K Number
K202713
Device Name
TrueView 100 Pro
Date Cleared
2020-11-18

(63 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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. 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.
More Information

Not Found

No
The summary describes a standard X-ray imaging system for specimens and does not mention any AI or ML capabilities in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

No
The device is an imaging system used to verify tissue excision and improve workflow, not to treat a condition or disease.

Yes

The device provides digital X-ray images of specimens "in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure." This verification process, based on imaging, serves a diagnostic purpose to ensure the accuracy and completeness of the biopsy.

No

The device description clearly outlines multiple hardware components including a system monitor, touch-screen display, touchpad, and imaging cabinet, indicating it is a physical system, not software-only.

Based on the provided information, this 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 status. This testing is done outside the body.
  • Device Function: The TrueView 100 Pro is a cabinet X-ray system used to image surgical and core biopsy specimens. While it examines tissue specimens, it does so using X-ray technology to create images, not by performing biochemical, immunological, or microbiological tests on the specimens themselves.
  • Intended Use: The intended use is to "allow rapid verification that the correct tissue has been excised during the biopsy procedure" by providing digital X-ray images. This is a visual assessment of the specimen's physical characteristics (size, shape, density) using X-rays, not a diagnostic test performed on the specimen's biological properties.

The device is a medical imaging device specifically designed for specimen radiography, which falls under the category of radiology or imaging equipment, not in vitro diagnostics.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MWP

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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

various anatomical regions

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgical suite, stereotactic biopsy suite, pathology lab

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K182727

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.

Not Found

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).

Not Found

§ 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.

0

November 18, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are both simple and recognizable.

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

1

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)
✓ 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 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

4

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
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.

5

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®
Specimen
Radiography
System
Predicate
(K182727) | TrueView 100 Pro
Specimen
Radiography
System
Proposed | Comparison |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Indications
for Use | A cabinet X-ray
system used to
provide digital X-ray | A cabinet X-ray
system used to
provide digital X-ray | Same |
| | 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. | 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. | |
| principle of
operation | X-ray imaging
principle | X-ray imaging
principle | Same |
| Level
of
Concern | Moderate | Moderate | Same |
| Method of
Use | Cabinet X-ray
system used for
imaging small to
large biopsy and
surgical specimens | Cabinet X-ray
system used for
imaging small to
large biopsy and
surgical specimens | Same |
| Mechanism
of Action | Sample verification:
obtain correct
margins,
specimen of
interest, etc. | Sample verification:
obtain correct
margins,
specimen of interest,
etc. | Same |
| Physical | | | |
| Construction | Fully integrated
system with
movable base
casters | Fully integrated
system with
movable base
casters | Similar;
designed for
ease of use and
transportation |
| Size | 24 x 26 x 66.5 | 23.6 x 28.3 x 64.9 | Similar: slim |
| (W x D x H)
(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)
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
mAs | User selects kV and
mAs | Same |
| Auto | System determines
optimum kV and
mAs | System determines
optimum kV and
mAs | Same |
| System Performance | | | |
| Time to
Preview |