TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

{0}------------------------------------------------ April 24, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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 O&R Director Room 3A05, Building 2, No.8 Changting Road, High-tech Zone Suzhou, Jiangsu 215151 CHINA Re: K230136 Trade/Device Name: TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-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 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 {1}------------------------------------------------ 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. 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 {2}------------------------------------------------ # Indications for Use Submission Number (if known) K230136 Device Name TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for COMPAI. The logo features a stylized brain inside of a blue outline of a head. The word "COMPAI" is written in blue, with the "I" in "COMPAI" being teal and having a plus sign above it. 510(k) Premarket Notification Submission 510(k) Summary K230136 TrueView 200 Pro-US Specimen Radiography System {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for COMPAI. The logo features a stylized human head in blue and teal, with the brain area highlighted in teal. To the right of the head is the word "COMPAI" in blue, with the "AI" portion in teal and a plus sign above the "i". 510(k) Premarket Notification Submission #### K230136 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 ## ldentification of the Device: | Proprietary/Trade Name: | TrueView 200 Pro-US<br>Specimen Radiography System (TrueView 200 Pro-US) | |-------------------------|--------------------------------------------------------------------------| | Classification Name: | Cabinet X-Ray System | | Regulatory Number: | 21 CFR 892.1680 | | Product Code: | MWP | | Device Class: | Class II | | Review Panel: | Radiology | ## Identification of the Legally Marketed Predicate Device: | Trade Name: | TrueView 100 Pro | |--------------------------|---------------------------------------| | | Specimen 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 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for COMPAI. The logo features a blue and teal brain graphic on the left side of the image. To the right of the brain graphic is the word "COMPAI" in blue and teal lettering. There is a plus sign to the right of the "I" in COMPAI. 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 200 Pro-US 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 200 Pro-US includes the following major components: system monitor, 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 unit is mounted on casters for easy transportation. 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 200 Pro-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 bv 807.92(a)(6) The TrueView 200 Pro-US has the same indications for use and principles of operation, similar general configuration and operating parameters to the predicate device cited. The technological characteristics of the TrueView 200 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for CompAI. The logo features a stylized brain inside of a blue circle. The text "COMPAI" is next to the logo, with the "AI" in a lighter blue color and a plus sign above the "i". 510(k) Premarket Notification Submission Pro-US have been compared to the predicate device cited and is covered in detail in the Substantial Equivalence section of this submission. | | TrueView 200 Pro-US<br>Specimen Radiography<br>System | TrueView 100 Pro Specimen<br>Radiography System<br>(K202713) | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | A cabinet X-ray system used<br>to provide digital X-ray<br>images of surgical and core<br>biopsy specimens from<br>various anatomical regions in<br>order to allow rapid<br>verification that the correct<br>tissue has been excised<br>during the procedure.<br>Doing the verification in the<br>same room as the procedure<br>or nearby improves<br>workflow, thus reducing the<br>overall operative time. | A cabinet X-ray system used<br>to provide digital X-ray<br>images of surgical and core<br>biopsy specimens from<br>various anatomical regions in<br>order to allow rapid<br>verification that the correct<br>tissue has been excised<br>during the biopsy procedure.<br>Doing the verification in the<br>same room as the procedure<br>or nearby improves<br>workflow, thus reducing the<br>time the patient needs to be<br>under examination. | | principle of<br>operation | X-ray imaging principle | X-ray imaging principle | | Level<br>of<br>Concern | Moderate | Moderate | | Method of<br>Use | Cabinet X-ray system used<br>for imaging small to large<br>biopsy and surgical<br>specimens | Cabinet X-ray system used<br>for imaging small to large<br>biopsy and surgical<br>specimens | | Mechanism<br>of Action | Sample verification:<br>obtain correct margins,<br>specimen of interest, etc. | Sample verification:<br>obtain correct margins,<br>specimen of interest, etc. | | Construction | Fully integrated system with<br>movable base casters | Fully integrated system with<br>movable base casters | | Size<br>(W x D x H)<br>(in.) | 23.6 × 28.3 × 63.8 | 23.6 x 28.3 x 64.9 | | Detector<br>Technology | Active-pixel CMOS | Active-pixel CMOS | | Active<br>Imaging Area<br>Size | 11.4 cm x 14.6 cm<br>12cm×14cm | 11.4 cm x 14.6 cm | | Pixel Size | 49.5 µm pixels<br>50 µm pixels | 49.5 µm pixels | | Limiting<br>Spatial<br>Resolution | 10 lp/mm | 10 lp/mm | | Output Image | 14-bit image data | 14-bit image data | | Display<br>Monitor | 2.3 MP High<br>luminescence diagnostic<br>monitor | 2.3 MP High<br>luminescence diagnostic<br>monitor | | Operating<br>System | Windows 10 | Windows10 | | User<br>Interface | Integrated touch screen, track<br>pad | Integrated touch screen,<br>track pad | | Energy<br>Range | 20-50 kV | 20-50 kV | | Anode Type | Tungsten | Tungsten | | Tube Current | 1 mA | 1 mA | | Exposure | Up to 20 mAs | Up to 20 mAs | | Focal Spot<br>Size | 50 µm | 50 µm | | Manual | User selects kV and mAs | User selects kV and mAs | | Auto | System determines optimum<br>kV and mAs | System determines optimum<br>kV and mAs | | Time to<br>Preview | < 20 seconds | < 20 seconds | | Cycle Time | < 60 seconds | < 60 seconds | | Safety<br>Features | Door interlock, passcode key,<br>fully shielded | Door interlock, passcode<br>key, fully shielded | | Indicators | Power, door open, ready,<br>X-ray ON | Power, door open, ready,<br>X-ray ON | | Magnification | Specimen tray positions at<br>1.0, 1.5x and 2.0x, | Specimen tray positions at<br>1.0, 1.5x and 2.0x, | ## Comparison with Predicate Device {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for COMPAI. The logo features a stylized head with a brain inside, with the name "COMPAI" written in bold letters next to it. The "AI" portion of the name is in a lighter shade of teal, while the rest of the name is in a darker blue. 510(k) Premarket Notification Submission {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains a logo for "COMPAI+". The logo features a stylized human head in profile, with the brain area represented by a teal-colored, swirling design. The head is enclosed within a blue, curved shape that extends into a series of blue squares, resembling a digital or pixelated effect. The text "COMPAI" is written in a combination of blue and teal, with a plus sign in teal next to the "I". 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 200 Pro-US successfully performed design control verification tests and validation tests. The TrueView 200 Pro-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 200 Pro-US 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 200 Pro-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 200 Pro-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 200 Pro-US is safe and effective and substantially equivalent to the predicate device cited.