(14 days)
InVivoDental is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment
InVivoDental is a volumetric imaging software designed specifically for dental clinicians. The software reads DICOM data from dental CT machines including I-CAT, NewTom, MecuRay and Accuitomo. The software runs in Windows XP operating system and visualizes the DICOM data on the computer screen. The software is downloaded over the internet and installed on the customer's computer.
The provided text does not contain details about specific acceptance criteria or a study proving device performance against those criteria. It is a 510(k) summary indicating that the device is substantially equivalent to predicate devices based on its intended use, product, performance, and software information. The only mention of testing is a general statement: "Results of in-vitro testing demonstrate that the InVivoDental is safe and effective for its intended use."
Therefore, I cannot provide the requested information in the structured format you provided. The document lacks the detailed performance study data, sample sizes, ground truth establishment, or expert involvement that your questions inquire about.
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510(K) SUMMARY OR 510(K) STATEMENT 5.
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: March 5, 2007
APR - 6 2007
Applicant Information:
Anatomage Inc. 111 N. Market Street #930 San Jose, CA 95113
Contact Person
Robert J. Chin Ph.D. Phone Number: (650) 593-5225
Device Information:
| Trade Name: | InVivoDental™ |
|---|---|
| Classification: | Class II |
| Classification Name: | Imaging Processing System |
Physical Description:
InVivoDental is a volumetric imaging software designed specifically for dental clinicians. The software reads DICOM data from dental CT machines including I-CAT, NewTom, MecuRay and Accuitomo. The software runs in Windows XP operating system and visualizes the DICOM data on the computer screen. The software is downloaded over the internet and installed on the customer's computer.
Intended Use:
InVivoDental is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment
Equivalent Device: .
The subject device is substantially equivalent in intended use and/or method of operation to the Materialise N. V. SimPlant System (K022849, K053592), Cybermed Vimplant (K053155) And Implant Logic VIP System (K060267)
Test Results:
Performance
Results of in-vitro testing demonstrate that the InVivoDental is safe and effective for its intended use.
Anatomage
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Summary:
Outhmally.
Based on the intended use, product, performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
、
Anatomage
CONFIDENTIAL
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Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human figures in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Anatomage, Inc. c/o Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131
2007
Re: K070803
Trade/Device Name: InVivoDental™ Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 22, 2007 Received: March 23, 2007
Dear Mr. Christensen:
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 indives 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 Corneric 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, Trou nrey, 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 Reeister.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Underneath "FDA" is the word "Centennial" in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for the centennial anniversary of the Food and Drug Administration (FDA).
Promoting and Promoting Public Health
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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 (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.
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 Part 801), please contact the 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) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
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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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
InVivoDental
Indications for Use:
InVivoDental is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment
Prescription Use V (Part 21 CFR 801 Subpart D)
ANDIOR
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)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070803
Page 1 of 1
Anatomage
Page 6
§ 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).