(37 days)
Not Found
No
The description focuses on hardware and basic image processing, with no mention of AI or ML algorithms for image analysis or interpretation. The "SmartAEC" feature is described as a continuous adjustment based on measured transmission, which is a rule-based or algorithmic approach, not necessarily AI/ML.
No
The device is used for generating mammographic images for screening and diagnosis, which are diagnostic purposes, not therapeutic.
Yes
The device generates mammographic images for screening and diagnosis of breast cancer, which are diagnostic purposes. It also explicitly mentions that the images are transferred to PACS "for diagnosis and archiving."
No
The device description clearly outlines multiple hardware components including an image acquisition system, gantry, digital detector, x-ray tube, high voltage generator, compression paddle(s), and multi-slit collimator. While it includes software for image processing and user interface, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The MicroDose SI (model L50) is a mammography system. It uses X-rays to generate images of the breast. It does not analyze biological specimens.
- Intended Use: The intended use is for generating mammographic images for screening and diagnosis of breast cancer. This is an in vivo (within the living body) imaging procedure, not an in vitro (in glass/outside the body) diagnostic test.
The device description and intended use clearly indicate that this is an imaging device used directly on a patient, not a device that analyzes samples taken from a patient.
N/A
Intended Use / Indications for Use
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.
Product codes
MUE
Device Description
The MicroDose SI (model L50) is a full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition workstation is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving.
The MicroDose SI (model L50) detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The MicroDose SI (model L50) uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system.
The MicroDose SI (model L50) provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.
The changes compared to the L30 model involves a minor modification to the collimator, such that the range of breast thickness that can be imaged on the device is slightly expanded.
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
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)
Not Found
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 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.
0
PHILIPS
FEB 0 1 2013
510(k) Summary (21 CFR 807.92)
A. SUBMITTER INFORMATION
Submitter's name Address
Philips Digital Mammography Sweden AB Smidesvägen 5 SE-171 41 Solna Sweden 3009307584
Establishment registration number Contact person Telephone FAX Title Date of the summary preparation
Mr. Gustav Lins +46-8-623 52 00 +46-8-623 52 01 Manager Regulatory Affairs 2012-12-21
B. DEVICE IDENTIFICATION
Device trade name Device common name Classification name Classification product code Device class Regulation code
MicroDose SI (model L50) Full-Field Digital Mammography X-ray System Full-Field Digital Mammography X-ray System MUE 11 21 CFR 892.1715
C. DEVICE DESCRIPTION
The MicroDose SI (model L50) is a full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition workstation is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving.
The MicroDose SI (model L50) detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The MicroDose SI (model L50) uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system.
The MicroDose SI (model L50) provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC
1
continuously adjusts the exposure based on measured transmission from the leading detector edge.
The changes compared to the L30 model involves a minor modification to the collimator, such that the range of breast thickness that can be imaged on the device is slightly expanded.
D. INDICATIONS FOR USE
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.
| Predicate device | |
|---|---|
| Device Classification | |
| Name | Full Field Digital, System, X-ray, Mammographic |
| 510(k) Number | K110025, K120255 |
| Device Name | Philips MicroDose |
| Model | L30 |
| Applicant | Philips Digital Mammography Sweden AB |
| Product Code | MUE |
| Advisory Committee | Radiology |
E. PREDICATE DEVICE
ட். TECHNICAL CHARACTERISTICS
The technical characteristics of the predicate device, the Philips MicroDose L30 have been described in two separate 510(k) submissions. The K110025 is the original application that cleared the device itself; the K120255 was used to gain FDA approval for the quantitative reduced dose claim for the MicroDose system. The basic fundamental technology which is described in these applications remains the same for the MicroDose SI (model L50).
In summary, the L30 and L50 models are based on the same photon counting detector technology, characterized by the absence of electronic noise. The configuration of silicon strip detectors for converting the X-ray quanta to electrical pulses is identical for the two models and there are merely slight modifications to the pulse counting electronics
G. CONCLUSION
The MicroDose SI (model L50) is based on the same fundamental technology as the predicate L30 model and there is no change in intended use. The equivalence in performance is supported through the performed verification and validation activities. The modifications to the device that are the subject of this 510(k) submission are minor in nature and are well characterized by the design control process and the physical laboratory test results showing the comparative performance of the modified device to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2013
Phillips Digital Mammogramography C/O Gustav Lins Manager Regulatory Affairs SOLNA SE-171 41 SMIDESVAGEN 5 SWEDEN
Re: K123995
Trade/Device Name: Microdose SI (Model L50) Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Lins:
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/CDRH0ffices/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/ResourcesforYou/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): _
MicroDose SI (model L50) Device Name:
Indications for Use:
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same
clinical applications as traditional film/screen systems.
Prescription Use _ X (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 OF 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
K123995 510(k)
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