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 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.

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.

AI/ML Overview

This 510(k) summary does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria for the new "Dynamic Edge Gating" feature beyond compatibility. The document explicitly states: "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." This indicates that the current submission (K112768) is a modification to an already cleared device, and thus, relies on previous clearances for performance validation.

However, based on the information provided, we can infer some details related to the device's functionality and the predicate device's performance, as well as the context of substantial equivalence.

Here's an analysis based on the provided text, highlighting the absence of specific details for the requested categories related to this specific submission:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from device function/Indications for Use)	Reported Device Performance (from the document)
Target Localization Accuracy: Ability to accurately determine the 3D position of Beacon transponders.	"The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon® transponders." (Indications for Use) "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." (Device Description)
Gating Functionality: Ability to signal a beam-hold to a radiation therapy system when the target moves outside defined limits and remove the beam-hold when it returns.	"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." (Device Description)"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." (Indications for Use)
Compatibility with Radiation Therapy Systems: Successful integration and communication with external radiation therapy systems with gating interfaces.	"The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." (Indications for Use)
Real-Time Monitoring and Tracking: Continuous display and recording of patient motion.	"Real Time Monitor patient motion" (No change from predicate) "Real Time Tracking Patient motion" (No change from predicate) "Display and Record motion" (No change from predicate)
Electrical Safety: Compliance with relevant international standards.	"IEC 60601-1; IEC 60601-1-1" (No change from predicate)
EMC Safety: Compliance with relevant international standards.	"IEC 60601-1-2" (No change from predicate)

Note on Acceptance Criteria: The document primarily focuses on the capabilities and compatibility of the new feature and states "No change" in performance for core functionalities. It refers to previous submissions (K102373, K060906, K080726) for substantial equivalency and safety/effectiveness testing. Therefore, specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") for the new feature are not detailed in this particular summary. The "compatibility" statement for Varian and Siemens systems serves as a key performance criterion for the "Dynamic Edge Gating" component.

Study Details (for the new "Dynamic Edge Gating" feature)

Based on the provided 510(k) summary, specific details about a new study for the "Dynamic Edge Gating" feature are largely absent, as the submission relies on previous clearances.

Sample size used for the test set and the data provenance:
- Not explicitly stated for the "Dynamic Edge Gating" feature. The document states, "The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." This implies testing was done, but specific sample sizes (e.g., number of tests, duration, patient data if any) are not provided. The provenance of data for this compatibility testing is also not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated for this submission. The determination of "compatibility" for the gating feature would likely involve technical verification against specifications of the interfaced systems, rather than expert interpretation of medical images or outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not stated for this submission. This refers to methods for resolving discrepancies in expert opinion, which is not relevant for the type of technical compatibility testing implied here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a patient localization and motion monitoring system, not an AI diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The core device operation, including localization and gating, functions largely automatically once parameters are set. The "Dynamic Edge Gating" component autonomously signals beam holds based on defined tracking limits. The "compatibility" testing would have assessed this automated function. However, the device is explicitly "an adjunct in treatment planning and radiation therapy" and involves operator alignment, so it's not entirely without human involvement in its overall use. The performance of the gating system itself (signaling beam holds) is an automated function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Dynamic Edge Gating" feature's "compatibility" claim: The ground truth would likely be the actual operational state of the interfaced Varian and Siemens radiation therapy systems (i.e., did the beam-hold signal correctly trigger a beam hold, and did the release signal correctly release it, according to the predefined motion thresholds). This is a technical validation against the expected behavior of the interconnected systems. For the underlying localization, the ground truth would be precise physical measurements of transponder positions.
The sample size for the training set:
- Not applicable. This device is hardware and software for real-time localization and gating based on electromagnetic signals. It does not explicitly mention machine learning or AI models that require a "training set" in the conventional sense (e.g., for image classification or diagnosis). Its functionality is based on known physics and engineering principles.
How the ground truth for the training set was established:
- Not applicable. (See #7).

Summary of the K112768 Submission's Approach:

This 510(k) submission (K112768) is for an updated version of an existing device (Calypso System) with an added feature, "Dynamic Edge Gating." The document explicitly states that there are "no changes to the device performance, software or hardware" for the core system. The primary focus of this new submission, regarding performance and a "study," is the compatibility of the "Dynamic Edge Gating" feature with specific Varian and Siemens radiation therapy systems. The claim of "substantial equivalency" largely rests on the predicate device's existing performance data and the successful technical integration of the new gating function. Specific, detailed reports of new clinical studies with quantitative acceptance criteria for this particular submission are not provided within the 510(k) summary.

Summary

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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: 206-254-0600 Fax: 206-254-0606

Contact:	Marcia A PageVice 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 892.5050Class IIProduct code - LHN, IYE
Predicate devices:	Calypso® 4D Localization System (K060906, K080726,K102373)

Device Description:

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Indications for Use:

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/orSpecification ofnew/modified device	K102373 Cleared DeviceFeature/Specification	Device with Change
Infrared optical system	Cameras and infrared targetson array and BeaconTransponders	No change
Monitoring	Real Time Monitor patientmotion	No change
Tracking	Real Time Tracking Patientmotion	No change
Gating	Interface to external systems	No change
Records	Display and Record motion	No change
Computer hardware andsoftware	Computer systems (consoleand tracking station) tocontrol device functions andprovide for user interface	No change
Electromagnetictechnology (array)	Used to track motion duringtherapeutic procedures	No change
compatibility with theenvironment and otherdevices	Operates in a radiationtherapy system environment	No change
electrical safetymechanical 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1

Regulation Number and Section

§ 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.