T-001-007 Manufacturer declaration of conformity_MDR
AI Labs Group SL, located at the Street Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain), with SRN ES-MF-000025345, certifies under its responsibility that the manufactured product:
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Version | 1.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| Intended purpose | The device is computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. The device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision. |
The complete intended purpose can be consulted below, in the section Intended use or purpose.
Complies with the applicable standards:
- UNE-EN ISO 13485:2016 Quality management systems. Requirements for regulatory purposes.
- UNE-EN 62304:2007/CORR:2009/A1:2016 Medical device software. Software life cycle processes.
- UNE-EN ISO 14971:2019 Medical devices/health products. Application of risk management to MD.
- UNE-EN ISO 15223-1: 2017 Health products. Symbols to be used on labels, labelling and information to be supplied.
- UNE-EN 1041: 2009/A1:2014 Information provided by the manufacturer of medical devices.
- UNE-EN 62366:2009/A1:2015 Application of usability engineering to medical devices.
Complies with the following common specification:
- Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.
And complies with the provisions of the Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices and issued under the exclusive responsibility of AI Labs Group SL.
Classification: Class IIa (Rule 11)
The conformity assessment route is based on a quality management system and on assessment of technical documentation according to the Annex IX or the above mentioned regulation.
Certificate ID: To include
Notified body: BSI (British Standards Institution) number 2797.
All documentation supporting this CE Declaration of Conformity is preserved in the document management system of the manufacturer, supported by the Quality System approval to ISO 13485 by BSI.
This document was issued in Bilbao, on the following date:
Signature and date |
|---|
| General Manager full name |
Intended use or purpose
Intended use
The device is a computational software-only medical device intended to support health care providers in the assessment of skin structures, enhancing efficiency and accuracy of care delivery, by providing:
- quantification of intensity, count, extent of visible clinical signs
- interpretative distribution representation of possible International Classification of Diseases (ICD) categories.
Quantification of intensity, count and extent of visible clinical signs
The device provides quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others; including, but not limited to:
- erythema,
- desquamation,
- induration,
- crusting,
- xerosis (dryness),
- swelling (oedema),
- oozing,
- excoriation,
- lichenification,
- exudation,
- wound depth,
- wound border,
- undermining,
- hair loss,
- necrotic tissue,
- granulation tissue,
- epithelialization,
- nodule,
- papule
- pustule,
- cyst,
- comedone,
- abscess,
- draining tunnel,
- inflammatory lesion,
- exposed wound, bone and/or adjacent tissues,
- slough or biofilm,
- maceration,
- external material over the lesion,
- hypopigmentation or depigmentation,
- hyperpigmentation,
- scar,
- ictericia
Image-based recognition of visible ICD categories
The device is intended to provide an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image.
Device description
The device is a computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. Its principal function is to provide a wide range of clinical data from the analyzed images to assist healthcare practitioners in their clinical evaluations and allow healthcare provider organisations to gather data and improve their workflows.
The generated data is intended to aid healthcare practitioners and organizations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.
The device should never be used to confirm a clinical diagnosis. On the contrary, its result is one element of the overall clinical assessment. Indeed, the device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision.
Intended medical indication
The device is indicated for use on images of visible skin structure abnormalities to support the assessment of all diseases of the skin incorporating conditions affecting the epidermis, its appendages (hair, hair follicle, sebaceous glands, apocrine sweat gland apparatus, eccrine sweat gland apparatus and nails) and associated mucous membranes (conjunctival, oral and genital), the dermis, the cutaneous vasculature and the subcutaneous tissue (subcutis).
Intended patient population
The device is intended for use on images of skin from patients presenting visible skin structure abnormalities, across all age groups, skin types, and demographics.
Intended user
The medical device is intended for use by healthcare providers to aid in the assessment of skin structures.
User qualification and competencies
In this section we specificy the specific qualifications and competencies needed for users of the device, to properly use the device, provided that they already belong to their professional category. In other words, when describing the qualifications of HCPs, it is assumed that healthcare professionals (HCPs) already have the qualifications and competencies native to their profession.
Healthcare professionals
No official qualifications are needes, but it is advisable if HCPs have some competencies:
- Knowledge on how to take images with smartphones.
IT professionals
IT professionals are responsible for the integration of the medical device into the healthcare organisation's system.
No specific official qualifications are needed, but it is advisable that IT professionals using the device have the following competencies:
- Basic knowledge of FHIR
- Understanding of the output of the device.
Use environment
The device is intended to be used in the setting of healthcare organisations and their IT departments, which commonly are situated inside hospitals or other clinical facilities.
The device is intended to be integrated into the healthcare organisation's system by IT professionals.
Operating principle
The device is computational medical tool leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures.
Body structures
The device is intended to use on the epidermis, its appendages (hair, hair follicle, sebaceous glands, apocrine sweat gland apparatus, eccrine sweat gland apparatus and nails) and associated mucous membranes (conjunctival, oral and genital), the dermis, the cutaneous vasculature and the subcutaneous tissue (subcutis).
In fact, the device is intended to use on visible skin structures. As such, it can only quantify clinical signs that are visible, and distribute the probabilities across ICD categories that are visible.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001