(118 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with such technologies. The description focuses on image analysis for positioning and verification, which can be achieved with traditional image processing techniques.
No
The device aids in patient positioning and treatment portal verification for Linac, but it does not directly treat or diagnose a disease.
No
Explanation: This device is for analyzing patient position and calculating shift correction factors, as well as treatment portal verification and record-keeping, which are functions related to treatment delivery and quality assurance, not diagnosis of a disease or condition.
No
The description explicitly states the device is used "in conjunction with Linac and Digital Panel," which are hardware components. While the device performs analysis and calculation, it is dependent on and interacts with these external hardware systems, indicating it is not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- TiGRT IVS Function: The description of TiGRT IVS clearly states its purpose is for analyzing the patient's position during radiation therapy, calculating positioning shifts, and verifying treatment portals. This involves analyzing images of the patient's body in relation to the treatment equipment, not analyzing biological samples.
Therefore, TiGRT IVS falls under the category of a medical device used for treatment planning and delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
Product codes
IYE
Device Description
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K09255D
Summary of Safety and Effectiveness
July 20, 2009
1. Submitter's Information
Common/Usual Name:
Image Viewing System
Proprietary Name:
TiGRT IVS, TiGRT
DEC 1 5 2009
:
Applicant Name and Address:
LinaTech, LLC 1294 Kifer Road, #705 Sunnyvale, CA 94086 Telephone: 408-733-2051 Fax: 408-733-2045
2. Predicate Devices
ExacTrac (K072046)
3. Classification
This device is classified as a Class II device according to 21 CFR 892.5050.
4. Performance Standards
No applicable standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
1
5. Intended Use and Device Description
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
The intended use is the same as the predicate device.
6. Biocompatibilitv
No new issues of biocompatibility are raised with regard to this device.
7. Summary of Substantial Equivalence
This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.
2
Table 1: Comparison of TiGRT IVS Modified Device with Predicate Device
: 上
. .
| Characteristic | Current Modified
Device TIGRT IVS | Predicate Device
ExacTrac (K072046) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
System | Windows XP / Vista
/7 | Windows XP Professional |
| Networking | TCP/IP | TCP/IP |
| Intended Use | TiGRT IVS is
intended to be used
in conjunction with
Linac and Digital
Panel for analyzing
the current patient
position and
calculating the
patient positioning
shift correction
factor, as well as the
treatment portal
verification and
record. | The ExacTrac 3rd party system is
intended to be used in conjunction
with the MHI-TM2000 radiation
therapy linear accelerator system
manufactured by Mitsubishi Heavy
Industries, Ltd. ExacTrac 3rd Party
uses the images received from the
MHI-TM2000 linear accelerator for
analyzing the current patient position
and calculating - when applicable - a
necessary correction shift. The
correction shift is then exported to the
MHI-TM2000 linear accelerator.
The ExacTrac 3rd Party system uses
stereoscopic x-ray or cone beam CT
registration and optical tracking of
infrared reflective markers in order to
localize and correct the patient
position before and during treatment. |
| Application(Use) | Patient tracking and
positioning,
Portal verification
and record, | Patient tracking and positioning,
Portal verification and record. |
| DICOM | DICOM 3/RT | DICOM 3/RT |
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Jonathan Yao, Ph.D. President and CEO LinaTech LLC 1294 Kifer Road, Suite 705 SUNNYVALE CA 94086
DEC 1 5 2009
Re: K092550
Trade/Device Name: TiGRT IVS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 30, 2009 Received: November 5, 2009
Dear Dr. Yao:
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 (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
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Page 2 -
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K092550
Device Name:____TiGRT IVS
Indications for Use:
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
(PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use ____________________________(Per 21 CFR 801.109)
_
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510 (k) Number _