CoreLite X-Ray Specimen Cabinet

K193317 · Cirdan Imaging Limited · MWP · Dec 13, 2019 · Radiology

Device Facts

• Record ID: K193317
• Device Name: CoreLite X-Ray Specimen Cabinet
• Applicant: Cirdan Imaging Limited
• Product Code: MWP · Radiology
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 Story

CoreLite is a self-contained cabinet X-ray system for point-of-care verification of biopsy specimens. It consists of an X-ray cabinet and a PC running DICOM-compliant software. The system acquires digital X-ray images of excised tissue, allowing clinicians to verify that the correct tissue was removed during the biopsy procedure. The device is used in hospitals or healthcare facilities (radiology/mammography clinics). The user interface allows for patient data entry (manual or via DICOM Modality Worklist), image acquisition, review, and transmission to PACS. By enabling immediate verification in or near the procedure room, the device improves workflow and reduces patient time under examination. The cabinet includes shielding and interlock circuits for safety.

Clinical Evidence

Bench testing included electrical safety (IEC 61010-1, 61010-2-091, 61010-2-101), EMC (IEC 61326-1, FCC), and image quality verification using phantom test objects and high-contrast resolution targets. Clinical benchmarking against the predicate device was performed, with results judged to be equivalent.

Technological Characteristics

Cabinet X-ray system; Tungsten anode; Beryllium window filtration; Indirect CMOS sensor technology; Imaging area 42 x 67 mm; Integrated shielding and interlock circuits; DICOM/PACS connectivity; Touch-driven UI; Complies with IEC 61010-1, IEC 61010-2-091, IEC 61010-2-101, IEC 61326-1, 21 CFR 1020.40, and 47 CFR 15.107/15.109.

Indications for Use

Indicated for patients undergoing biopsy procedures requiring rapid verification of excised tissue from various anatomical regions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Faxitron CoreVision Digital Specimen Radiography (DSR) System (K082432)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

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) | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 [phone] |

#### Legally Marketed Predicate Device

| Trade Name: | Faxitron CoreVision Digital Specimen<br>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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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)

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<br>Description. | CoreVision (Predicate) | CoreLite |
|-------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Environment<br>of Use | Hospital/Healthcare Facility<br>(Radiology/mammography<br>Clinic) | Hospital/Healthcare Facility<br>(Radiology/mammography<br>Clinic) |
| Integrated<br>shielding | Yes | Yes |
| Anode<br>material | Tungsten | Tungsten |
| Focal Spot | 50 um nominal | 50 um nominal |
| Window<br>Filtration | Beryllium | Beryllium |
| Detection<br>technology | Indirect | Indirect |
| Sensor<br>Technology | CMOS | CMOS |
| Imaging Area<br>(mm) | 26 X 75 mm | 42 X 67 mm |
| Software Level<br>of Concern | Moderate | Moderate |
| DICOM<br>Modality<br>Worklist | YES | YES |
| PACS<br>connectivity | YES | YES |
| UI | Traditional Windows UI<br>(toolbar, dropdown menus<br>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.