(10 days)
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.
The provided text describes a 510(k) premarket notification for the Collimare "Collimator Family" device, which is an X-ray beam limiting device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes, ground truth establishment, or any details related to AI/human reader studies.
The document primarily focuses on:
- Submission details: Submitter, contact, common/trade/classification names, predicate devices.
- Device description and intended use: Control of X-ray beams for diagnostic imaging.
- Performance standards / Safety Information: References existing regulatory standards (21 CFR Section 1020.30, .31 & .32; UL 60601-1; IEC 60825-1).
- FDA correspondence: The FDA's determination of substantial equivalence to predicate devices.
- Indications for Use statement.
Therefore, I cannot provide the requested information in the table or answer the specific questions as the input text does not contain it. This type of document, a 510(k) summary and FDA decision letter, typically attests to compliance with established safety and performance standards rather than presenting novel clinical study data with specific acceptance criteria as you might see for a diagnostic AI device.
In summary, none of the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC/standalone studies is present in the provided text.
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K073/24
Image /page/0/Picture/1 description: The image contains a logo and the word "Collimare". The logo is on the left side of the image and consists of a stylized design with lines and bars. The word "Collimare" is on the right side of the image and is written in a simple, sans-serif font. The text is black and the background is white.
NOV 1 6 2007
510(k) Summary
| Date: | August 24, 2007 |
|---|---|
| 510(k) Number | |
| Submitter: | Collimare, LLC13406 W 60 TH PLArvada, CO 80004 |
| Contact: | Howard C. Thomas, President |
| Phone: | (303) 955-3091 |
| Fax: | (303) 955-3092 |
| Common Device Name: | Manual or Automatic Collimator |
| Trade Name: | Collimare "Collimator Family" |
| Classification Name: | Diagnostic X-ray Beam Limiting Device |
| Classification Regulation Number: | IZX & IZW |
| Classification Committee/Panel: | Radiology |
| Predicate Devices: | X-Ray Collimating Devices K810598Manufactured by Eureka X-Ray TubeAXT150MC K972966 Manufacturedby Applied X-Ray Technologies |
Description: The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.
Intended Use: The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
Performance Standards / Safety Information: X-Ray Performance Standard 21 CFR Section 1020.30, .31 & .32 // UL 60601-1 Standard for Safety, Medical Electrical Equipment // IEC 60825-1 Ed: 1 Safety of laser products - Part 1: Equipment classification and requirements
Collimare, LLC 13406 W 60™ PL Arvada, CO 80004 P: 303.955.3091 F: 303.955.3092
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem featuring three wavy lines above a bird-like figure, all rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Collimare LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K073124
Trade/Device Name: Collimare "Collimator Family" Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW and IZX Dated: November 5, 2007 Received: November 6, 2007
Dear Mr. Job:
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 Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use
510(k) Number (if known): KC73124
Device Name: _Collimare "Collimator Family"
Indications for Use:
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hore 75 Wtz
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K073124
§ 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.