CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING

K112768 · Calypso Medical Technologies, Inc. · LHN · Nov 18, 2011 · Radiology

Device Facts

• Record ID: K112768
• Device Name: CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
• Applicant: Calypso Medical Technologies, Inc.
• Product Code: LHN · Radiology
• Decision Date: Nov 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Calypso® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon® transponders. The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces. Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures. Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

Device Story

Calypso System uses non-ionizing electromagnetic and optical technology for continuous localization of treatment targets during radiation therapy. System detects electromagnetic signals from implanted Beacon transponders to measure target location in 3D. Operator uses data to align patient to therapy system isocenter and monitor position during treatment. Dynamic Edge Gating feature interfaces with external radiation therapy systems (Varian/Siemens) to trigger beam-hold when target moves outside defined tracking limits; automatically resumes beam when target returns to limits. Used in clinical radiation therapy environments by trained personnel. Provides objective, continuous tracking to improve treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance data previously submitted and cleared under K102373.

Technological Characteristics

Electromagnetic and infrared optical sensing; operates in radiation therapy environment. Interfaces with external radiation therapy systems for gating. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-1 (mechanical safety), and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring radiation therapy target localization and monitoring. Beacon transponders are indicated for soft tissue marking; permanent transponders are indicated for implantation in the prostate and peri-prostatic tissue (prostatic bed).

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

• Calypso® 4D Localization System (K060906, K080726, K102373)

Submission Summary (Full Text)

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# P /3 NOV 1 8 2011

#### 510(K) SUMMARY

This 510(k) Summary is provided in accordance with 21 CFR 807.92.

Date of preparation: 14 November 2011

Submitter information:

Calypso Medical Technologies, Inc. 2101 Fourth Avenue, Suite 500 Seattle, WA 98121

Phone: [phone] Fax: [phone]

| Contact: | Marcia A Page<br>Vice President Quality Assurance and Regulatory Affairs |
|----------------------|--------------------------------------------------------------------------|
| Device trade name: | Calypso® System with Dynamic Edge™ Gating |
| Common name: | Patient localization system |
| Classification name: | Medical charged-particle radiation therapy system |
| Classification: | CFR 892.5050<br>Class II<br>Product code - LHN, IYE |
| Predicate devices: | Calypso® 4D Localization System (K060906, K080726,<br>K102373) |

#### Device Description:

The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive markers, called Beacon® transponders. The Beacon Transponders are implanted in either the prostatic tissue (i.e., prostatic bed). When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions.

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The system operator uses this information to align the patient's treatment target to the isocenter of the therapy system prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.

The Dynamic Edge Gating feature enables the Calypso System to connect with radiation therapy systems configured with gating capabilities via an interface to external systems. With this feature added to the Calypso System, a beam hold is signaled to the radiation therapy system when the treatment target position has moved outside the defined tracking limits. The radiation therapy system is signaled to remove the beam-hold upon the target's return to a position inside the defined tracking limits.

#### Indications for Use:

The Calypso® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon® transponders.

The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces.

Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

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| Feature and/or<br>Specification of<br>new/modified device | K102373 Cleared Device<br>Feature/Specification | Device with Change |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------|
| Infrared optical system | Cameras and infrared targets<br>on array and Beacon<br>Transponders | No change |
| Monitoring | Real Time Monitor patient<br>motion | No change |
| Tracking | Real Time Tracking Patient<br>motion | No change |
| Gating | Interface to external systems | No change |
| Records | Display and Record motion | No change |
| Computer hardware and<br>software | Computer systems (console<br>and tracking station) to<br>control device functions and<br>provide for user interface | No change |
| Electromagnetic<br>technology (array) | Used to track motion during<br>therapeutic procedures | No change |
| compatibility with the<br>environment and other<br>devices | Operates in a radiation<br>therapy system environment | No change |
| electrical safety<br>mechanical safety | IEC 60601-1; IEC 60601-1-1 | No change |
| EMC Safety | IEC 60601-1-2 | No change |

Technological Characteristics - See device comparison table below

#### Summary of Performance Testing:

There has been no change to the device performance, software or hardware. Testing performed in support of K102373 demonstrated substantial equivalency and safety and effectiveness.

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Image /page/3/Picture/0 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 top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a tail.

#### 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

NOV 1 8 2011

Ms. Marcia Page Vice President Quality Assurance and Regulatory Affairs Calypso Medical Technologies, Inc. 2101 4th Avenue, Suite 500 SEATTLE WA 98121

Re: K112768

Trade/Device Name: Calypso® System with Dynamic Edge™ Gating Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN and IYE Dated: September 21, 2011 Received: September 22, 2011

Dear Ms. Page:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## KII2768

### INDICATIONS FOR USE

510(k) Number (if known): K112768

Device Name: Calypso® System with Dynamic Edge™ Gating

Indications for Use:

The Calypso® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon® transponders.

The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces.

Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mahal D. O'Kee

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112168

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