(33 days)
BTI-Scan is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.
BTI Scan is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also intended as a pre-operative software for simulating / evaluating dental implant placement and surgical treatment options.
The provided text is a 510(k) summary for the BTI-Scan device, which describes its intended use, predicate device, and the FDA's clearance. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on the study that proves the device meets specific criteria, as this information is not present in the provided document.
The document primarily focuses on establishing substantial equivalence to a predicate device (SimPlant System) and obtaining regulatory clearance based on that equivalence, rather than providing detailed performance study data.
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Ko5 1392
JUN 2 9 2005
GLOBAL HARMONIZATION PILOT 510 (K) SUBMISSION BTI-Scan
510 (K) SUMMARY
510 (K) SUMMARY. SAFETY AND EFFECTIVENESS INFORMATION BTI-SCAN
| SUBMITTER'S NAME. ADDRESS ANDTELEPHONE NUMBER: | B.T.I. Biotechnology Institute, S.L.Parque Tecnológico de ÁlavaLeonardo da Vinci, 14 BMiñano (Álava)01510 SpainPH: 34 945 297030FAX: 34 945 297031 |
|---|---|
| CONTACT PERSON | Leyre Zúñiga HernandoQuality and Regulatory Affairs Pharmacist |
| SUMARY PREPARATION DATE: | May 2005 |
| ESTABLISHMENT REGISTRATIONNo: | 3004417597 |
| PROPRIETARY NAME: | BTI-Scan |
| COMMON NAME: | Image Processing System and preoperativesoftware for simulating/ evaluating dentalimplant placement and surgical treatmentoptions |
| CLASSIFICATION NAME: | Image Processing System(Sec. 892.2050) |
| PRODUCT CODE: | LLZ |
| DEVICE CLASSIFICATION: | Class II |
PREDICATE DEVICE
The BTI-Scan is claimed to be substantially equivalent in material, design, and function to the SimPlant System cleared by FDA under 510 (k) K033849 on May 25, 2004
DEVICE DESCRIPTION
BTI Scan is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also intended as a pre-operative software for simulating / evaluating dental implant placement and surgical treatment options.
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GLOBAL HARMONIZATION PILOT 510 (K) SUBMISSION BTI-Scan
INTENDED USE
BTI Scan is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also intended as a pre-operative transler of imaging moothating dental implant placement and surgical treatment options.
SUBSTANTIAL EQUIVALENCE
The BTI-Scan is considered to be substantially equivalent to the SimPlant System
CONCLUSION
CONSECONO is considered to be substantially equivalent in design, material and function to the SimPlant System
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Levre Zúñiga Hernando Quality and Regulatory Affairs Pharmacist B.T.I. Biotechnology Institute, S.L. Leonardo da Vinci, 14-B Miñano Menor, Alava, 01510 SPAIN
Re: K051392
Trade/Device Name: BTI-Scan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 18, 2005 Received: June 1, 2005
Dear Mr. Hernando:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (0S) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to organization of substantial equivalence of your device to a legally prematics notification - 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 Part 801), please 11 you uses office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GLOBAL HARMONIZATION PILOT 510 (K) SUBMISSION BTI-Scan
Indications for Use
510(k) Number (if known): _ Ko S /392
Device Name: BTI-Scan
Indications for Use:
BTI-Scan is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.
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)
Nancy Brogdon
(Division Sigh-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _
§ 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).