(65 days)
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Varian Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a porable unit thich operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency invester and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Varian flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture founovide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.
The provided text describes a 510(k) submission for the MinXray CMDR-2S Digital Diagnostic X-Ray System (Mobile). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to establish device performance against specific acceptance criteria.
Therefore, many of the requested elements (acceptance criteria, specific study design, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in the provided document for a de novo testing of the device's diagnostic performance. The document primarily relies on bench testing and comparison to a predicate device's existing performance.
Here's an analysis based on the provided information, noting where details are not available:
1. Table of Acceptance Criteria and Reported Device Performance
No specific performance acceptance criteria for diagnostic accuracy or specific metrics (like sensitivity, specificity) are defined or reported for the CMDR-2S device itself in the provided text. The submission focuses on substantial equivalence to a predicate device based on technical characteristics and intended use.
| Characteristic | Acceptance Criteria (Not explicitly stated for diagnostic performance, but implied by substantial equivalence) | Reported Device Performance (Implied by substantial equivalence) |
|---|---|---|
| Intended Use | Identical to predicate device: For qualified physician/technician on adult/pediatric subjects for diagnostic x-rays (not mammography). | SAME as predicate device |
| Configuration | Mobile System | SAME as predicate device |
| Generator | High Frequency, 80 kHz | SAME as predicate device (Mikasa X-Ray) |
| Performance Standard | 21 CFR 1020.30 (Radiation safety and performance standards for diagnostic X-ray systems) | Complies with SAME standard as predicate device |
| Image Quality / Diagnostic Capability | Implied to be equivalent to the predicate device (MinXray CMDR-1S) due to "few technological differences" and bench testing. | Considered "as safe and effective" as predicate based on bench tests. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. The document describes bench testing to compare the new device to a predicate, not a clinical study with a patient test set for diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. No patient test set with expert-established ground truth is described.
4. Adjudication method for the test set
- Not applicable / Not provided. No patient test set is 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
- No. This is a medical device 510(k) for an X-ray system, not an AI-powered diagnostic tool. An MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. It's a digital X-ray system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. For the purpose of this 510(k), the "ground truth" is implied by the predicate device's established safety and effectiveness, supported by bench testing of the new device's components and system functionality.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the 510(k) context):
The "study" that proves the device meets the acceptance criteria (which, in a 510(k), primarily means substantial equivalence to a legally marketed predicate device) is documented as "bench testing."
- Purpose: To demonstrate that the MinXray CMDR-2S Digital Diagnostic X-Ray System (Mobile) is as safe and effective as the predicate device (MinXray CMDR-1S, K082627) despite key component changes (Dell laptop instead of Panasonic, dicomPACS® software included, Varian 4336R digital panel instead of CANON CXDI 50G).
- Methodology (implied): Bench testing was performed to verify the proper system operation and ensure that the new components (computer, digital panel, software) function harmoniously and meet performance standards identical to those of the predicate device (21 CFR 1020.30). The submission states, "The results of bench testing indicates that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation."
- Conclusion: Based on this bench testing, MinXray Inc. concluded that the CMDR-2S is "as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device." The FDA concurred with this assessment, granting the 510(k) clearance.
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APR 2 3 2010
510(k) Summary 510(k) Number MinXray, Inc. 3611 Commercial Avenue -Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Tel. 1-847-564-0323 Fax 1-847-564-9040 Date Prepared: February 4, 2010 Contact: Keith Kretchmer, President
-
- Identification of the Device: Proprietary-Trade Name: CMDR-2S Digital Diagnostic X-Ray System (Mobile)
-
- Classification Name: Mobile x-ray system, Product Code 90 IZL and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Picture Archiving and Communications System 90 LLZ.
Common/Usual Name: Digital Mobile Diagnostic X-Ray System
- Equivalent legally marketed devices: MinXray CMDR-1S, K082627; DICOMPACS, OEHM 3. UND REHBEIN GMBH K091364; CPI Rad Vision. CPI Canada, K083224
-
- Indications for Use (intended use) This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
-
- Description of the Device: This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Varian Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a porable unit thich operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency invester and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Varian flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture founovide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation.
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7. Substantial Equivalence Chart
| Characteristic | MinXray CMDR-1S, K082627.Digital Diagnostic X-Ray System(Mobile) | MinXray CMDR-2SDigital Diagnostic X-Ray System (Mobile) |
|---|---|---|
| Intended Use: | Intended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography | SAME |
| Configuration | Mobile System | SAME |
| Computer | Panasonic laptop | Dell laptop |
| Generator | High Frequency | SAME |
| PerformanceStandard | 21 CFR 1020.30 | SAME |
| Generator | Uses high frequency generator madeby Mikasa X-Ray in Japan. 80 khz. | SAME generator |
| PACS software | Not included | dicomPACS® |
| Power Source | 120 V 50/60 Hz AC 20 amp | SAME |
| Digital Panel | CANON CXDI 50G | Varian 4336R |
7. Conclusion
After analyzing bench tests, it is the conclusion of MinXray Inc that the CMDR-2S Digital Diagnostic X-Ray System is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT" on the right. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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
MinXray, Inc. % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8726 Ferrara Ct NAPLES FL 34114
APR 2 3 2010
Re: K100449
Trade/Device Name: CMDR-2S Digital Diagnostic X-Ray Systems (Mobile) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: February 11, 2010 Received: February 18, 2010
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 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 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 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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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,
Donald J. Trump
Donald J. St.Pierre 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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510(k) Number (if known): K10 บิ £ £ 9 ______________________________________________________________________________________________________________________________________
Device Name: CMDR-2S Digital Diagnostic X-Ray System (Mobile)
Indications For Use:
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. (Not for mammographic use),
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of-Device Bvaluation (ODE) ○ LU
Robert Becker
Division of Radiologic aluation and Safety
510K. K100449
Page 1 of 1
12
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.