(447 days)
Not Found
No
The summary describes a standard digital mammography system and does not mention any AI or ML components or capabilities.
No.
The device is used for imaging (diagnosis, screening) and needle localization, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnosis, screening, or for needle localization in case of stereotactic biopsy," with a specific mention of "diagnosis of breast cancer."
No
The device description explicitly states that Helianthus is a "mammography solution composed of equipment and software" and an "integrated system that includes both the X-ray delivery system and integrated detector," listing numerous hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body ("in vitro").
- Helianthus Function: Helianthus is a mammography system that uses X-rays to create images of the breast. It is a medical imaging device that operates on the patient's body to produce images for diagnosis. It does not analyze samples taken from the body.
Therefore, based on the provided information, Helianthus falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MUE
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
Mentions image processing
Acquisition software, acquisition work station (AWS), and accessories.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Full-Field Digital Mammography
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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
§ 892.1715 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.
0
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
1
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)
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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3
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
4
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
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
to produce two- | The mammography X-ray
unit system acquires | Same; while the
Indications for Use are |
| Attribute | Helianthus | Planmed
Clarity/Planmed Oy | Comparison |
| | 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. | digital 2D
mammographic images.
The mammography X-ray
unit system is intended
to be used for screening
and diagnosis of breast
cancer. | stated somewhat
differently, both
devices acquire digital
2D mammographic
images and intended
to be used for
screening and
diagnosis of breast
cancer. Both include a
stereotactic biopsy
device. |
| Presentation | FFDM system composed
of a mammography unit,
C-arm, acquisition work
station and stereotactic
biopsy device | FFDM system composed
of a mammography unit,
C-arm, acquisition work
station and stereotactic
biopsy device | Same |
| Electrical Power | For 115/220/230/240
Vac:
Momentary:
85/45/43/41 A
Long-time:
2.5/1.3/1.2/1.2 A | 250VA, 4500VA max. 5
seconds | Similar; higher
characteristics. Raises
no new questions of
safety and
effectiveness. |
| Generator Type | High frequency | High frequency | Same |
| X-ray Tube | XM1016T
XK1016T | M113T | Similar; X-ray tubes
XM1016T and
XK1016T have similar
characteristics than
M113T tube. Raises
no new questions of
safety and
effectiveness. |
| Detector | Amorphous Selenium | TFT/PIN Photodiode
amorphous silicon FPD | Similar; the physical
laboratory testing
results show the
equivalence in terms
of performance. No
impact on safety. |
| Attribute | Helianthus | Planmed
Clarity/Planmed Oy | Comparison |
| Breast Compression
System - Maximum
compression that
can be applied (N) | 200 | 200 | Different; Helianthus
complies with
IEC60601-2-45 (for
power driven
compression limited
to 200N). |
| Radiation Shield -
Radiation Protection
Screen (w x h x d
(cm)) and Lead
Equivalence of the
Protection Screen
(mm Pb) | 70 x 200 integrated in
optional remote AWS
Or
70x210 optional (in case
of local AWS)
0.34 (0.5 optional) | 77.5 x 188
0.3 (0.5) | Similar. Raises no new
questions of safety
and effectiveness. |
| Stereotactic Biopsy
Device | Complies with IEC
60601-2-45 | Complies with IEC 60601-
2-45 | Same |
| DICOM | DICOM Services, SCU,
Storage Commitment,
MPPS, worklist
management SCU,
structured report,
media storage, print | DICOM Services, SCU,
Storage Commitment,
MPPS, worklist
management SCU,
structured report, media
storage, print | Same |
| Complies with ISO
10993-1 | Yes | Yes | Same |
| Electrical Safety
Testing Passed | Yes | Yes | Same |
Table 5A - Comparison of Characteristics
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6
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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
8
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.