The CoreLite device is a cabinet X-ray system used to provide digital X-ray images of specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Performing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Device Description

The CoreLite Specimen Radiography System is a self-contained digital imaging system for verification of breast biopsy specimens at the point of care which enables the procedure to be completed faster. The system is comprised of the x-ray cabinet and the PC with DICOM compliant software which provides the user interface, means to enter patient details (either directly or from a DICOM Modality Worklist, if available) and the means to acquire, review and save or transmit DICOM images to the Picture Archiving and Communication System (PACS). The cabinet incorporates shielding and interlock circuits to meet requlatory requirements.

AI/ML Overview

The provided FDA 510(k) summary for the Cirdan Imaging Limited CoreLite device indicates that it is a cabinet X-ray system for verifying breast biopsy specimens. It states that the device was benchmarked against a predicate device (Faxitron CoreVision Digital Specimen Radiography (DSR) System) in a clinical setting to demonstrate substantial equivalence. However, the document does not provide detailed acceptance criteria or the specifics of a study proving the device meets particular quantitative performance metrics with associated sample sizes, ground truth establishment, or expert involvement as typically requested.

Based on the provided text, here is the information that can be extracted and a clear indication of what is not present:

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

The document does not provide a table of explicit quantitative acceptance criteria for image quality or clinical performance, nor does it present specific numerical performance results. It only states a qualitative outcome for the comparison study.

Acceptance Criteria	Reported Device Performance
Not specified	Clinical equivalence to the predicate device was judged.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document only mentions "a clinical setting" for benchmarking.
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The document states "the results were judged to be equivalent to the predicate," implying expert judgment, but does not detail the number or qualifications of these experts.

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

Not specified.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study described was a benchmarking of the device (CoreLite) against a predicate device, focusing on image quality and clinical equivalence. There is no mention of AI assistance or its effect on human readers. The CoreLite system is described as a digital imaging system, not an AI-powered diagnostic aid.

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

The CoreLite is an X-ray system itself, not an algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable in the typical sense of AI algorithms. The system's performance revolves around its ability to produce digital X-ray images for verification. "Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets" which could be considered a standalone technical performance assessment of image quality.

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

The document implies a qualitative assessment against the predicate device in a clinical setting. It states "the results were judged to be equivalent to the predicate." This suggests the ground truth was likely established by comparison to the established predicate device's performance, potentially through expert comparison of images or assessment of successful specimen verification. Specific details about the ground truth (e.g., pathology confirmation of tissue presence) are not provided.

8. The sample size for the training set

Not applicable. The CoreLite is an X-ray imaging system, not a machine learning algorithm that requires a training set.

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

Not applicable, as it's not an AI/ML device requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2019

Cirdan Imaging Limited % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114

Re: K193317

Trade/Device Name: CoreLite Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: November 27, 2019 Received: November 29, 2019

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T, Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193317

Device Name Corelite

Indications for Use (Describe)

Performing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for CIRDAN. The logo consists of a green spiral on the left and the word "CIRDAN" in black letters on the right. The spiral is made up of several concentric circles that get smaller as they move towards the center.

Section 5. 510(K) Summary

Premarket Notification 510 (k) Summary, as required by 21 CFR 807.92

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

Date Prepared: 11th October 2019

Identification of the Device:

Trade Name:	CoreLite
Classification Name:	Stationary X-Ray System
Classification Regulation:	21 CFR 892.1680
Product Code (Precode):	MWP
Device Class:	Class II
Panel:	Radiologic Devices Panel

Manufacturer:

Cirdan Imaging Ltd 8 Enterprise Crescent, Ballinderry Road, Lisburn, BT28 2BP, County Antrim, Northern Ireland, United Kingdom

Contact:	Jenna McGarry
	QARA
	Phone +44 (0)2892 660880

Legally Marketed Predicate Device

Trade Name:	Faxitron CoreVision Digital SpecimenRadiography (DSR) System
Classification Name:	Cabinet X-Ray System
Classification Regulation:	21 CFR 892.1680
Product Code (Precode):	MWP
Device Class:	Class II
Panel:	Radiologic Devices Panel
Submitter/510K Holder:	Faxitron Bioptics Inc.
Clearance	K082432 (Cleared 21st November 2008)

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Image /page/4/Picture/0 description: The image shows the logo for CIRDAN. The logo consists of a green spiral symbol on the left and the word "CIRDAN" in black capital letters on the right. The spiral symbol is made up of several concentric circles that curve inward to form a spiral shape. The word "CIRDAN" is written in a simple, sans-serif font.

DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)

INDICATIONS FOR USE - as required by 807.92(a)(5)

Performing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

DEVICE CLAIMS - as required by 807.92(a)

The CoreLite X-ray Specimen Cabinet has been designed to comply with the following standards and regulations:

. IEC 61010-1:2010. Ed.3
IEC 61010-2-091:2012. Ed.1 .
. IEC 61010-2-101:2015. Ed.2
IEC 61326-1:2012. Ed.2 ●
21 CFR 1020.40, ●
47 CFR 15.107, 15.109 .

CoreLite Software supports the DICOM Store and Modality Worklist services.

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Image /page/5/Picture/0 description: The image contains the word "CIRDAN" in a bold, sans-serif font. To the left of the word is a green spiral design. The spiral consists of several concentric curves that create a sense of depth and movement. The overall design is simple and modern.

TECHNOLOGICAL CHARACTERISTICS SUMMARY- as required by 807.92(a)(6)

The CoreLite X-ray Specimen Cabinet has the same indications for use, general configuration, and principles of operation as the predicate devices listed above. The technological characteristics of the CoreLite X-ray Specimen Cabinet have been compared to the predicate device cited and is covered in detail in the Substantial Equivalence section of this submission.

UseDescription.	CoreVision (Predicate)	CoreLite
Environmentof Use	Hospital/Healthcare Facility(Radiology/mammographyClinic)	Hospital/Healthcare Facility(Radiology/mammographyClinic)
Integratedshielding	Yes	Yes
Anodematerial	Tungsten	Tungsten
Focal Spot	50 um nominal	50 um nominal
WindowFiltration	Beryllium	Beryllium
Detectiontechnology	Indirect	Indirect
SensorTechnology	CMOS	CMOS
Imaging Area(mm)	26 X 75 mm	42 X 67 mm
Software Levelof Concern	Moderate	Moderate
DICOMModalityWorklist	YES	YES
PACSconnectivity	YES	YES
UI	Traditional Windows UI(toolbar, dropdown menusetc.)	Streamlined touch driven UI

COMPARISON WITH PREDICATE DEVICE.

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Image /page/6/Picture/0 description: The image shows the word "CIRDAN" in black, with a green spiral to the left of the word. The spiral is made up of several concentric circles that get progressively smaller as they move towards the center. The word "CIRDAN" is in a simple, sans-serif font.

PERFORMANCE DATA TESTING AND REVIEW- as required by 807.92(b)(1)

The CoreLite system successfully performed design control verification tests and validation tests.

The CoreLite complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems and in-vitro products) and international EMC standards/regulations including FCC.

Compliance was demonstrated by the third-party test house, a member of the NRTL scheme.

Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets. Additionally, the device was benchmarked against the predicate in a clinical setting: the results were judged to be equivalent to the predicate.

Results of these performance tests, combined with design and comparison with the predicate device, support substantial equivalence.

SUBSTANTIAL EQUIVALENCE SUMMARY

The CoreLite X-ray Specimen Cabinet has the same indications for use as the predicate device cited. The technical characteristics of the CoreLite Xray Specimen Cabinet are the same or similar to the predicate device and do not raise any new questions on the safety and effectiveness of the proposed device.

CONCLUSIONS - as required 807.92(b)(3)

We conclude that the documentation and testing included in this submission indicates that the CoreLite X-ray Specimen Cabinet is safe and effective and substantially equivalent to the predicate device cited.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.