(106 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-driven devices.
No
The device is a treatment planning system used to plan radiation treatments, not to deliver therapy itself.
No
Explanation: The device is described as a "Radiation Therapy Treatment Planning System." Its function is to plan radiation treatments and calculate radiation dose, not to diagnose a medical condition.
Unknown
The provided text describes a Radiation Therapy Treatment Planning System (TPS), which is inherently software-based for dose calculation and planning. However, the summary does not explicitly state that the device is only software and does not include any associated hardware components (e.g., a dedicated workstation, specific input devices, etc.) that are part of the regulated device. While the core function is software, the description doesn't definitively exclude hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic." This describes a system used to plan a medical treatment, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description reinforces the intended use as a treatment planning system for radiation therapy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on planning a physical treatment (radiation therapy).
N/A
Intended Use / Indications for Use
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
Product codes
MUJ
Device Description
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
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
oncology clinic
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)
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.
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
1090893
JUL 1 5 2009
510(k) Executive Summary
July 8, 2009
1. Submitter's Information
Company Name: Company Address: LinaTech, LLC 1294 Kifer Road, #705 Sunnyvale, CA 94086
Trade Name: TiGRT TPS
Common Name: Radiation Treatment Planning System Classification Name: System, Planning, Radiation Therapy Treatment
2. Predicate Device Identification
21 CFR 892.5050 Radiation Treatment Planning System Product Code: MUJ Device Class: II
3. Legally Marketed Equivalent Device
WIMRT (K041971)
4. Intended Use and Device Description
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
The intended use is the same as the predicate device.
1
5. Technological Characteristics of the Device as to Compared to Predicate Device
| Characteristic | Current Modified Device
TiGRT TPS | Predicate Device
WiMRT (K041971) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating System | Windows XP Professional
Windows Vista | Windows XP Professional |
| Networking | TCP/IP | TCP/IP |
| Intended Use | TiGRT TPS is a Radiation
Therapy Treatment Planning
System for radiation dose
planning of patients
undergoing external beam
treatment in the oncology
clinic. TiGRT TPS is used to
plan radiation treatments
with linear accelerators and
other similar teletherapy
devices with x-ray, electron
and/or photon energies from
1 to 25MV, as well as
Cobalt-60. | The product WiMRT is a
Radiation Therapy Treatment
Planning System for radiation
dose planning of patients
undergoing external beam
treatment in the oncology clinic.
WiMRT is used to plan radiation
treatments with linear
accelerators and other similar
teletherapy devices with x-ray
energies from 1 to 25MV, as
well as Cobalt-60, and electron
energies from 1 to 25 MeV. |
| Application(Use) | Conformal Planning;
Step & Shoot Inverse IMRT
Planning
Dynamic Sliding Window
Inverse IMRT Planning
SRS and SRT. | Conformal Planning;
Step & Shoot Inverse IMRT
Planning
Dynamic Sliding Window
Inverse IMRT Planning
SRS and SRT |
| Dose Calculation
Algorithm | Super-position Convolution | Super-position Convolution |
| IMRT
Optimization
Algorithm | Genetic Algorithm for IMRT
segmentation, Auto-beam
angle selection | Genetic Algorithm for IMRT
segmentation, Auto-beam angle
selection |
| DICOM | DICOM 3/RT | DICOM 3/RT |
Predicate Product Comparison Table:
2
Comparisons Summary
A. Intended Use
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
The intended use is the same as the predicate device.
B. Technological Characteristics
The predicate device is presently in commercial distribution globally including the United States of America. The TiGRT TPS has the similar technological characteristics and is similar in design, function, and application to the predicate device.
The Technological Characteristics are the same as the predicate devices.
C. Differences
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.
D. Argument for Substantial Equivalence to Predicate Devices
The intended use and the technological characteristics of TiGRT TPS are the same as the predicate device and therefore we believe it is Substantially Equivalent to it.
6. Biocompatibility
No new issues of biocompatibility are raised with regard to this device.
3
7. Summary for Performance Testing
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.
| Performance Documentation | Concern |
|---|---|
| Level of Concern of TPS | Major |
| TiGRT TPS Description | Provided |
| TiGRT TPS Risk Management | Provided |
| TiGRT TPS Hazard Analysis Report | Provided |
| TiGRT TPS Product Requirement Specification | Provided |
| TiGRT TPS Architecture Design Chart | Provided |
| TiGRT TPS Software Design Description | Provided |
| TiGRT TPS PRS/SDD Traceability Matrix | Provided |
| TiGRT TPS PRS/STT Traceability Matrix | Provided |
| TiGRT TPS Development Environment Description | Provided |
| TiGRT TPS Verification and Validation Documents | Provided |
| TiGRT TPS Revision Level History | Provided |
| TiGRT TPS Unresolved Anomalies (Bugs or Defects) | Provided |
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the body and wings. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2009
Mr. Jonathan Yao President : LinaTech, LLC 1294 Kifer Road, Suite 705 SUNNYVALE CA 94086
Re: K090893
Trade/Device Name: TiGRT TPS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 18, 2009 Received: June 22, 2009
Dear Mr. 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 of medical
5
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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):_____________________________________________________________________________________________________________________________________________________
Device Name: _ TiGRT TPS
Indications for Use:
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
(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 ﺳﮯ
OR Over-The-Counter Use
(Per 21 CFR 801.109)
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Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number