R 72

• K Number: K030487
• Device Name: R 72
• Manufacturer: RALCO S.R.L.
• Date Cleared: 2003-08-01 ( 168 days)
• Product Code: KPW
• Regulation Number: 892.1610
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K946320
• Predicate For: K093596 , K110856

Intended Use

Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.

Device Description

R72 X-Ray Collimator: External cover in abs plastic Single-layer, square field radiological collimator. Focus/mounting flange plane distance is 70mm. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ralco Model R72 X-Ray Collimator, based on the provided 510(k) summary:

This device (Ralco Model R72 X-Ray Collimator) is not an AI-powered device, therefore, many of the requested sections (sample sizes for test/training sets, expert details, MRMC studies, standalone performance) are not applicable as they relate to studies typically performed for AI/ML medical devices. The submission focuses on demonstrating substantial equivalence to a predicate device through bench and user testing.

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Acceptance Criteria and Device Performance

Characteristic	Acceptance Criteria (Predicate Device K946320)	Reported Device Performance (Ralco Model R72 K030487)
Intended Use	As a collimator on Model for operation on stationary units with fixed or rotating anode x-ray tube. Maximum radiation protection 150 kVp. Manual shutter control. Electronic timer for the activation of the light field. Plastic ABS covers.	As a collimator on Model for installation on portable and mobile units with fixed anode x-ray tubes. Maximum radiation protection 125 kVp. Two knobs on either side of the unit provide for the manual control of shutters. Electronic timer for the activation of the light-field simulating the x-ray field. (Note: Intended Use for R72 is specifically for portable/mobile units).
Physical Characteristics: Size	207mm H x 196mm W x 237mm D.	123 mm H x 168 mm W x 200 mm D
Physical Characteristics: Weight	9.5 kg	3.6 kg
Electrical: Energy Source	24 V 100w (lamp)	SAME (24 V 100w lamp)
Electrical: Timer	30 sec for light field projection lamp	SAME (30 sec for light field projection lamp)
Radiation Protection: kVp	150 kVp max	125 kVp max (Note: Lower than predicate device, consistent with intended use for portable/mobile units with fixed anode tubes).
Standards & Safety: Performance Standard	21 CFR 1020.30	SAME (21 CFR 1020.30)
Standards & Safety: Electrical safety	UL 2601, IEC 60601-1	SAME (UL 2601, IEC 60601-1)
Additional Specifications (from Device Description)	(Implicit in predicate: standard features for manual collimator, specific to stationary units, potentially with rotating anodes)	External adjustment of mirror angulation; High luminosity (quartz iodide lamp 100W 24V); Timer limiting projection lamp exposure to 30 seconds (adjustable); Radiation protection up to 125 kVp 4mA; Minimum inherent filtration 2mm aluminum equivalent; Continuous film coverage from 0x0 cm to 35x35 cm ±1% FFD at an FFD of 70cm. Warning: Not to be used with rotating anode X-ray tubes.

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Study Proving Device Meets Acceptance Criteria

The study described is a comparison to a legally marketed predicate device (Ralco Model R302, K946320) to demonstrate substantial equivalence. The device is an X-Ray Collimator, a hardware component, not an AI/ML device.

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

   • Test Set: Not explicitly quantifiable in terms of "samples" or "data" as would be for an AI model. The testing involved "bench and user testing." The document does not provide the number of units tested or the specific conditions of "user testing."
   • Data Provenance: Not specified, but implied to be from testing conducted by Ralco srl (Italy). The nature of "bench and user testing" suggests prospective testing rather than retrospective data analysis.

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

   • Not applicable as this is a hardware device submission, not an AI/ML device requiring expert ground truth for classification or interpretation. Testing would involve adherence to technical specifications and safety standards.

3. Adjudication method for the test set:

   • Not applicable for this type of submission. The evaluation is based on technical specifications and functional equivalence.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in image interpretation.

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

   • Not applicable. This device is a passive hardware component, not an algorithm. Its function is to limit the X-ray beam, and its performance is inherent in its design and physical characteristics, not in an interpretive algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance would be derived from engineering specifications, direct measurements (bench testing), and compliance with recognized standards (e.g., 21 CFR 1020.30, UL 2601, IEC 60601-1). For functional aspects like timer accuracy or beam coverage, the ground truth would be the expected performance based on design and physical measurement.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable, as there is no training set.

Summary

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K030487

AUG - 1 2003

Page 1 of 2

EXHIBIT 2 510(k) Summary of Safety and Effectiveness RALCO srl Via Schiapparelli 27/33 20035 LISSONE (MI) ITALY Tel: [phone] Fax: [phone] E-MAIL: [e-mail] June 10, 2003

Contact: Vincenzo Velardi, President and CEO

• Identification of the Device: 1. Proprietary-Trade Name: Model R72 Manually Operated X-Ray Collimator Classification Name: COLLIMATOR, MANUAL, RADIOGRAPHIC, Product Code IZX Common/Usual Name: Manually Operated X-Ray Collimator.
• 2. Equivalent legally marketed devices: Ralco Model R302, K946320
• Indications for Use (intended use): Model R72 is intended to be used as an X-Ray beam 3. limitation device on portable and mobile diagnostic X-Ray units.
• 4. Description of the Device: R72 X-Ray Collimator: External cover in abs plastic

Single-layer, square field radiological collimator.

Focus/mounting flange plane distance is 70mm.

The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.

Specifications

Warning: This collimator is not to be used with rotating anode X-ray tubes.

• · External adjustment of mirror angulation.
• · High luminosity provided by a quartz iodide lamp (100W 24V).
• · Timer limiting projection lamp exposure time to 30 seconds, adjustable, thus
• extending lamp life and preventing overheating.
• · Radiation protection up to 125 kVp 4mA .
• · Minimum Inherent filtration 2mm aluminum equivalent. (1mm on request)
• · Continuous film coverage from 0x0 cm to 35x35 cm ±1% FFD at an FFD of 70cm.
• 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.

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Characteristic	Ralco Model R302, K946320	Ralco Model R72 K030487
Intended Use:	As a collimator on Model for operation on stationary units with fixed or rotating anode x-ray tube. Maximum radiation protection 150 kVp. Manual shutter control. Electronic timer for the activation of the light field. Plastic ABS covers	As a collimator on Model for installation on portable and mobile units with fixed anode x-ray tubes. Maximum radiation protection 125 kVp. Two knobs on either side of the unit provide for the manual control of shutters. Electronic timer for the activation of the light-field simulating the x-ray field.
Physical characteristics:
Size	207mm H x 196mm W x 237mm D.	123 mm H x 168 mm W x 200 mm D
Weight	9.5 kg	3.6 kg
Energy Source:	24 V 100w (lamp)	SAME
Timer	30 sec for light field projection lamp	SAME
KvP	150 KvP max	125 max
Standards and Safety characteristics:
Performance Standard	21 CFR 1020.30	SAME
Electrical safety:	UL 2601, IEC 60601-1	SAME

• 6. Substantial Equivalence Chart, Model R72

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Ralco that the Model R72 is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

RALCO S.R.L. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K030487

Trade/Device Name: Model R72 X-Ray Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnoatic x-ray beam-limiting device Regulatory Class: II Product Code: 90 KPW

Dated: June 10, 2003 Received: June 13, 2003

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 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 (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.

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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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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j) Indications for Use

·

510(k) Number K030487

Device Name: Model R72 X-Ray Collimator

Indications for Use: Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over the Counter Use (Per 21 CFR 801.109)

Carole L. Symons

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

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.