(47 days)
Blue Sky Plan is intended to be used as conversion software for Computed Tomography (CT) generated DICOM images into a format that allows a dentist to assess the anatomic topography of the maxilla and mandible as well as location of important structures. It allows the information to be used for pre-surgical treatment planning of dental implant procedures. The Blue Sky Plan software is deployed on standard personal computer hardware using a Windows operating system.
Blue Sky Plan™ is dental imaging software which loads DICOM images and provides 3D visualization. 2D image reformation for surgical implant planning and stent fabrication, which allows the virtual position of implants from the images supplied by computerized tomography.
The provided text is a 510(k) summary for the medical device "Blue Sky Plan," a 3D Dental Image Processing Software. It outlines the device's description, indications for use, and a comparison to predicate devices, ultimately concluding substantial equivalence.
However, the document does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria. It states that "Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission," implying a comparison to predicate devices was performed, but no specifics of this comparison or any standalone performance study are provided.
Therefore, I cannot populate the requested table and sections with information directly from the provided text.
Based on the absence of explicit information in the provided document, the following points cannot be addressed:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance metrics are mentioned.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
- Adjudication method for the test set: No test set is described.
- 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 is described. The device is software for image visualization and planning, not explicitly "AI" in the modern sense or assistance to human readers in a diagnostic capacity beyond providing 3D views.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is described.
- The type of ground truth used: No ground truth is described.
- The sample size for the training set: No training set is described.
- How the ground truth for the training set was established: No training set is described.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological compatibility, without detailing specific performance studies or acceptance criteria for a new device evaluation.
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APR 2 2 2009
న. 510(k) Summary
| Trade Name: | Blue Sky Plan |
|---|---|
| Common Name: | 3D Dental Image Processing Software |
| Classification Name: | Picture archiving and communications system -21 CFR 870.2050. Thisdevice is categorized as LLZ and is regulated as Class II. |
| Submitter Information: | Blue Sky Bio, LLC888 E. Belvidere Rd., Suite 212Grayslake, IL 60030 USATel: 718.376.0422; Toll Free Tel: 888.446.6724Fax: 888.234.3685 |
| Summary Prepared By: | Albert Zickmann, DDSPresident |
| Date Prepared: | February 26, 2009 |
| Predicate Devices: | Virtual Implant Placements (VIP), K060267Accurex, K061126 |
Device Description:
Blue Sky Plan™ is dental imaging software which loads DICOM images and provides 3D visualization. 2D image reformation for surgical implant planning and stent fabrication, which allows the virtual position of implants from the images supplied by computerized tomography.
Indications for Use:
Blue Sky Plan is intended to be used as conversion software for Computed Tomography (CT) generated DICOM images into a format that allows a dentist to assess the anatomic topography of the maxilla and mandible as well as location of important structures. It allows the information to be used for pre-surgical treatment planning of dental implant procedures. The Blue Sky Plan software is deployed on standard personal computer hardware using a Windows operating system.
Technological Characteristics:
The technological characteristics of the new device are compatible to those of the predicate devices.
Conclusions:
The indications for use are consistent with the previously indicated predicate devices and in the applicable FDA classification regulation. Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2009
Dr. Albert Zickmann President Blue Sky Bio, LLC 888 E. Belvidere Road, Suite 212 GRAYSLAKE IL 60030
Re: K090607
Trade/Device Name: Blue Sky Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 3, 2009 Received: March 6, 2009
Dear Dr. Zickmann:
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 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 (OS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 4.
510(k) Number (if known): K090607
Device Name: Blue Sky Plan
Indications for Use:
Blue Sky Plan is intended to be used as conversion software for Computed Tomography (CT) generated DICOM images into a format that allows a dentist to assess the anatomic topography of the maxilla and mandible as well as location of important structures. It allows the information to be used for pre-surgical treatment planning of dental implant procedures. The Blue Sky Plan software is deployed on standard personal computer hardware using a Windows operating system.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Azuim Khan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
CONFIDENTIAL
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).