(29 days)
The RSM 2430C is a detector indicated for use in screening and diagnostic mammography.
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.
Here's a breakdown of the acceptance criteria and study information for the RSM 2430C device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K162670) | Reported Device Performance (RSM 2430C) |
|---|---|---|
| DQE @ 2 lp/mm | 43% | 43% |
| DQE @ 5 lp/mm | 30% | 30% |
| MTF @ 2 lp/mm | 70% | 70% |
| MTF @ 5 lp/mm | 30% | 30% |
| Resolution | 3,072 X 2,304 (6.1M) | 3,840 x 3,072 (6.1M) |
| Intended Use | Screening and diagnostic mammography | Screening and diagnostic mammography |
| Technological characteristics | Same as predicate (indirect conversion, CsI scintillator, TFT a-Si) | Same as predicate (indirect conversion, CsI scintillator, TFT a-Si) |
| Operating principle | Same as predicate | Same as predicate |
| Materials Scintillator | CsI | CsI |
| Design features | Same as predicate | Same as predicate |
Note: The document states that the RSM 2430C's performance (DQE, MTF, Resolution) is the same as the predicate device (RSM 1824C). The resolution value provided for the subject device refers to the increased pixel count due to the larger detector size, but the performance characteristics (DQE, MTF) are declared equivalent.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document mentions a "single-blinded concurrence study" but does not specify the number of cases or images included in the test set for the clinical image evaluation.
- Data Provenance: Not explicitly stated. The study was "conducted in compliance with CDRH's Guidance," which typically suggests a controlled clinical setting, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The text only mentions a "single-blinded concurrence study" for clinical image evaluation but doesn't detail the methodology for ground truth establishment or the specifics of the expert readers (number, qualifications, or experience).
4. Adjudication method for the test set
- This information is not provided in the document. The text refers to a "single-blinded concurrence study" but does not specify how disagreements or consensus were achieved among readers (e.g., 2+1, 3+1).
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
- No, a MRMC comparative effectiveness study was not done (or at least not described in this context). This submission is for a new Full-Field Digital Mammography System (detector), not an AI-powered diagnostic tool. The clinical study mentioned is a "concurrence study" to demonstrate equivalence in diagnostic capability between the new detector and a predicate detector, not to evaluate human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a digital X-ray detector, which is a hardware component for image acquisition in mammography. It is not an algorithm or AI software for interpretation, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used
- This information is not explicitly stated. For a "clinical image evaluation" and "concurrence study," ground truth would typically be established based on expert interpretation (e.g., biopsy results, long-term follow-up, or consensus readings by highly experienced radiologists). However, the document does not elaborate on how ground truth was determined.
8. The sample size for the training set
- This device is a hardware component (detector) and does not involve a "training set" in the context of machine learning or AI. Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
- As the device is a hardware component and not an AI algorithm, the concept of a "training set" and associated "ground truth" for training is not applicable.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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,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 : | cwshin@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: | 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)]
- . 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 indicatedfor use in screening and diagnosticmammography. | The RSM 1824C is a detector indicated foruse in screening and diagnosticmammography. | |
| 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/mm30% at 5 lp/mm | 43% at 2 lp/mm30% at 5 lp/mm | |
| MTF | 70% @ 2 lp/mm30% @ 5 lp/mm | 70% at 2 lp/mm30% 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 | February1. | 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 BasicSafety And Essential Performance (IEC 60601- 1:2005, Mod) |
|---|---|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For BasicSafety And Essential Performance – Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices.(General I (QS/RM)) |
| IEC 62220-1-2: | Medical electrical equipment - Characteristics of digital X-ray imagingdevices - Part 1-2: Determination of the detective quantum efficiency -Detectors used in mammography |
| IEC 61267: | Medical Diagnostic X-ray Equipment – Radiation Conditions for Use inthe 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.
§ 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.