(53 days)
Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications fluoroscopic applications.
This is a compact collimator with an external cover in ABS plastic. It is a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.
This 510(k) summary describes a manual X-ray collimator (Model R 72B) and primarily focuses on demonstrating its substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for algorithm-based devices.
Here's an analysis based on the provided text, addressing the points where information is available or noting where it's not applicable for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (implicit: comparable to predicate device) | "The results of bench, safety test, and laboratory testing indicates that the new device is as safe and effective as the predicate device." |
| Identical Components and Specifications (implicit: for substantial equivalence) | "This device is identical to the predicate device made with the same components and specifications." |
| Conformity to US Performance Standards | "The device conforms to US Performance Standards..." |
| CSA Listed to US Standards for Safety for Medical Devices | "...and is CSA Listed to US Standards for safety for medical devices." |
| Few Technological Differences (implicit: for substantial equivalence) | "...has few technological differences..." |
| Identical Indications for Use | "...and has identical indications for use..." |
Summary of Device Performance: The device (Model R 72B Manual X-Ray Collimator) was determined to be substantially equivalent to the predicate device (Ralco Model R72, K030487) based on bench, safety, and laboratory testing. It is reported to be identical in components and specifications, conforms to US Performance Standards, is CSA Listed, has few technological differences, and shares identical indications for use.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of this 510(k) submission. This submission is for a physical medical device (an X-ray collimator) and focuses on engineering specifications, safety testing (bench, electrical, mechanical), and comparison to a predicate device. It does not involve a "test set" of clinical data to evaluate an algorithm's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. Since there is no "test set" in the context of a clinical performance study involving image interpretation by experts, there is no ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This submission is for a physical X-ray collimator, not an AI or imaging software device that would typically undergo an MRMC study to evaluate human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a manual X-ray collimator; there is no embedded algorithm to evaluate in a standalone capacity.
7. The Type of Ground Truth Used
The "ground truth" for this device relates to its engineering specifications, safety features, and performance as a physical component in an X-ray system. This would be established through:
- Engineering specifications and drawings: Defining the design, materials, and dimensions.
- Bench testing: Verifying mechanical function, field size accuracy, light field/X-ray field congruence, leakage radiation, etc.
- Safety testing: Ensuring electrical safety, radiation safety (e.g., leakage radiation limits), and compliance with relevant standards (e.g., CSA listing).
- Comparison to predicate device: Direct comparison of features and performance characteristics to the legally marketed predicate.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an AI or algorithm development for this physical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
In summary: K093596 is a 510(k) for a manual X-ray collimator. The approval is based on demonstrating substantial equivalence to a predicate device (Ralco Model R72, K030487) through bench, safety, and laboratory testing, confirming identical components, specifications, and indications for use, and adherence to relevant performance and safety standards. The concepts of clinical test sets, ground truth by experts, and AI performance evaluations are not relevant to this type of device submission.
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510(K) Summary, K093596 Lumos, Inc. 45945 Trefoil Lane, Suite 112 Sterling, VA 20166 Office: (703) 796-1890 Fax: (703) 796-1893 Date prepared: November 18, 2009
Contact person: James Whittaker, President and CEO
JAN 1 2 2010
Identification of the Device: 1.
Proprietary-Trade Name: Model R 72B Manual X-RAY Collimator Classification Name: collimator, manual, radiographic, Product Code KPW Common/Usual Name: Manual X-Ray Collimator.
- Equivalent legally marketed devices: This device is IDENTICAL to the Ralco Model R72 2. (K030487). This submission sets a baseline for Lumos Inc. to manufacture and control the design of the collimator shown in K030487 ..
- Indications for Use (intended use): Intended for use in diagnostic or fluoroscopic applications. 3.
- Description of the Device: This is a compact collimator with an external cover in ABS plastic. It is ব a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.
- Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and 5. laboratory testing indicates that the new device is as safe and effective as the predicate device. This device is identical to the predicate device made with the same components and specifications. The device conforms to US Performance Standards and is 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. Model R 72B is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devise,
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines, giving it a modern and abstract appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Lumos, Inc. (formerly Ralco, Inc.) % Mr. Daniel Kamm Principal Consultant Kamm & Associates 8726 Ferrara Ct. NAPLES FL 34114
Re: K093596
Trade/Device Name: Model R 72B Manual Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: KPW Dated: May 20, 2009 Received: November 25, 2009
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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misburoning and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 coax 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. Your 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); medical device reporting (reporting of medical
JAN 1 2 2010
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device-related adverse events} (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting 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): K093 (x)
Device Name: Model R 72B Manual Collimator
Indications For Use:
Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or
fluoroscopic applications 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)
Heler Rumen
(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.