K Number
K193317
Device Name
CoreLite X-Ray Specimen Cabinet
Date Cleared
2019-12-13

(14 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a standard digital X-ray system for specimen imaging and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.

No
The CoreLite device is an imaging system designed for rapid verification of excised tissue specimens during biopsy procedures. It provides digital X-ray images to confirm that the correct tissue has been removed, which primarily serves to improve workflow and reduce patient examination time. It does not directly treat, diagnose, or prevent disease in a patient, which are characteristics of a therapeutic device.

No
The device is used to verify that the correct tissue has been excised during a biopsy procedure, which is a procedural verification rather than the diagnosis of a disease or condition. It visualizes specimens, but does not identify a disease or condition.

No

The device description explicitly states it is comprised of an x-ray cabinet and a PC with software, indicating it includes hardware components beyond just software.

Based on the provided information, the CoreLite device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs are used to examine specimens from the human body to provide information about a physiological state, health, or disease. They typically involve tests performed on biological samples like blood, urine, tissue, etc., outside of the body.
  • The CoreLite device is an X-ray system used to image specimens after they have been excised from the body. Its purpose is to verify that the correct tissue has been removed during a biopsy procedure. It's a tool for imaging the physical specimen, not for performing a diagnostic test on the specimen's biological properties.

The device falls under the category of medical imaging equipment, specifically a specimen radiography system. Its function is to provide visual confirmation of the excised tissue, which is a procedural step rather than a diagnostic test on the specimen itself.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MWP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

specimens from various anatomical regions (specifically mentions breast biopsy specimens later in device description)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital/Healthcare Facility (Radiology/mammography Clinic)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082432

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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

1

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

2

Indications for Use

510(k) Number (if known) K193317

Device Name Corelite

Indications for Use (Describe)

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.

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

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.

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

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 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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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.

| Use

Description.CoreVision (Predicate)CoreLite
Environment
of UseHospital/Healthcare Facility
(Radiology/mammography
Clinic)Hospital/Healthcare Facility
(Radiology/mammography
Clinic)
Integrated
shieldingYesYes
Anode
materialTungstenTungsten
Focal Spot50 um nominal50 um nominal
Window
FiltrationBerylliumBeryllium
Detection
technologyIndirectIndirect
Sensor
TechnologyCMOSCMOS
Imaging Area
(mm)26 X 75 mm42 X 67 mm
Software Level
of ConcernModerateModerate
DICOM
Modality
WorklistYESYES
PACS
connectivityYESYES
UITraditional Windows UI
(toolbar, dropdown menus
etc.)Streamlined touch driven UI

COMPARISON WITH PREDICATE DEVICE.

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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.