TrueView 100 Pro
Device Facts
| Record ID | K202713 |
|---|---|
| Device Name | TrueView 100 Pro |
| Applicant | Compai Healthcare (Shenzhen) Co.,Ltd |
| Product Code | MWP · Radiology |
| Decision Date | Nov 18, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
TrueView 100 Pro is a self-contained, mobile cabinet X-ray system for imaging surgical and core biopsy specimens. Used in surgical suites, stereotactic biopsy suites, and pathology labs by clinicians to verify excision of intended tissue/lesions. Input: specimen placed in cabinet; system generates high-resolution X-ray images. Operation: user selects manual or auto-exposure modes (kV/mAs); system produces 14-bit digital images on a touch-screen display. Output: digital X-ray images allow clinicians to confirm presence of lesions or calcifications in real-time, improving workflow and reducing patient time under examination.
Clinical Evidence
No clinical studies were performed. Substantial equivalence was demonstrated through non-clinical bench testing, including functional, performance, safety, and usability testing. The device met all applicable IEC and EN standards for electrical safety and EMC.
Technological Characteristics
Cabinet X-ray system; tungsten anode X-ray source (20-50 kV, 1 mA, up to 20 mAs); active-pixel CMOS digital detector; 49.5 µm pixel size; 10 lp/mm spatial resolution; 2.3 MP diagnostic monitor; Windows 10 OS; integrated touch-screen/touchpad; mobile on casters; fully shielded cabinet with door interlock. Software: moderate level of concern.
Indications for Use
Indicated for patients undergoing surgical or core biopsy procedures where rapid verification of excised tissue, lesions, or site markers is required across 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
- Trident® HD Specimen Radiography System (K182727)
Submission Summary (Full Text)
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November 18, 2020
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CompAI Healthcare (Shenzhen) Co., Ltd. % Wang Yan QARA Manager 8B, Huangting Building, No.355, Fuhua Road, Futian Street. Futian District Shenzhen, Guangdong 518026 CHINA
#### Re: K202713
Trade/Device Name: TrueView 100 Pro Specimen Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: September 8, 2020 Received: September 16, 2020
Dear Wang Yan:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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,
For
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K202713
Device Name
TrueView 100 Pro Specimen Radiography System
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 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.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span> <div style="width:15px; height:15px; border:1px solid black; display:flex; justify-content:center; align-items:center;"> <span>✓</span> </div> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div style="display:flex; align-items:center;"> <span> <div style="width:15px; height:15px; border:1px solid black;"></div> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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Image /page/3/Picture/0 description: The image shows the 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, with the "AI" portion in teal and a plus sign above the "i".
CompAl Healthcare (Shenzhen) Co., Ltd 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
510(k) Premarket Notification Submission
Section 5: 510(k) Summary
TrueView 100 Pro Specimen Radiography System
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Image /page/4/Picture/0 description: The image shows the logo for COMPAI. The logo features a stylized brain in blue and teal, with a pixelated effect extending from the top. The text "COMPAI" is written in bold, blue letters, with a teal plus sign next to the "I".
Healthcare (Shenzhen) Co., Ltd 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
510(k) Premarket Notification Submission
#### 510(k) Summary
K202713
Date Prepared: August 18, 2020 CompAI Healthcare (Shenzhen) Co.,ltd Manufacturer: 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District, Shenzhen, P.R.China
| Contact Person: | Wang Yan |
|-----------------|--------------------------------------|
| | QARA Manager |
| | CompAI Healthcare (Shenzhen) Co.,ltd |
| | +86 512 67236750 |
| | yan.wang@comp-ai.com |
#### ldentification of the Device:
| Proprietary/Trade Name: | TrueView 100 Pro Specimen Radiography<br>System (TrueView 100 Pro) |
|-------------------------|--------------------------------------------------------------------|
| 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: | Trident® HD 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: | Hologic, Inc. |
| Clearance: | K182727 (cleared January 10, 2019) |
#### Device Description:
The TrueView 100 Pro is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The TrueView 100 Pro includes the following major components: a system monitor, touch-screen display, a touchpad, and an imaging cabinet.
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Image /page/5/Picture/0 description: The image is a logo for COMPAI. The logo features a blue outline of a human head with a green brain inside. The word "COMPAI" is written in blue, with the "I" in "COMPAI" being green and having a plus sign next to it. There are also some blue squares above the head.
Healthcare (Shenzhen) Co., Ltd 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
510(k) Premarket Notification Submission
The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.
Dedicated specimen radiography systems are intended for use in the following environments:
- The surgical suite
- · The stereotactic biopsy suite
- The pathology lab
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 of the specimen, the presence of a lesion or calcification in the extracted sample can be confirmed by the user reviewing the digital image.
#### Indications for Use:
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.
# Standards:
- A IEC 61010-1:2010 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 1: General Requirements
- A IEC 61010-2-091:2012 – Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 2-091: Particular Requirements for Cabinet X-ray Systems
- > IEC6101-2-101:2018 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- > EN 61326-1:2013 - Electrical Equipment for Measurement, Control, and Laboratory Use - EMC Requirements, General Requirements
- A EN 61326-2-6:2013 – Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-6: Particular requirements for in vitro diagnostic (IVD) medical equipment
- A EN 55011 (Class A) - Industrial, Scientific and Medical (ISM) Electromagnetic Radio-Frequency Equipment Disturbance Characteristics - Limits and Methods of Measurement
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Image /page/6/Picture/0 description: The image shows the 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 brain is made up of a series of interconnected lines, and the word "COMPAI" is written in a sans-serif font. There is a plus sign next to the I in COMPAI.
Healthcare (Shenzhen) Co., Ltd 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
510(k) Premarket Notification Submission
- ISO 14971: 2019 Medical devices Application of Risk Management to A Medical Devices
- A IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 62304:2006/AMD1:2015 Medical device software Software life A cycle processes
# FDA Guidance Documents:
- "Applying Human Factors and Usability Engineering to Medical Devices," A issued on February 3, 2016
- A "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices," issued on September 1, 2016
- > "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005
- "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf > (OTS) Software," issued on January 14, 2005
- > "Off-the-Shelf Software Use in Medical Devices," issued on September 9, 2019
- > "Compliance Guide for Cabinet X-Ray Systems" issued on September 19, 2007
- > Format for Traditional and Abbreviated 510(k)s Guidance for Industry and Food and Drug Administration Staff
# Comparison with Predicate Device:
The TrueView 100 Pro and its predicate device, the Trident® HD Specimen Radiography System, have the same intended use, general configuration, principles of operation, and operating parameters.
# Substantial Equivalence:
The TrueView 100 Pro Specimen Radiography System employs the same fundamental scientific technology as its predicate devices, as below table:
| | Trident®<br>Specimen<br>Radiography<br>System<br>Predicate<br>(K182727) | TrueView 100 Pro<br>Specimen<br>Radiography<br>System<br>Proposed | Comparison |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Indications<br>for Use | A cabinet X-ray<br>system used to<br>provide digital X-ray | A cabinet X-ray<br>system used to<br>provide digital X-ray | Same |
| | images of surgical<br>and core biopsy<br>specimens from<br>various anatomical<br>regions in order to<br>allow rapid<br>verification that the<br>correct tissue has<br>been excised during<br>the biopsy<br>procedure.<br>Doing the<br>verification in the<br>same room as the<br>procedure or nearby<br>improves workflow,<br>thus reducing the<br>time the patient<br>needs to be under<br>examination. | images of surgical<br>and core biopsy<br>specimens from<br>various anatomical<br>regions in order to<br>allow rapid<br>verification that the<br>correct tissue has<br>been excised during<br>the biopsy<br>procedure.<br>Doing the<br>verification in the<br>same room as the<br>procedure or nearby<br>improves workflow,<br>thus reducing the<br>time the patient<br>needs to be under<br>examination. | |
| principle of<br>operation | X-ray imaging<br>principle | X-ray imaging<br>principle | Same |
| Level<br>of<br>Concern | Moderate | Moderate | Same |
| Method of<br>Use | Cabinet X-ray<br>system used for<br>imaging small to<br>large biopsy and<br>surgical specimens | Cabinet X-ray<br>system used for<br>imaging small to<br>large biopsy and<br>surgical specimens | Same |
| Mechanism<br>of Action | Sample verification:<br>obtain correct<br>margins,<br>specimen of<br>interest, etc. | Sample verification:<br>obtain correct<br>margins,<br>specimen of interest,<br>etc. | Same |
| Physical | | | |
| Construction | Fully integrated<br>system with<br>movable base<br>casters | Fully integrated<br>system with<br>movable base<br>casters | Similar;<br>designed for<br>ease of use and<br>transportation |
| Size | 24 x 26 x 66.5 | 23.6 x 28.3 x 64.9 | Similar: slim |
| (W x D x H)<br>(in.) | | | design for ease of use and transportation |
| Digital Image Receptor | | | |
| Detector Technology | TFT-based direct capture technology | Active-pixel CMOS | Different |
| Active Imaging Area Size | 12 cm x 14 cm (MFD)<br>20 cm x 20 cm (HDT) | 11.4 cm x 14.6 cm | Trident® HD is available with two detectors for variety in image size and preference |
| Pixel Size | 70 µm pixels | 49.5 µm pixels | Similar, TrueView 100 Pro pixel size is 29% smaller |
| Limiting Spatial Resolution | 7.1 lp/mm | 10 lp/mm | Similar, TrueView 100 Pro has 41% more line pairs per mm. |
| Output Image | 14-bit image data | 14-bit image data | Same |
| Acquisition Workstation | | | |
| Display Monitor | 2 MP High luminescence diagnostic monitor | 2.3 MP High luminescence diagnostic monitor | Similar, TrueView 100 Pro slightly improved resolution |
| Operating System | Windows 10 | Windows10 | Same |
| User Interface | Integrated touch screen, track pad | Integrated touch screen, track pad | Same |
| X-ray Source | | | |
| Energy Range | 20-50 kV | 20-50 kV | Same |
| Anode Type | Tungsten | Tungsten | Same |
| Tube Current | 1 mA | 1 mA | Same |
| Exposure | Up to 20 mAs | Up to 20 mAs | Same |
| Focal Spot Size | 50 µm | 50 µm | Same |
| Exposure Modes | | | |
| Manual | User selects kV and<br>mAs | User selects kV and<br>mAs | Same |
| Auto | System determines<br>optimum kV and<br>mAs | System determines<br>optimum kV and<br>mAs | Same |
| System Performance | | | |
| Time to<br>Preview | < 20 seconds | < 20 seconds | Same |
| Cycle Time | < 60 seconds | < 60 seconds | Same |
| Cabinet | | | |
| Safety<br>Features | Door interlock,<br>passcode key, fully<br>shielded | Door interlock,<br>passcode key, fully<br>shielded | Same |
| Indicators | Power, door open,<br>ready, X-ray ON | Power, door open,<br>ready, X-ray ON | Same |
| Magnification | Specimen tray<br>positions at 1.5x and<br>2.0x, autosensed | Specimen tray<br>positions at 1.5x and<br>2.0x, autosensed | Same |
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Image /page/7/Picture/0 description: The image shows the 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 has a plus sign above it.
CompAl Healthcare (Shenzhen) Co., Ltd
8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,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 brain and head in blue and teal, with a pixelated effect trailing off the top of the head. The text "COMPAI" is written in a bold, sans-serif font, with the "COMP" in blue and the "AI" in teal, and a plus sign next to the AI.
CompAl Healthcare (Shenzhen) Co., Ltd
8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
510(k) Premarket Notification Submission
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Image /page/9/Picture/0 description: The image is a logo for a company called COMPAI. The logo features a stylized brain inside of a letter C. The word COMPAI is written in a sans-serif font, with the letters COM in blue and the letters PAI in teal. There is a plus sign in teal to the right of the letters PAI.
ompAl Healthcare (Shenzhen) Co., Ltd 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
#### 510(k) Premarket Notification Submission
# Summary of Testing:
Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the development of the system:
- •Risk Analysis
- •Requirements Reviews
- ·Design Reviews
- ·Testing on unit level (Module verification)
- ·Integration testing (System verification)
- ·Performance testing (Verification)
- · Safety testing (Verification)
- ·Simulated use testing (Validation)
The TrueView 100 Pro successfully performed system design control verification and validation tests, which are summarized in accordance with FDA's Guidance for the Content of Premarket Submissions for Software
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Image /page/10/Picture/0 description: The image shows the 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".
thcare (Shenzhen) Co., Ltd 8B,Huangting Building, No.355, Fuhua Road,Futian Street,Futian District,Shenzhen,P.R.China
510(k) Premarket Notification Submission
Contained in Medical Devices (issued May 11, 2005) based on a moderate level of concern.
The TrueView 100 Pro complies with IEC 61010 standards, as performed by the third-party test house, Intertek. No clinical studies have been performed. Substantial equivalence has been demonstrated by nonclinical testing. Additional bench testing, including functional testing and usability testing, was also performed on the TrueView 100 Pro Specimen Radiography System. The comparative and other performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate Trident® HD system (K182727).
Summary of Clinical Tests:
The subject of this premarket submission. The TrueView 100 Pro, did not require clinical studies to support substantial equivalence.
# Conclusion:
Based on the information submitted in this premarket notification. The TrueView 100 Pro is substantially equivalent to the Trident® HD system (K182727). The design, operation, basic construction, and materials used are substantially equivalent to the predicate device. CompAl Healthcare considers the TrueView 100 Pro to be as safe, as effective, and with performance substantially equivalent to the predicate device(s).
