Real Time Image Gating System for Proton Beam Therapy Systems

K171049 · Hitachi, Ltd. Healthcare · LHN · Dec 26, 2017 · Radiology

Device Facts

• Record ID: K171049
• Device Name: Real Time Image Gating System for Proton Beam Therapy Systems
• Applicant: Hitachi, Ltd. Healthcare
• Product Code: LHN · Radiology
• Decision Date: Dec 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

Device Story

Accessory to Hitachi proton beam therapy systems (PBTS); tracks implanted fiducial markers near tumors to control proton beam delivery. Inputs: X-ray fluoroscopy images from two distinct planes. Processing: Pattern recognition technology identifies marker position in 3D space at regular frame rates; calculates spatial position relative to planned coordinates. Output: Gating signals sent to PBTS irradiation controller. Usage: Installed on PBTS workstation; operated by clinical staff during radiation therapy. Function: Synchronizes beam delivery with tumor position; enables irradiation only when marker is within tolerance. Benefit: Reduces proton beam exposure to healthy tissue outside target area; improves accuracy for moving tumors.

Clinical Evidence

Bench testing only. Evaluated dose measurement of fluoroscopic X-ray at isocenter and skin surface, static fiducial marker recognition accuracy, system latency, moving marker tracking, interlock interface functionality, and interplay effect.

Technological Characteristics

Software-based accessory installed on PBTS workstation. Utilizes pattern recognition for fiducial marker tracking via dual-plane X-ray fluoroscopy. Provides real-time 3D spatial monitoring and interlock signaling to irradiation controller. No specific materials or hardware standards cited.

Indications for Use

Indicated for patients undergoing proton beam therapy where tumor position requires tracking via implanted fiducial markers to manage motion, such as respiration, during radiation delivery.

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

• MedCom GmbH's Verisuite (K133914)
• Elekta Ltd.'s XVI R5.0 (K131965)

Reference Devices

• Anzai Medical's AZ-733VI (K160432)

Submission Summary (Full Text)

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December 26, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Hitachi, Ltd. Healthcare % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street. NW WASHINGTON DC 20016

# Re: K171049

Trade/Device Name: Real Time Image Gating System for Proton Beam Therapy Systems Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2017 Received: December 1, 2017

Dear Mr. Kahan:

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 of medical 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

#### K171049

Device Name

Real Time Image Gating System for Proton Beam Therapy Systems Indications for Use (Describe)

The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY

#### Hitachi Ltd.'s Real Time Image Gating System

#### Submitter

Hitachi Ltd. Healthcare Hitachi Works 3-1-1, Saiwai-cho, Hitachi-shi lbaraki, JAPAN 317-8511

Phone: [phone] Facsimile: [phone]

Contact Person: Tomoyuki Seino Date Prepared: April 7, 2017

### Name of Device:

Real Time Image Gating System for Proton Beam Therapy Systems

#### Common or Usual Name:

System, radiation therapy, charged-particle, medical

### Classification Name:

Medical charged-particle radiation therapy system (21 CFR 892.5050)

### Regulatory Class:

Class II

### Product Code:

LHN

### Predicate Devices

K133914 MedCom GmbH's Verisuite K131965 Elekta Ltd.'s XVI R5.0

#### Reference Devices

K160432 Anzai Medical's AZ-733VI

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### Device Description

The Real-time Image Gating System for proton beam therapy (RGS) is a gating signal generator accessory to proton beam therapy systems (PBTS) and used to track an implanted fiducial and to control the proton beam. The RGS is installed on the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller.

This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the X-ray imaging systems. The marker is implanted near the tumor using image guided implantation. Using two diagnostic X-ray sources and two X-ray FPDs configured around the treatment isocenter, the imaging data are combined to obtain precise 3D trajectories in the RGS. The RGS tracks the implanted marker on the image, and this chosen marker's position viewed in 3 dimensions. Using X-ray fluoroscopy devices in two distinct planes, the location of marker on the fluoroscopic image is automatically extracted using the pattern recognition technology of the RGS and the spatial position of the marker is calculated and monitored throughout the treatment. Synchronized irradiation of the tumor with gating control occurs only when the marker is within a given tolerance from its planned coordinates relative to the beam isocenter. This synchronized irradiation is performed at high speed which enables accurate irradiation of a tumor whose position may move inside the body, e.g., due to respiration.

## Intended Use / Indications for Use

The Real-time Image Gating System is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

### Summary of Technological Characteristics

The RGS is a software-based accessory installed in the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. Similarly, the Verisuite and XVI predicates use software-based image processing systems for verification.

This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the fluoroscopic X-ray imaging systems of the PBTS. Similarly, the Verisuite and XVI use fluoroscopic X-ray during treatment to identify implanted fiducial markers.

Although neither the XVI nor the Verisuite includes a gating functionality, each can be used with separately-controlled gating system. Although the inclusion of the gating functionality could impact the safety or effectiveness of the device, it does not raise new questions of safety or effectiveness. In addition, other legally-marketed devices with respiratory gating systems have been cleared by the agency to control the delivery of radiation therapy, including Anzai Medical's AZ-733VI respiratory gating system (K160432). The gating of the proton beam is an

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additional safety feature of the RGS that reduces proton beam exposure to areas outside of the target treatment area

## Performance Data

The following tests were performed to establish equivalence of the Real Time Gating System:

- . Dose measurement of fluoroscopic X-ray at the isocenter and skin surface position on the X-ray tube side
- Recognition accuracy of a static fiducial marker .
- System latency
- . Tracking of moving marker
- Interlock interface testing ●
- Interplay effect ●

### Conclusions

The Real Time Gating System is as safe and effective as the VeriSuite and XVI devices. The Real Time Gating System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Real Time Gating System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Real Time Gating System is as safe and effective as the predicate devices. Thus, the Real Time Gating System is substantially equivalent.