Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that TechCare Trauma uses an "artificial intelligence algorithm" and "machine learning techniques" for image analysis. It also mentions "Supervised Deep Learning" as the methodology.

Therapeutic

No
The device aids in the detection and characterization of medical conditions, but it does not directly treat or provide therapy to patients.

Diagnostic

Yes

The device is explicitly described as "radiological computer assisted detection and diagnostic software for suspected fractures" and is intended to "aid in the detection, localization, and characterization of fractures and/or elbow joint effusion." It also states its intended users are "clinicians with the authority to diagnose fractures and/or elbow joint effusions," even though its results are not for stand-alone decision-making.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that TechCare Trauma is a "software as Medical Device (SaMD)" and relies solely on images provided by DICOM sources, processing them and sending results to DICOM destinations. There is no mention of accompanying hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
TechCare Trauma's Function: TechCare Trauma analyzes medical images (2D X-ray radiographs). It does not analyze biological specimens.
Intended Use: The intended use is to aid in the detection, localization, and characterization of fractures and elbow joint effusion on radiographs. This is image analysis, not in vitro testing.
Device Description: The device is described as "software as Medical Device (SaMD)" and a "radiological computer assisted detection and diagnostic software for suspected fractures". This aligns with medical imaging software, not IVD.

Therefore, TechCare Trauma falls under the category of medical imaging software, specifically a Computer-Assisted Detection/Diagnosis (CADe/x) device, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found".

Overview

Intended Use / Indications for Use

TechCare Trauma is intended to analyze 2D X ray radiographs using techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs of:

Study Type (Anatomic Area of Interest)	Radiographic View(s) Supported	Findings	Patient Population
Ankle	Frontal, Lateral, Oblique	Fracture	Adults, Infants, Children, Adolescents
Foot	Frontal, Lateral, Oblique	Fracture	Adults, Infants, Children, Adolescents
Knee	Frontal, Lateral, Oblique	Fracture	Adults, Infants, Children, Adolescents
Leg (includes Tibia/Fibula)	Frontal, Lateral	Fracture	Adults, Infants, Children, Adolescents
Femur	Frontal, Lateral	Fracture	Adults
Wrist	Frontal, Lateral, Oblique	Fracture	Adults, Children, Adolescents
Hand/Finger	Frontal, Lateral, Oblique	Fracture	Adults, Infants, Children, Adolescents
Elbow	Lateral	Elbow Joint Effusion	Adults, Children, Adolescents
Forearm	Frontal, Lateral	Fracture	Adults, Infants, Children, Adolescents
Arm (includes Humerus)	Frontal, Lateral	Fracture	Adults, Neonates, Infants, Children, Adolescents
Shoulder	Frontal, Lateral	Fracture	Adults, Infants, Children, Adolescents
Clavicle	Frontal	Fracture	Adults, Children, Adolescents, Neonates, Infants
Pelvis	Frontal	Fracture	Adults, Infants, Children, Adolescents
Hip	Frontal, Lateral	Fracture	Adults, Infants, Children, Adolescents
Thorax (includes ribs)	Frontal, Lateral, Ribs series	Fracture	Adults

TechCare Trauma can provide results for fracture in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

The intended users of TechCare Trauma are clinicians with the authority to diagnose fractures and/or elbow joint effusions in various settings including primary care (e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well as radiologists who review radiographs across settings.

TechCare Trauma results are not intended to be used on a stand-alone basis for clinical decision-making. Primary diagnostic and patient management decisions are made by the clinical user.

Product codes

QBS

Device Description

The TechCare Trauma device is a software as Medical Device (SaMD). More specifically it is defined as a "radiological computer assisted detection and diagnostic software for suspected fractures".

As a CADe/x software, TechCare Trauma is an image processing device intended to aid in the detection and localization of fractures and elbow joint effusions on acquired medical images (2D X-ray radiographs).

TechCare Trauma uses an artificial intelligence algorithm to analyze acquired medical images (2D X-ray radiographs) for features suggestive of fractures and elbow joint effusions.

TechCare Trauma can provide results for fractures in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over) regardless of their condition.

TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).The device detects and identifies fractures and elbow joint effusions based on a visual model's analysis of images and provides information about the presence and location of these prespecified findings to the user.

It relies solely on images provided by DICOM sources. Once integrated into existing networks, TechCare Trauma automatically receives and processes these images without any manual intervention. The processed results, which consist of one or more images derived from the original inputs, are then sent to specified DICOM destinations. This ensures that the results can be seamlessly viewed on any compatible DICOM viewer, allowing smooth into medical imaging workflows.

TechCare Trauma can be deployed on-premises or on cloud and be connected to multiple DICOM sources / destinations (including but not limited to DICOM storage platform, PACS, VNA and radiological equipment, such as X-ray systems), ensuring easy integration into existing clinical workflows.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Mentions AI algorithm and machine learning techniques.

Input Imaging Modality

2D X-ray radiographs

Anatomical Site

Ankle, Foot, Knee, Leg (includes Tibia/Fibula), Femur, Wrist, Hand/Finger, Elbow, Forearm, Arm (includes Humerus), Shoulder, Clavicle, Pelvis, Hip, Thorax (includes ribs)

Indicated Patient Age Range

Fracture: Neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).
Elbow Joint Effusions: Children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

Intended User / Care Setting

Clinicians with the authority to diagnose fractures and/or elbow joint effusions in various settings including primary care (e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well as radiologists who review radiographs across settings.

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

The training of TechCare Trauma was performed on a training dataset of 95266 images (age: range [0 – 102]; mean 53.3 +/- 26.4, median : 58) for all anatomical areas of interest in the Indications for Use and from various manufacturers.

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

Standalone performance testing for fracture detection was performed on a dataset of 4109 radiographs of US adult patients (age: range [22 – 93]; mean 60.5 +/- 17.5 years) and a dataset of 2872 radiographs of US pediatric patients (age: range [0 – 21.9]; mean 12.2 +/- 5.6 years). Cases were obtained from various states in the US (at least 4), and various imaging hardware manufacturers (at least 14). These datasets were independent of the data used for model training, tuning, and establishment of device operating points.

Performance testing for EJE detection was performed on a dataset of 280 radiographs of US adult patients (age: range [22 – 93]; mean 63.0 +/- 17.3 years) and a dataset of 483 radiographs of US pediatric patients (age: range [2 – 21.7]; mean 9.2 +/- 5.5 years).

The ground-truth was established by American Board of Radiology (ABR)-certified radiologists with a minimum of 5 years of experience since ABR certification. Pediatric and adult cases followed two parallel ground-truthing (GT) pathways: the pediatric cases were annotated by a pediatric GT panel made of three ABR-certified pediatric radiologists and the adult cases by an adult GT panel made of three ABR-certified musculoskeletal (MSK) radiologists independently interpreted each case for the presence or absence of fracture and EJE using the standard clinical definitions of these pathologies. The third radiologist independently reviewed the cases where there was disagreement between the first two. The final reference standard was determined by majority consensus.

MRMC study data:
4 dataset populations were individualized, obtained from sites that were different from the training data sites to ensure the independence of the test data from training data:

Adult US population for fracture detection (304 radiological cases)
Pediatric US population for fracture detection (256 radiological cases)
Adult US population for EJE detection (109 radiological cases)
Pediatric US population for EJE detection (100 radiological cases)

The ground truth was established by ABR-certified radiologists with at least five years of experience. Pediatric cases were annotated by a panel of three pediatric radiologists, while adult cases were reviewed by a panel of three MSK radiologists. Two radiologists independently assessed each case, with a third reviewing cases with initial disagreements. The final reference standard was determined by majority consensus.

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

Study Type: Standalone Performance Testing and Clinical Data (MRMC retrospective reader study).

Standalone Performance Testing:

Sample Size:
- Fracture detection: 4109 US adult radiographs, 2872 US pediatric radiographs.
- EJE detection: 280 US adult radiographs, 483 US pediatric radiographs.
Key Results:
- Fracture detection (ROC-AUC):
  - Adults: 0.962 [0.957; 0.967]
  - Pediatrics: 0.962 [0.955; 0.969]
- EJE detection (ROC-AUC):
  - Adults: 0.965 [0.936; 0.986]
  - Pediatrics: 0.976 [0.963; 0.986]
- The testing demonstrated high image-level ROC-AUC with narrow 95% confidence intervals for both fracture and elbow joint effusion (EJE) detection in adult and pediatric populations.
- TechCare Trauma performs with high accuracy across study types (anatomic areas of interest, views, patient age and sex and machine) and across potential confounders including different imaging hardware manufacturers and displaced/non-displaced fractures.

Clinical Data (MRMC retrospective reader study):

Sample Size:
- Adult US population for fracture detection (304 radiological cases)
- Pediatric US population for fracture detection (256 radiological cases)
- Adult US population for EJE detection (109 radiological cases)
- Pediatric US population for EJE detection (100 radiological cases)
Key Results: The diagnostic accuracy of readers in the intended use population is superior when aided by TechCare Trauma than when unaided by TechCare Trauma, as measured at the task of fracture and/or EJE detection using the AUC of the ROC curve.
- Adult fracture detection:
  - Reader ROC AUC significantly improved from 0.865 [0.822; 0.907] to 0.955 [0.924; 0.979], a delta of 0.090 [0.060; 0.121] (p

Regulation Number and Section

§ 892.2090 Radiological computer-assisted detection and diagnosis software.

(a)
Identification. A radiological computer-assisted detection and diagnostic software is an image processing device intended to aid in the detection, localization, and characterization of fracture, lesions, or other disease-specific findings on acquired medical images (e.g., radiography, magnetic resonance, computed tomography). The device detects, identifies, and characterizes findings based on features or information extracted from images, and provides information about the presence, location, and characteristics of the findings to the user. The analysis is intended to inform the primary diagnostic and patient management decisions that are made by the clinical user. The device is not intended as a replacement for a complete clinician's review or their clinical judgment that takes into account other relevant information from the image or patient history.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithm, including a description of the algorithm inputs and outputs, each major component or block, how the algorithm and output affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide improved assisted-read detection and diagnostic performance as intended in the indicated user population(s), and to characterize the standalone device performance for labeling. Performance testing includes standalone test(s), side-by-side comparison(s), and/or a reader study, as applicable.
(iii) Results from standalone performance testing used to characterize the independent performance of the device separate from aided user performance. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, positive and negative predictive values, and diagnostic likelihood ratio). Devices with localization output must include localization accuracy testing as a component of standalone testing. The test dataset must be representative of the typical patient population with enrichment made only to ensure that the test dataset contains a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant disease, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Results from performance testing that demonstrate that the device provides improved assisted-read detection and/or diagnostic performance as intended in the indicated user population(s) when used in accordance with the instructions for use. The reader population must be comprised of the intended user population in terms of clinical training, certification, and years of experience. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, positive and negative predictive values, and diagnostic likelihood ratio). Test datasets must meet the requirements described in paragraph (b)(1)(iii) of this section.(v) Appropriate software documentation, including device hazard analysis, software requirements specification document, software design specification document, traceability analysis, system level test protocol, pass/fail criteria, testing results, and cybersecurity measures.
(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the device instructions for use, including the intended reading protocol and how the user should interpret the device output.
(iii) A detailed description of the intended user, and any user training materials or programs that address appropriate reading protocols for the device, to ensure that the end user is fully aware of how to interpret and apply the device output.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) A detailed summary of the performance testing, including test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as anatomical characteristics, patient demographics and medical history, user experience, and imaging equipment.

Summary

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January 17, 2025

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Milvue % John Smith Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street NW Washington, DC 20004

Re: K242171

Trade/Device Name: TechCare Trauma Regulation Number: 21 CFR 892.2090 Regulation Name: Radiological computer assisted detection and diagnosis software Regulatory Class: Class II Product Code: QBS Dated: July 24, 2024 Received: December 16, 2024

Dear John Smith:

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 (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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Samul for

Jessica Lamb, Ph.D. Assistant Director Imaging Software 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

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Indications for Use

510(k) Number (if known) K242171

Device Name TechCare Trauma

Indications for Use (Describe)

TechCare Trauma is intended to analyze 2D X ray radiographs using techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs of:

| Study Type
(Anatomic Area of
Interest) | Radiographic
View(s) Supported | Findings | Patient Population |
|----------------------------------------------|-----------------------------------|-------------------------|-------------------------------------------|
| Ankle | Frontal, Lateral,
Oblique | Fracture | Adults, Infants, Children,
Adolescents |
| Foot | Frontal, Lateral,
Oblique | Fracture | Adults, Infants, Children,
Adolescents |
| Knee | Frontal, Lateral,
Oblique | Fracture | Adults, Infants, Children,
Adolescents |
| Leg (includes
Tibia/Fibula) | Frontal, Lateral | Fracture | Adults, Infants, Children,
Adolescents |
| Femur | Frontal, Lateral | Fracture | Adults |
| Wrist | Frontal, Lateral,
Oblique | Fracture | Adults, Children, Adolescents |
| Hand/Finger | Frontal, Lateral,
Oblique | Fracture | Adults, Infants, Children,
Adolescents |
| Elbow | Lateral | Elbow Joint
Effusion | Adults, Children, Adolescents |
| | Forearm | Frontal, Lateral | Fracture |

Table 1 : Intended Use Overview

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| Study Type
(Anatomic Area of
Interest) | Radiographic
View(s) Supported | Findings | Patient Population |
|----------------------------------------------|-----------------------------------|-------------------------|-----------------------------------------------------|
| | Lateral | Elbow Joint
Effusion | Adults, Children, Adolescents |
| Arm (includes
Humerus) | Frontal, Lateral | Fracture | Adults, Neonates, Infants, Children,
Adolescents |
| | Lateral | Elbow Joint
Effusion | Adults, Children, Adolescents |
| Shoulder | Frontal, Lateral | Fracture | Adults, Infants, Children,
Adolescents |
| Clavicle | Frontal | Fracture | Adults, Children, Adolescents,
Neonates, Infants |
| Pelvis | Frontal | Fracture | Adults, Infants, Children,
Adolescents |
| Hip | Frontal, Lateral | Fracture | Adults, Infants, Children,
Adolescents |
| Thorax (includes ribs) | Frontal, Lateral, Ribs
series | Fracture | Adults |

TechCare Trauma can provide results for fracture in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over).

The intended users of TechCare Trauma are clinicians with the authority to diagnose fractures and/or elbow joint effusions in various settings including primary care (e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well as radiologists who review radiographs across settings.

TechCare Trauma results are not intended to be used on a stand-alone basis for clinical decision-making. Primary diagnostic and patient management decisions are made by the clinical user.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/6/Picture/0 description: The image shows the word "MILVUE" in large, green letters. Below the word, in smaller letters, is the phrase "NEW TECH NEW CARE". The words "NEW TECH" are in a dark teal color, while the words "NEW CARE" are in the same green color as the word "MILVUE".

K242171

510(k) SUMMARY

Milvue's TechCare Trauma

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a)

Date Prepared: 17th of January 2025

Submitter 1.

Milvue 29 rue du Faubourg Saint-Jacques, 75014 Paris - FRANCE

Primary Contact Person:

Mathieu Quintin Quality and Regulatory Affairs Director Tel: +33 6 64 22 46 28 Email: mathieu@milvue.com

Secondary Contact Person:

Dr Alexandre Parpaleix CEO Tel : +33 6 03 02 47 79 Email: alexandre@milvue.com

2. Subject Device

Trade Name: TechCare Trauma Manufacturer: Milvue Classification Name: Radiological computer assisted detection/diagnosis software for fracture Regulation: Regulation: 21 CFR 892.2090 Regulatory Class: Class II Product Code: QBS

3. Predicate Device

Trade Name: BoneView 1.1-US Manufacturer: Gleamer 510(k) reference: K222176 Classification Name: Radiological computer assisted detection/diagnosis software for fracture Regulatory Class: Class II

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Image /page/7/Picture/0 description: The image shows the word "MILVUE" in large, green, sans-serif font. Below the word "MILVUE" is the phrase "NEW TECH NEW CARE". The word "NEW" is in blue, and the words "TECH" and "CARE" are in green.

Product Code: QBS

4. Device Description