(424 days)
No reference devices were used in this submission.
No
The summary describes a standard digital mammography system and its image acquisition and processing capabilities. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for image analysis, interpretation, or workflow optimization beyond basic processing. The performance studies focus on image quality and physical characteristics, not AI/ML performance metrics.
No.
The device is intended for screening and diagnosis of breast cancer by acquiring mammographic images, not for treating the condition.
Yes
The device explicitly states its intended use for "screening and diagnosis of breast cancer" and "additional diagnostic workup of the breast." While it is an imaging system, the images it produces are used directly for diagnostic purposes, classifying it as a diagnostic device.
No
The device is a Full Field Digital Mammography (FFDM) system, which is a hardware device that acquires digital x-ray images. While it includes software for workflow control and image processing, it is fundamentally a hardware system.
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.
- Device Function: The Planmed Clarity 2D and Planmed Clarity S are imaging systems that use X-rays to create images of the breast. They do not analyze biological samples.
- Intended Use: The intended use is for "screening and diagnosis of breast cancer" and "additional diagnostic workup of the breast" through the acquisition and review of images.
While the device is used for diagnosis, it does so by producing images, not by performing tests on biological specimens. Therefore, it falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.
Product codes (comma separated list FDA assigned to the subject device)
MUE
Device Description
The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.
The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS. respectively), as a format of modality worklist. Subsequently, the images are acquired. processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Full Field Digital Mammography (FFDM)
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)
Biocompatibility testing: Not new patient contacting mechanical parts have been added; thus, no new biocompatibility testing was necessary.
Electrical safety and electromagnetic compatibility (EMC) testing: System complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-45, ISO 10993-1 for safety, and IEC 60601-1-2 for EMC. The flat panel detector type has been separately EMC tested by TÜV Rheinland.
Software Verification and Validation Testing: Software for this device was considered as a "Moderate" level of concern.
Physical laboratory testing (bench testing):
- Sensitometric response: Both detectors respond linearly to radiation exposure.
- Spatial resolution: Both systems perform similarly in terms of MTF.
- Noise analysis: The subject device has slightly better noise performance. SNR and CNR are slightly higher.
- Dynamic range: The subject device produces higher DQE than the predicate system.
- Repeated exposures: Ghost tolerance was similar.
- Automatic Exposure Control (AEC) performance: Organ and entrance doses are well within generally accepted levels (1.23 mGy organ dose with W/Ag beam quality for 40 mm PMMA phantom).
- Phantom test: RMI phantom scores and CDMAM test pass for both systems.
- Patient radiation dose: Both systems achieve radiation dose levels well within generally acceptable limits.
- Breast compression system: Powered compression pressure test results are similar.
Clinical image evaluation: Performed with the subject Clarity 2D system. 6 patients participated in routine breast cancer screening in Bulgaria. Images assigned BI-RADS score 1 or 2 were selected, with some diagnostic mammograms included. Two MQSA qualified experienced US radiologists independently reviewed the images. All images were rated good or excellent, confirming overall image quality was acceptable for all cases and image types.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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October 23, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Planmed Oy % Lars Moring Regulatory Affairs Manager Sorvaajankatu 7 Helsinki. 00880 FINLAND
Re: K192317
Trade/Device Name: Planmed Clarity 2D and Clarity S Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: September 22, 2020 Received: September 25, 2020
Dear Lars Moring:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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) K192317
Device Name
Planmed Clarity 2D and Clarity S
Indications for Use (Describe)
The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
(updated version 3.) K192317
I. SUBMITTER
Manufacturer
Planmed Oy Sorvaajankatu 7 FI-00880 Helsinki, Finland Phone: +358 20 7795 300 Fax: +358 20 7795 396 Contact person: Lars Moring
U.S. designated agent
Planmed USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2200 Fax: (630) 894 4271 Contact person : Brett Hines
Date Prepared: October 23, 2020
II. DEVICE
| Name of Device: | Planmed Clarity 2D and Clarity S |
|---|---|
| Common or Usual Name: | Full Field Digital Mammography (FFDM) System |
| Classification Name: | Full Field Digital Mammography (FFDM) System |
| (21 CFR 892.1715) | |
| Regulatory Class: | II |
| Product Code: | MUE |
III. PREDICATE DEVICE
Planmed Clarity Full Field Digital Mammography X-ray System, K163328 This predicate system has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.
The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS. respectively), as a format of modality worklist. Subsequently, the images are acquired. processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
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V. INDICATIONS FOR USE
The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. Both systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D and S systems may also be used for additional diagnostic workup of the breast.
The Indications for Use (IFU) statement are the same for both subject and predicate systems.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
General
Both predicate and subject devices are using the same basic operating principles and are technically very similar. The Clarity 2D system is similar to the predicate Clarity. The 2D system can be technically upgraded to a DBT system in the field (not for the US market). The Clarity S system is a value system derived from Clarity and it cannot be upgraded to DBT. The dual touchscreen user interfaces of Clarity and Clarity 2D are omitted from Clarity S. X-ray generation and control are identical in both systems. The compression system and AEC technology are the same.
Integrated detector
The digital full field flat panel detector is a new version of the Clarity detector. The new detector has essentially identical imaging characteristics and signal processing as the predicate device. Quality assurance with pixel defect acceptance criteria comparison is similar. Pixel matrixes are identical, pixel width 83 um. ADC bit depth is 16 bit for the subject system vs. 14 bit for the predicate system. Software interface to communicate with the detector has not been changed.
X-ray unit
Dimensions of the units are similar.
X-rav tube
Units use the same X-ray tube.
X-ray generator
Units use the same X-ray generator.
X-rav anti-scatter grid
Same grid is used on both systems.
Software
The Clarity Manager workstation software was changed to run on Windows 10 instead of Windows 7 of the predicate system. The software of the system has been improved to include encrypted DICOM communication. Imaging sequence has been made shorter by improving the software interface with the detector and with some optimization of the x-ray generator timing. The software has been adapted for the higher dynamic range of the new detector version (from 14 bit to 16 bit). Also some new hardware version related changes of the user interfaces have been made. A detailed software description document is included with this submission along with a comprehensive description of changes between software versions of the predicate device to the subject device.
Risks
Cyber security risks and their mitigations have been addressed more closely and comprehensively with the latest software release for the subject systems. New hazards in comparison to predicate device have been identified and addressed.
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Table 1: Comparison of device specifications
| Device | Planmed Clarity 2D | Planmed Clarity S | Planmed Clarity |
|---|---|---|---|
| Subject device | Subject device | Predicate device | |
| General comparison | |||
| Description | Full Field Digital | ||
| Mammography system | Full Field Digital | ||
| Mammography system | Full Field Digital | ||
| Mammography system | |||
| System configuration | X-ray stand and | ||
| Workstation PC | X-ray stand and | ||
| Workstation PC | X-ray stand and | ||
| Workstation PC | |||
| Application software | Clarity Manager 2.3 on | ||
| Windows 10 | Clarity Manager 2.3 on | ||
| Windows 10 | Clarity Manager 1.3 on | ||
| Windows 7 | |||
| User interfaces | Touch screen user | ||
| interface side displays on | |||
| both sides of x-ray stand | No side displays on x-ray | ||
| stand, user interface | |||
| included in workstation | |||
| PC display | Touch screen user | ||
| interface side displays | |||
| on both sides of x-ray | |||
| stand | |||
| 'Side access' feature | |||
| for easier patient | |||
| positioning | yes, standard | not available | yes, standard |
| Control switches | additional C-arm control | ||
| switches, compression | |||
| fine adjustment | no additional switches | additional C-arm control | |
| switches, compression | |||
| fine adjustment | |||
| Upgradeability | DBT with s2D (not in US) | ||
| stereotactic device (not | |||
| in US) optional | not upgradeable to 3D | ||
| not upgradeable with | |||
| stereotactic device | DBT with s2D (not in US) | ||
| stereotactic device (not | |||
| in US) optional | |||
| Detector comparison | |||
| Detector type | Varex Paxscan 3024MX | Varex Paxscan 3024MX | Varex Paxscan 3024M |
| Detector technology | Amorphous silicon (a-Si) | ||
| with Csl:TI scintillator | |||
| TFT array | Amorphous silicon (a-Si) | ||
| with Csl:TI scintillator | |||
| TFT array | Amorphous silicon (a-Si) | ||
| with Csl:TI scintillator | |||
| TFT array | |||
| Pixel matrix | 2816x3584 | 2816x3584 | 2816x3584 |
| Size of active area | 23.1x29.1cm | 23.1x29.1cm | 23.1x29.1cm |
| Pixel size | 83 μm | 83 μm | 83 μm |
| ADC bit depth | 16 bit | 16 bit | 14 bit |
| Pixel fill factor | 0.52 | 0.52 | 0.70 |
| Readout time | 236 ms | 236 ms | 495 ms |
(all other imaging effecting specifications are substantially equal for all these systems)
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Since the subject systems are almost identical to the predicate device, no new patient contacting mechanical parts have been added to the subject system. Hence no new biocompatibility testing was necessary. Thus, there is no risk or concern to the patient's safety from contact with the materials of construction of this new mammography unit. Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Planmed Clarity mammography system. The system complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-28, IEC
6
60601-2-45, ISO 10993-1 for safety, and IEC 60601-1-2 for EMC. The only electrical difference is the flat panel detector type which has been separately emc tested by TÜV Rheinland (please see attached emc testing report in VOL17.)
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
Physical laboratory testing
The performance of the system was tested according to Class II Special Controls Guidance Document: Full-Field Digital Mammography System Document issued on: March 27, 2012.
Summary of physical laboratory testing (bench testing) results:
-
- Sensitometric response: Both detectors respond linearly to radiation exposure
- Spatial resolution: Both systems perform similar in terms of MTF since the detector 2. scintillator material or thickness are the same and detector element pixel size is the same.
-
- Noise analysis: The subject device has slightly better noise performance. Also SNR and CNR are slightly higher.
-
- Dynamic range: The subject device produces higher DQE than the predicate system.
-
- Repeated exposures: Ghost tolerance was similar.
-
- Automatic Exposure Control (AEC) performance: With automatic filtration change the organ and entrance doses are well within generally accepted levels. With a 40 mm PMMA phantom corresponding to an average breast thickness and glandularity, organ dose was measured 1.23 mGy with W/Ag beam quality.
-
- Phantom test: RMI phantom scores for all attributes are similar for subject and predicate devices. CDMAM test passes with both systems.
-
- Patient radiation dose: With varving phantom thickness and varying adiposity and glandularity factors, both systems achieve radiation dose levels well within generally acceptable limits.
-
- Breast compression system: Powered compression pressure test results are similar.
Clinical image evaluation
Clinical image evaluation was performed with the subject Clarity 2D system. Purpose was to determine if the image quality were judged to be of sufficiently acceptable quality for mammographic usage when reviewed by MQSA qualified experienced radiologists. The images were taken in one site in Bulgaria where 6 patients participated to routine breast cancer screening. Images assigned BI-RADS score 1 or 2 were selected for the evaluation. Some cases also included diagnostic mammograms, i.e. spot and/or magnification images. The images were then reviewed by two MQSA qualified experienced US radiologists independently. All images were rated good or excellent and thus the overall image quality was acceptable for all cases and image types.
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Planmed Clarity 2D and S full field digital mammography systems perform as intended in the specified use conditions. The clinical image evaluation also shows that the devices equipped with the new detector version perform comparably to the predicate device that is currently marketed for the same intended use.