The MammoScan® Full-Field Digital Mammography System is a device intended to produce planar digital x-ray images of the entire breast. The MammoScan is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoScan is intended to be used in the same clinical applications as traditional film/screen systems.

Device Description

The Adani MammoScan is a full-field type digital mammography system comprised of an image acquisition system, a gantry and an acquisition station, equipped with PC computer, keyboard, mouse, monitor and a protective shield. The image acquisition system includes a built-in digital detector of CCD-TDI technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression mechanism, and slit collimator. The slit-collimator shapes the beam and limits the x-ray beam to the active width of the detector, which prevents image degradation caused by scattered radiation. During image acquisition, the internal swing arm is motor driven to pivot at the x-ray tube with the slit collimator, causing the detector (at the other end of the swing arm and on the far side of the breast support) to swing in an arc under the breast support from one edge of the breast support to the other. The x-ray, which is shaped into a flat fan-shaped beam by the slit collimator, passes through the compressed breast tissue as it sweeps across the breast support and falls on the image detector underneath. The acquisition workstation is the user interface for preparing and initiating image acquisition, image pre- and post-processing, and image transfer to the desired destination (e.g. PACS) for interpretation and archiving. The MammoScan® Full-Field Digital Mammography System consists of a high-voltage generator, gantry, an acquisition work station with a technologist shield and accessories. The patient is imaged at the gantry contains the diagnostic source (x-ray tube, filter, and collimator), built-in solid state image detector, breast support, and compression assembly. The gantry can be raised, lowered, and rotated, under motorized control, to accommodate patients of all statures, standing and/or sitting, to produce images in all standard views.

AI/ML Overview

The provided document describes the Adani MammoScan, a Full-Field Digital Mammography System, and its submission for FDA 510(k) clearance. The device's acceptance criteria are established through a comparison to a legally marketed predicate device, the Fischer SenoScan Full-Field Digital Mammography System (P010017), and adherence to various medical device safety and performance standards.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Adani MammoScan are primarily based on demonstrating substantial equivalence to the predicate device, Fischer SenoScan, and meeting established performance standards for digital mammography systems. The study concludes that the performance of the Adani MammoScan is "as well as or better than" the predicate device and that its images are of "sufficiently acceptable quality for clinical mammographic usage."

Aspect	Acceptance Criteria (Based on Predicate & Standards)	Reported Device Performance (Adani MammoScan)
Indications for Use	The device should be indicated for producing radiographic images of the human breast for diagnostic and screening mammography, used in the same clinical applications as traditional film-based mammographic systems. (Matching predicate)	"Produce planar digital x-ray images of the entire breast. Indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. Intended to be used in the same clinical applications as traditional film/screen systems." (Matches predicate)
Safety & Effectiveness	Should employ similar technology, materials, and comparable safety and effectiveness features to the predicate device, present no new safety or efficacy issues, and conform to relevant medical device safety standards.	"Employs the same fundamental technological characteristics as its predicate device." "X-ray technology is substantially equivalent to the Fischer SenoScan." "Introduces no new safety or efficacy issues." Conforms to standards: EN 60601-1, EN 60601-1-2, EN 60601-1-3, EN 60601-1-6, IEC 60601-2-45, EN ISO 15223-1, EN ISO 14971, EN 62220-1-2, EN 62304, EN 62366, EN 1041, EN ISO 14155.
Detector Information	Should have comparable detector type (Cesium iodide with TDI CCDs), pixel dimensions (27 µm native, 54 µm normal), fill factor (100%), X-Ray interaction material (CsI:Tl), A/D conversion bit depth (12 bits), decay rate of phosphor afterglow (less than 3 µs), image read-out mechanism (CCD TDI), and cooling method (Air/Fan) to the predicate. Some variations in detector area and matrix size are acceptable if overall performance is maintained.	Type: Cesium iodide with 2 TDI CCD's (Predicate had 4 TDI CCD's) Detector Area: 22x0.7 cm (Predicate was 21x1 cm) Maximum field size: 22x30 cm (Matches predicate) Pixel dimensions: Native pixel size 27 µm, 54 µm in normal operation mode (Matches predicate) Fill factor: 100 % (Matches predicate) Matrix size: 4096x5560 pixels (Predicate had 4096x5625 pixels) X-Ray interaction material: CsI:Tl (Matches predicate) A/D conversion bit depth: 16 bits (Predicate had 12 bits) Scanning rate: 4.6 Cm/sec (Predicate was "-") Decay rate of the phosphor afterglow: less than 3 µs (Matches predicate) Image read-out mechanism: CCD TDI (Matches predicate) Method of detector cooling: Air/Fan (Matches predicate) Power source: 220 VAC (Matches predicate)
X-Ray Parameters	Should have comparable X-Ray tube model, focal spot size (0.3 mm), inherent filtration (0.76 mm Be), target material (Rhenium-tungsten facing on molybdenum), heat capacity (600 KHU), additional equivalent filtration (0.5 mm Al normal, 2.0 mm Al calibration), collimator operation (fixed front/sides, motorized rear), and projected X-Ray beam (around 1x22cm) to the predicate.	X-Ray tube model name: Varian RAD70 or IAE XM 1016T (Predicate Varian RAD73) Focal Spot Size: 0.3 mm (Matches predicate) Inherent filtration: 0.76 mm Be or 0.5 mm Be (Predicate 0.76 mm Be) Target material: Rhenium-tungsten (Predicate Rhenium-tungsten facing on molybdenum) Heat capacity: 600 kHU or 300 kHU (Predicate 600 KHU) Additional Equivalent Filtration: 0.5 mm Al in normal operation, 2.0 mm Al for calibration (Matches predicate) Collimator operation: Fixed at front and sides, motorized rear blade (Matches predicate) Projected X-Ray beam: 0.7x22 cm (Predicate 1x22cm)
Generator Information	Should have comparable generator type (High frequency), maximum power (12 kW), output voltage range (20-45 kV), output current range (80-200 mA), and backup timer (Yes) to the predicate.	Type: High frequency, Model name: Sedecal SHF-1030-M (Predicate High frequency) Maximum power: 10 kW (Predicate 12 kW) Output voltage range: 20-50 kV with 0.1 kV step, maximum ripple 1% (Predicate 20-45 kV with 1 kV step, maximum ripple 3%) Output current range: 5-250 mA (Predicate 80-200 mA) Output mAs range: 0.1 to 1200 mAs (Predicate "-") Operation of AEC: AEC is implemented using pre-scan (not on generator level) (Predicate "-") Backup timer: Yes (Matches predicate)
Image Quality	Images should be of sufficiently acceptable quality for clinical mammographic usage, comparable to the predicate device in aspects like Sensitometric response, Spatial resolution, Noise analysis, Signal-to-noise - DQE, Dynamic range, Automatic exposure control performance, Phantom testing, Patient radiation dose, and Image erasure/fading/repeated exposure.	"Image attribute evaluation... concluded that the images were of sufficiently acceptable quality for clinical mammographic usage." "This comparison showed that the Adani MammoScan device performed as well as or better than the predicate devices in all relevant areas."
Biocompatibility	Patient contact materials should meet ISO 10993 for cytotoxicity, irritation, and sensitization.	"Biocompatibility testing according to ISO 10993 was performed for the patient contact material, the compression plate: cytotoxicity, irritation, sensitization." (Meets standard)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions an "Image attribute evaluation" and that "Performance data from non-clinical testing... was compared with data from the PMA Summary of Safety and effectiveness of the predicate device." However, the specific sample size for images used in the clinical image attribute evaluation, data provenance (country of origin), and whether it was retrospective or prospective are not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions an "Image attribute evaluation," but it does not specify the number of experts who participated in this evaluation or their specific qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for the image attribute evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a comparison of the Adani MammoScan to a predicate device, the Fischer SenoScan. It states: "Performance data from non-clinical testing of the Adani MammoScan ... was compared with data from the PMA Summary of Safety and effectiveness of the predicate device. This comparison showed that the Adani MammoScan device performed as well as or better than the predicate devices in all relevant areas."

However, this is not an MRMC comparative effectiveness study involving human readers with and without AI assistance. The Adani MammoScan is a Full-Field Digital Mammography system itself, not an AI software intended to assist human readers. Therefore, an effect size of human readers improving with AI vs without AI assistance is not applicable in this context. The study aims to show the device's inherent equivalence to a predicate system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done for the device itself. The non-clinical (bench) testing evaluated various technical parameters of the Adani MammoScan, such as:

Sensitometric response
Spatial resolution
Noise analysis
Signal-to-noise - DQE
Dynamic range
Automatic exposure control performance
Phantom testing
Patient radiation dose
Image erasure, fading and repeated exposure

This testing represents the "algorithm only" or device-only performance without a human in the loop for interpretation evaluation. The "Image attribute evaluation" also assessed the inherent quality of the images produced by the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Image attribute evaluation," the ground truth was expert assessment or consensus on the "sufficiently acceptable quality for clinical mammographic usage." The non-clinical (bench) testing used physical measurements and phantom images as ground truth against established technical performance standards and predicate device data. There is no mention of pathology or outcomes data being used for this specific 510(k) submission.

8. The sample size for the training set

This document describes a 510(k) submission for a physical medical imaging device (a full-field digital mammography system), not an AI algorithm that requires a training set. Therefore, the concept of a training set sample size is not applicable in this submission. The device's technical specifications and performance were evaluated, not a learning algorithm.

9. How the ground truth for the training set was established

As there is no training set for this device (as explained in point 8), the concept of establishing ground truth for a training set is not applicable.

Summary

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October 20, 2017

ADANI % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K172027

Trade/Device Name: Adani MammoScan Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: September 18, 2017 Received: September 21, 2017

Dear Mr. Kamm:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) 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.

Robert Ochs

Robert Ochs, Ph.D. 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) K17 2027

Device Name Adani MammoScan

Indications for Use (Describe)

The MammoScan® Full-Field Digital Mammography System is a device intended to produce planar digital x-ay images of the entire breast. The MammoScan is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoScan is intended to be used in the same clinical applications as traditional film/screen systems.

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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510(k) Summary K17 ADANI Selitski St., 7 Minsk, Belarus 220075, Tel. Selitski St., 7 Minsk, Belarus 220075 Tel.+375292145846, Contact: Vladimir Klokov, Vice President Date Prepared: June 4, 2017

1. Identification of the Device: Proprietary-Trade Name: Adani MammoScan® Classification Name: Full-Field Digital Mammography System Product Code: MUE Regulation 892.1715 Common/Usual Name: Digital Mammography System.
Equivalent legally marketed device: P010017, SenoScan® Full-Field Digital Mammography System, Fischer 2. Imaging Corporation Denver, CO 80026. Classification Name: Full-Field Digital Mammography System Product Code: MUE Regulation 892.1715 Common/Usual Name: Digital Mammography System.
1. Indications for Use (intended use): The MammoScan® Full-Field Digital Mammography System is a device intended to produce planar digital x-ray images of the entire breast. The MammoScan is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoScan is intended to be used in the same clinical applications as traditional film/screen systems.
Description of the Device: The Adani MammoScan is a full-field type digital mammography system comprised ধ . of an image acquisition system, a gantry and an acquisition station, equipped with PC computer, keyboard, mouse, monitor and a protective shield. The image acquisition system includes a built-in digital detector of CCD-TDI technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression mechanism, and slit collimator. The slit-collimator shapes the beam and limits the x-ray beam to the active width of the detector, which prevents image degradation caused by scattered radiation. During image acquisition, the internal swing arm is motor driven to pivot at the x-ray tube with the slit collimator, causing the detector (at the other end of the swing arm and on the far side of the breast support) to swing in an arc under the breast support from one edge of the breast support to the other. The x-ray, which is shaped into a flat fan-shaped beam by the slit collimator, passes through the compressed breast tissue as it sweeps across the breast support and falls on the image detector underneath. The acquisition workstation is the user interface for preparing and initiating image acquisition, image pre- and post-processing, and image transfer to the desired destination (e.g. PACS) for interpretation and archiving. The MammoScan® Full-Field Digital Mammography System consists of a high-voltage generator, gantry, an acquisition work station with a technologist shield and accessories. The patient is imaged at the gantry contains the diagnostic source (x-ray tube, filter, and collimator), built-in solid state image detector, breast support, and compression assembly. The gantry can be raised, lowered, and rotated, under motorized control, to accommodate patients of all statures, standing and/or sitting, to produce images in all standard views.
1. Safety and Effectiveness, comparison to predicate device. The Adani MammoScan system employs the same fundamental technological characteristics as its predicate device and The X-ray technology is substantially equivalent to the Fischer SenoScan Full Field Digital Mammography System, approved by FDA via P010017. Clinical uses for which Adani MammoScan was designed are equivalent to those cleared for Fischer SenoScan.

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The Adani MammoScan and Fischer SenoScan use same technology for converting x-rays to the electric signal. The results of bench, clinical, and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis and software validation has been performed. An examination of the substantial equivalence chart below reveals the use of nearly identical or equivalent technology throughout.

6. Substantial Equivalence Chart, MammoScan® vs. Predicate

Parameter	Predicate device, SenoScan®, P010017	New device, MammoScan®, thissubmission
Indications	The SenoScan® Full-Field Digital MammographySystem is a dedicated mammography systemintended to produce radiographic images of thehuman breast for the purpose of diagnostic andscreening mammography. The SenoScan® Full-Field Digital Mammography system is intendedto be used in the same clinical applications astraditional film-based mammographic systems	The MammoScan® Full-Field DigitalMammography System is a device intended toproduce planar digital x-ray images of the entirebreast. The MammoScan is indicated forgenerating mammographic images that can beused for screening and diagnosis of breast cancer.The MammoScan is intended to be used in thesame clinical applications as traditionalfilm/screen systems.
Detector Information
Type	Cesium iodide with 4 TDI CCD's	Cesium iodide with 2 TDI CCD's
Detector area	21x1 cm	22x0.7 cm
Maximum field size	22x30 cm	22x30 cm
Pixel dimensions	Native pixel size 27 µm54 µm in normal operation mode	Native pixel size 27 µm54 µm in normal operation mode
Fill factor	100 %	100 %
Matrix size	4096x5625 pixels	4096x5560 pixels
X-Ray interactionmaterial	Csl:TI	Csl:TI
A/D conversion bitdepth	12 bits	16 bits
Scanning rate	-	4.6 Cm/sec
Decay rate of thephosphor afterglow	less than 3 µs	less than 3 µs
Image read-outmechanism.	CCD TDI	CCD TDI
Method of detectorcooling	Air/Fan	Air/Fan
Power source	220 VAC	220 VAC
X-Ray Parameters:
X-Ray tube modelname	Varian RAD73	Varian RAD70 or IAE XM 1016T
Focal Spot Size	0.3 mm	0.3 mm
Inherent filtration	0.76 mm Be	0.76 mm Be or 0.5 mm Be
Target material	Rhenium-tungsten facing on molybdenum	Rhenium-tungsten
Heat capacity	600 KHU	600 kHU or300 kHU
Parameter	Predicate device, SenoScan®, P010017	New device, MammoScan®, this submission
AdditionalEquivalent Filtrationin X-ray Beam	0,5 mm Al in normal operation2,0 mm Al for calibration – automatically selected	0,5 mm Al in normal operation2,0 mm Al for calibration - automatically selected
Collimator operation	Fixed at front and sides, motorized rear blade	Fixed at front and sides, motorized rear blade
Projected X-Ray beam	1x22cm	0,7x22 cm
Generator Information
Type	High frequency	High frequency, Model name :Sedecal SHF-1030-M
Maximum power	12 kW	10 kW
Output voltagerange	20-45 kV with 1 kV stepmaximum ripple 3%	20-50 kV with 0.1 kV stepmaximum ripple 1%
Output currentrange	80-200 mA	5-250 mA, From 5 mA to 80 mA in 0.1 mA stepsand from 80 mA to 250 mA in 1 mA steps
Output mAs range	-	0.1 to 1200 mAs
Operation of AEC	-	AEC is implemented using pre-scan (not ongenerator level)
Backup timer:	Yes	Yes
Photo	Image: SenoScan	Image: MammoScan

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1. Description of non-clinical (bench) testing: The device has been evaluated for as electrical, electromagnetic, radiation, and mechanical safety, and has been found to conform to the following medical device safety standards:

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EN 60601-1:2006/ A1:2013 General Requirements for Safety

EN 60601-1-2:2007/ A:2010 EMC Electromagnetic compatibility-Requirements and tests EN 60601-1-3:2008/ A:2010 Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-6:2010/ A1:2015 Collateral Standard: Usability

IEC 60601-2-45:2011 Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

EN ISO 15223-1:2012 Symbols to be used with medical device labeling and information to be supplied EN ISO 14971:2012 - Application of risk management to medical devices

EN 62220-1-2:2010 Determination of the detective quantum efficiency - Detectors used in mammography EN 62304:2006 + AMD1:2015 CSV Medical device software life-cycle processes

EN 62366:2008/ A1:2015 Medical devices – Application of usability engineering to medical devices

EN 1041:2008/ A1:2013 Information supplied by the manufacturer of medical devices

EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice

Performance data from non-clinical testing of the Adani MammoScan covering Sensitometric response, Spatial resolution, Noise analysis, Signal-to-noise - DQE, Dynamic range, Automatic exposure control performance, Phantom testing, Patient radiation dose, and Image erasure, fading and repeated exposure was compared with data from the PMA Summary of Safety and effectiveness of the predicate device. This comparison showed that the Adani MammoScan device performed as well as or better than the predicate devices in all relevant areas.

Biocompatibility testing according to ISO 10993 was performed for the patient contact material, the compression plate: cytotoxicity, irritation, sensitization.

8. SUMMARY OF THE CLINICAL IMAGE ATTRIBUTE EVALUATION

An image attribute evaluation was conducted in accordance with the Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Full-Field Digital Mammography System [issued: March 27, 2012] which concluded that the images were of sufficiently acceptable quality for clinical mammographic usage.

9. SAFETY INFORMATION

The Adani MammoScan system introduces no new safety or efficacy issues other than those already identified with the predicate device. The results of the Risk analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and is consistent with the level of concern indicated in the "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" document issued on: March 27, 2012.

1. Conclusion: The Adani MammoScan described in this substantially equivalent to the predicate device in respects of indication for use and image quality. The proposed and predicate devices utilize similar technology and materials, comparable safety and effectiveness features, and are similar in design and construction. The information submitted in this application shows that none of the technical differences between the systems raises new questions of safety and effectiveness. All collected performance data demonstrate that the devices are substantially equivalent. Our conclusion is that Adani MammoScan is as safe and effective as the legally marketed predicate device. After analyzing bench, clinical, risk analysis, software validation and standards testing data, it is the conclusion of Adani that the MammoScan® Full Field Digital Mammography System is as safe and effective as the predicate device, has no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.