Helianthus

K202822 · Metaltronica Spa · MUE · Dec 15, 2021 · Radiology

Device Facts

• Record ID: K202822
• Device Name: Helianthus
• Applicant: Metaltronica Spa
• Product Code: MUE · Radiology
• Decision Date: Dec 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Indications for Use

Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.

Device Story

Helianthus is a full-field digital mammography (FFDM) system used in clinical settings by healthcare professionals. It acquires 2D digital breast images using an integrated X-ray generator, tube, collimator, beam filter, and amorphous selenium detector. The system includes a breast compression unit and an optional stereotactic biopsy device (BYM 3D DMD). An acquisition workstation (AWS) processes the X-ray signals into digital images. Radiologists view these images to diagnose breast cancer, perform screenings, or guide needle localization for biopsies. The device benefits patients by providing high-quality diagnostic imaging for early breast cancer detection and precise biopsy guidance.

Clinical Evidence

Clinical image evaluation performed per FDA Class II Special Controls Guidance for FFDM systems. Expert radiologists reviewed images produced by the Helianthus system, confirming acceptable diagnostic quality equivalent to the predicate device.

Technological Characteristics

FFDM system; high-frequency X-ray generator; Amorphous Selenium detector; breast compression system (max 200N); stereotactic biopsy device. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMD), IEC 60601-2-45 (biopsy/mammography), and ISO 10993-1 (biocompatibility). Connectivity via DICOM (SCU, Storage Commitment, MPPS, worklist management, structured report, print).

Indications for Use

Indicated for patients requiring two-dimensional digital mammographic imaging for breast cancer diagnosis, screening, or needle localization during stereotactic biopsy.

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

• Planmed Clarity (K163328)

Submission Summary (Full Text)

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December 15, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around an emblem. To the right, there is a blue square with the letters "FDA" in white. Next to the square, the text "U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue.

Metaltronica Spa % Rachel Paul Senior Consultant QA&RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP NETHERLANDS

Re: K202822

Trade/Device Name: Helianthus Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: November 4, 2021 Received: November 5, 2021

Dear Rachel Paul:

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

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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,

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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### Indications for Use

510(k) Number (if known) K202822

Device Name Helianthus

Indications for Use (Describe)

Helianthus is intended to produce two dimensional digital mammographic images of the breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.

| 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)

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# 510(k) Summary

## Helianthus

#### 1. Submission Sponsor

Metaltronica Spa Pomezia (RM) via delle Monachelle 66 CAP 00071 Italy Contact Name: Gloria Pesce Delfino Contact Title: Head of Regulatory and Technical Documentation

### 2. Submission Correspondent

Emergo Europe Consulting Prinsessegracht 20 The Hague 2514AP The Netherlands Office Phone: [phone] Email: [e-mail] Contact: Rachel Paul Title: Senior Consultant, QA&RA

#### 3. Date Prepared

10/28/2021

#### 4. Device Identification

| Trade/Proprietary Name: | Helianthus |
|-------------------------|---------------------------------------|
| Common/Usual Name: | Full-field digital mammography system |
| Classification Name: | Full-field digital mammography system |
| Regulation Number: | 892.1715 |
| Product Code: | MUE |
| Class: | Class 2 |
| Classification Panel: | Radiology |

### 5. Legally Marketed Predicate Device(s)

Device name: Planmed Clarity 510(k) number: K163328

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#### Manufacturer: Planmed Oy

The Planmed Clarity is a mammography X-ray unit system that acquires digital 2D mammographic images. The Planmed Clarity mammography X-ray unit system is intended to be used for screening and diagnosis of breast cancer. It incorporates a stereotactic biopsy device.

#### 6. Indication for Use Statement

Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.

#### 7. Device Description

Helianthus is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging.

Helianthus is a digital mammography system also called full-field digital mammography (FFDM) system. It is an integrated system that includes both the X-ray delivery system and integrated detector. It consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. The image receptor system consists of a built-in full-filed solid state detector, acquisition software, acquisition work station (AWS), and accessories. It includes an optional stereotactic biopsy device (BYM 3D DMD) with its respective Operator's Manual.

Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy

### 8. Substantial Equivalence Discussion

The following table compares the Helianthus to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

| Attribute | Helianthus | Planmed<br>Clarity/Planmed Oy | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K163328 | N/A |
| Product Code | MUE | MUE | Same |
| Regulation Number | 892.1715 | 892.1715 | Same |
| Intended Use | Helianthus is intended<br>to produce two- | The mammography X-ray<br>unit system acquires | Same; while the<br>Indications for Use are |
| Attribute | Helianthus | Planmed<br>Clarity/Planmed Oy | Comparison |
| | dimensional digital<br>mammographic images<br>of the breast for<br>diagnosis of breast<br>cancer. Its intended use<br>is for diagnosis,<br>screening, or for needle<br>localization in case of<br>stereotactic biopsy. | digital 2D<br>mammographic images.<br>The mammography X-ray<br>unit system is intended<br>to be used for screening<br>and diagnosis of breast<br>cancer. | stated somewhat<br>differently, both<br>devices acquire digital<br>2D mammographic<br>images and intended<br>to be used for<br>screening and<br>diagnosis of breast<br>cancer. Both include a<br>stereotactic biopsy<br>device. |
| Presentation | FFDM system composed<br>of a mammography unit,<br>C-arm, acquisition work<br>station and stereotactic<br>biopsy device | FFDM system composed<br>of a mammography unit,<br>C-arm, acquisition work<br>station and stereotactic<br>biopsy device | Same |
| Electrical Power | For 115/220/230/240<br>Vac:<br>Momentary:<br>85/45/43/41 A<br>Long-time:<br>2.5/1.3/1.2/1.2 A | 250VA, 4500VA max. 5<br>seconds | Similar; higher<br>characteristics. Raises<br>no new questions of<br>safety and<br>effectiveness. |
| Generator Type | High frequency | High frequency | Same |
| X-ray Tube | XM1016T<br>XK1016T | M113T | Similar; X-ray tubes<br>XM1016T and<br>XK1016T have similar<br>characteristics than<br>M113T tube. Raises<br>no new questions of<br>safety and<br>effectiveness. |
| Detector | Amorphous Selenium | TFT/PIN Photodiode<br>amorphous silicon FPD | Similar; the physical<br>laboratory testing<br>results show the<br>equivalence in terms<br>of performance. No<br>impact on safety. |
| Attribute | Helianthus | Planmed<br>Clarity/Planmed Oy | Comparison |
| Breast Compression<br>System - Maximum<br>compression that<br>can be applied (N) | 200 | 200 | Different; Helianthus<br>complies with<br>IEC60601-2-45 (for<br>power driven<br>compression limited<br>to 200N). |
| Radiation Shield -<br>Radiation Protection<br>Screen (w x h x d<br>(cm)) and Lead<br>Equivalence of the<br>Protection Screen<br>(mm Pb) | 70 x 200 integrated in<br>optional remote AWS<br>Or<br>70x210 optional (in case<br>of local AWS)<br>0.34 (0.5 optional) | 77.5 x 188<br>0.3 (0.5) | Similar. Raises no new<br>questions of safety<br>and effectiveness. |
| Stereotactic Biopsy<br>Device | Complies with IEC<br>60601-2-45 | Complies with IEC 60601-<br>2-45 | Same |
| DICOM | DICOM Services, SCU,<br>Storage Commitment,<br>MPPS, worklist<br>management SCU,<br>structured report,<br>media storage, print | DICOM Services, SCU,<br>Storage Commitment,<br>MPPS, worklist<br>management SCU,<br>structured report, media<br>storage, print | Same |
| Complies with ISO<br>10993-1 | Yes | Yes | Same |
| Electrical Safety<br>Testing Passed | Yes | Yes | Same |

#### Table 5A - Comparison of Characteristics

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#### 9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of Helianthus and to show substantial equivalence to the predicate device, Metaltronica Spa completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Helianthus passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

- Cytotoxicity testing of breast support material per ISO 10993-5 - Passed
- . Irritation testing of breast support material per ISO 10993-5 – Passed
- Sensitization testing of breast support material per ISO 10993-10 – Passed
- Chemical characterization of compression paddles Demonstrated chemical stability ●
- Cytotoxicity testing of compression paddles part per ISO 10993-5 - Passed
- . Irritation testing of compression paddles part per ISO 10993-5 – Passed
- Sensitization testing of compression paddles part per ISO 10993-10 – Passed
- Electrical safety testing per IEC 60601-1 – Passed
- . Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
- . Photobiological safety of lamps and lamp systems testing per IEC 62471 – Passed
- . Software verification and validation per IEC 62304/FDA Guidance – software system met its specification and fulfilled its purpose
- . Assessment of the imaging characteristics of the Helianthus system through physical laboratory testing (sensitometric response, spatial resolution, noise analysis, signal-to-noise transfer – DQE, dynamic range, image erasure and fading, repeated exposure test, automatic exposure control performance, phantom testing, patient radiation dose, breast compression system) as required by the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System issued on April 4, 2012 (Section 8 Physical Laboratory Testing) - the Helianthus performed as intended and was established to be substantially equivalent in terms of safety and effectiveness to the predicate device.
- Positioning accuracy of the biopsy needle of the Stereotactic Biopsy Device per IEC 60601-2-45 -. Passed
- . Vibrations testing per EN 60721-3-2 and environmental tests (shock and fall testing) on an mammography unit and accessories when in the crate - Demonstrated package integrity maintained
- . Vibrations and shock testing per ISTA 1A of the AWS Monitor - Demonstrated package integrity maintained
- . Mechanical and environmental testing and rudimentary transportation case testing per EN 60721-3-2 of the detectors - Demonstrated package integrity maintained

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#### 10. Clinical Performance Data

A clinical image evaluation as required by the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the Helianthus and determined that the images, reviewed by expert radiologists, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from a predicate device.

### 11. Statement of Substantial Equivalence

Helianthus has the same intended use as the Planmed Clarity. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, Helianthus has been determined to be substantially equivalent to Planmed Clarity.