(315 days)
Not Found
No
The description focuses on standard image processing techniques like segmentation, contour detection, and measurement, without mentioning AI or ML algorithms. The performance studies described are integration and beta testing, not studies typically associated with validating AI/ML models.
No
The device is intended to assist physicians in assessing possible airway obstruction and for analysis of anatomy, physiology, and pathology. It does not provide any form of therapy.
Yes
Explanation: The device is intended to "assist the physician in assessing possible airway obstruction," which indicates a diagnostic purpose.
Yes
The device is described as a "software package" and an "independent image analysis software tool" that runs on "standard PC hardware." It processes medical images and provides analysis capabilities without mentioning any proprietary or specialized hardware components included as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Ziostation with the CT PULMONARY ANALYSIS option is an image processing workstation software package. It analyzes medical images (CT scans) to assist in the assessment of possible airway obstruction. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for viewing, quantifying, manipulating, and managing medical images to aid in reading and review. The CT PULMONARY ANALYSIS option assists in assessing possible airway obstruction based on image analysis.
Therefore, since the device operates on medical images and not biological samples, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ, JAK
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 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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT DICOM compliant images
Anatomical Site
Pulmonary / Lung / Bronchial airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Name | |
| Classification Name | Picture Archiving and Communications System (PACS) |
| System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ | |
| Applicant: | Qi Imaging, LLC |
| 1235 Radio Road, Suite 110 | |
| Redwood City, CA 94065 | |
| Tel 650-413-1300 | |
| Fax 650-596-7319 | |
| Contact | Richard Ball |
| Director, Regulatory and Quality Affairs |
Intended Use
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.
Predicate Devices
Table 2: Predicate devices to CT Pulmonary Analysis Software Tool
| Qi Imaging tool | Manufacturer of Predicate
Device | Device Name | 510(k)
Number |
|-----------------------|-------------------------------------|-----------------------------------|------------------|
| CT PULMONARY ANALYSIS | VIDA | VIDA Pulmonary
Workstation 2.0 | K083227 |
| | Intrasense | Myrian v1.11.2
XP-Lung | K113620 |
1
K130552
Page 2 of 2
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 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.
2
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.
3
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,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
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
5
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