Who is the manufacturer of Z-DOSE29?

Zetta Medical Technologies, LLC filed the 510(k) submission for Z-DOSE29 (K170273).

What is the FDA product code for Z-DOSE29?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Z-DOSE29?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Z-DOSE29?

syngo VA48 (SOMARIS/7 VA48) (K143400); SafeCT-29 (K153331).

Who can help prepare an FDA 510(k) submission like Z-DOSE29?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Z-DOSE29

K170273 · Zetta Medical Technologies, LLC · JAK · Apr 28, 2017 · Radiology

Device Facts

Record ID	K170273
Device Name	Z-DOSE29
Applicant	Zetta Medical Technologies, LLC
Product Code	JAK · Radiology
Decision Date	Apr 28, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

Indications for Use

Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning.

Device Story

Z-DOSE29 is a software-based dose check system for CT scanners; resides on a remote computer on the same local area network as the CT host. Inputs: DICOM images/CTDI values from CT host computer. Operation: software captures CTDI values per series; compares against AAPM dose check guidelines; displays notifications on CT console. Accumulates CTDI values for dose alerts; utilizes relay hardware to disable scanning upon alert until operator password entry. Output: visual notifications/alerts on CT display; database records accessible via web browser. Used in clinical settings by CT operators. Benefits: ensures dose optimization; prevents over-the-limit scans; provides automated compliance with NEMA XR-25/XR-29 standards.

Clinical Evidence

Bench testing only. Verification and validation performed on four different CT scanner models (GE Light Speed 32, Siemens Sensation 16, Philips Brilliance 64, Toshiba Aquilion 64) and nine systems total. Testing confirmed accurate CTDI extraction (99% accuracy on >2400 datasets), correct notification/alert triggering against AAPM guidelines, and successful relay-based scan disabling. No clinical data presented.

Technological Characteristics

Software-based system running on Windows 10 (.NET framework 4.0+). Connectivity: LAN-based communication with CT host. Hardware: off-the-shelf computer with relay interface for scan control. Standards: NEMA XR-25, NEMA XR-29, AAPM dose check guidelines. Data output: local database with web browser access and Excel export. Cybersecurity: standard OS-level controls.

Indications for Use

Indicated for use by professional personnel to provide dose check features (notifications and alerts) to CT scanners, comparing CTDI values to predefined thresholds prior to scanning.

Regulatory Classification

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.

Predicate Devices

syngo VA48 (SOMARIS/7 VA48) (K143400)
SafeCT-29 (K153331)

Submission Summary (Full Text)

{0}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 28, 2017 Zetta Medical Technologies, LLC. Main M. Ghazal President 1313 Ensell Road Lake Zurich. Illinois 60047 Re: K170273 Trade/Device Name: Z-DOSE29 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: January 30, 2017 Received: January 30, 2017 Dear Main Ghazal: 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- Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other to create a sense of depth and unity. {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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 Division of Industry and Consumer Education 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, Michael D. O'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170273 Device Name Z-DOSE29 #### Indications for Use (Describe) Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning. Type of Use (Select one or both, as applicable) | ☒ Registration Use (Part 81 CFR 98.6 Subpart D) | ☐ On-Site Combustion Use (81 CFR 98.6 Subpart C) | |--------------------------------------------------------------------------------------------------|--------------------------------------------------| |--------------------------------------------------------------------------------------------------|--------------------------------------------------| | X | Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness - 1. Applicant & Submitted By: Zetta Medical Technologies, LLC. 1313 Ensell Road, Lake Zurich, IL 60047 Phone: (847) 550-9990 Fax: (847) 550-9994 Contact Person: Main M. Ghazal, President Date Prepared: January 22nd 2017 - 2. Identification of the Device: Trade Name: Z-DOSE29 Common Name: Computed Tomography X-ray system Classification Name: 21 CFR, 892.1750, JAK, Radiology - 3. Predicate Device: | Manufacturer | Trade name/model | 510(k) Number | Regulation Number | Product code | |--------------|----------------------------------|------------------|----------------------|-----------------| | Siemens | syngo ® VA48 (SOMARIS/7 VA48) | K143400 | 892.1750 | JAK | | Medic Vision | SafeCT-29 | K153331 | 892.1750 | JAK | - 4. Indications for Use: Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning. - 5. Device Description: Z-DOSE29 Dose Check provides the Dose Check feature to CT scanners as specified by the NEMA XR-25 standard and the Dose Check feature of NEMA XR-29*. This includes both Dose Notifications (for individual series) and Dose Alerts (for accumulated dose). The Z-DOSE29 Dose Check software, which is installed on a remote computer that resides on the same local area network as the CT host computer, receives DICOM images from the CT host computer. The software captures CTDI values for each prescribed CT series, compares the values to AAPM dose check guideline (version 1.0) values and displays notification message(s) on the CT scanner operator's console. The Z-DOSE29 Dose Check software also adds the CTDI values from the individual series and displays alert message(s) on the CT scanner operator's console if the accumulated CTDI value exceeds a predefined ALERT threshold. *NEMA XR-29 incorporates NEMA XR-25 Dose Check feature {4}------------------------------------------------ In the event of an Alert, and in addition to displaying the alert message to the CT operator, Z-DOSE29 utilizes a relay to disable scanning until a correct password is inputted by the CT operator. The Z-DOSE29 Dose Check software also records CTDI values and CT exam information into a local a database. Information in the database can be accessed by authorized users via a web browser. The Z-DOSE29 Dose Check software runs on a Windows operating system 10 with a .net framework 4.0 or higher version. - 6. Substantial Equivalence Table The subject device Z-DOSE29 Dose Check System is substantially equivalent to the two predicate devices, Syngo® VA48 and SafeCT-29. Detailed comparison of Z-DOSE29 with SingoVA48 and SafeCT-29 is listed in Table-1. | | Table -1: Comparison among Z-DOSE29, Syngo® VA48 and SafeCT-29 CT Dose Check | |--|------------------------------------------------------------------------------| |--|------------------------------------------------------------------------------| | | | Systems | | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Z-DOSE29 | Syngo® VA48 | SafeCT-29 | | Indications for Use | Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning. | The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross- sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.) | The SafeCT-29 is intended for providing Computed Tomography Dose Check feature to Computed Tomography X-ray systems. The SafeCT-29 is specifically indicated for providing the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds, for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel. | | Data Inputs | Z-DOSE29 is a software based solution to extract CTDI information from CT computer's screen through a | Host CT Digital Data directly interfaced by the device software. | The SafeCT-29 uses its own input separate hardware: The device is interfaced to the CT screen via a video splitter that provides a copy of the CT screen in | | Characteristics | Z-DOSE29 | Syngo® VA48 | SafeCT-29 | | | local area network (LAN) connection. | | real-time. The CT screen data is captured by grabbing and digitizing the video signal. The captured data is interpreted by OCR software. | | Scan Controls | Software and hardware | Software | Software & hardware | | Dose Notification for individual series | Designed to perform the "Dose Notification" feature of NEMA XR-25 | Designed to perform the "Dose Notification" feature of NEMA XR-25 | Unknown | | Dose Alert for accumulated CTDI | Designed to perform the "Dose Alert" feature of NEMA XR-25 | Designed to perform the "Dose Alert" feature of NEMA XR- 25 | The software extracts accumulated CTDIvol per Z axis location from the CT screen whenever such information is displayed by the scanner. For scanners that do not present such information, the accumulated CTDIvol is calculated by the SafeCT-29 software. The calculation follows the AAPM guidelines and assumes "worst case scenario" (i.e. calculated CTDIvol may be higher than the actual value) in order to prevent over-the-limit scans. The SafeCT-29 assumes that each z- axis position gets the displayed maximum CTDIvol value, and calculates the accumulated CTDIvol accordingly. | | Display | Host CT Screen | Host CT Screen | The SafeCT-29 has its own external display monitor as a separate hardware. SafeCT-29. | | Characteristics | Z-DOSE29 | Syngo® VA48 | SafeCT-29 | | | | | generates an audio alert to ensure the user is aware of notifications and warnings displayed on the SafeCT-29 display monitor. | | Man machine interface | Host CT keyboard & mouse | Host CT keyboard & mouse | SafeCT-29 own dedicated keyboard & mouse | | Record data output | Data is saved in a local database, which can be accessed by authorized users via a web browser. Data can also be exported to excel files. | Not known | Data is saved in the Device's internal memory and can be exported with a USB memory stick | | Processor hardware | Off-the-shelf computer | Host CT Processor | Dedicated Off-the-shelf processor and controls | {5}------------------------------------------------ {6}------------------------------------------------ Z-DOSE29 CT Dose Check system has similar indications for use as predicate device. The main difference is that the predicate devices employ either same CT host computer or a separate computer, that receive video signal from CT host screen for notifications, while Z-DOSE29 uses a remote computer on the same LAN as CT host computer for notifications and alerts. Performance testing, along with verification and validation activities demonstrate that Z-DOSE29 is as safe and effective as predicate device. - 7. Performance Testing: Z-DOSE29 has been designed, verified and validated in compliance with FDA 21 CFR Part 820 requirements. Z-DOSE29 software uses off-the-shelf software (OTS) to capture and extract CTDI information from CT host computer. Testing performed on OTS using more than 2400 image data sets indicated that OTS accurately extracts CTDI information from more than 99% of the images. The CT operator can manually input the CTDI values into the software in the event the software doesn't read the correct CTDI value. Z-DOSE29 was verified to meet system requirement specifications (SRS) on four different CT scanners from different manufacturers (test results summary shown in Table-2 below) and lower level requirements were verified on 9 different systems. Reference Guidance Documents · National Electrical Manufacturers Association, "NEMA Standards Publication XR 25-2010 Computed Tomography Dose Check" - · National Electrical Manufacturers Association, "NEMA Standards Publication XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management" Section 2.3 - · "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11 2005 {7}------------------------------------------------ - "Guidance on Off-the-Shelf Software Use in Medical Devices" September 9, 1999 - "Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" October 2, 2014 | Requirement | Expected outcome | Scanners used for testing | Observed outcome | Test result | | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | SRS.001 Notification during Adult Head exam | The software captures the CTDI value for Adult Head and compares it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeds the threshold value, the software notifies the user by displaying a dialogue box. The dialogue box contains both captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | The software captured the CTDI value for Adult Head and compared it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeded the threshold value, the software notified the user by displaying a dialogue box. The dialogue box contained both captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | PASS | | | SRS.001 Notification during Adult Body exam | The software captures the CTDI value for Adult Body and compares it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeds the threshold value, the software notifies the user by displaying a dialogue box. The dialogue box contains both captured CTDI value as well as the threshold value | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | The software captured the CTDI value for Adult Body and compared it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeded the threshold value, the software notified the user by displaying a dialogue box. The dialogue box contained both captured CTDI value as well as the threshold value | PASS | | | Requirement | Expected outcome | Scanners used for testing | Observed outcome | Test result | | | | applied. The threshold value is configurable by the user in a text file. | | value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | | | | SRS.001 Notification during Pediatric Head exam | The software captures the CTDI value for Pediatric Head and compares it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeds the threshold value, the software notifies the user by displaying a dialogue box. The dialogue box contains both captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | The software captured the CTDI value for Pediatric Head and compared it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeded the threshold value, the software notified the user by displaying a dialogue box. The dialogue box contained both captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | PASS | | | | SRS.001 Notification during Pediatric Body exam | The software captures the CTDI value for Pediatric Body and compares it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeds the threshold value, the software notifies the user by displaying a dialogue box. The dialogue box contains both captured CTDI value as well as the | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | The software captured the CTDI value for Pediatric Body and compared it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeded the threshold value, the software notified the user by displaying a dialogue box. The dialogue box contained both | | | | | threshold value | | captured CTDI | | | | Requirement | Expected outcome | Scanners used for testing | Observed outcome | Test result | | | SRS.001 Notification during Perfusion exam | threshold value applied. The threshold value is configurable by the user in a text file. The software captures the CTDI value for Perfusion and compares it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeds the threshold value, the software notifies the user by displaying a dialogue box. The dialogue box contains both captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. The software captured the CTDI value for Perfusion and compared it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeded the threshold value, the software notified the user by displaying a dialogue box. The dialogue box contained both captured CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | | | SRS.002 Alert if total CTDI exceeds threshold | The software calculates total CTDI value from each series and compares the accumulated value to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the accumulated value exceeds the threshold value, the software alerts the user by displaying a dialogue | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | The software calculated total CTDI value from each series and compared the accumulated value to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the accumulated value exceeded the threshold value, the software alerted the | PASS | | | Requirement | Expected outcome | Scanners used for testing | Observed outcome | Test result | | | | | | | | | | | contains both accumulated CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | | user by displaying a dialogue box. The dialogue box contained both accumulated CTDI value as well as the threshold value applied. The threshold value is configurable by the user in a text file. | | | | SRS.003 Disable system during alert | Software shall use relay hardware to disable system from scanning when alert occurs | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | Software used relay hardware to disable system from scanning when alert occurred. | PASS | | | SRS.004 Record and Report | Software shall record and report CTDI and exam information. | GE Light Speed 32; Siemens Sensation 16; Philips Brilliance 64; Toshiba Aquilion 64; | Software recorded and reported CTDI and exam information. | PASS | | ## Table -2: Z-DOSE29 system level verification and validation summary {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ - 8. Safety and Effectiveness: Z-DOSE29 CT Dose Check system has similar indications for use as predicate device. The main difference is that the predicate devices employ either same CT host computer or a separate computer, that receive video signal from CT host screen for notifications, while Z-DOSE29 uses a remote computer on the same LAN as CT host computer for notifications and alerts. Risk analysis was performed to include design requirements and mitigations which prevent all known possible interferences in the normal operation of the host CT. Performance testing, along with verification and validation activities demonstrate that Z-DOSE29 is as safe and effective as predicate device. - 9. Conclusion: Z-DOSE29 is a CT Dose Check system which has similar indications for use as the predicate devices. Performance testing, verification and validation demonstrate that Z-DOSE29 is as safe and effective as the predicate devices.

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