Giotto Class (Models - 3000X-YY and 4000X-YY)

K200424 · Ims Giotto S.P.A. · MUE · Jun 18, 2020 · Radiology

Device Facts

• Record ID: K200424
• Device Name: Giotto Class (Models - 3000X-YY and 4000X-YY)
• Applicant: Ims Giotto S.P.A.
• Product Code: MUE · Radiology
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended Use

The intended use of the device Giotto Class is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

Device Story

Giotto Class (Models 3000X-YY and 4000X-YY) is a full-field digital mammography (FFDM) system. It acquires X-ray images of the breast for screening and diagnostic purposes. The system transforms X-ray attenuation data into high-resolution digital images for clinical review. Used in clinical settings by radiologists and radiologic technologists. Output is displayed on diagnostic workstations to assist in the detection of breast cancer. The device facilitates clinical decision-making by providing visual evidence of breast tissue morphology, aiding in early cancer detection and diagnostic accuracy.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance evaluation demonstrating that the device meets established standards for full-field digital mammography systems.

Technological Characteristics

Full-field digital mammography system; X-ray imaging; digital detector technology; Class II device; 21 CFR 892.1715; MUE product code. System includes X-ray generator, gantry, and digital image acquisition hardware. Connectivity via standard DICOM protocols for image transmission and storage.

Indications for Use

Indicated for screening and diagnostic examination of the breast for detection of breast cancer in patients requiring mammographic imaging.

Regulatory Classification

Identification

A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.

Predicate Devices

• Giotto Class (K173635)

Submission Summary (Full Text)

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June 18, 2020

IMS GIOTTO S.p.A. % Ms. Marisa Testa CEO - QA/RA Consultant Thema Srl Via Saragat, 5 Imola. Bo 40026 ITALY

Re: K200424

Trade/Device Name: Giotto Class (Models - 3000X-YY and 4000X-YY) Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: May 15, 2020 Received: May 20, 2020

Dear Ms. Testa:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hse 2. Nils

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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## Indications for Use

510(k) Number (if known) K200424

Device Name Giotto Class (Models - 3000X-YY and 4000X-YY)

Indications for Use (Describe)

The intended use of the device Giotto Class is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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