(56 days)
The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media.
The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, transforms them into three dimensional images and displays them on the workstation monitor for viewing.
This 510(k) summary for the i-CAT Scanner does not contain specific acceptance criteria or details about a study designed to prove the device meets those criteria. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable metrics.
Therefore, many of the requested information points cannot be extracted from this document.
However, I can provide what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define specific performance acceptance criteria (e.g., accuracy, resolution benchmarks) for the i-CAT Scanner, nor does it report performance metrics against such criteria. The "Conclusions" section broadly states that potential hazards are controlled by the design, verification, and validation process, and that the device complies with 21 CFR 807.87 and poses no new safety risks or effectiveness issues.
2. Sample size used for the test set and the data provenance:
Not specified. The document does not describe a clinical or technical test set used to evaluate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no described test set with ground truth is mentioned.
4. Adjudication method for the test set:
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
No MRMC study is mentioned. The document focuses on the device's technical specifications and intended use in comparison to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
Not applicable. This is an imaging device, not an AI algorithm for interpretation. Its performance is inherent in the image acquisition and reconstruction process, which is then interpreted by a human.
7. The type of ground truth used:
Not explicitly stated for any performance evaluation. The document implies that the device's ability to "construct a three dimensional model" and "measure distances and thickness" is a functional truth, but it doesn't detail how the accuracy of these functions was verified against a "ground truth."
8. The sample size for the training set:
Not applicable. This device is an X-ray scanner, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available from the document:
- Device Name: i-CAT Scanner
- Intended Use: Constructs a three-dimensional model from images taken during a rotational X-ray sequence. Intended for use whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects, specifically for TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
- Substantial Equivalence: Claimed against NewTom QR - DVT 9000 (K003787) and 3D Accu-I-tomo XYZ Slice View Tomograph (K030450).
- General Compliance: The device is stated to comply with 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues. Potential hazards are reportedly controlled by design development, verification, and validation processes, including a risk management system.
The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance testing and acceptance criteria. For devices like this X-ray scanner, the performance is often assessed through bench testing and verification activities that ensure the device meets its design specifications (e.g., image quality, dose, measurement accuracy), but these specific details are not included in this summary.
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JUL - 3 2006
510 (k) Summary
Submitters Information
Name:
Address:
Phone Number:
Fax Number:
Person To Contact:
Date Of Summary:
Trade Name Of The Device:
Common Or Usual Name:
Classification Name:
Imaging Sciences International Inc.
1910 North Penn Road Hatfield PA, 19440
215-997-5666
215-997-5665
David W. Cowan Vice President of Engineering, Quality Assurance and Government Compliance
May 05, 2006
i-CAT Scanner
Extraoral Source X-ray System
Extraoral Source X-ray System
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Substantial Equivalence Claim: The Imaging Sciences International Inc. i-CAT Scanner is substantially equivalent to the devices listed below:
| Device: | NewTom QR - DVT 9000 |
|---|---|
| Manufacturer: | NIM s.r.1.Via Silverstrini, 2037135 VeronaItaly |
| 510 (k) Number: | K003787 |
| Device: | 3D Accu-I-tomo XYZ Slice View Tomograph |
| Manufacturer: | J. Morita Manufacturing Corporation680 Higashihama Minami-cho, Fushimi-kuJapan |
| 510 (k) Number: | K030450 |
Description Of The Device: The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media.
The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, transforms them into three dimensional images and displays them on the workstation monitor for viewing.
Intended Use Of The Device: The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
Comparison with Predicate Devices: The i-CAT Scanner reconstructs a three dimensional model from X-ray images similar to the model obtained using the predicate devices. It displays either two-dimensional cross-sections or three dimensional views and allows the user to take measurements on reconstructed images.
Conclusions: The i-CAT Scanner Acquires an X-ray rotational sequence and provides three-dimensional information on the analyzed volume. The potential hazards (e.g. electrical, mechanical, thermal, radiation, incorrect measurements or misdiagnosis) are controlled by the design development, verification and validation process which includes a risk management system.
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The i-CAT Scanner complies with the requirements of 21 CFR 807.87 and does not
pose any new safety risks or effectiveness issues.
:
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 3 2006
Mr. David W. Cowan Vice President of Engineering, Quality Assurance and Government Compliance Imaging Sciences International, Inc. 1910 North Penn Road HATFIELD PA 19440
Re: K061284
Trade/Device Name: i-CAT Scanner Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 5, 2006 Received: May 9, 2006
Dear Mr. Cowan:
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 croomerse 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 Nossmatic 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 offecting 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/9 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
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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 sectronic 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 legal|y marketed predicate device results in a classification for your device and thus, permitts 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.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). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistence 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 vours.
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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Indications for Use
510(k) Number (if known): _ K061284
Device Name: i-CAT Scanner
Indications For Use: The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K061284
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.