(43 days)
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion.
The Contrast Enhanced Digital Mammography (CEDM) Option used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM) is an imaging option, referred to as dual energy imaging. The Selenia Dimensions was designed to support dual energy imaging. A CEDM Duel Energy Subtracted Image (CEDM image) acquisition consists of two 2D images, taken in sequence and in the same breast compression. The first image is a standard 2D FFDM image, as is acquired during conventional FFDM imaging. The kVp range used is typically 25 to 33 kVp and the rhodium and silver filters are the conventional ones used in this kVp range. This is referred to as the 'low energy' image. Following the low energy acquisition, a second image is acquired. This will be referred to as the 'high energy' image, and it uses a copper filter and a kVp range of 45 to 49 kVp. A weighted subtraction method is then used to subtract the contents of the low energy image from the high energy image. The two images are acquired in rapid succession to minimize the potential of patient motion that can create structural noise and can degrade image contrast. The low energy image together with the subtracted image is used clinically to evaluate the patient.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification for a Contrast Enhanced Digital Mammography (CEDM) system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
The 510(k) summary mentions:
- Summary of Testing: "Dual energy images captured, saved and/or transmitted by the Selenia Dimensions 2D FFDM conform with ACR/NEMA Digital Imaging Communications in Medicine version 3.0." and "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820." These are general statements about compliance with standards and regulations, not specific performance metrics or a detailed clinical study for efficacy or accuracy.
- Comparison with Predicate Devices: It states that the device and predicate have "the same intended use, general configuration, principles of operation, and similar operating parameters," which is central to substantial equivalence.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text, as this information is not present.
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Contrast Enhanced Digital Mammography 510(k) Premarket Notification
510(k) Summary
JAN 2 9 2013
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87 (b)
Product Name: Contrast Enhanced Digital Mammography
Product Classification Name: Full Field Digital Mammography System
Product Classification Code: MUE CFR Section: 892,1715
Classification Panel: Radiology Class II
Manufacturer: Hologic, Inc. 36-37 Apple Ridge Road Danbury, CT 06810 USA
- Deborah Thomas Contact Person: Telephone Number: 781-999-7558 Fax Number: 866-652-8674
- Date Prepared: December 14, 2012
Predicate Devices:
K103485 GE Healthcare Contrast Enhanced Spectral Mammography
Device Description:
The Contrast Enhanced Digital Mammography (CEDM) Option used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM) is an imaging option, referred to as dual energy imaging. The Selenia Dimensions was designed to support dual CEDM Duel Energy Subtracted Image (CEDM image) acquisition energy imaging. consists of two 2D images, taken in sequence and in the same breast compression. The first image is a standard 2D FFDM image, as is acquired during conventional FFDM imaging. The kVp range used is typically 25 to 33 kVp and the rhodium and silver filters are the conventional ones used in this kVp range. This is referred to as the 'low energy' image. Following the low energy acquisition, a second image is acquired. This will be referred to as the 'high energy' image, and it uses a copper filter and a kVp range of 45 to 49 kVp.
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A weighted subtraction method is then used to subtract the contents of the low energy image from the high energy image. The two images are acquired in rapid succession to minimize the potential of patient motion that can create structural noise and can degrade The low energy image together with the subtracted image is used image contrast. clinically to evaluate the patient.
Indications for Use:
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion.
Comparison with Predicate Devices:
The Contrast Enhanced Digital Mammography and predicate device. GE Healthcare Contrast Enhanced Spectral Mammography, K103485, have the same intended use, general configuration, principles of operation, and similar operating parameters.
Summary of Testing
Dual energy images captured, saved and/or transmitted by the Selenia Dimensions 2D FFDM conform with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.
Conclusion
The Contrast Enhanced Digital Mammography imaging option design, operation, construction and materials are similar to the existing marketed predicate device with no additional risks or hazards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 29, 2013
Hologic, Inc. % Ms. Deborah Thomas Senior Regulatory Specialist 35 Crosby Drive BEDFORD MA 01730
Re: K123873
Trade/Device Name: Contrast Enhanced Digital Mammography (CEDM) Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: December 14, 2012 Received: December 18, 2012
Dear Ms. Thomas:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sean M. Boyd -S for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123873
Device Name:
Contrast Enhanced Digital Mammography
Indications for Use:
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sean M.' Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)________________________________________________________________________________________________________________________________________________________________________ K123873
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§ 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.