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.

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

AI/ML Overview

Based on the provided text, the document describes the substantial equivalence determination for the Helianthus full-field digital mammography system, comparing it to the predicate device, Planmed Clarity. However, the text does not contain detailed information about acceptance criteria or a specific study proving the device meets these criteria in the format requested.

The document states that:

Non-Clinical Performance Data (Section 9) demonstrates that "Results confirm that the design inputs and performance specifications for the device are met." This section lists various tests (e.g., electrical safety, software verification, imaging characteristics through physical laboratory testing).
Clinical Performance Data (Section 10) states: "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."

Therefore, the full details required to populate all fields of your request (e.g., specific acceptance criteria values, sample sizes for test/training sets, exact number and qualifications of experts, adjudication methods, MRMC study details, types of ground truth) are NOT present in the provided text.

Below, I will fill in what can be inferred or explicitly stated from the provided text, and clearly mark where information is not provided.

Acceptance Criteria and Device Performance (Inferred/Stated from Text)

Acceptance Criteria Category	Acceptance Criteria (Specific Values)	Reported Device Performance
Non-Clinical Performance
Biocompatibility (Breast Support Material)	Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-5 (Irritation), ISO 10993-10 (Sensitization)	Passed all specified ISO 10993 tests.
Biocompatibility (Compression Paddles)	Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-5 (Irritation), ISO 10993-10 (Sensitization); Demonstrated chemical stability	Passed all specified ISO 10993 tests; Demonstrated chemical stability.
Electrical Safety	Compliance with IEC 60601-1	Passed.
Electromagnetic Disturbance (EMD)	Compliance with IEC 60601-1-2	Passed.
Photobiological Safety	Compliance with IEC 62471	Passed.
Software Verification & Validation	Compliance with IEC 62304 / FDA Guidance; Software system met its specification and fulfilled its purpose.	Software system met its specification and fulfilled its purpose.
Imaging Characteristics (Physical Lab)	As required by FDA Guidance (April 4, 2012, Section 8): Sensitometric response, spatial resolution, noise analysis, DQE, dynamic range, image erasure and fading, repeated exposure test, Automatic Exposure Control performance, phantom testing, patient radiation dose, breast compression system. Specific quantitative acceptance values are not provided in this text.	Performed as intended and established to be substantially equivalent in terms of safety and effectiveness to the predicate device.
Stereotactic Biopsy Device Accuracy	Compliance with IEC 60601-2-45 (Positioning accuracy of the biopsy needle)	Passed.
Mechanical/Environmental Testing	Compliance with EN 60721-3-2 (Vibrations, shock, fall) for mammography unit and accessories, AWS Monitor (ISTA 1A), and detectors.	Demonstrated package integrity maintained for all tested components (mammography unit/accessories, AWS Monitor, detectors).
Clinical Performance
Image Quality - Mammographic Usage	Images determined to be "sufficiently acceptable quality for mammographic usage" and "substantially equivalent to those from a predicate device" (per FDA Guidance, April 4, 2012, Section 9)	Images, reviewed by expert radiologists, were of sufficiently acceptable quality for mammographic usage and were substantially equivalent to those from a predicate device.

Study Details:

A table of acceptance criteria and the reported device performance: Included above. (Note: Specific quantitative values for imaging acceptance criteria are not provided, only that they were assessed per FDA guidance and found equivalent.)
Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided. The text only states "A clinical image evaluation... was conducted."
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided. The text states "images, reviewed by expert radiologists."
- Qualifications: "expert radiologists" - Further specific qualifications (e.g., years of experience, subspecialty) are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. The text only states images were "reviewed by expert radiologists."
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable / Not provided. The document describes a traditional 510(k) for a Full-Field Digital Mammography System (the imaging device itself), not an AI-assisted interpretation or CAD device. The clinical study was to demonstrate image quality equivalence rather than reader performance with/without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an FFDM system, meaning it produces images for human interpretation, not an algorithm that performs diagnosis standalone. The physical laboratory tests (Section 9) could be considered "standalone" evaluation of the system's technical image quality parameters.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For clinical image evaluation, the ground truth for acceptability and equivalence was based on the review by expert radiologists. The text implies a subjective assessment of image quality for mammographic usage and comparison to the predicate. It does not mention pathology or outcomes data as "ground truth" for the image evaluation itself, though such data would underpin the overall purpose of mammography.
- For non-clinical performance tests, the ground truth was based on compliance with established international standards (e.g., ISO, IEC) and internal requirements.
The sample size for the training set: Not applicable/Not provided. This device is a traditional imaging system, not an AI model requiring a "training set" in the machine learning sense. The testing (non-clinical and clinical) is for verification and validation.
How the ground truth for the training set was established: Not applicable. As above, there's no mention of a "training set" for an AI model.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com 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

7. Device Description

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

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	PlanmedClarity/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 intendedto produce two-	The mammography X-rayunit system acquires	Same; while theIndications for Use are
Attribute	Helianthus	PlanmedClarity/Planmed Oy	Comparison
	dimensional digitalmammographic imagesof the breast fordiagnosis of breastcancer. Its intended useis for diagnosis,screening, or for needlelocalization in case ofstereotactic biopsy.	digital 2Dmammographic images.The mammography X-rayunit system is intendedto be used for screeningand diagnosis of breastcancer.	stated somewhatdifferently, bothdevices acquire digital2D mammographicimages and intendedto be used forscreening anddiagnosis of breastcancer. Both include astereotactic biopsydevice.
Presentation	FFDM system composedof a mammography unit,C-arm, acquisition workstation and stereotacticbiopsy device	FFDM system composedof a mammography unit,C-arm, acquisition workstation and stereotacticbiopsy device	Same
Electrical Power	For 115/220/230/240Vac:Momentary:85/45/43/41 ALong-time:2.5/1.3/1.2/1.2 A	250VA, 4500VA max. 5seconds	Similar; highercharacteristics. Raisesno new questions ofsafety andeffectiveness.
Generator Type	High frequency	High frequency	Same
X-ray Tube	XM1016TXK1016T	M113T	Similar; X-ray tubesXM1016T andXK1016T have similarcharacteristics thanM113T tube. Raisesno new questions ofsafety andeffectiveness.
Detector	Amorphous Selenium	TFT/PIN Photodiodeamorphous silicon FPD	Similar; the physicallaboratory testingresults show theequivalence in termsof performance. Noimpact on safety.
Attribute	Helianthus	PlanmedClarity/Planmed Oy	Comparison
Breast CompressionSystem - Maximumcompression thatcan be applied (N)	200	200	Different; Helianthuscomplies withIEC60601-2-45 (forpower drivencompression limitedto 200N).
Radiation Shield -Radiation ProtectionScreen (w x h x d(cm)) and LeadEquivalence of theProtection Screen(mm Pb)	70 x 200 integrated inoptional remote AWSOr70x210 optional (in caseof local AWS)0.34 (0.5 optional)	77.5 x 1880.3 (0.5)	Similar. Raises no newquestions of safetyand effectiveness.
Stereotactic BiopsyDevice	Complies with IEC60601-2-45	Complies with IEC 60601-2-45	Same
DICOM	DICOM Services, SCU,Storage Commitment,MPPS, worklistmanagement SCU,structured report,media storage, print	DICOM Services, SCU,Storage Commitment,MPPS, worklistmanagement SCU,structured report, mediastorage, print	Same
Complies with ISO10993-1	Yes	Yes	Same
Electrical SafetyTesting 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.

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
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.(b)
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.