(37 days)
AeroPilot is a software device that is used in conjunction with REGIUS Unitea to control Konica Minolta Digital Radiography systems. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/ screen systems in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
The AeroPilot is a software device that is used in conjunction with our REGIUS Unitea. K071436, to control Konica Minolta Digital Radiography systems. The AeroPilot is the software designed to be installed in Off-the-shelf PC (operation console) which is one of component of REGIUS Unitea and works with Konica Minolta Digital Radiography systems to be an interface with X-ray generator or between REGIUS Unitea and the specified Konica Minolta Digital Radiography systems, and to acquire X-ray images like the specified Konica Minolta Digital Radiography systems do.
The provided text is a 510(k) Summary for the AeroPilot device, which is a software device used to control Konica Minolta Digital Radiography systems. The document focuses on establishing substantial equivalence to predicate devices and does not detail a study with specific acceptance criteria, test set characteristics, expert involvement, or adjudication methods for evaluating algorithm performance. Instead, it relies on demonstrating equivalence in configuration, specifications, and principle of operation, along with performance testing to show equivalent image quality.
Therefore, many of the requested fields cannot be extracted or are not applicable from the provided document.
Here's a summary of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- The document states that a "Risk Analysis for the AeroPilot (software) was conducted on the basis of ISO14971...the risk associated with all of the identified hazards was reduced to an acceptable level or ALARP." This is a high-level acceptance criterion related to risk management.
- It also states, "the results of performance testing show that the image quality of proposed device is equivalent to the predicate device." This implies an acceptance criterion for image quality, but specific numerical criteria (e.g., sensitivity, specificity, resolution, contrast) are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Risk Level | Reduced to an acceptable level or ALARP (As low as reasonably practicable) based on ISO14971. |
| Image Quality | Equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-read ground truth study is described for the device's performance. The comparison is against predicate device performance, implying technical specifications and image quality rather than diagnostic accuracy by humans.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 MRMC study was mentioned. The device is a control software for a digital radiography system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "performance testing" to show "image quality... equivalent to the predicate device." This suggests a standalone evaluation of the device's technical output (image quality), but specific metrics and a detailed study design are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance testing appears to be the image quality and functionality of the predicate device. The new device's performance is compared against the established performance of existing Konica Minolta Digital Radiography systems.
8. The sample size for the training set: Not applicable, as this is a software device for controlling hardware and acquiring images, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.
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KI 234 9
510(k) Summary
as required by 807.92
DEC 2 0 2012
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Establishment Registration Number: 3004485675
2. Submitter's Name and Address
Shiqeyuki Kojima Manager Regulations and Standards Section, Quality Assurance Center No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Telephone: 81-42-589-8429 Fax: 81-42-589-8053
3. Date of Submission
November 9, 2012
-
- Device Trade Name AeroPilot
5. Common Name
Picture Archiving Communications System
6. Classification, Product Code
Class II, 90LLZ
7. Predicate Device
AeroDR SYSTEM, 510(k) number K102349 AeroSync for AeroDR SYSTEM, 510(k) number K102349 AeroDR SYSTEM with P-21, 510(k) number K113248 (Konica Minolta Digital Radiography system)
8. Indications for Use
AeroPilot is a software device that is used in conjunction with REGIUS Unitea Unitea to control Konica Minolta Digital Radiography system. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/ screen systems in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
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9. Device Description
The AeroPilot is a software device that is used in conjunction with our REGIUS Unitea. K071436, to control Konica Minolta Digital Radiography systems. The AeroPilot is the software designed to be installed in Off-the-shelf PC (operation console) which is one of component of REGIUS Unitea and works with Konica Minolta Digital Radiography systems to be an interface with X-ray generator or between REGIUS Unitea and the specified Konica Minolta Digital Radiography systems, and to acquire X-ray images like the specified Konica Minolta Digital Radiography systems do.
10. Risk Analysis
The Risk Analysis for the AeroPilot (software) was conducted on the basis of ISO14971, "Medical devices - Application of risk management to medical devices". As a result of risk control measures, the risk associated with all of the identified hazards was reduced to an acceptable level or ALARP (As low as reasonably practicable).
Please refer to the Section 13, Software, Appendix 13-G
11. Substantial Equivalence to Predicate Device
The predicate devices of AeroPilot is our Konica Minolta Digital Radiography systems (K102349, K120477, K113248).
A comparison of the Indications for Use, Configuration, Specifications, and Principal of Operation of this proposed device and the predicate devices has shown in Section 9. Substantial Equivalence Comparison Table.
The result of the Section 9, above mentioned the Risk Analysis showed that there is no new safety and efficacy issue of the proposed device. Also, the results of performance testing show that the image quality of proposed device is equivalent to the predicate device. Please refer to the section 15 and Section 14(as reference data)
Therefore, the function of AeroPilot is substantially equivalent to the specified function that AeroDR SYSTEMS have.
12. Conclusion
Comprehensively, we conclude that the AeroPilot has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 20, 2012
Konica Minolta Medical & Graphic, Inc. % Mr. Russell Munves Storch, Amini & Munves, P.C. Official Correspondent 140 East 45th Street, 25th floor Two Grand Tower NEW YORK, NY 10017
Re: K123499
Trade/Device Name: AeroPilot Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified flouroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: November 9, 2012 Received: November 13, 2012
Dear Mr. Munves:
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. Munves
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Janine M. Morris -S
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: K123499
Device Name: Aero Pilot
Indications for Use:
AeroPilot is a software device that is used in conjunction with REGIUS Unitea to control Konica Minolta Digital Radiography systems. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Prescription Use __ Yes_______________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 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)
Janine M. Morris -S
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
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.