(63 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 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.
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.
This document, a 510(k) Premarket Notification Summary for the TrueView 100 Pro Specimen Radiography System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable metrics.
The information provided does not include:
- A table of acceptance criteria with reported device performance.
- Specific sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
- Information on the number or qualifications of experts, or adjudication methods for ground truth in a test set.
- Details of a multireader multicase (MRMC) comparative effectiveness study or standalone algorithm performance.
- Sample size for a training set or how ground truth for a training set was established.
Instead, the submission relies on comparing the technical specifications and performance characteristics of the TrueView 100 Pro to its predicate device, the Trident® HD Specimen Radiography System (K182727), to argue for substantial equivalence.
Here's an analysis of the information available in the provided text:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparative table between the TrueView 100 Pro and the predicate device. While this table lists various technical specifications and operational parameters, it does not explicitly define acceptance criteria for each parameter and then report the TrueView 100 Pro's performance against those criteria. Instead, it compares the TrueView 100 Pro's specifications directly to the predicate's specifications to demonstrate "similarity" or "improvement."
Here's a summary of the technical comparison presented in the document, which can be interpreted as the basis for performance claims relative to the predicate:
| Feature | Predicate (Trident® K182727) | TrueView 100 Pro (Proposed) | Comparison |
|---|---|---|---|
| Indications for Use | Same as proposed | A cabinet X-ray system for digital X-ray images of surgical and core biopsy specimens to verify tissue removal. Improves workflow by reducing patient examination time. | Same |
| 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 for imaging small to large biopsy and surgical specimens | Cabinet X-ray system 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 (W x D x H) | 24 x 26 x 66.5 (in.) | 23.6 x 28.3 x 64.9 (in.) | Similar: slim design for ease of use and transportation |
| Detector Technology | TFT-based direct capture technology | Active-pixel CMOS | Different |
| Active Imaging Area | 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; TrueView has one size. |
| 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 |
| 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 | Windows 10 | Same |
| User Interface | Integrated touch screen, track pad | Integrated touch screen, track pad | Same |
| 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), Auto (System determines optimum kV and mAs) | Manual (User selects kV and mAs), Auto (System determines optimum kV and mAs) | Same |
| Time to Preview | < 20 seconds | < 20 seconds | Same |
| Cycle Time | < 60 seconds | < 60 seconds | Same |
| Cabinet Safety Features | Door interlock, passcode key, fully shielded | Door interlock, passcode key, fully shielded | Same |
| Indicators | Power, door open, ready, X-ray ON | Power, door open, ready, X-ray ON | Same |
| Magnification | Specimen tray positions at 1.5x and 2.0x, autosensed | Specimen tray positions at 1.5x and 2.0x, autosensed | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states: "No clinical studies have been performed." Therefore, there is no test set in the sense of a clinical study, and no associated sample size or data provenance information. The testing performed was "non-clinical."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Since no clinical studies were performed and no clinical test set was used, there were no experts used to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set was used, there was no adjudication method for a clinical test set.
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:
The document states: "No clinical studies have been performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human reader improvement with AI assistance is reported. The TrueView 100 Pro is a specimen radiography system, not explicitly an AI-assisted diagnostic device, though "CompAI Healthcare" suggests AI may be part of their general portfolio. The current submission, however, focuses on the physical radiography system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a "Specimen Radiography System," which produces images for human review. The submission does not describe an AI algorithm or a standalone performance evaluation of such an algorithm. The assessment is on the system's ability to produce images that are "equivalent performance and equivalent safety and effectiveness as the predicate."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the absence of clinical studies, there is no mention of "ground truth" established through expert consensus, pathology, or outcomes data. The "ground truth" for the non-clinical tests would be the established engineering and performance specifications of the device and its compliance with relevant standards (e.g., IEC 61010) via bench testing.
8. The sample size for the training set:
The document does not describe any training set as it pertains to a machine learning or AI algorithm. The device is an imaging system designed to capture X-ray images, not an AI model requiring a training set in the typical sense.
9. How the ground truth for the training set was established:
As no training set (for an AI algorithm) is mentioned, there is no information on how its ground truth would have been established.
Summary of the Study and Conclusion:
The "study" described is a non-clinical bench testing and verification/validation process to demonstrate substantial equivalence to a legally marketed predicate device (Trident® HD Specimen Radiography System, K182727).
The document highlights the following non-clinical tests:
- 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)
These tests were performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (given a moderate level of concern). The TrueView 100 Pro also complies with IEC 61010 standards, validated by the third-party test house Intertek.
The conclusion relies entirely on these non-clinical tests: "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)." The submission asserts that the "design, operation, basic construction, and materials used are substantially equivalent to the predicate device," leading to the conclusion that the TrueView 100 Pro is "as safe, as effective, and with performance substantially equivalent to the predicate device(s)."
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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)
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
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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
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 RadiographySystem (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®SpecimenRadiographySystemPredicate(K182727) | TrueView 100 ProSpecimenRadiographySystemProposed | Comparison | |
|---|---|---|---|
| Indicationsfor Use | A cabinet X-raysystem used toprovide digital X-ray | A cabinet X-raysystem used toprovide digital X-ray | Same |
| images of surgicaland core biopsyspecimens fromvarious anatomicalregions in order toallow rapidverification that thecorrect tissue hasbeen excised duringthe biopsyprocedure.Doing theverification in thesame room as theprocedure or nearbyimproves workflow,thus reducing thetime the patientneeds to be underexamination. | images of surgicaland core biopsyspecimens fromvarious anatomicalregions in order toallow rapidverification that thecorrect tissue hasbeen excised duringthe biopsyprocedure.Doing theverification in thesame room as theprocedure or nearbyimproves workflow,thus reducing thetime the patientneeds to be underexamination. | ||
| principle ofoperation | X-ray imagingprinciple | X-ray imagingprinciple | Same |
| LevelofConcern | Moderate | Moderate | Same |
| Method ofUse | Cabinet X-raysystem used forimaging small tolarge biopsy andsurgical specimens | Cabinet X-raysystem used forimaging small tolarge biopsy andsurgical specimens | Same |
| Mechanismof Action | Sample verification:obtain correctmargins,specimen ofinterest, etc. | Sample verification:obtain correctmargins,specimen of interest,etc. | Same |
| Physical | |||
| Construction | Fully integratedsystem withmovable basecasters | Fully integratedsystem withmovable basecasters | Similar;designed forease of use andtransportation |
| 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 andmAs | User selects kV andmAs | Same |
| Auto | System determinesoptimum kV andmAs | System determinesoptimum kV andmAs | Same |
| System Performance | |||
| Time toPreview | < 20 seconds | < 20 seconds | Same |
| Cycle Time | < 60 seconds | < 60 seconds | Same |
| Cabinet | |||
| SafetyFeatures | Door interlock,passcode key, fullyshielded | Door interlock,passcode key, fullyshielded | Same |
| Indicators | Power, door open,ready, X-ray ON | Power, door open,ready, X-ray ON | Same |
| Magnification | Specimen traypositions at 1.5x and2.0x, autosensed | Specimen traypositions at 1.5x and2.0x, 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
{8}------------------------------------------------
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
{9}------------------------------------------------
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
{10}------------------------------------------------
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).
§ 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.