(29 days)
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No
The document describes a standard digital X-ray imaging system for specimens and does not mention any AI or ML capabilities for image analysis, interpretation, or workflow optimization beyond basic DICOM functionality.
No.
The device is used to generate X-ray images of excised tissue for verification purposes, not to treat a disease or condition.
No
The device is used to verify that the correct tissue has been excised from a biopsy specimen, and confirms the presence of a lesion, marker or calcification in the extracted sample. It does not provide a diagnosis of a patient's condition.
No
The device description explicitly states it is a "cabinet x-ray system" comprised of an "x-ray cabinet," "optional cart," and a "PC with DICOM compliant software." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Solas OR device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition. The key is that the testing is done outside the body ("in vitro").
- Solas OR Function: The Solas OR is an X-ray system used to image surgical and core biopsy specimens after they have been removed from the body. Its purpose is to verify that the correct tissue has been excised. While it examines a specimen taken from the body, it does so using an imaging modality (X-ray) to visualize the physical structure of the specimen, not to perform biochemical, immunological, or other tests on the specimen's components.
- Intended Use: The intended use clearly states it's for "providing digital X-ray images of surgical and core biopsy specimens" to "allow rapid verification that the correct tissue has been excised." This is an imaging and verification function, not a diagnostic test performed on the specimen itself.
- Device Description: The description focuses on the X-ray imaging capabilities, the cabinet, software, and image handling. It doesn't mention any components or processes related to analyzing the chemical or biological properties of the specimen.
In summary, the Solas OR is a medical imaging device used to visualize excised tissue specimens, not a device that performs diagnostic tests on those specimens.
N/A
Intended Use / Indications for Use
The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.
Product codes (comma separated list FDA assigned to the subject device)
MWP
Device Description
The Solas OR cabinet x-ray system is a self-contained, direct-detection digital imaging system for imaging small to medium surgical and biopsy specimens. The system is comprised of the x-ray cabinet, optional cart and the PC with DICOM compliant software which provides the user interface, the 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 regulatory requirements. The cabinet cart is mounted on casters to allow for easy transportation.
Specimen radiography units are utilized to confirm removal of the intended tissue, lesion, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution x-ray image of the specimen, the presence of a lesion, marker or calcification in the extracted sample can be confirmed by the user reviewing the digital image.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
Various anatomical regions (surgical and core biopsy specimens)
Indicated Patient Age Range
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Intended User / Care Setting
surgical suite, biopsy suite
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 performance has been benchmarked against the predicate in a clinical setting.
Results of these performance tests, combined with design and comparison with the predicate device, support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cirdan Imaging Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K213691
Trade/Device Name: Solas OR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: November 22, 2021 Received: November 23, 2021
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
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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); 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 medical devices and radiation-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) K213691
Device Name Solas OR
Indications for Use (Describe)
The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.
Type of Use (Select one or both, as applicable)
| X 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 on the right. The spiral is made up of several concentric circles, and the word "CIRDAN" is in a sans-serif font.
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
15th October 2021 Date Prepared:
Identification of the Device:
| Trade Name:
Regulation Name:
Classification Requlation:
Product Code (Precode):
Device Class:
Panel: | Solas OR
Stationary X-Ray System
21 CFR 892.1680
MWP
Class II
Radiologic Devices Panel |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Cirdan Imaging Ltd
Riverbank,
The Green,
Tullynacross Road
Lambeg,
County Antrim,
Northern Ireland,
United Kingdom
BT27 5SR |
| Contact: | Paul Matthews
Head of QARA
Phone +44 (0)2892 660880 |
Legally Marketed Predicate Device
| Trade Name: | BioVision Digital Specimen Radiography
System |
|----------------------------|--------------------------------------------------|
| Regulation Name: | Stationary X-Ray System |
| Classification Regulation: | 21 CFR 892.1680 |
| Product Code (Precode): | MWP |
| Device Class: | Class II |
| Panel: | Radiologic Devices Panel |
| Submitter/510K Holder: | Bioptics, Inc. |
| Clearance | K091558 (Cleared July 17, 2009) |
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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 letters on the right. The spiral symbol is made up of several concentric circles that curve inward towards the center. The word "CIRDAN" is written in a bold, sans-serif font.
DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)
The Solas OR cabinet x-ray system is a self-contained, direct-detection digital imaging system for imaging small to medium surgical and biopsy specimens. The system is comprised of the x-ray cabinet, optional cart and the PC with DICOM compliant software which provides the user interface, the 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 regulatory requirements. The cabinet cart is mounted on casters to allow for easy transportation.
Specimen radiography units are utilized to confirm removal of the intended tissue, lesion, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution x-ray image of the specimen, the presence of a lesion, marker or calcification in the extracted sample can be confirmed by the user reviewing the digital image.
INDICATIONS FOR USE - as required by 807.92(a)(5)
A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
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Image /page/5/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 progressively smaller towards the center. The word "CIRDAN" is written in a bold, sans-serif font.
DEVICE CLAIMS – as required by 807.92(a)
The Solas OR cabinet X-ray system has been designed to comply with the following standards and requlations:
- . IEC 61010-1:2010. Ed.3
- IEC 61010-2-091:2012. Ed.1 .
- IEC 61010-2-101:2015. Ed.2 .
- IEC 61326-1:2013. Ed.2 .
- 21 CFR 1020.40, ●
- 47 CFR 15.107, 15.109 .
- 47 CFR 15.107, 15.107 .
Solas OR software supports the DICOM Store and Modality Worklist services.
TECHNOLOGICAL CHARACTERISTICS SUMMARY- as required by 807.92(a)(6)
The Solas OR cabinet x-ray system has the same indications for use, general configuration, and principles of operation as the predicate device cited. The technological characteristics of the Solas OR cabinet x-ray system have been compared to the predicate device cited and is covered in detail in the Substantial Equivalence section of this submission.
COMPARISON WITH PREDICATE DEVICE.
| Characteristic | Bioptics BioVision
(Predicate K091558) | Solas OR |
|----------------------------------------------------------------|--------------------------------------------------------------|--------------------------------|
| Environment of Use | surgical suite, biopsy suite | surgical suite, biopsy suite |
| Used for excised surgical and
percutaneous biopsy specimens | YES | YES |
| Integrated shielding | Yes | Yes |
| Anode material | Tungsten | Tungsten |
| Window Filtration | Beryllium | Beryllium |
| Detection technology | Indirect | Direct |
| Sensor Technology | CMOS | CdTel Hybrid CMOS |
| Imaging Area mm(nominal) | 10 cm x 15 cm | 12 cm x 15 cm |
| Resolution (contact mode) | 10 lp/mm | 10 lp/mm |
| Software Level of Concern | Moderate | Moderate |
| DICOM Modality Worklist | YES | YES |
| PACS connectivity | YES | YES |
| UI | Traditional Windows UI
(toolbar, dropdown menus
etc. ) | Streamlined touch driven
UI |
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Image /page/6/Picture/0 description: The image shows the CIRDAN logo. 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. The word "CIRDAN" is in a sans-serif font and is all uppercase.
PERFORMANCE DATA TESTING AND REVIEW- as required by 807.92(b)(1)
The Solas OR system successfully performed design control verification tests and validation tests.
The Solas OR complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems) and international EMC standards/regulations including FCC.
Compliance to IEC 61010 standards was demonstrated by a third-party test house which is 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 performance has been benchmarked against the predicate in a clinical setting.
Results of these performance tests, combined with design and comparison with the predicate device, support substantial equivalence.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Solas OR X-ray Specimen Cabinet has the same indications for use as the predicate device cited. The technical characteristics of the Solas OR 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 Solas OR X-ray Specimen Cabinet is safe and effective and substantially equivalent to the predicate device cited.