
- Safety Standards: Adherence to US Performance Standards and CSA Listing for safety.
- Functional Testing: The ability to correctly define round and elliptical fields as intended.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a mechanical and electronic system, not an AI model that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As explained in point 8, there is no "training set" in the typical sense for this device.
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510(k) Summary: K083029. DEC 0 5 2008 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 October 7, 2008 Contact person: Vincenzo Velardi, President and CEO
1. Identification of the Device:
Proprietary-Trade Name: Model R605DASM Automatic X-RAY Collimator Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator.
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- Indications for Use (intended use): Intended for use in diagnostic/fluoroscopic applications.
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- Description of the Device: This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..
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- Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and laboratory testing indicates that the new device is as safe and effective as the press, and The predicate device was made for Omega Medical Imaging and in fact carries virtually the same model name as the new Ralco device. The predicate employs a round field, same as our new device. The new 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 R605DASM is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivaliant to the predicate device.
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Raico SRL % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
DEC 0 5 2008
Re: K083029
Trade/Device Name: Model R605DASM 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: November 24, 2008
Received: November 25, 2008
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |
|---|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | |
| 21 CFR 894.xxx | (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 Biometrics' (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/odrh/industry/support/index.html.
Sincerely vours.
Arput M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosur
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Indications for Use
Kor3029 510(k) Number (if known):__
Device Name: __Model R605DASM Automatic X-RAY Collimator
Indications For Use: Model R605DASM 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __ 682029
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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.