(96 days)
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 procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.
The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView Core 100Pro-US includes the following major components: touch-screen control display, and an imaging cabinet. This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding.
The provided FDA submission for the TrueView Core 100Pro-US Core Specimen Radiography System is not an AI/ML device. It is a cabinet X-ray system used for digital X-ray imaging of surgical and core biopsy specimens. Therefore, the specific criteria requested for AI/ML devices regarding acceptance criteria, study details, human reader improvement, and ground truth establishment (for training/test sets) are not applicable to this submission.
The document discusses performance data related to the device's electrical safety, mechanical hazards, and electromagnetic compatibility, as shown by compliance with IEC 61010 standards and various functional and usability tests.
Here is a summary of the information that is applicable and found in the document:
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on compliance with standards rather than specific acceptance criteria in the context of diagnostic accuracy for AI/ML.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ANSI UL 61010-1 3rd Ed, May 12, 2012 | Complies |
| IEC 61010-2-091:2019 | Complies |
| IEC 61010-2-101:2018 | Complies |
| IEC 61326-1 Ed 3.0 2020-10 | Complies |
| IEC 61326-2-6 Ed 3.0 2020-10 | Complies |
| ISTA 3B-2017 | Complies |
| 21 CFR 1020.40 | Complies |
| Functional testing | Successfully performed |
| Usability testing | Successfully performed |
| Time to Preview | < 20 seconds |
| Cycle Time | < 60 seconds |
2. Sample sized used for the test set and the data provenance: Not applicable as this is not an AI/ML device with a diagnostic algorithm. Performance testing focused on hardware safety and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary, the document describes a traditional medical device (an X-ray system) and details its compliance with relevant safety and performance standards through bench testing, rather than an AI/ML diagnostic system that would require a test set, ground truth, and expert evaluations.
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April 24, 2023
Image /page/0/Picture/1 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, 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.
CompAI Healthcare (Suzhou) Co.,ltd % Xueqiao Wang Q&R Director Room 3A05, Building 2, No.8 Changting Road, High-tech Zone Suzhou, Jiangsu 215151 CHINA
Re: K230140
Trade/Device Name: TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: January 17, 2023 Received: March 24, 2023
Dear Xueqiao Wang:
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
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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 (OS) 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
Indications for Use (Describe)
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 procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.
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 a logo for COMPAI. The logo features a stylized human head with a brain inside, rendered in blue and teal. To the right of the head is the word "COMPAI" in blue and teal, with a plus sign above the "i" in teal. Above the head is a series of blue squares that appear to be fading away.
CompAl Healthcare (Suzhou) Co.,ltd Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China
510(k) Premarket Notification Submission
510(k) Summary
TrueView Core 100Pro-US Core Specimen Radiography System
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Image /page/4/Picture/0 description: The image is a logo for COMPAI. The logo features a stylized brain in blue and teal, with the word "COMPAI" in blue and teal next to it. The "I" in COMPAI is teal and has a plus sign next to it. The brain is made up of two parts: a blue outline of a head and a teal brain inside the head.
CompAl Healthcare (Suzhou) Co.,ltd Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China
510(k) Premarket Notification Submission
K230140 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: | January 17, 2023 |
|---|---|
| Manufacturer: | CompAl Healthcare (Suzhou) Co.,ltd |
| Room 3A05, Building 2, No.8 Changting Road, High-tech | |
| Zone, Suzhou, Jiangsu, P.R. China |
Xueqiao Wang Contact Person: Q&R Director CompAl Healthcare (Suzhou) Co.,ltd +86 512 67236750 xueqiao.wang@comp-ai.com
Identification of the Device:
| Proprietary/Trade Name: | TrueView Core 100Pro-USCore Specimen Radiography System (TrueView Core100Pro-US) |
|---|---|
| Classification Name: | Cabinet X-Ray System |
| Regulatory Number: Product | 21 CFR 892.1680 |
| Code: | MWP |
| Device Class: | Class II |
| Review Panel: | Radiology |
Identification of the Legally Marketed Predicate Device:
| Trade Name: | TrueView 100 ProSpecimen Radiography System |
|---|---|
| Classification Name: | Cabinet X-Ray System |
| Regulatory Number: | 21 CFR 892.1680 |
| Product Code: | MWP |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | CompAl Healthcare (Shenzhen) Co., Ltd. |
| Clearance: | K202713 |
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Image /page/5/Picture/0 description: The image is a logo for COMPAI. The logo features a stylized human head in profile, with the brain area highlighted in a lighter shade of blue and green. The word "COMPAI" is written in bold, blue letters to the right of the head, with a plus sign in green next to the "I".
Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China
510(k) Premarket Notification Submission
DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)
The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised.
The TrueView Core 100Pro-US includes the following major components: touch-screen control display, and an imaging cabinet.
This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding.
This system is intended to use in the following environments:
- · Surgical suites
- · Biopsy suites
- · Pathology labs
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 procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.
DEVICE CLAIMS - as required by 807.92(a)
The TrueView Core 100Pro-US has been designed to comply with the following standards and requlations:
- ANSI UL 61010-1 3rd Ed, dated May 12, 2012 with revision through ● July 19, 2019
- IEC 61010-2-091:2019 ●
- IEC 61010-2-101:2018
- IEC 61326-1 Edition 3.0 2020-10
- IEC 61326-2-6 Edition 3.0 2020-10
- . ISTA 3B-2017
- 21 CFR 1020.40
TECHNOLOGICAL CHARACTERISTICS SUMMARY- as required by 807.92(a)(6)
The TrueView Core 100Pro-US has the same indications for use and principles of operation, similar general configuration and operating parameters
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Image /page/6/Picture/0 description: The image shows the logo for COMPAI. The logo features a blue outline of a head with a green brain inside. The word "COMPAI" is written in blue and green next to the head.
CompAl Healthcare (Suzhou) Co.,ltd Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China
510(k) Premarket Notification Submission
to the predicate device cited. The technological characteristics of the TrueView Core 100Pro-US have been compared to the predicate device cited and is covered in detail in the Substantial Equivalence section of this submission.
| TrueView Core 100Pro-USCore SpecimenRadiography System | TrueView 100 Pro SpecimenRadiography System(K202713) | |
|---|---|---|
| Indicationsfor Use | A cabinet X-ray system usedto provide digital X-rayimages of surgical and corebiopsy specimens fromvarious anatomical regionsin order to allow rapidverification that the correcttissue has been excisedduring the procedure.Doing the verification in thesame room as the procedureor nearby improvesworkflow, thus reducing theoverall operative time. | A cabinet X-ray system usedto provide digital X-rayimages of surgical and corebiopsy specimens fromvarious anatomical regionsin order to allow rapidverification that the correcttissue has been excisedduring the biopsy procedure.Doing the verification in thesame room as the procedureor nearby improvesworkflow, thus reducing thetime the patient needs to beunder examination. |
| principle ofoperation | X-ray imaging principle | X-ray imaging principle |
| LevelofConcern | Moderate | Moderate |
| Method ofUse | Cabinet X-ray system usedfor imaging biopsy andsurgical specimens | Cabinet X-ray system usedfor imaging biopsy andsurgical specimens |
| Mechanismof Action | Sample verification:obtain correct margins,specimen of interest, etc. | Sample verification:obtain correct margins,specimen of interest, etc. |
| Construction | Fully integrated system withUnder-Chassis | Fully integrated system withmovable base casters |
| Size(W x D x H)(in.) | 18.3 x 15 x 20.8 | 23.6 x 28.3 x 64.9 |
| Detector | Active pixel CMOS | Active pixel CMOS |
| Technology | ||
| ActiveImaging AreaSize | $5.7cm \times 6.4cm$ | $11.4 cm x 14.6 cm$ |
| Pixel Size | 49.5 µm pixels | 49.5 µm pixels |
| LimitingSpatialResolution | 10 lp/mm | 10 lp/mm |
| Output Image | 14-bit image data | 14-bit image data |
| DisplayMonitor | 2.1Mp Highluminescence diagnosticmonitor | 2.3 MP Highluminescence diagnosticmonitor |
| OperatingSystem | Windows 10 | Windows10 |
| UserInterface | Integrated touch screen | Integrated touch screen, track pad |
| EnergyRange | 10-30 kV | 20-50 kV |
| Anode Type | Tungsten | Tungsten |
| Tube Current | 1 mA | 1 mA |
| Exposure | Up to 20 mAs | Up to 20 mAs |
| Focal SpotSize | 50 µm | 50 µm |
| Manual | User selects kV and mAs | User selects kV and mAs |
| Auto | System determines optimumkV and mAs | System determines optimumkV and mAs |
| Time toPreview | < 20 seconds | < 20 seconds |
| Cycle Time | < 60 seconds | < 60 seconds |
| SafetyFeatures | Door interlock, passcodekey, fully shielded | Door interlock, passcodekey, fully shielded |
| Indicators | Power, door open, ready,X-ray ON | Power, door open, ready,X-ray ON |
| Magnification | Specimen tray positions at1.0x and 1.5x, autosensed | Specimen tray positions at1.0x, 1.5x and 2.0x,autosensed |
Comparison with Predicate Device
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Image /page/7/Picture/0 description: The image shows the logo for COMPAI. The logo features a blue and teal design with a stylized brain and head. The word "COMPAI" is written in blue and teal next to the head design, with a plus sign above the "i".
CompAI Healthcare (Suzhou) Co.,ltd Room 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China
510(k) Premarket Notification Submission
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Image /page/8/Picture/0 description: The image shows the logo for COMPAI. The logo features a stylized head with a brain inside, rendered in blue and teal. To the right of the head is the word "COMPAI" in blue, with the "i" having a teal dot and a plus sign above it. The logo appears to represent a company focused on artificial intelligence and cognitive solutions.
hou) Co Itd om 3A05, Building 2, No.8 Changting Road, High-tech Zone, Suzhou, Jiangsu, P.R. China
510(k) Premarket Notification Submission
PERFORMANCE DATA TESTING AND REVIEW- as required by 807.92(b)(1)
The TrueView Core 100Pro-US successfully performed design control verification tests and validation tests.
The TrueView Core 100Pro-US complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems) and international EMC standards.
Compliance to IEC 61010 standards was demonstrated by a third-party test house, Intertek.
Additional bench testing, including functional testing and usability testing, was also performed on the TrueView Core 100Pro-US Core Specimen Radiography System.
Results of these performance tests, combined with design and comparison with the predicate device, support substantial equivalence.
SUBSTANTIAL EQUIVALENCE SUMMARY
The TrueView Core 100Pro-US has the same indications for use and principles of operation, similar general configuration and operating parameters to the predicate device cited. The technical characteristics of the TrueView Core 100Pro-US 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 TrueView Core 100Pro-US is safe and effective and substantially equivalent to the predicate device cited.
§ 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.