The Dunlee "FORMAT" collimator family restricts the dimensions of the diagnostic X-rav field by limiting the size of the primary X-ray beam.
The Dunlee manual "FORMAT M" collimators are intended for use in diagnostic X-ray systems during radiographic examinations.
The Dunlee automatic "FORMAT A" collimators are intended for use in diagnostic X-ray systems during radiographic and fluoroscopic examinations.

Device Description

The Dunlee "FORMAT" collimator family is a family of Beam-Limiting Devices, which comprises both manual and automatic collimators. The manual collimators are to be used in diagnostic radiographic X-ray systems, and the automatic collimators are to be used in both diagnostic fluoroscopy X-ray systems and diagnostic radiographic X-ray systems.

AI/ML Overview

This 510(k) summary describes a device called the "Dunlee 'FORMAT' collimator family," which comprises both manual and automatic collimators for diagnostic X-ray systems. The submission asserts that this device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The provided document does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it focuses on general compliance with safety and performance standards and substantial equivalence to predicate devices.

However, based on the Safety Information section, we can infer the acceptance criteria are compliance with:

Acceptance Criterion (Inferred from Safety Information)	Reported Device Performance (as stated in the document)
Compliance with Performance Standards for Ionizing Radiation Emitting Products (21CFR1020.30, 21CFR1020.31, 21CFR1020.32)	The Dunlee "FORMAT" collimator family will comply with the applicable requirements.
Compliance with National Safety Standard UL 2601-1	The Dunlee "FORMAT" collimator family will comply.
Compliance with National Safety Standard CAN/CSA-C22.2 no. 601-1	The Dunlee "FORMAT" collimator family will comply.
Compliance with International Safety Standard IEC 60601-1	The Dunlee "FORMAT" collimator family will comply.
Compliance with International Safety Standard IEC 60601-1-2	The Dunlee "FORMAT" collimator family will comply.
Compliance with International Safety Standard IEC 60601-1-3	The Dunlee "FORMAT" collimator family will comply.
Compliance with International Safety Standard IEC 60601-2-28	The Dunlee "FORMAT" collimator family will comply.
Compliance with International Safety Standard IEC 60601-2-43	The Dunlee "FORMAT" collimator family will comply.
No new indications for use introduced	The Dunlee "FORMAT" collimator family does not introduce any new indications for use.
No new potential hazards introduced	The Dunlee "FORMAT" collimator family does not result in any new potential hazard.
Substantial equivalence to predicate devices	Dunlee considers the FORMAT collimator family to be substantially equivalent with the predicate devices.

2. Sample size used for the test set and the data provenance:

The document does not mention a traditional "test set" sample size or data provenance in the context of a clinical performance study. The evaluation presented is one of compliance with standards and substantial equivalence to predicate devices, not direct performance data from a specific patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable or provided in the document. The substantial equivalence determination for this type of device (X-ray collimator) typically relies on engineering specifications, safety standards, and comparison to existing devices, rather than a "ground truth" derived from expert image interpretation or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable or provided. There is no mention of a test set that would require an adjudication method.

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:

This document does not describe an MRMC comparative effectiveness study. The device is an X-ray beam-limiting device (collimator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this section is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This document does not describe a standalone performance study in the context of an algorithm. The device is hardware (a collimator), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

As discussed, a traditional "ground truth" for clinical performance is not applicable to the submission for an X-ray collimator. The "truth" in this context is adherence to engineering specifications, regulatory standards, and the demonstrated functionality of the device in limiting X-ray beams as intended.

8. The sample size for the training set:

The document does not mention a "training set" sample size. This is not an AI/machine learning device that undergoes a training phase with data.

9. How the ground truth for the training set was established:

This information is not applicable as there is no "training set" for this type of device.

Summary

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JUL 2 1 2003

Ko31597

Philips Medical Systems

510(k) SUMMARY

Company name:Address:	Philips Medical Systems North America Company22100 Bothell Everett HighwayP.O. Box 3003Bothell, WA 98041-3003, U.S.A.
Registration No.:	1217116
Contact person:Telephone No.:	Lynn Harmer(425) 487-7312
Date prepared:	2003-03-20
Device (trade) name:	Dunlee "FORMAT" collimator family
Classification name:	Diagnostic X-ray Beam-Limiting Device (21CFR892.1610),Class II (Procodes: 90 IZW & 90 IZX).
Common/usual name:	Automatic resp. Manual Radiographic Collimator.

Predicate device:

The Dunlee manual "FORMAT M" collimators are substantially equivalent to the pre-. amendment manual collimators with codenumbers 9804 602 60501 and 9804 602 61501 (BRH accession number 7410693), manufactured by Philips Medical Systems.
The Dunlee automatic "FORMAT A" collimators are substantially equivalent to the NICOL . collimator family manufactured by Philips Medical Systems, which has been determined to be substantially equivalent to legally marketed predicate devices under number K990423.

Device description:

Intended use:

. The Dunlee "FORMAT" collimator family restricts the dimensions of the diagnostic X-rav field by limiting the size of the primary X-ray beam.
. The Dunlee manual "FORMAT M" collimators are intended for use in diagnostic X-ray systems during radiographic examinations.
. The Dunlee automatic "FORMAT A" collimators are intended for use in diagnostic X-ray systems during radiographic and fluoroscopic examinations.

Safety information:

The Dunlee "FORMAT" collimator family will comply with the applicable requirements of the . performance standards for ionizing radiation emitting products (21CFR1020.30, 21CFR1020.31 and 21CFR1020.32).
. The Dunlee "FORMAT" collimator family will comply with national safety standards UL 2601-1 and CAN/CSA-C22.2 no. 601-1.
The Dunlee "FORMAT" collimator family will comply with international safety standards . IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28 and IEC 60601-2-43.

Conclusion:

The Dunlee "FORMAT" collimator family does not introduce any new indications for use, nor does the use of the devices result in any new potential hazard. Dunlee considers the FORMAT collimator family to be substantially equivalent with the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

JUL 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431

Re: K031597

Trade/Device Name: Dunlee "Format" Collimator Family Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beamlimiting device Regulatory Class: II Product Code: 90 IZW and IZX Dated: May 19, 2003 Received: June 9, 2003

Dear Ms. Harmer:

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 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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510(k) Number (if known): K 0 3 /5 97

Device Name: DUNLEE "FORMAT" COLLIMATOR FAMILY

The Format collimator family will be used in Radiography, Fluoroscopy, Cardio and Vascular Xray systems. It has the following functionality (configuration dependant):

X-ray field limitation (rectangular and circular); rectangular shuttering in some configurations . with direct user control at the collimator head (direct shutter control)
Simulation of X-ray field by a light field .
Measurement of source image distance (with an electronic or mechanical ruler) ●
Spectral filtering ●
Wedge filtering (semi-transparent filtering)
Dose measurement (Area Exposure Product Measurement device) .

Format family consists of a manual version and automatic versions. The product configuration of the automatic version depends on the configuration of the X-ray system. It's a modular concept in which collimator functionalities can be added for radiographic or fluoroscopy applications,

The automatic collimators have an ISO-CAN software interface with the system through which they receive system commands at open-close level.

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David G. Ingram

Division Sign-Off ivision of Reproductive, Abdominal. and Radiological D 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Indications for Use

Regulation Number and Section

§ 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.