(52 days)
i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis. The software is to be operated and used by doctor, dentists and other legally qualified professionals.
i-Dixel is a medical and dental diagnostic application for processing, archiving, and managing diagnostic images from multiple imaging modalities and other patient information. i-Dixel processes acquired 2D/3D images for diagnostic use. Any patient record, name, ID, diagnosis, or image can be retrieved by simply clicking the mouse on the desired item in the easy-to-manage filing system made up of patient folders and their images.
The provided text is a 510(k) summary for the i-Dixel image viewer software. It claims substantial equivalence to a previously cleared device (3DX Integrated Information System, part of K030450). The document does not describe a study to prove the device meets specific acceptance criteria in the way a performance study for a novel diagnostic algorithm would.
Instead, the submission relies on the concept of substantial equivalence to an existing predicate device. This means the manufacturer is asserting that the i-Dixel is so similar to the legally marketed 3DX Integrated Information System that it does not raise new questions of safety and effectiveness, and therefore does not require new clinical performance data to demonstrate its capabilities.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
No direct acceptance criteria or reported performance metrics are provided because this is a substantial equivalence submission for an image viewer software, not a diagnostic algorithm with quantifiable performance targets. The "performance" is implicitly deemed equivalent to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. There is no mention of a test set or data provenance because no explicit performance study was conducted. The equivalence is based on the functional similarity to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth was established for a test set as no performance study was detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
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
Not applicable. No MRMC study was performed or discussed, as the device is an image viewer and not an AI-powered diagnostic tool in the sense of providing assistance to human readers for interpretation tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The i-Dixel is described as image viewer software, and its "performance" is assessed through its functional equivalence to a predicate image viewer, not as a standalone algorithm with diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was used as no explicit performance study was conducted.
8. The sample size for the training set
Not applicable. The document does not mention any training of an algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.
Summary of the Device's Claimed "Acceptance" (Substantial Equivalence):
The core of the submission for i-Dixel is the claim of substantial equivalence to the "3DX Integrated Information System," which is incorporated into a legally marketed device, "3D Accu-I-tomo XYZ Slice View Tomograph (K030450)." The document states:
- "i-Dixel is slightly revised version of 3DX Integrated Information System which is incorporated to FDA- cleared device..."
- "...all changes are minor and don't pose any additional safety concerns. Safety charges are min has not changed between these two models and we judge these two software ane substantially equal."
- "Consequently, it is self-explanatorily evident that this i-Dixel is substantially equivalent to 3DX Integrated Information System..."
Therefore, the "acceptance criteria" here are implicitly that the i-Dixel performs its intended functions (processing, archiving, managing diagnostic images, viewing, printing, etc.) in a manner that is functionally equivalent to the predicate device, 3DX Integrated Information System, without introducing new safety or effectiveness concerns. The "study" proving this is essentially the manufacturer's self-assessment and comparison to the predicate device, which the FDA then reviewed to affirm substantial equivalence.
{0}------------------------------------------------
073704
510(k) SUMMARY J. Morita USA Inc.'s i-Dixel
11:0 Z 1 2
1. Submitter Name and Address with Phone/Fax
Registration No. 2081055 Registration No. 3002807636 Initial Distributor: Manufacturer: J. Morita USA, Inc. J. MORITA MFG. CORP. 9 Mason 680 Higashihama Minami-cho Irvine, CA 92618 Fushimi-ku, Kyoto USA Japan 612-8533 Telephone: 949-581-9600 +81-75-611-2141 Facsimile: 949-581-9688 +81-75-605-2354
2. Contact Person
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
3. Date Summary Prepared
November 12, 2007
4. Device Name
Trade or Proprietary Name:
i-Dixel
Common Name:
Product Code:
Image viewer software
Classification Name:
Picture archiving and communications system (21CFR892.2050) LLZ
5. Substantial Equivalency
Substantial equivalency is claimed against the following devices:
{1}------------------------------------------------
i-Dixel is practically the same as 3DX Integrated Information System, which is incorporated in our legally marketed device, 3D Accu-I-tomo X YZ Slice View Tomograph (K030450). i-Dixel is also presumably the same as N-Liten which is incorporated to ProMax 3D (Planmeca Ov, Finland).
6. Description of the Device
i-Dixel is a medical and dental diagnostic application for processing, archiving, and managing diagnostic images from multiple imaging modalities and other patient information. i-Dixel processes acquired 2D/3D images for diagnostic use. Any patient record, name, ID, diagnosis, or image can be retrieved by simply clicking the mouse on the desired item in the easy-to-manage filing system made up of patient folders and their images.
i-Dixel is used in the medical environment and has the following functions as the entire system.
-
- An image is acquired from X-ray equipment and saved in the database.
-
- It saves data in the patient database besides the image.
-
- Information in the image etc. saved in the patient data base can be seen,
-
- It prints the image with applying information.
-
- It makes maintenance of the patient database.
-
- The image is imported and exported by various forms.
-
- It is operated under the network environment.
-
- It has the function of the input authentication by the password with operator ID to prevent patient's fault and data being lost by the operational mistake.
-
- It is operated with 3D imaging modalities manufactured by J. Morita Mfg. Co.
-
- It is operated with 2D imaging modalities or other panoramic/cephalometric x-ray device manufactured by J. Morita.
-
- It can be connected with modalities which comply with TWAIN specifications.
-
- It can incorporate images of device which is compatible to drivers including DixelD or 3DXD by J. Morita Mfg. Co.
-
- It can import data from video camera.
7. Intended Use
i-Dixel can be used as viewer or database of medical imaging to support the diagnostic by medical imaging.
8. Safety and Effectiveness of the Device
i-Dixel is slightly revised version of 3DX Integrated Information System which is incorporated to FDA- cleared device (See below) in J. MORITA MFG. CORP.
{2}------------------------------------------------
Information of the device which 3DX Integrated Information System is incorporated:
ਾ
| No. | Device | 510(k) number | Functions of the device | NOTE |
|---|---|---|---|---|
| 1 | 3D accu-i- tomo | K030450 | Dental x-ray computedtomography | 3D |
The i-Dixel is a slightly modified model from 3DX Integrated Information System but all changes are minor and don't pose any additional safety concerns. Safety charges are min has not changed between these two models and we judge these two software ane substantially equal.
Consequently, it is self-explanatorily evident that this i-Dixel is substantially equivalent to 3DX Integrated Information System which is incorporated to 3D Accu-I-tomo XYZ Slice View Tomograph (K030450) in the sense of similar characteristics.
3/3
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers. The symbol is black and the text is also in black.
FEB 21 2008 Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
J. Morita USA, Inc. % Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 WASHINGTON DC 20005
Re: K073704
Trade/Device Name: i-Dixel Image Viewer Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2007 Received: December 31, 2007
Dear Mr. Barritt:
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.
Image /page/3/Picture/10 description: The image is a circular logo commemorating the centennial of the FDA from 1906-2006. The letters FDA are in bold, stacked on top of the word "Centennial". The logo is surrounded by a circular border with text, but the text is not legible.
Protecting and Promoting Public Health.
{4}------------------------------------------------
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 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.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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/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
{5}------------------------------------------------
Indications for Use
510(K) Number: anknown Device Name: i-Dixel Indications for Use:
i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis.
The software is to be operated and used by doctor, dentists and other legally qualified professionals.
Prescription Use AND/OR (Part21CFR801 Subpart D)
Over-The-Counter Use (Part21CFR807 Subpart C).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODB)
(Division Sign-Off).
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(K) Number: L078704
Prescription Use (Part21CFR801.109) Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal 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).