The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

Device Description

The MiniCAT is a dedicated X-ray imaging device that acquires a 360-degree rotation x-ray sequence of images. The MiniCAT consists of both software and hardware components. The software is used for image acquisition, processing, and viewing and consists of the following main functional units patient database, study (scan) acquisition, study reconstruction, study view, report generation, and file saving. The software also controls the hardware components of the device. The major hardware components include the X-ray source, scanning arm (motor), and detector.

AI/ML Overview

This submission is for a special 510(k) to address reported software failures in the MiniCAT device, specifically regarding a forced 10-minute delay between scans, running the software as a Windows shell, a daily calibration date checking function, and DICOM image unique identifiers compliance. This is a modification to a previously cleared device (K032243). The focus of the performance data is on software verification and validation, as the changes are software-only and do not raise new questions of safety or effectiveness regarding the core imaging performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Software Requirements (Implicit):	Software Verification and Validation Results:
Prevent scanning during "dwell" time.	A forced 10-minute delay has been added between scans to prevent the user from scanning during the "dwell" time.
Software stability and environment compatibility.	The software has been modified to run as a Windows shell.
Ensure daily calibration is performed.	The software includes a daily calibration date checking function that displays a warning message to the user prior to scanning, if the calibration has not yet been performed that day.
Compliance with DICOM standard for UIDs.	The DICOM image unique identifiers (UIDs) have been brought into compliance with the DICOM standard.
Overall safe and effective function for intended use.	"The Xoran MiniCAT computed tomography x-ray system met all requirements and functions as intended. Thus, the modified MiniCAT is safe and effective for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in the context of clinical image evaluation, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) for such a test set. This submission is for software modifications, and the "performance data" section focuses on software verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The provided text does not mention the use of experts to establish a ground truth for a test set. The submission focuses on software functionality rather than diagnostic performance assessed by human readers.

4. Adjudication Method for the Test Set

The provided text does not mention an adjudication method. As no expert review or test set is described, adjudication would not be applicable within the scope of this regulatory submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement

An MRMC comparative effectiveness study was not done or at least not reported in this submission. The submission is for software modifications to an existing device, not for a new device requiring a comprehensive clinical performance evaluation with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone performance study of the algorithm's diagnostic capabilities (without human-in-the-loop) was not explicitly described for this software modification. The performance data focuses on verification and validation of the software changes themselves. The core imaging algorithm's standalone performance would have been assessed in the initial 510(k) for the MiniCAT (K032243).

7. The Type of Ground Truth Used

For the software modifications, the "ground truth" was programmatic and functional:

Compliance with specifications: The "forced 10-minute delay" was verified to correctly implement the delay.
Operating system compatibility: "Running as a Windows shell" was verified for correct integration.
Warning message functionality: The "daily calibration date checking function" was verified to display the warning under the correct conditions.
DICOM standard adherence: "DICOM image unique identifiers (UIDs) have been brought into compliance" was verified against the DICOM standard.

There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic performance, as that was not the scope of this specific software modification submission.

8. The Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This submission is about software modifications, not the development or training of a new AI/machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Since there is no mention of a training set, there is no information on how its ground truth was established.

Summary

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K113421

510(k) SUMMARY

Xoran Technologies, Inc.'s MiniCAT

JUL 1 1 2012

Sponsor/Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Xoran Technologies, Inc. 5210 S. State Road Ann Arbor, MI, 48108

(734) 418-5156 Phone: Facsimile:

. Ms. Martha J. Rumford Contact Person: Regulatory Affairs Manager

Name of Device: Xoran MiniCAT™ CT Scanner

Common or Usual Name: Computed Tomography X-Ray System

Classification Name: Computed Tomography X-Ray System

Predicate Devices

Xoran Technologies, Inc., MiniCAT™ (K032243)

Purpose of the Special 510(k) notice

The MiniCAT is a modification to the cleared MiniCAT. This Special 510(k) Notice - Corrective Action Being Effected is to address certain reported software failures in the MiniCAT device. No injuries resulted from the reported failures.

Intended Use

Technological Characteristics

The MiniCAT software has been modified as follows:

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A forced 10-minute delay has been added between scans to prevent the user from scanning . during the "dwell" time.
The software has been modified to run as a Windows shell. .
. The software includes a daily calibration date checking function that displays a warning message to the user prior to scanning, if the calibration has not yet been performed that day.
The DICOM image unique identifiers (UIDs) have been brought into compliance with the . DICOM standard.

Performance Data

Verification and Validation testing were performed to support this software modification. The Xoran MiniCAT computed tomography x-ray system met all requirements and functions as intended. Thus, the modified MiniCAT is safe and effective for its intended use.

Substantial Equivalence

MiniCAT has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate MiniCAT. The minor differences in the device software do not raise any new questions of safety or effectiveness. Software verification and validation testing demonstrates that the modified MiniCAT functions as intended and is as safe and effective as the predicate MiniCAT for its intended use. Thus, the MiniCAT is substantially equivalent.

IIDC - 031044000002 - 3325758 v1

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUL 1 1 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Martha J. Rumford Regulatory Affairs Manager Xoran Technologies, Inc. 5210 S. State Road ANN ARBOR MI 48108

Re: K113421

Trade/Device Name: MiniCAT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 12, 2012 Received: June 13, 2012

Dear Ms. Rumford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prior to 114) 20, 1977, is accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to neview subject to the general controls provisions of the Act. The r va may, alores, manns of the Act include requirements for annual registration, listing of general vonlive provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is bluestified (600 acorregulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I loase be advisou that I Drist issue of the your device complies with other requirements of the Act that I Dri has made a acterimistics as administered by other Federal agencies. You must or any I catal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related ad reless chality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form marketing your device as described in your Section 510(k) premarket whil anow you to begal mainen.ing your antial equivalence of your device to a legally marketed nonicate 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 Parts 801 and If you desire specific ad not 10. Join Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Theose 1100, processions regarding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Four international Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):_

Device Name: MiniCAT

Indications for Use:

Prescription Use X (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 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 Radiological Devices
Lwin Dovice Evaluation and Safety

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113421

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Regulation Number and Section

§ 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.