(135 days)
R104/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographic/fluoroscopic applications.
These are square-field single- or, optionally, multi-layer x-ray collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.
The provided K110856 document details the premarket notification for RALCO's R104/A, R108, and R108 F Manual X-Ray Collimators. However, it does not contain specific acceptance criteria or an explicit study report with performance metrics in the way a clinical trial or algorithm validation study would.
Instead, this submission focuses on establishing substantial equivalence to a predicate device (K030487 Ralco R72 Manual Collimator) based on bench testing and safety testing. The core argument is that the new devices are "as safe and effective" as the predicate device due to similar design, intended use, and conformance to US Performance Standards.
Here's an analysis based on the information provided, highlighting what is and is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text, inferred) | Reported Device Performance (from text) |
|---|---|
| Safety and Effectiveness Equivalence: As safe and effective as the predicate device (K030487 Ralco R72 Manual Collimator). | "The results of bench, safety test, and laboratory testing indicates that the new devices are as safe and effective as the predicate device." |
| Technological Differences: Few technological differences compared to the predicate device. | "have few technological differences" (compared to the predicate device). |
| Indications for Use: Identical indications for use as the predicate device. | "has identical indications for use" (compared to the predicate device). |
| Conformance to Standards: Conforms to US Performance Standards and CSA Listed to US Standards for safety for medical devices. | "The new devices conform to US Performance Standards and are CSA Listed to US Standards for safety for medical devices." |
| Light Field Accuracy: Direct visualization of the x-ray field by a light beam that corresponds to the x-ray beam within a tolerance of two percent of the selected FFD (SID) value. | "Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value." (This is a design specification, not a specific test result from a study in the provided text, but implies it was met). |
Missing Information:
- Specific quantitative metrics for "safety" and "effectiveness" are not provided. For example, there are no reported measurements of radiation leakage, field size accuracy (beyond the 2% tolerance claim), or shutter precision from the bench tests.
- The document does not elaborate on the specific "bench, safety test, and laboratory testing" that led to these conclusions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "bench, safety test, and laboratory testing" but does not provide details on the number of units tested or the specific conditions.
- Data Provenance: Not specified, but generally, bench and laboratory testing for a device like this would be conducted by the manufacturer (Ralco srl, in Italy). The testing would be prospective in nature, as it's part of the design verification and validation process for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of information is not applicable to this submission. The device is a mechanical X-ray collimator. Its performance is evaluated through engineering and physical measurements (e.g., light field accuracy, shutter movement, structural integrity, electrical safety), not through expert interpretation of medical images or clinical outcomes. Therefore, there is no "ground truth" derived from medical experts in the context of a diagnostic reading study.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, typically for AI algorithms or reader performance studies. This is a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission is for a physical medical device (X-ray collimator), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance would be objective physical measurements and engineering specifications, e.g., using calibrated measuring equipment to verify dimensions, light intensity, field accuracy, mechanical movement tolerances, and electrical safety parameters. It is not based on expert consensus, pathology, or outcomes data in the medical sense.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" for its development or validation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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AUG 1 0 2011
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 Date prepared: March 18, 2011 Contact person: Vincenzo Velardi, President and CEO
Identification of the Device: 1.
Proprietary-Trade Name: R104/A, R108 and R108 F Manual X-Ray Collimators Classification Name: collimator, automatic, radiographic, Product Code IZX Common/Usual Name: Manual X-Ray Collimator.
Equivalent legally marketed devices: K030487 Ralco R72 Manual Collimator. 2.
Indications for Use (intended use): Intended for use in diagnostic/fluoroscopic applications. 3.
- Description of the Device: These are square-field single- or, optionally, multi-layer x-ray 4. collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.
- . 5. Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and laboratory testing indicates that the new devices are as safe and effective as the predicate device. The predicate employs a square field, same as our new device. The new devices conform to US Performance Standards and are CSA Listed to US Standards for safety for medical devices.
- Conclusion: After analyzing both bench and safety testing data, it is the conclusion of Ralco that the 6. R104/A, R108 and R108 F Manual X-Ray Collimators are as safe and effective as the predicate device, have few technological differences, and has identical indications for use, thus rendering them substantially equivalent to the predicate device.
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Image /page/1/Figure/0 description: The image shows two comparison photographs of two different devices. The device on the left is labeled "Predicate", and the device on the right is labeled "R104/A". Both devices appear to be housed in square or rectangular enclosures with cylindrical features on the sides and circular features on top. The image is presented in black and white.
R108 R108
F
Image /page/1/Figure/2 description: The image shows two different electronic devices. Both devices are box-shaped and appear to be made of metal. The device on the left has a circular opening on top and several knobs on the front. The device on the right has a similar circular opening on top, as well as a display screen and knobs on the front.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
RALCO S.R.L. % Mr. Daniel Kamm. P.E. Regulatory Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
AUG 10 2011
Re: K110856
Trade/Device Name: R104/A. R108 and R108 F Manual X-Ray Collimators Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam limiting device Regulatory Class: II Product Code: IZX Dated: August 7. 2011 Received: August 8, 2011
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. Iisting 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,
Mary Patel
Mary S. Pastel. Sc.D. 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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Indications for Use
510(k) Number (if known): K1117 88
Device Name: R104/A, R108 and R108 F Manual X-Ray Collimators
Indications For Use:
R104/A, R108 and R108 F Manual X-Ray Collimators are 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 In Vitro Diagnostic Devices (OIVD)
Mary Scott
(Dission Sig Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110856
Page 1 of 1
§ 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.