(122 days)
The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The digital diagnostic x-ray system consists of a generator, a tube, an x-ray console, a beam limiting device, an image receptor, a u-arm stand and software. The digital panels supplied are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Product features: This system is designed to maintain the alignment between a tube and the image receptor, regardless of the angle on the image receptor or image tilt positions. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on patients. Its flexibility makes the system ideal for all patient examinations including the standing, sitting and lying patient positions.
The provided 510(k) summary for K132921 describes the Galaxy Plus Digital Radiography System.
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution targets) for the device. Instead, the primary acceptance criterion appears to be demonstrated substantial equivalence to the predicate device (DRGEM Corporation's DIAMOND-5A, 6A, 8A, K102408) through non-clinical and clinical testing, and the ability to produce images of "good diagnostic quality."
Given this, the table would look like this:
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with EN/IEC 60601-1: 2006 (for Stand & System) | Test reports submitted; unit successfully underwent electrical safety testing. |
| EMC | Compliance with IEC 60601-1-2:2007, EN/IEC 60601-1-2:2007, CISPR 11:2009/A1:2010, IEC 61000-3-2:2005/A1:2008/A2:2009, IEC 61000-3-3:2008 | Test reports submitted; unit successfully underwent electromagnetic compatibility testing. |
| Radiation Protection | Compliance with EN/IEC 60601-1-3; EN/IEC 60601-2-28; EN/IEC 60601-2-54 | Test reports submitted; compliance demonstrated. |
| Software Validation | Software validation conducted. | Software validation performed; updated software (previously cleared in K093816) employed. |
| Risk Analysis | Risk analysis conducted. | Risk analysis performed. |
| Biocompatibility | Performed in accordance with applicable ISO standards. | Biocompatibility testing performed. |
| Image Quality (Clinical) | Images for all four panels to be of "good diagnostic quality" as evaluated by board-certified radiologists, and obtained in accordance with FDA Guidance Document on Solid State Imaging Devices. The device is "as safe, as effective, and performs as well as or better than" the predicate device. | Clinical images for all four panels obtained, evaluated by board-certified radiologists, and found to be of "good diagnostic quality." This implicitly means the device performs at least as well as the predicate in producing diagnostically acceptable images for its intended use (generating radiographic images of human anatomy, excluding mammography). |
| Non-clinical Performance | Demonstrated by respective panel manufacturers. | Non-clinical performance tests provided by the panel manufacturers. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., the number of patients or images). It vaguely states "Clinical images for all four panels were obtained."
- Data Provenance: Not explicitly stated (e.g., country of origin). It states the images were obtained "in accordance with the FDA Guidance Document on Solid State Imaging Devices," implying they met U.S. regulatory standards for data collection, but no further details on location or retrospective/prospective nature are provided. It is likely retrospective or a limited prospective case series given the summary nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified. The document states "They were evaluated by board certified radiologist." This could imply one or more radiologists.
- Qualifications: "board certified radiologist." The experience level in years is not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1, none). It simply states the images "were evaluated by board certified radiologist." This suggests either independent evaluations or a consensus approach, but the specific process is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention an MRMC study. The comparison is primarily against the predicate device's technological characteristics and the general standard of "good diagnostic quality" for radiographic images, rather than a comparative effectiveness study with human readers.
6. Standalone Performance
Yes, a standalone evaluation was performed. The clinical images generated by the algorithm/system only (i.e., the Galaxy Plus Digital Radiography System itself) were evaluated by radiologists for their diagnostic quality. This evaluation was independent of human interpretation improvements; it assessed the quality of the raw output from the device.
7. Type of Ground Truth Used
The ground truth used for the clinical evaluation was expert consensus/evaluation by "board certified radiologist[s]" who determined the images were of "good diagnostic quality." There is no mention of pathology, outcomes data, or other objective measures of truth. For a diagnostic imaging device like an X-ray system, "good diagnostic quality" determined by an expert is a common form of ground truth for substantial equivalence.
8. Sample Size for the Training Set
The document does not mention a "training set" or provide any sample size for training. This device is a digital radiography system, not an AI/ML algorithm that typically requires a large training set in the way a diagnostic AI would. The software components are an update of previously cleared software (K093816), implying its core functionality was already established. The emphasis is on the image acquisition hardware and its ability to produce images.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of this 510(k) summary (because it's not a de novo AI/ML solution), the method for establishing ground truth for a non-existent training set is not applicable here. The software is an update of a previously cleared version, suggesting its underlying principles and performance were evaluated during its initial clearance (K093816).
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510(k) Summary K132921
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- Submitter: Name - MEDIEN INTERNATIONAL Co., Ltd. JAN 1 7 2014 Address - Medien Office Tower, 50, Heungan-daero 427 Beon-gil Dongan-gu Anyang-si, KOREA, REPUBLIC OF 435-040 Tel - +82-31-451-9466 Fax - +82-31-451-9468 Contact - Jaehyun Lee, ihlee@medien.co.kr Date prepared: December 6, 2013
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- Identification of the Device: Galaxy Plus Digital Radiography System Classification Name: Stationary x-ray system ; Common/Usual Name: Stationary x-ray system (digital) Regulation Number: 21 CFR 892.1680 Product Codes: MQB and KPR
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- Predicate Device: Manufacturer: DRGEM Corporation , Device: DIAMOND-5A, 6A, 8A, 510(k) Number: K102408
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- A description of the device: The digital diagnostic x-ray system consists of a generator, a tube, an x-ray console, a beam limiting device, an image receptor, a u-arm stand and software. The digital panels supplied are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Product features: This system is designed to maintain the alignment between a tube and the image receptor, regardless of the angle on the image receptor or image tilt positions. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on patients. Its flexibility makes the system ideal for all patient examinations including the standing, sitting and lying patient positions.
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- Intended use of the device: The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
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- The Galaxy Plus has essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. See the comparison table below. The differences between the Galaxy and the predicate device are: The Galaxy is available in both straight and U-Arm configurations, the predicate is only U-Arm. The Galaxy generators are available on 40 and 50 kW High Frequency versions, and the predicate generators are available in 52. 68. and 82 kW versions. Four digital panels are available. Two of them are the same panels as employed by the predicate DRGEM in K102408, and the other two panels were cleared by Sedecal in K130883. The software employed is our software that was previously cleared in K093816, but updated. We employ high frequency generator technology, the same generator technology as used in the predicate device.
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| Comparison Table | ||
|---|---|---|
| Characteristic | Predicate Device: DRGEM CorporationDevice: DIAMOND-5A, 6A, 8A510(k) Number: K102408 | Galaxy Plus Digital Radiography SystemK132921 |
| Indications | The DIAMOND-5A,6A,8A DigitalDiagnostic X-ray System is indicated foruse in generating radiographic images ofhuman anatomy. This device is notintended for mammographicapplications. | The Galaxy Plus Digital Radiography System isindicated for use in generating radiographicimages of human anatomy. This device is notintended for mammographic applications. |
| DigitalReceptor Panel | Atlaim Atal 8 or Atal 8C | Galaxy F or Galaxy FC (Atal 8 or Atal 8C ascleared in K113812) orToshiba FDX4343R, FDX3543RP, as clearedin K130883. |
| PanelCommunication | Tethered Ethernet, one panel | Same |
| PanelResolution | 9.4 megapixel | Galaxy F or Galaxy FC (Atal 8 or Atal 8C ascleared in K113812): 9.4 megapixelToshiba FDX4343R, FDX3543RP, as clearedin K130883.: 9.4 megapixel for 17 x 17, 7.5megapixel for 14 x 17. |
| Panel Size | 17 X 17 | 17 X 17 or 14 X 17 |
| Pixel Size | 139 µm | 143 µm Toshiba139 µm Galaxy (Atal) |
| DICOM | Yes, Via Panel | SAME |
| Tube Stand | C-Arm | SAME |
| Generator | "GXR" 52, 68, and 82 kW | "CMP 200":40, 50kW |
| Safety | EN/IEC 60601-1, (2006)EN/IEC 60601-1-2 (2007) | SAME |
| Photo | Image: X-ray machine | Available in two configurations:Image: X-ray machine |
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K132921
Page 3 of 3
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- Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. Biocompatibility testing was performed in accordance with applicable ISO standards. Test reports were submitted for the following standards: EN/IEC 60601-1: 2006 Electrical Safety Testing for the Stand . EN/IEC 60601-1: 2006 Electrical Safety Testing for the System EN/IEC 60601-1-3 Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment EN/IEC 60601-2-28 Medical electrical equipment Part 2. Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis EN/IEC 60 601-2-54 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy EMC System Test Results: IEC 60601-1-2:2007, EN/IEC 60601-1-2:2007 CISPR 11:2009/A1:2010 IEC 61000-3-2:2005/A1 :2008/A2:2009 IEC 61000-3-3:2008. In addition a CSA(US) certification was provided for the generator. Non-clinical performance tests were provided by the respective panel manufacturers.
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- Description of clinical tests. Clinical images for all four panels were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by board certified radiologist and found to be of good diagnostic quality.
- Conclusions drawn: The nonclinical and clinical tests that demonstrate that the device is as ത safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002
January 17, 2014
Medien International Co., Ltd. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K132921
Trade/Device Name: Galaxy Plus Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, KPR Dated: December 12, 2013 Received: December 16, 2013
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 (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.
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Page 2-Mr. Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris 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): K 132921
Device Name: Galaxy Plus Digital Radiography System
Indications for Use:
The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
Prescription Use X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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(Division Sign-Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
K132921 510(k)
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§ 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.