(58 days)
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. The Digital X-ray Radiography System is designed to perform rudiographic X-ray cvario 1. consists of a control cabinet, a high voltage (HV) generator, an X-ray source assembly including an X-ray tube and an collimator, an Overhead Tube Suspension, a amorphous silicon (a-Si) detector, an elevating radiographic Table, a radiographic wall stand unit and a workstation.
The provided text describes a 510(k) submission for a Digital X-ray Radiography System (model Eagle-DR2000A). The submission aims to demonstrate substantial equivalence to a predicate device, the Revolution XR/d Digital Radiographic Imaging System (K012389).
However, the provided document does not contain any information about the acceptance criteria or the study that proves the device meets those criteria, specifically concerning device performance in terms of image quality metrics, clinical outcomes, or comparative effectiveness studies (e.g., MRMC studies).
The document primarily focuses on:
- General device identification and classification.
- Intended use statement.
- Comparison to a predicate device.
- A high-level description of the device components.
- Non-clinical bench tests conducted to verify compliance with various safety and performance standards (e.g., IEC standards for electrical safety, radiation protection, and biological evaluation).
- The FDA's letter of clearance, stating substantial equivalence.
Therefore, I cannot populate the requested table and study information based on the provided text. The document states that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards." This indicates that the acceptance criteria for this 510(k) submission were primarily related to compliance with established safety and performance standards for X-ray equipment and demonstrating equivalence to a legally marketed predicate device, rather than detailed clinical performance metrics in a human study.
Based on the provided text, I can only provide the following, with many fields explicitly stated as "Not mentioned in the provided text":
Analysis of Acceptance Criteria and Study to Prove Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through compliance with recognized standards and general safety/performance. It does not detail specific performance criteria related to diagnostic accuracy, image quality metrics, or human reader performance, nor does it describe any associated clinical studies or reader studies. The "Non-Clinical Test Conclusion" section primarily lists compliance with various IEC and CFR standards related to electrical safety, radiation protection, and biological compatibility.
Given the nature of a 510(k) for a general radiography system as a replacement for film/screen systems, the primary "acceptance criteria" appear to be robust engineering and safety compliance, and equivalence to a predicate device, rather than a specific clinical performance threshold beyond what the predicate already demonstrated.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Substantial Equivalence | Device is Substantially Equivalent (SE) to predicate (Revolution XR/d Digital Radiographic X-ray System, K012389) in respect of safety and effectiveness. | "The proposed device... is determined to be Substantially Equivalent (SE) to the predicate device..." |
| Electrical Safety | Compliance with IEC60601-1+A1+A2 | "The test results demonstrated that the proposed device complies with the following standards: IEC60601-1+A1+A2..." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "The test results demonstrated that the proposed device complies with... IEC 60601-1-2..." |
| Radiation Performance Standards | Compliance with CFR 1020.30, CFR 1020.31, IEC 60601-2-7, IEC 60601-1-3, IEC 60601-2-28, IEC60601-2-32 | "The test results demonstrated that the proposed device complies with... CFR 1020.30, CFR 1020.31, IEC 60601-2-7, IEC 60601-1-3, IEC 60601-2-28, IEC60601-2-32." |
| Biocompatibility | Compliance with ISO 10993-5 (In Vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization) | "The test results demonstrated that the proposed device complies with... ISO 10993-5, ISO 10993-10." |
| Image Quality / Clinical Performance | Not mentioned in the provided text. | Not mentioned in the provided text (beyond general statement of SE). There is no mention of specific image quality metrics (e.g., DQE, MTF, SNR) or clinical performance studies (e.g., diagnostic accuracy, sensitivity, specificity). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not mentioned in the provided text. The document refers to "bench tests" for compliance with standards, not a test set of patient data.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not mentioned in the provided text.
- Qualifications: Not mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned in the provided text. This type of method would typically be used in reader studies or clinical trials, which are not described.
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
- MRMC Study: Not mentioned in the provided text. The device is a digital X-ray radiography system, not specifically an AI-based diagnostic tool for assisting human readers. Its primary purpose, as stated, is to "replace radiographic film/screen systems," implying a direct imaging modality replacement.
- Effect Size of Improvement: Not applicable/not mentioned, as no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable/not mentioned. This device is an imaging system, not an algorithm being evaluated for standalone diagnostic performance. Its primary function is to generate images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not mentioned in the provided text. This information would be relevant if clinical performance or diagnostic accuracy studies were conducted, which are not detailed here. The "ground truth" for this 510(k) appears to be compliance with engineering and safety standards, as well as functional equivalence to a predicate device.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable/not mentioned. The provided document does not describe any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable/not mentioned, as no training set is described.
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Premarket Notification 510(k) Submission
Section III 510(k) Summary
Project #: M0042012Bc
AUG 222 2012
510(k) Summary Section III
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: _
- Date of Submission: Mar 10. 2012 1.
-
- Sponsor
Beijing Sinopharm Hundric Mediline Info. Tech. Co., Ltd The 3rd floor No.10, 5th Bo'xing Road, Beijing Economic-technological Development Zone, Beijing, 100176, P.R. China Contact Person: Tong han Position: Quality Manager Tel: +86-10-62968301 Fax: +86-10-62968315 Email: tong.han@tcl.com
Submission Correspondent 3.
Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai. 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification 4.
. .. .
Proposed Device Name: Digital X-ray Radiography System Proposed Device Model: Eagle-DR2000A Classification: II Product Code: KPR Regulation Number: 21 CFR 892.1680 Review Panel: Radiology
::
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Intended Use Statement:
The Digital X-ray Radiography System is indicated for use in generating radiographic imars of ' ' ' a anatomy. It is intended to replace radiographic film/screen systems in all general purpose dha, he us procedures. This device is not intended for mammographic applications.
- Predicate Device Identification 5.
510(k) Number: K012389
Product Name: Revolution XR/d Digital Radiographic Imaging System Manufacturer: GE Medical System
- Device Description 6.
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Digital X-ray Radiography System is designed to perform rudiographic X-ray cvario 1. consists of a control cabinet, a high voltage (HV) generator, an X-ray source assembly including an X-ray tube and an collimator, an Overhead Tube Suspension, a amorphous silicon (a-Si) detector, an elevating radiographic Table, a radiographic wall stand unit and a workstation.
7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC60601-1+A1+A2:1988 Medical Electrical Equipment- Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment2, 1995
IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests
CFR 1020.30 Performance Standards for Ionizing Radiation Emitting Products
CFR 1020.31 Radiographic equipment
IEC 60601-2-7 (1998) Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
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IEC 60601-1-3: 1994, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-28: 1993, Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-1-1:2000, Medical electrical equipment -- Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems.
IEC60601-2-32:1994, Medical electrical equipment - Part 2: Particular requirements for the salety of associated equipment of X-ray equipment - Ed. 1.0.
ISO 10993-5:2009 Standard, "Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity"
ISO 10993-10:2010 Standard: Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
Substantially Equivalent Conclusion 8.
The proposed device, Digital X-ray Radiography System, is determined to be Substantially Equivalent (SE) to the predicate device, Revolution XR/d Digital Radiographic X-ray System (K012389). in respect of safety and effectiveness.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Beijing Sinopharm Hundric Mediline Info. Tech. Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd. P.O. Box 237-023 SHANGHAI 200030 CHINA
AUG 2222012
Re: K121854
Trade/Device Name: Digital X-ray Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 21, 2012 Received: June 25, 2012
Dear Ms. Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreases you the enactment date of the Medical Device Amendments, or to conniner of the roughts 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 r va may, disrelore, mance of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is blassified (200 regulations affecting your device can be found in Title 21, additional controls. Dations increases and to 895. 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 I lease of advised alar I DA 3 issuance ex or a complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirement that I DA has made a acteriminations administered by other Federal agencies. You must of any I coural statuted and regainments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality systems ( ( = ) regarine ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = will anow you to begin marketing your active as ween of your device to a legally marketed notification. The FDA indulig of Subsidential value and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and II you desire specific advice for your device of our leasening egaluation and Safety at (301) 796-607), please commer the regulation entitled, "Misbranding by reference to premarket 5450. Also, please note regarding the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
under the MDK regulation (21 ℃FFCT at 005), product goblem/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 Tour may 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section II Indications for Use
510(k) Number: Device Name: Digital X-ray Radiography System
Indications for Use:
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USF (21 C) R 801 Subpart (1)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division of Radiological Devices
5121854
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.