RSM 2430C

K170930 · DRTECH Corporation · MUE · Apr 27, 2017 · Radiology

Device Facts

• Record ID: K170930
• Device Name: RSM 2430C
• Applicant: DRTECH Corporation
• Product Code: MUE · Radiology
• Decision Date: Apr 27, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended Use

The RSM 2430C is a detector indicated for use in screening and diagnostic mammography.

Device Story

RSM 2430C is an indirect conversion digital flat panel X-ray detector; functions as a square plate. Input: X-ray photons absorbed in a Cesium Iodide (CsI) scintillator layer; energy generates light distribution. Light converted to electrical signal via PIN diode within thin-film transistor (TFT) pixels; signal amplified and converted to digital format. Output: Digital image data for viewing, storage, or remote transmission. Used in clinical settings by radiology staff; integrated with mammography X-ray systems. Healthcare providers use images for screening and diagnostic mammography to detect breast abnormalities. Benefits include high-resolution digital imaging for improved diagnostic capability compared to analog systems.

Clinical Evidence

Single-blinded clinical concurrence study conducted per FDA Class II Special Controls Guidance for Full Field Digital Mammography Systems. Study compared images from the subject device (RSM 2430C) against the predicate (RSM 1824C). Results confirmed the subject device provides images of equivalent diagnostic capability.

Technological Characteristics

Indirect conversion digital flat panel detector; CsI scintillator; a-Si TFT array. Pixel pitch: 76 µm. Resolution: 3,840 x 3,072. Connectivity: DICOM (NEMA PS 3.1-3.20). Standards: AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 62220-1-2, IEC 61267.

Indications for Use

Indicated for use in screening and diagnostic mammography for patients requiring mammographic imaging.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• RSM 1824C (K162670)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 27, 2017

DRTECH Corporation Choul-Woo Shin Vice President Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu. Seongnam-si, 13230 REPUBLIC OF KOREA

Re: K170930

Trade/Device Name: RSM 2430C Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: March 24, 2017 Received: March 29, 2017

Dear Choul-Woo Shin:

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

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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 devicerelated 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.

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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Robert Oaks

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) K170930

Device Name RSM 2430C

Indications for Use (Describe)

The RSM 2430C is a detector indicated for use in screening and diagnostic mammography.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

[As required by 21 CFR 807.92]

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)]

03/24/2017

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

| Name of Sponsor: | DRTECH Corporation |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil,<br>Jungwon-gu, Seongnam-si, Gyeonggi-do, 13230, Republic of Korea |
| Contact Name: | Choul-Woo Shin |
| Telephone No.: | + 82-31-779-7783 |
| Fax No.: | + 82-31-779-7790 |
| Email Address : | [e-mail] |
| Registration Number: | 3005172103 |
| Name of Manufacturer: | Same as Sponsor |

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

| • Trade Name: | RSM 2430C |
|------------------------------|-------------------------------------------------|
| • Common Name: | Digital Flat Panel X-ray Detector |
| • Classification Name: | Full Field Digital, System, X-ray, Mammographic |
| • Classification Panel: | Radiology |
| • Classification Regulation: | 21 CFR 892.1715 |
| • Product Code: | MUE |
| • Device Class: | II |

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

| • 510(k) Number: | K162670 |
|-------------------------|-------------------------------------------------|
| • Applicant: | DRTECH Corporation |
| • Trade Name: | RSM 1824C |
| • Classification Name: | Full Field Digital, System, X-ray, Mammographic |
| • Classification Panel: | Radiology |

- Classification Regulation: 21 CFR 892.1715 ●
- Product Code: MUE
- Device Class: II

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

<Modification>

- . Addition of RSM 2430C: The only difference between the subject device and the predicate device is the size of their detectors. This is to notify that RSM 2430C has the exact same functionality and software with the predicate device (K162670) that has been cleared under the 510(k) process.

| Items | Subject Device | Predicate Device (K162670) |
|--------------------|----------------|----------------------------|
| Model Name | RSM 2430C | RSM 1824C |
| Detector Size (mm) | 240 x 300 | 180 x 240 |

The RSM 2430C detector panel is an indirect conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive scintillator layer. The energy of the incoming photons generates light distribution in the scintillator layer. Light is converted to a modulated electrical signal through PIN diode within the pixel of the thin film transistor. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

## 6. Intended Use [21 CFR 807.92(a)(5)]

The intended use has not changed as a result of the modification and is as follows:

The RSM 2430C is a detector indicated for use in screening and diagnostic mammography.

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

The RSM 2430C detector panel is an indirect conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive scintillator layer. The energy of the incoming photons generates light distribution in the scintillator layer. Light is converted to a modulated electrical signal through PIN diode within the pixel of the thin film transistor. The amplified signal is converted to a voltage signal, and then it is converted from an analog to digital signal which can be transmitted to a print-out image viewer, transmitted to remote viewing, or stored as an electronic data file for later viewing.

Based on a technical feature comparison, the subject device was found to be similar to the predicate device in regards of detector technology (CsI).

Comparisons with the predicate, devices show the technological characteristics of the RSM 2430C to be same to the predicate devices. The RSM 2430C is functionally identical to the predicate devices.

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# 8. Hardware and Software Requirements

- Mammography X-ray System
- : Mammography CR System which has 2430 size Bucky.

| Contents | Requirement |
|------------|--------------------------------|
| Bucky Size | Small size( 24 x 30) or higher |
| Grid | Moving |
| Filter | Mo, Rh (applicable W and Ag) |
| kVp | 20 ~ 35(Mo), 28 ~ 39(Rh) |
| mAs | 3 ~ 500 |

#### - Software Requirement

: The product is compatible with Rconsole1 that has been cleared under the 510(k) process (K162670).

# 9. Substantial Equivalence [21 CFR 807.92(b)]

| Parameter | Subject Device | Predicate Device | |
|---------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--|
| 510(K) Number | Unknown | K162670 | |
| Manufacturer | DRTECH Corporation | | |
| Model Name | RSM 2430C | RSM 1824C | |
| Classification Name | Full Field Digital, System, X-ray, Mammographic | | |
| Classification Panel | Radiology | | |
| Classification Regulation | 21 CFR 892.1715 | | |
| Product Code | MUE | | |
| Device Class | Class II | | |
| Intended Use | The RSM 2430C is a detector indicated<br>for use in screening and diagnostic<br>mammography. | The RSM 1824C is a detector indicated for<br>use in screening and diagnostic<br>mammography. | |
| Pixel Pitch | 76 um | 76 µm | |
| Image Size | 291.8 x 233.5 mm | 233.4 x 175.1mm | |
| Materials Scintillator | CsI | CsI | |
| DOE | 43% at 2 lp/mm<br>30% at 5 lp/mm | 43% at 2 lp/mm<br>30% at 5 lp/mm | |
| MTF | 70% @ 2 lp/mm<br>30% @ 5 lp/mm | 70% at 2 lp/mm<br>30% at 5 lp/mm | |
| Resolution | 3,840 x 3,072 (6.1M) | 3,072 X 2,304 (6.1M) | |
| Detector Type | TFT a-Si | TFT a-Si | |
| Acquisition devices | Digital X-ray Detector | Digital X-ray Detector | |

When compared to the predicate devices (K162670), the RSM 1824C presented in this submission has the same:

- Intended Use
- Technological characteristics
- · Operating principle
- Materials Scintillator

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- · Design features
- · Performance (DQE, MTF, Resolution)

A few differences are as follows

- · Image Size
There is no significant difference between the RMS 2430C and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device in design, function, materials, operational principles and intended use. The difference in the sizes of the detectors only result in the difference in the X-ray images can be taken. Therefore, the difference in the sizes of the detectors does not affect the safety and effectiveness. Also, the results of the clinical image evaluation proved the clinical effectiveness of the subject device.

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

Non-Clinical Performance Testing has been considered according to the IEC 6220-1-2, IEC 61267 and CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.

| Test Laboratory | Date of Issue | Report Number | Standard | Test Result |
|-----------------|----------------|---------------|------------------------------|-------------|
| DRTECH | February<br>1. | DRT-PTR-014 | IEC6220-1-2:2007, | × Pass |
| | 2017 | | Medical electrical equipment | □ Fail |
| | | | - Characteristics of digital | |
| | | | X-ray imaging devices - Part | |
| | | | 1-2: Determination of the | |
| | | | detective quantum efficiency | |
| | | | - Detectors used in | |
| | | | mammography | |
| | | | IEC 61267;2005, Medical | |
| | | | Diagnostic X-ray Equipment | |
| | | | – Radiation Conditions for | |
| | | | Use in the Determination of | |
| | | | Characteristics | |

The RSM 2430C complies with the following international and FDA-recognized consensus standards:

| AAMI ANSI ES60601-1: | Medical Electrical Equipment -- Part 1: General Requirements for Basic<br>Safety And Essential Performance (IEC 60601- 1:2005, Mod) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For Basic<br>Safety And Essential Performance – Collateral Standard: Electromagnetic<br>Compatibility - Requirements And Tests (Edition 3) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices.<br>(General I (QS/RM)) |
| IEC 62220-1-2: | Medical electrical equipment - Characteristics of digital X-ray imaging<br>devices - Part 1-2: Determination of the detective quantum efficiency -<br>Detectors used in mammography |
| IEC 61267: | Medical Diagnostic X-ray Equipment – Radiation Conditions for Use in<br>the Determination of Characteristics |
| NEMA PS 3.1 - 3.20: | Digital Imaging and Communications in Medicine (DICOM) Set |

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

The single-blinded concurrence study conducted in compliance with CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System) confirmed that the new x-ray detectors (RSM 2430C) provide images of equivalent diagnostic capability to the predicate device, RSM 1824C. The results of the study demonstrate substantial equivalence.

## 12. Conclusion [21 CFR 807.92(b)(3)]

The RSM 2430C is substantially equivalent to the currently marketed and predicate device (RSM 1824C(K162670) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, substantial equivalence 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 62220-1 and NEMA PS 3.1 -3.20. Also, substantial equivalence was demonstrated through a clinical test, which was conducted in compliance with the requirements specified in the "CDRH's 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 subject device (RMS 2430C) 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 device is as safe and effectiveness.