(41 days)
AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The AeroDR X70 is not intended for mammography
The AeroDR X70 is a stationary x-ray system with a ceiling mounted tube support, a floor mounted table and wall stand. The image receptor and the image receptor holder is placed in the table or the wall stand. The ceiling stand and the table are motorized for up and down movements, all other movements are manually operated. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance, a generator control console and an Image system console.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device (AeroDR X70 Stationary X-ray System) is a conventional X-ray system, not an AI-powered device. Therefore, the "acceptance criteria" and "device performance" described primarily relate to safety and equivalency to a predicate device, rather than specific diagnostic performance metrics (like sensitivity, specificity, or AUC) that would be relevant for an AI-enabled diagnostic tool.
The "acceptance criteria" can be inferred from the standards the device meets to demonstrate safety and substantial equivalence.
| Acceptance Criteria (Inferred) | Reported Device Performance and Evidence |
|---|---|
| Safety and Electrical Requirements: Conformance to relevant medical electrical equipment safety standards. | Evidence: The device meets several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32) and NEMA XR7 regarding general safety, electromagnetic compatibility, radiation protection, programmable electrical medical systems, high-voltage generators, X-ray source assembly, and associated equipment. "The same scope of testing has been preformed by certification body." |
| Equivalent Imaging Capability: Ability to produce radiographic images of various portions of the human body, equivalent to the predicate device. | Evidence: "The provided performance data demonstrate that the imaging system in the AeroDR X70 system is substantially equivalent to the predicated device with reqards to the capability of producing radiographic images of various portions of the human body.""AeroDR X70 digital image system...have the same imaging principle, physical characteristic and Intended use" as the predicate device. |
| Intended Use: Consistent with obtaining radiographic images of various human body portions, excluding mammography. | Evidence: "AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The AeroDR X70 is not intended for mammography." This matches the predicate device's intended use. |
| Functional Equivalence: Similar mechanical and operational characteristics compared to the predicate device. | Evidence: "The AeroDR X70 is basically the same product as the predicate device Intuition." Both have motorized ceiling stand and table, manual operation for other movements. Wallstand modifications are noted but considered equivalent functionality (e.g., magnetic vs. manual brake release). |
Based on the provided document, the device described is a conventional X-ray system, not an AI-powered device. Therefore, the following sections about AI-specific study details (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this submission. The "study" here refers to the testing and comparison performed to demonstrate substantial equivalence to a predicate conventional X-ray system.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for an AI device.
- For this conventional X-ray system, the "test set" would refer to the tests performed against the safety and performance standards listed (IEC, NEMA). The document does not specify a "sample size" in terms of patient data or images used for testing, as it's not a diagnostic AI algorithm. The testing focused on hardware performance and safety.
- Data Provenance: Not specified as it's not a data-driven AI device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable for an AI device.
- For this conventional X-ray system, "ground truth" relates to compliance with engineering and safety standards, validated by accredited certification bodies. No medical experts are mentioned as establishing "ground truth" for the device's technical performance or safety tests.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable for an AI device.
- For the conventional X-ray system, the "adjudication" would involve technical verification against the standards by a certification body. The specific process (e.g., how disputes or interpretations during testing are resolved) is not detailed.
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. Not applicable as this is a conventional X-ray system without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. Not applicable as this is a conventional X-ray system without an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for an AI device.
- For the conventional X-ray system, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Conformance to international safety and performance standards (IEC, NEMA).
- Direct comparison of technical specifications and imaging principles with a legally marketed predicate device.
- Performance data demonstrating the imaging system's capability to produce radiographic images, implicitly checked against expected image quality for general radiography.
8. The Sample Size for the Training Set
- Not applicable as this is a conventional X-ray system, not an AI model. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable as this is a conventional X-ray system, not an AI model.
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K1211.09
Image /page/0/Picture/1 description: The image shows the Konica Minolta logo. The logo consists of a circular graphic above the company name. The graphic is made up of several horizontal lines. The text "KONICA MINOLTA" is in a bold, sans-serif font.
MAY 2 3 2012
Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan
510 (k) Summary
Date of summary: October 19, 2011
510(k) Owner:
KONICA MINOLTA MEDICAL & GRAPHIC, INC. no. 1 Sakura-machi, hino-shi Tokyo, 191-8511, JAPAN +81 42-589-8429 Phone: Fax: +81 42-589-8053
Contact person:
| Name: | Shigeyuki Kojima |
|---|---|
| Position: | Manager Regulation Division |
| Phone: | +81 42-589-8429 |
| E-mail: | shigeyuki.kojima@konicaminolta.jp |
Device Name and Classification
Trade name Classification name Device Product Code Regulation Number Device classification
AeroDR X70 Stationary X-ray System RADIOLOGY KPR 892.1680 Class II
Predicate device
The following legally marketed device to which Konica Minolta claims equivalence
- Intuition manufactured by Arcoma AB, K073632
Device description
The AeroDR X70 is a stationary x-ray system with a ceiling mounted tube support, a floor mounted table and wall stand. The image receptor and the image receptor holder is placed in the table or the wall stand.
The ceiling stand and the table are motorized for up and down movements, all other movements are manually operated.
The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance, a generator control console and an Image system console.
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Image /page/1/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a black circle with horizontal white lines across the middle. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
Konica Minolta Medical & Granbic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan
Intended use
AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment.
The AeroDR X70 is not intended for mammography
Comparison of device technological Characteristics
The AeroDR X70 is basically the same product as the predicate device Intuition. Both devices have the ceiling stand and the table motorized for up and down movements, all other movements are manually operated. The Wallstand in both Systems are counter weighted balanced. The AeroDR X70 Wallstand has some modifications in the brake release; the Intuition Wallstand is equipped with manual brake release for the detector holder but the AeroDR X70 brake for the same function is magnetic and operated electrically.
AeroDR X70 digital image system consisting of REGIUS CONSOLE CS-3000 and flat panel AERODR, compared to Intuition image system consisting of CXDI-50G have the same imaging principle, physical characteristic and Intended use,
Non Clinical data
The provided performance data demonstrate that the imaging system in the AeroDR X70 system is substantially equivalent to the predicated device with reqards to the capability of producing radiographic images of various portions of the human body,
To verify that the subject device is as safe as the predicate device the same scope of testing has been preformed by certification body. The following standards are met to demonstrate the safety of the subject device
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Image /page/2/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a black circle with three horizontal white lines across the middle. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
Konica Minolta Medical & Graphic, Inc. No.1 Saxura-machi. Hino-shi, Tokyo 191-8511, Japan
| Standard | Ver | Description |
|---|---|---|
| IEC 60601-1 +A1 +A2 | 1988 | Medical Electrical Equipment - Part 1: General Requirements forSafety |
| IEC 60601-1-2 | 2001 | Electromagnetic Compatibility - Requirements and Tests |
| IEC 60601-1-3 | 1994 | General Requirements for Radiation Protection in Diagnostic X-Ray Equipment |
| IEC60601-1-4 +A1 | 1996 | General Requirements for Safety - Collateral Standard:Programmable Electrical Medical Systems |
| IEC 60601-2-7 | 2007 | Particular Requirements for the Safety of High-VoltageGenerators of Diagnostic X-Ray Generators |
| IEC 60601-2-28 | 1993 | Particular Requirements for the Safety of X-Ray Source Assy. andX-Ray Tube Assy. for Medical Diagnosis |
| IEC 60601-2-32 | 1994 | Part 2: Particular requirements for the Safety of AssociatedEquipment of X-ray Equipment |
| NEMA XR7 | 1995(R2000) | High-Voltage X-Ray Cable Assemblies and Receptacles |
Clinical data
No clinical data was needed to demonstrate substantial equivalence.
Conclusion
Based on the information in this submission similarity to the predicate device (The Arcoma AB Intuition system) and the results of our design control activities, including sub supplier agreements, it is our opinion that the Konica Minolta AreoDR X70 system described in this submission is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the seal is a stylized graphic of what appears to be an abstract representation of a human figure or a symbol related to health and well-being.
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
Konica Minolta Medical & Graphic, Inc. % Mr. Williams Sammons Technical Reviewer Intertek Testing Services NA, Inc. 2307 E Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K121109
Trade/Device Name: AeroDR X70 Regulation Number: 21 CFR 872.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 11, 2012 Received: April 12, 2012
Dear Mr. Sammons:
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
MAY 2 3 2012
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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,
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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Image /page/5/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circular emblem with horizontal lines inside, positioned above the text "KONICA MINOLTA". The emblem is black, and the text is in a bold, sans-serif font.
Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo,191-8511, Japan
Indication for Use
510(k) Number: K i2-1109
Device Name: AeroDR X70
AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The AeroDR X70 is not intended for mammography
Prescription Use X_ ' And/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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 Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121109
4 - 1
§ 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.