(96 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard X-ray imaging and hardware components.
No.
The device is used to provide digital X-ray images for verification of excised tissue, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any medical condition.
Yes
This device is a diagnostic device as it provides digital X-ray images of surgical and biopsy specimens to allow rapid verification that the correct tissue has been excised during a procedure. This verification process involves interpreting images to diagnose, confirm, or rule out the presence of specific tissue.
No
The device description clearly outlines hardware components such as a system monitor, touch-screen control display, imaging cabinet, and shielding, 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 devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This examination is typically performed outside of the living body.
- Device Function: The TrueView 200 Pro-US is a cabinet X-ray system used to image surgical and core biopsy specimens. While these specimens are derived from the human body, the device's purpose is to provide radiographic images of the physical specimen itself to verify that the correct tissue has been excised. It's essentially a form of imaging the physical sample, not performing a diagnostic test on the sample's biological properties or components.
- Intended Use: The intended use is to "allow rapid verification that the correct tissue has been excised during the procedure." This is a workflow and procedural verification step, not a diagnostic test to determine a disease state or physiological condition based on the specimen's biological characteristics.
- Lack of Biological Analysis: The description focuses on the X-ray imaging principle and the physical components of the system. There is no mention of analyzing biological markers, chemical properties, or other characteristics of the specimen that would be typical of an IVD.
In summary, the TrueView 200 Pro-US is a medical imaging device used to visualize physical specimens for procedural verification, not a device that performs diagnostic tests on the biological properties of those specimens.
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 procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.
Product codes
MWP
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray imaging
Anatomical Site
various anatomical regions (for surgical and core biopsy specimens)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical suites, Biopsy suites, Pathology labs
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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)
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)
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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
TrueView 200 Pro-US 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 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
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 |
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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
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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
Specimen Radiography
System | TrueView 100 Pro Specimen
Radiography System
(K202713) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 procedure.
Doing the verification in the
same room as the procedure
or nearby improves
workflow, thus reducing the
overall operative time. | 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. |
| principle of
operation | X-ray imaging principle | X-ray imaging principle |
| Level
of
Concern | Moderate | Moderate |
| 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 |
| Mechanism
of Action | Sample verification:
obtain correct margins,
specimen of interest, etc. | Sample verification:
obtain correct margins,
specimen of interest, etc. |
| Construction | Fully integrated system with
movable base casters | Fully integrated system with
movable base casters |
| Size
(W x D x H)
(in.) | 23.6 × 28.3 × 63.8 | 23.6 x 28.3 x 64.9 |
| Detector
Technology | Active-pixel CMOS | Active-pixel CMOS |
| Active
Imaging Area
Size | 11.4 cm x 14.6 cm
12cm×14cm | 11.4 cm x 14.6 cm |
| Pixel Size | 49.5 µm pixels
50 µm pixels | 49.5 µm pixels |
| Limiting
Spatial
Resolution | 10 lp/mm | 10 lp/mm |
| Output Image | 14-bit image data | 14-bit image data |
| Display
Monitor | 2.3 MP High
luminescence diagnostic
monitor | 2.3 MP High
luminescence diagnostic
monitor |
| Operating
System | Windows 10 | Windows10 |
| User
Interface | Integrated touch screen, track
pad | Integrated touch screen,
track pad |
| Energy
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
Size | 50 µm | 50 µm |
| Manual | User selects kV and mAs | User selects kV and mAs |
| Auto | System determines optimum
kV and mAs | System determines optimum
kV and mAs |
| Time to
Preview |