Predicate Devices

Reference Devices

P010025

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard digital mammography system that acquires and processes images, but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The image processing mentioned appears to be standard digital image processing for mammography.

Therapeutic

No.
The device is used for imaging (diagnosis and screening), not for treating a condition or disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "The RMF-2000 is intended to be used for screening and diagnosis of breast cancer." Additionally, the "Device Description" reiterates that "RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer."

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a gantry, X-ray tube, detector, and control desk, indicating it is a physical medical device system that includes software, not a software-only device.

IVD (In Vitro Diagnostic)

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 (like blood, urine, or tissue) to provide information about a person's health.
Device function: The RMF-2000 is an imaging device that uses X-rays to create images of the breast. It does not analyze biological specimens.
Intended Use: The intended use is for screening and diagnosis of breast cancer through imaging, not through the analysis of in vitro samples.

Therefore, based on the provided information, the RMF-2000 is a medical imaging device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer.

This unit is intended for use in the same clinical applications as traditional screen film mammography systems.

Product codes

MUE

Device Description

The system consists of a gantry with integrated high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel C-arm on the gantry contains the X-ray tube on the top end and the breast support with the X-ray detector on the bottom end. The detector is a full field digital mammography detector.

RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer. RMF-2000 is designed to be used in the same clinical application for 2D screening mammographic systems. The screening examination exposes X-rays to the left and the right breasts of the patient to acquire images. Also, the RMF-2000 can be used to additional precision diagnosis for breasts.

The device's software provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Breast

Indicated Patient Age Range

Adult for the purpose of mammography screening

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)

A clinical image evaluation in accordance with the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the RMF-2000 and determined that the images, reviewed by MQSA qualified interpreting physicians, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K110798

Reference Device(s)

P010025

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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January 26, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DRTECH Corporation % Suyeon Back Assistant manager Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29 Dunchon-daero 541 beon-gil. Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216 KOREA

Re: K220073

Trade/Device Name: RMF-2000 Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: December 14, 2022 Received: December 14, 2022

Dear Suyeon Back:

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

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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 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 (OS) 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,

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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)

K220073 Device Name RMF-2000

Indications for Use (Describe)

The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer.

This unit is intended for use in the same clinical applications as traditional screen film mammography systems.

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

[As required by 21 CFR 807.92]

K220073

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

14/12/2022

2. Submitter's Information [21 CFR 807.92(a) (1)]

• Name of Sponsor:	DRTECH Corporation
• Address:	Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil,
Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
• Contact Name:	Suyeon, Back
• Telephone No.:	+ 82-31-779-7727
• Fax No.:	+ 82-31-779-7790

Email Address : ● syback@drtech.co.kr
Registration Number: 3005172103
Name of Manufacturer: ● Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

• Trade Name:	RMF-2000
• Common Name:	Digital Mammography system
• Classification Name:	Full Field Digital, System, X-ray, Mammographic
• Classification Panel:	Radiology
• Classification Regulation:	21 CFR 892.1725
• Product Code:	MUE
• Device Class:	II

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4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

(1) Predicate Device

●

510(k) Number: K110798
GENERAL ELECTRIC COMPANY Applicant: .
Trade Name: SENOGRAPHE DS ●
Classification Name: ● Full Field Digital, System, X-ray, Mammographic
. Classification Panel: Radiology
. Classification Regulation: 21 CFR 892.1715
Product Code: MUE .
Device Class: II ●

(2) Reference Device

PMA Number: P010025
Applicant: Hologic, Inc.
Trade Name: Selenia Dimensions .
. Classification Name: Full Field Digital, System, X-ray, Mammographic
- Classification Panel: Radiology .
- Classification Regulation: 21 CFR 892.1715
- Product Code: ● MUE
- Device Class: II ●

5. Description of the Device [21 CFR 807.92(a) (4)]

The system consists of a gantry with integrated high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel C-arm on the gantry contains the X-ray tube on the top end and the breast support with the X-ray detector on the bottom end. The detector is a full field digital mammography detector.

RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer. RMF-2000 is designed to be used in the same clinical application for 2D screening mammographic systems. The screening examination exposes X-rays to the left and the right breasts of the patient to acquire images. Also, the RMF-2000 can be used to additional precision diagnosis for breasts.

The device's software provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.

6. Indication for Use [21 CFR 807.92(a)(5)]

The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer.

This unit is intended for use in the same clinical applications as traditional screen film mammography systems.

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7. Technological Characteristics [21 CFR 807.92(a)(6)]

RMF-2000 system is a Full-Field Digital Mammography in which the X-ray film is replaced by proven X-ray detector technology with smallest 76um (indirect) and 65um (direct) pixel size.

With a built-in generator, RMF-2000 is easy to install in small spaces as there is no need for a separate generator compartment.

Using two parameter of thickness and density, which are able to get when a patient takes an x-ray image, according to patient's breast type calculate optimal dose automatically to provide a uniform, high-quality mammogram.

Reliable and precise automatic exposure control perfectly optimizes and determines the exposure parameters in accordance with each patient's breast characteristics with AEC and Dual Filter technology.

Collimator setting is changed automatically for each different paddle barcode recognition system.

With the auto-positioning function, the screening protocol set during patient registration is automatically recognized by the system to quickly and easily set the next screening position. The system maintains the patient height information, so no additional height adjustment is required.

Parameter	Subject Device	Predicate Device	Remark
510(K)
Number	Unknown	K110798	-
Manufacturer	DRTECH Corporation	GENERAL ELECTRIC
COMPANY	-
Model Name	RMF-2000	SENOGRAPHE DS	-
Classification
Name	Full Field Digital, System,
X-ray, Mammographic
Radiology	Full Field Digital, System,
X-ray, Mammographic
Radiology	Same
Classification
Panel			Same
Classification
Regulation	21 CFR 892.1715	21 CFR 892.1715	Same
Product Code	MUE	MUE	Same
Device Class	Class II	Class II	Same
Intended Use	The RMF-2000 generates
2D digital mammography
images. The RMF-2000 is
intended to be used for
screening and diagnosis of
breast cancer.

8. Substantial Equivalence [21 CFR 807.92(b)]

510(k) Summary

6

510(k) Summary

7

The predicate device (K110798) and the subject device, RMF-2000 are equivalent in terms of the following matters:

Intended Use
Patient population
Detector size
Exposure mode
Generator Type
· Breast Compression System
SID
DICOM

A few differences are as follows

Pixel Pitch
Resolution
· Materials Scintillator
Detector Type
Power supply

There is no significant difference between the RMF-2000 and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device.

Even though the predicate device and the subject device differ, the differences are not critical in terms of the diagnostic purposes because the clinical image evaluation demonstrate that the subject devices are substantially equivalent to the predicate device.

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Parameter	Subject Device	Reference Device	Remark
Manufacturer	DRTECH Corporation	Hologic	-
Model Name	RMF-2000	Selenia Dimensions	-
PMA Number	-	P010025	-
Classification
Name	Full Field Digital, System, X-ray, Mammographic		Same
Classification
Panel	Radiology		Same
Classification
Regulation	21 CFR 892.1715		Same
Product Code	MUE		Same
Device Class	Class II		Same
Intended Use	The RMF-2000 generates
2D digital mammography
images. The RMF-2000 is
intended to be used for
screening and diagnosis of
breast cancer.
This unit is intended for use
in the same clinical
applications as traditional
screen film mammography
systems.	The Hologic Selenia
Dimensions generates digital
mammographic images that
can be used for screening and
diagnosis of breast cancer.
The Selenia Dimensions
system is intended for use in
the same clinical
applications as Full Field
Digital Mammography
systems for screening
mammograms.	Same
Design	Detector
Size	240 x 300mm	240 x 290mm	Same or
Higher
	Pixel
Pitch	65um	70um	Same or
Higher
	Resolution	4,608x 3,584	3,328x 4,096	Same or
Higher
Materials
Scintillator	a Se direct.
RSM 2430 UDP (Selenium)	a Se direct.	Same
TFT	Amorphous Selenium	Amorphous Selenium	Same

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| Exposure
mode | AEC (Automatic Exposure
Control), Manual | AEC (Automatic Exposure
Control), Manual | Same |
|-------------------------|---------------------------------------------|---------------------------------------------|------|
| Anatomical
Sites | Breast | Breast | Same |
| Communication
Method | Wire | Wire | Same |

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9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]

The RMF-2000 introduces no new safety or efficacy issues other than those already identified with the predicate device. To demonstrate the safety and effectiveness of RMF-2000 and to demonstrate substantial equivalence to the predicate device, RMF-2000 has completed the following non-clinical tests. This confirms that the design inputs and performance specifications of this equipment have been met. The RMF-2000 has been tested according to internal requirements, national standards and international standards indicated below to support safety and effectiveness and substantial equivalence to predicate device.

The RMF-2000 complies with the following international and FDA-recognized consensus standards:

| | AAMI ANSI ES60601-1: Medical Electrical Equipment -- Part 1: General Requirements for Basic
Safety and Essential Performance (IEC 60601- 1:2005, Mod) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For Basic
Safety And Essential Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements And Tests (Edition 4) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices.
(Second edition) |
| IEC 60601-2-45: | Medical electrical equipment - Part 2-45: Particular requirements for the
basic safety and essential performance of mammographic X-ray equipment
and mammographic stereotactic devices (Edition 3.1) |
| IEC 62304: | Medical device software - Software life cycle processes |
| IEC 60601-1-3: | Medical electrical equipment - Part 1-3: General requirements for basic
safety and essential performance - Collateral Standard: Radiation
protection in diagnostic X-ray equipment (Edition 2.1) |
| IEC 60601-1-6: | Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability |
| IEC 62220-1-2: | Medical electrical equipment - Characteristics of digital X-ray imaging
devices - Part 1-2: Determination of the detective quantum efficiency -
Detectors used in mammography |
| ISO 10993-1: | Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process |
| ISO 10993-5: | Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity (Third edition) |
| ISO 10993-10: | Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization (Third edition) |
| ISO 15223-1: | Symbols to be used with medical device labels, labeling and information to
be supplied |

And RMF-2000 complies with the FDA guidance document entitled 'Class II Special Controls Guidance Document: Full-Field Digital Mammography System, ' March 27, 2012.

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10. Summary of Clinical Data [21 CFR 807.92(b)(2)]

A clinical image evaluation in accordance with the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the RMF-2000 and determined that the images, reviewed by MQSA qualified interpreting physicians, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from predicate device.

11. Conclusion [21 CFR 807.92(b)(3)|

The RMF-2000 is substantially equivalent to the currently marketed predicate device in terms of design, fundamental scientific technology, and indications for use, safety, and effectiveness.

Substantial equivalence for Digital Mammography system (RMF-2000) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 60601-2-45, IEC 62304, IEC 60601-1-3, IEC 60601-1-6, IEC 62220-1-2, A AMI ANSI ISO 10993-1, ISO 10993-5, and ISO 10993-10.

Also, substantial equivalence was demonstrated through a clinical test, which was conducted in accordance with in the "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System".

The results of these tests demonstrate that the RMF-2000 meets the acceptance criteria, and the device is adequate for its intended use.

The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrate that the RMF-2000 is substantially equivalent to the predicate device.