TIGRT TPS

K090893 · Linatech, LLC · MUJ · Jul 15, 2009 · Radiology

Device Facts

• Record ID: K090893
• Device Name: TIGRT TPS
• Applicant: Linatech, LLC
• Product Code: MUJ · Radiology
• Decision Date: Jul 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

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.

Device Story

TiGRT TPS is a radiation therapy treatment planning system used by oncology clinicians to design external beam radiation treatments. It processes patient data to calculate radiation dose distributions for linear accelerators and teletherapy devices (1-25MV x-ray/electron/Cobalt-60). The system supports conformal planning, step-and-shoot inverse IMRT, dynamic sliding window inverse IMRT, SRS, and SRT. It utilizes super-position convolution for dose calculation and a genetic algorithm for IMRT segmentation and auto-beam angle selection. Clinicians use the output to finalize treatment plans, which are then delivered to patients to optimize tumor targeting while sparing healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench testing documentation, including risk management, hazard analysis, and software verification/validation.

Technological Characteristics

Radiation therapy treatment planning software; operates on Windows XP/Vista; supports TCP/IP networking; DICOM 3/RT compliant. Algorithms: Super-position convolution (dose calculation), Genetic Algorithm (IMRT segmentation), Auto-beam angle selection. Software level of concern: Major.

Indications for Use

Indicated for radiation dose planning in patients undergoing external beam radiation therapy using linear accelerators or teletherapy devices (x-ray, electron, or Cobalt-60) in an oncology clinic setting.

Regulatory Classification

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.

Predicate Devices

• WIMRT (K041971)

Submission Summary (Full Text)

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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.

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# 5. Technological Characteristics of the Device as to Compared to Predicate Device

| Characteristic | Current Modified Device<br>TiGRT TPS | Predicate Device<br>WiMRT (K041971) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating System | Windows XP Professional<br>Windows Vista | Windows XP Professional |
| Networking | TCP/IP | TCP/IP |
| Intended Use | TiGRT TPS is a Radiation<br>Therapy Treatment Planning<br>System for radiation dose<br>planning of patients<br>undergoing external beam<br>treatment in the oncology<br>clinic. TiGRT TPS is used to<br>plan radiation treatments<br>with linear accelerators and<br>other similar teletherapy<br>devices with x-ray, electron<br>and/or photon energies from<br>1 to 25MV, as well as<br>Cobalt-60. | The product WiMRT is a<br>Radiation Therapy Treatment<br>Planning System for radiation<br>dose planning of patients<br>undergoing external beam<br>treatment in the oncology clinic.<br>WiMRT is used to plan radiation<br>treatments with linear<br>accelerators and other similar<br>teletherapy devices with x-ray<br>energies from 1 to 25MV, as<br>well as Cobalt-60, and electron<br>energies from 1 to 25 MeV. |
| Application(Use) | Conformal Planning;<br>Step & Shoot Inverse IMRT<br>Planning<br>Dynamic Sliding Window<br>Inverse IMRT Planning<br>SRS and SRT. | Conformal Planning;<br>Step & Shoot Inverse IMRT<br>Planning<br>Dynamic Sliding Window<br>Inverse IMRT Planning<br>SRS and SRT |
| Dose Calculation<br>Algorithm | Super-position Convolution | Super-position Convolution |
| IMRT<br>Optimization<br>Algorithm | Genetic Algorithm for IMRT<br>segmentation, Auto-beam<br>angle selection | Genetic Algorithm for IMRT<br>segmentation, Auto-beam angle<br>selection |
| DICOM | DICOM 3/RT | DICOM 3/RT |

Predicate Product Comparison Table:

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#### 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.

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## 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

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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 [phone] or [phone] 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