(245 days)
No
The description explicitly states that the device "does not perform automated image analysis but provides advanced imaging manipulation tools." The listed features are standard image processing and review tools, not indicative of AI/ML.
No
The device is described as software for reviewing and processing ophthalmic medical images to support diagnosis and monitoring, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies," indicating its role in the diagnostic process. Additionally, the "Device Description" mentions its ability to "review diagnostic data, clinical information and reports, from ophthalmic diagnostic instruments."
Yes
The device is explicitly described as a "cloud-based software application with a web-based interface" and its function is to review, process, and analyze data and images from other ophthalmic devices. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, the iCare ALTIUS CW is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- iCare ALTIUS CW's Function: The iCare ALTIUS CW processes and analyzes ophthalmic medical images and data generated by other ophthalmic devices. It does not directly analyze biological specimens from the patient's body.
- Intended Use: The intended use clearly states it's for the review, processing, and analysis of ophthalmic medical images and data to support healthcare professionals in diagnosis and monitoring. This is focused on interpreting imaging and clinical data, not analyzing biological samples.
While it's a medical device that aids in diagnosis, its mechanism of action is based on image and data processing, not the analysis of in vitro specimens.
N/A
Intended Use / Indications for Use
iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data, measurements and reports, generated by ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.
Product codes
NFJ
Device Description
iCare ALTIUS CW is a cloud-based software application with a web-based interface able to:
- review medical ophthalmic images, including videos,
- digitally process images,
- review diagnostic data, clinical information and reports,
from ophthalmic diagnostic instruments. CW does not perform automated image analysis but provides advanced imaging manipulation tools.
CW allows to review and process diagnostic data and multiple images with different formats (e.g. PDFS, JPEG, ...) and provides the following features:
- image manipulation filters such as zooming, changing brightness and contrast and gamma, RGB filtering,
- side-by-side image comparison (detached or synchronized mode) with different layouts,
- advanced imaging tools, such as flicker between different pictures and mosaics of several images,
- review and print reports generated by ophthalmic devices. -
CW integrates with PACS software systems, which provide the medical images and reports, to be analysed by the CW. The patient data and medical images exchange between CW and PACS is done through computerized networks using secured network communication.
The web-based interface of CW is designed to be used through a desktop PC or a laptop using keyboard and mouse (further details in the technical requirements section).
The User Interface is available in the languages required by the applicable regulatory requirement of the country where the device is placed on the market.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ophthalmic medical images, including videos
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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)
Software Verification and Validation Testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions."; Basic Documentation was submitted. The software also complies with the IEC 62304 standard for software life cycle processes.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
August 22, 2024
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 features a stylized image of a human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Centervue Spa Luca Scienza Quality and Regulatory Manager Via San Marco 9H Padova, 35129 Italy
Re: K234076
Trade/Device Name: iCare ALTIUS CW Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: December 21, 2023 Received: December 22, 2023
Dear Luca Scienza:
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 (the 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.
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).
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Page 2
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 QS 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.
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 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).
Sincerelv.
Elvin Y. Ng-S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K234076
Device Name iCare ALTIUS CW
Indications for Use (Describe)
iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data, measurements and reports, generated by ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.
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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3
Regulatory information
| Device Name: | iCare ALTIUS CW |
|---|---|
| Type of 510(k) submission: | Traditional |
| 510(k) number: | K234076 |
| Date: | August 21, 2024 |
| Manufacturer: | CenterVue S.p.A. |
| via San Marco 9H | |
| 35129 Padova Italy | |
| 510(k) Owner: | CenterVue S.p.A. |
| via San Marco 9H | |
| 35129 Padova Italy | |
| Phone: +39 049 501 8399 | |
| Fax: +39 049 501 8398 | |
| FDA Registration Number: | 3008422902 |
| Owner/Operator Number: | 10032778 |
| Applicant and Contact: | Mr. Luca Scienza |
| CenterVue S.p.A. | |
| QARA Manager | |
| Via San Marco 9h | |
| 35129 Padova, ITALY | |
| Email: luca.scienza@icare-world.com | |
| Phone: +39 049 501 8399 | |
| Fax: +39 049 501 8398 | |
| Product Code: | NFJ |
| Regulation Number: | 892.2050 |
| Common name: | Medical image management and processing system |
| Review Panel: | Ophthalmic |
| Device Class: | Class II |
| Indications for use: | iCare ALTIUS CW is a Medical Device Software indicated |
| for the review, processing and analysis of ophthalmic | |
| medical images, for the review of video, clinical and | |
| diagnostic data, measurements and reports, generated by |
4
ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.
5
Device description
iCare ALTIUS CW is a cloud-based software application with a web-based interface able to:
- review medical ophthalmic images, including videos,
- digitally process images, ।
- review diagnostic data, clinical information and reports,
from ophthalmic diagnostic instruments. CW does not perform automated image analysis but provides advanced imaging manipulation tools.
CW allows to review and process diagnostic data and multiple images with different formats (e.g. PDFS, JPEG, ...) and provides the following features:
- । image manipulation filters such as zooming, changing brightness and contrast and gamma, RGB filtering,
- side-by-side image comparison (detached or synchronized mode) with different layouts,
- advanced imaging tools, such as flicker between different pictures and mosaics of several images,
- review and print reports generated by ophthalmic devices. -
CW integrates with PACS software systems, which provide the medical images and reports, to be analysed by the CW. The patient data and medical images exchange between CW and PACS is done through computerized networks using secured network communication.
The web-based interface of CW is designed to be used through a desktop PC or a laptop using keyboard and mouse (further details in the technical requirements section).
The User Interface is available in the languages required by the applicable regulatory requirement of the country where the device is placed on the market.
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Technical Specifications
| iCare ALTIUS CW - TECHNICAL SPECIFICATIONS | |
|---|---|
| User PC | Desktop or laptop |
| Display resolution | Minimum: 1280 × 800 pixels |
| PC RAM | Minimum: 8GB (with minimum 4 GB free RAM for the browser) |
| Browser | MS Edge version 97.0.1072.55 (January 6, 2022) or later |
| Mozilla Firefox version 96.0 (January 11, 2022) or later | |
| Safari version 15.2 (December 14 Dec 2021) or later | |
| Chrome version 97.0.4692.71 (January 4, 2022) or later | |
| Internet connection | Reliable broadband connection |
| Accessory: | No accessories |
| PACS supported: | iCare ALTIUS |
| Image processing features | Basic: |
| Zoom, Pan, Brightness, Contrast, Gamma, RGB filtering | |
| Image comparison (detached or synchronized) | |
| Cup-to-Disc ratio annotation | |
| Advanced: | |
| Flickering between different pictures and/or imaging modalities | |
| Mosaic (montage) |
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Predicate devices
The predicate device selected is identified as follows:
| Device Name: | FORUM |
|---|---|
| Manufacturer: | Carl Zeiss Meditec AG |
| 510(k) Number: | K213527 |
| Product Code: | NFJ |
| Classification Name: | Medical image management and processing system |
| Regulation No: | 892.2050 |
Comparison of technological characteristics with the predicate device(s)
iCare ALTIUS CW is substantially equivalent to the predicate device except for the following aspects:
- absence of purely database features (delegated to a non-medical device software PACS) -
- provision of measurements only in dimensionless units (cup-to-disc ratio) -
- provision of mosaic and flickering features -
- different system architecture (Client/Server VS Cloud Software with web interface). -
Differences in technological characteristics are limited to the architecture of the system. Such differences are believed to have no effect on the safety and effectiveness of the device, as documented in the Risk Management process, in the Usability Engineering and demonstrated in device testing and verifications.
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contervue
Performance data
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions."; Basic Documentation was submitted. The software also complies with the IEC 62304 standard for software life cycle processes.
Conclusions
Based on the information contained within this submission, it is concluded that iCare ALTIUS CW is substantially equivalent to the identified predicate device already in interstate commerce within the USA, and that any differences that do exist have no effect on the safety and effectiveness of the device.