(130 days)
030010
PMA # 030010 Siemens Mammomat Novation DR
No
The document describes a standard digital mammography system and its workflow, focusing on image acquisition, processing, and display. There is no mention of AI, ML, or any related technologies like deep learning or neural networks. The description of image processing is generic and does not imply AI/ML.
No.
The device is used for screening and diagnosis of breast cancer by generating digital mammograms, not for treating any condition.
Yes
This device is specifically intended for "screening and diagnosis of breast cancer," and its output (digital mammograms) is used to "detect breast cancer."
No
The device description clearly states it is a "Full Field Digital Mammography (FFDM) system" and utilizes a "digital image receptor," indicating it is a hardware device that generates images, not solely software. While it includes software for workflow control and image processing, it is not a software-only medical device.
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 provide information for diagnosis, monitoring, or screening.
- Device function: The Planmed Nuance Excel is an X-ray imaging system. It uses X-rays to create images of the breast for the purpose of detecting breast cancer. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "screening and diagnosis of breast cancer" using "digital mammograms." This is an imaging modality, not an in vitro test.
Therefore, based on the provided information, the Planmed Nuance Excel is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.
The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.
Product codes
MUE
Device Description
The Planmed Nuance Excel is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Nuance utilizes an amorphous selenium based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data.
The workflow with Planmed Nuance Excel is controlled from the acquisition workstation and Planmed Nuance Manager 3 image 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 work list. 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
X-ray
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under supervision of a health care professional.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PMA # 030010 Siemens Mammomat Novation DR
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.
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Planned
SEP 2 3 2011
ENCLOSURE 8 P. 8-1
KII1361 510K) SUMMARY
DATE
May 18, 2011
PRODUCT, CLASSIFICATION NAME
Trade name: Planmed Nuance Excel Common name: Full Field Digital Mammography (FFDM) System Classification: MUE, Class II Regulation number: 21 CFR 892.1715
MANUFACTURER
Planmed Ov Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 300 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (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 : Bob Pienkowski
INTENDED USE
Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.
The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.
PRODUCT DESCRIPTION
The Planmed Nuance Excel is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Nuance utilizes an amorphous selenium based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data.
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ENCLOSURE 8 P. 8-2
The workflow with Planmed Nuance Excel is controlled from the acquisition workstation and Planmed Nuance Manager 3 image 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 work list. 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.
SUBSTANTIAL EQUIVALENCE
We consider this product modification to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:
PMA # 030010 Siemens Mammomat Novation DR
The comparison of characteristics supports substantial equivalence. Planmed Nuance Excel is as safe and effective as the predicate device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Planmed Ov % Mr. Bob Pienkowski Managing Director, US Agent Planmed USA, Inc. 100 North Gary Avenue, Suite A ROSELLE IL 60172
Re: K111361
Trade/Device Name: Planmed Nuance Excel Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: August 8, 2011 Received: August 10. 2011
SEP 2 3 2011
Dear Mr. Pienkowski:
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. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 hittp://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Planmed Nuance Excel
KIII361.
Indications For Use:
Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.
The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael D'Onofrio
(Division Sign Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111361
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