Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indications:

The CT PULMONARY ANALYSIS software option is an independent image analysis software tool providing additional image process capabilities to the Ziostation system. The CT PULMONARY ANALYSIS option is intended to assist the physician in assessing possible airway obstruction.

Device Description

CT PULMONARY ANALYSIS is an optional software package designed to be used with the basic Ziostation DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The added capabilities provided by this additional software option for use with CT DICOM compliant images are:

Segmentation of lung and bronchial airway
Contour detection of airway walls
Evaluation of bronchial dimensions
Observation of cross-sectional image and variance of diameter/thickness/area of airway wall along airway
Integrated 3D visualization with MPR or A/C/S slice/slab viewing
Low Attenuation Analysis by Lung Sections

AI/ML Overview

This 510(k) submission for the Qi Imaging CT Pulmonary Analysis software provides limited detail on the study and acceptance criteria. Based on the provided text, a comprehensive description including all requested fields cannot be fully constructed.

Here's an analysis of what is available and what is missing:

1. Table of acceptance criteria and reported device performance:

The document explicitly states: "The CT PULMONARY ANALYSIS software package successfully completed integration testing/verification testing prior to Beta validation. Software Beta testing/validation was successfully completed prior to final testing and release." However, no specific quantitative acceptance criteria or reported device performance metrics are provided in the document. This information is crucial for understanding the device's performance against predefined thresholds.

2. Sample size used for the test set and data provenance:

Test Set Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

MRMC Study Conducted: Not mentioned in the provided text. The document only states the software "is intended to assist the physician in assessing possible airway obstruction." It does not provide any comparative effectiveness data with or without AI assistance.
Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no MRMC study or comparative effectiveness data is presented.

6. Standalone (algorithm only without human-in-the-loop performance) study:

Standalone Study Conducted: The document does not explicitly state whether a standalone study was performed. The description of "Segmentation of lung and bronchial airway," "Contour detection," "Evaluation of bronchial dimensions," and "Observation of cross-sectional image and variance of diameter/thickness/area of airway wall along airway" suggests automated functions, but performance metrics for these in a standalone context are not provided.

7. Type of ground truth used:

Type of Ground Truth: Not specified.

8. Sample size for the training set:

Training Set Sample Size: Not specified.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not specified.

Summary of available information regarding the "study" that proves the device meets acceptance criteria:

The document briefly mentions a "Testing Summary":

"The CT PULMONARY ANALYSIS software package successfully completed integration testing/verification testing prior to Beta validation. Software Beta testing/validation was successfully completed prior to final testing and release. In addition, potential hazards have been addressed by the Qi Imaging Risk Management process."

This statement confirms that internal testing (integration, verification, and beta validation) was performed, indicating a development and testing process was followed. However, it does not provide details on the methodology, data, or results of these tests that would demonstrate compliance with specific acceptance criteria. The submission largely relies on demonstrating substantial equivalence to predicate devices (VIDA Pulmonary Workstation 2.0 and Myrian v1.11.2 XP-Lung) rather than detailed clinical performance studies for its own product.

Summary

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K130552
Page 1 of 2

510(k) Summary CT Pulmonary Analysis Qi Imaging, LLC

JAN 1 3 2014

This 510(k) summary is prepared in accordance with 21 CFR 807.92.

General Information

Trade Name	CT PULMONARY ANALYSIS
Common NameClassification Name	Picture Archiving and Communications System (PACS)System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ
Applicant:	Qi Imaging, LLC1235 Radio Road, Suite 110Redwood City, CA 94065Tel 650-413-1300Fax 650-596-7319
Contact	Richard BallDirector, Regulatory and Quality Affairs

Intended Use

Predicate Devices

Table 2: Predicate devices to CT Pulmonary Analysis Software Tool

Qi Imaging tool	Manufacturer of PredicateDevice	Device Name	510(k)Number
CT PULMONARY ANALYSIS	VIDA	VIDA PulmonaryWorkstation 2.0	K083227
	Intrasense	Myrian v1.11.2XP-Lung	K113620

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K130552
Page 2 of 2

Device Description

� Segmentation of lung and bronchial airway
Contour detection of airway walls o
o Evaluation of bronchial dimensions
o Observation of cross-sectional image and variance of diameter/thickness/area of airway wall along airway
0 Integrated 3D visualization with MPR or A/C/S slice/slab viewing 1
Low Attenuation Analysis by Lung Sections o

Materials

This software tool consists entirely of software. No materials are contained in this product.

Testing Summary

The CT PULMONARY ANALYSIS software package successfully completed integration testing/verification testing prior to Beta validation. Software Beta testing/validation was successfully completed prior to final testing and release. In addition, potential hazards have been addressed by the Qi Imaging Risk Management process.

Summary of Substantial Equivalence

CT PULMONARY ANALYSIS is substantially equivalent in intended use and function to the predicate devices identified above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

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

January 13, 2014

Qi Imaging, LLC % Mr. Richard Ball Director. Regulatory & Ouality Affairs 1235 Radio Road, Suite 110 REDWOOD CITY CA 94065

Re: K130552

Trade/Device Name: CT Pulmonary Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 7, 2014 Received: January 8, 2014

Dear Mr. Ball:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/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 Division of Small 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K | 30552

Device Name

CT PULMONARY ANALYSIS Software Tool for Ziostation

Indications for Use (Describe)

Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intervated for use by trained modical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication. The CT PULMONARY ANALYSIS software option is and in and one one only is software tool providing additional image process capabilities to the Ziostation system. The CT PULMONARY ANALYSIS option is intended to assist the providing in assessing possible airway obstruction.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

6073068 (301) 443-6740 દર

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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.