(39 days)
The XCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).
The xCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The xCAT™ can measure distances and thickness on two dimensional images. Images produced by the xCAT can be exported via Ethernet or onto optical media or a memory stick. The building blocks of the xCAT are a motorized scanning arm carrying an Xray source and image detector, and a computer running the xCAT software. The scanning arm 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 computer monitor for viewing.
The provided 510(k) summary for the Xoran xCAT™ does not contain information regarding specific acceptance criteria, a study proving device performance against such criteria, or details typically found in a clinical or performance study report. The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against defined metrics.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the text:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, resolution, noise levels) or report specific performance metrics for the xCAT™ beyond its intended imaging capabilities and reconstruction process.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No test set, sample size, or data provenance are mentioned, as a formal performance study against detailed acceptance criteria is not described.
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 provided. Ground truth establishment is not discussed, as there is no described test set or performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Adjudication methods are not applicable as no test set or ground truth establishment process is described.
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 provided. An MRMC study is not mentioned. The xCAT™ is described as an imaging device that produces images for human viewing and measurement, without explicit mention of AI assistance or human reader performance improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not provided. The document describes the device as producing images for viewing and measurement by a user, implying human intervention. There is no mention of a standalone algorithm performance evaluation without human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. As no performance study is detailed, the type of ground truth used is not specified.
8. The sample size for the training set:
- Not provided. The document describes the xCAT™ as an imaging device that reconstructs 3D images from X-ray sequences. It does not mention any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
- Not provided. This is not applicable, as no training set or AI component requiring ground truth for training is described.
Summary of what the document does provide regarding device evaluation:
The 510(k) submission establishes substantial equivalence to predicate devices (Neurologica's NL 3000 CereTom and Xoran Technologies Inc. MiniCATTM) rather than providing a detailed performance study with specific acceptance criteria. The basis for clearance is that its design, material, functionality, and technology are comparable to these existing, legally marketed devices, and it does not pose new safety or effectiveness issues.
The "study" implicitly referenced is the comparison to predicate devices, which allows the FDA to conclude that the device is substantially equivalent for its intended use. Potential hazards are stated to be controlled by a risk management system, including Hazard Analysis and Software Development and Validation Process, but no details of these processes or their outcomes are provided.
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510(K) SUMMARY
1.14. Identification of Submitter
Jim Bertolina, Ph.D. VP, New Product Development Xoran Technologies, Inc 309 N. First Street Ann Arbor, MI 48103 jbertolina@xorantech.com 310.525.0701 (phone)
Identification of Product 1.15.
| Name | xCAT™ |
|---|---|
| Manufacturer: | Xoran Technologies, Inc309 N. First StreetAnn Arbor, MI 48103 |
| Distributor | Xoran Technologies, Inc309 N. First StreetAnn Arbor, MI 48103 |
Marketed Devices 1.16.
The xCAT™ is substantially equivalent to the devices listed below:
| Device | MiniCAT™ |
|---|---|
| Manufacturer | Xoran Technologies309 N. First AvenueAnn Arbor, MI 48103 |
| 510(k) Number | K032243 |
| Device | NL 3000 CereTom |
| Manufacturer | Neurologica14 Electronics Ave.Danvers, MA 01923 |
| 510(k) Number | K051765 |
AUG - 7 2006
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1.17. Device Description
The xCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The xCAT™ can measure distances and thickness on two dimensional images. Images produced by the xCAT™ can be exported via Ethernet or onto optical media or a memory stick.
The building blocks of the xCAT'th are a motorized scanning arm carrying an Xray source and image detector, and a computer running the xCAT™ software. The scanning arm 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 computer monitor for viewing.
1.18. Intended Use
The xCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).
1.19. Comparison with the Predicate Devices
The xCAT™ reconstructs a three dimensional model from X-ray images similar to those obtained using the predicate devices. It displays either two-dimensional cross-sections or three dimensional views and allows the user to take measurements on the reconstructed images. The xCAT™ is substantially equivalent in design, material, functionality, and technology to the predicate devices (Neurologica's NL 3000 CereTom, ref: K051765, and Xoran Technologies Inc. MiniCATTM ref: K032243).
1.20. Conclusion
The xCAT™ by Xoran Technologies acquires an X-ray rotational sequence and provides three-dimensional information on the analyzed volume. It is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into its imaging gantry (such as the head, neck, wrist, ankle, hand, and foot), and is substantially equivalent in design, material, functionality, and technology to Neurologica's NL 3000 CereTom, ref: K051765, and Xoran Technologies Inc. MiniCATTM ref: K032243.
Potential hazards (e.g., electrical, mechanical, thermal, radiation, incorrect measurements, and misdiagnosis) are controlled by a risk management system including: Hazard Analysis and Software Development and Validation Process.
The xCAT™ is an X-ray imaging system that complies with the requirements of 21 CFR 807.87(h) and does not pose any new safety risks or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 7 2006
Jim Bertolina, Ph.D. VP. New Product Development Xoran Technologies, Inc. 309 N. First Street ANN ARBOR MI 48103
Re: K061834
Trade/Device Name: Xoran xCatTM Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 28, 2006 Received: June 29, 2006
Dear Dr. Bertolina:
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/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Under the acronym is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The text "FDA Centennial" is arranged in a circular fashion.
Protecting and Promoting Public Health
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Page 2 -
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 that I Drederal statutes and regulations administered by other Federal agencies. You must or uny 1 other 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 CI K I at 6075, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality byevelles (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) I mis letter will and my Jurie FDA finding of substantial equivalence of your device to a legally premated predicated 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.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 (210) 11 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy 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): K061834
Device Name: Xoran XCAT
Indications For Use:
The XCAT is intended to be used for x-ray computed tomography imaging of anatomy The XCAT is intended to be used for x fay sompact as the head, neck, wrist, ankle, hand and foot).
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Ch. Lypon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.