The Calypso System is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or 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.

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

Permanent Beacon transponders are indicated for implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed) to align and monitor the treatment isocenter in real time during radiation therapy.

Surface Beacon® transponders are indicated for temporary external placement on the skin. to monitor respiratory motion and other patient motion in real time during radiation therapy.

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 or near the treatment target or placed externally on the surface of a patient.

Implanted Beacon transponders when used with the Calypso System enable objective measurement of the location of the 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.

When using Surface Beacon transponders this information can be used to monitor respiratory motion and other patient motion in real time during radiotherapy. When correlated to the patient's treatment target motion the system provides objective measurement of the location of the target in 3 dimensions.

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

The Calypso® System with Dynamic Edge™ Gating is a patient localization system. The application describes its key features and how it differs from already cleared devices.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the Calypso System's performance (e.g., specific accuracy thresholds in millimeters or latency requirements in milliseconds). Instead, it makes a general statement about performance testing.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated, but implied)	Reported Device Performance
Target Localization Accuracy	Not explicitly stated (implied: accurate, precise, continuous localization)	"The Calypso System provides accurate, precise and continuous localization of a treatment isocenter..."
Gating Functionality (Dynamic Edge Gating)	Not explicitly stated (implied: compatible with radiation therapy systems, signals beam-hold/release appropriately)	"The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces."
Safety - Electrical & Mechanical	EN60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)	Device complies with EN60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
Safety - EMC	EN60601-1-2 ed. 2.0	Device complies with EN60601-1-2 ed. 2.0
Software, Hardware, and System Validation	Performance to satisfy intended use.	"Results of software, hardware and system verification and validations testing demonstrate that the Calypso System satisfies the intended use as described above."
Interoperability	Compatibility with Varian and Siemens radiation therapy systems.	"The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective) for performance testing. It generally refers to "software, hardware and system verification and validations testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts or a ground truth established by experts for performance testing related to target localization or gating. The performance testing appears to be internal engineering and validation tests rather than clinical studies requiring expert interpretation of ground truth.

4. Adjudication Method for the Test Set

As there is no mention of an expert panel or subjective assessment for performance testing, no adjudication method is described or implied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a localization and gating system, not an AI-based diagnostic imaging tool, so such a study would not typically apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The entire system, including the Dynamic Edge Gating feature, operates as an automated system to monitor and signal beam-holds based on target position. While a human operator defines the tracking limits, the gating process itself is standalone in its execution (i.e., the algorithm automatically signals the beam-hold/release without constant human intervention during the process). The performance testing would therefore inherently be "standalone" in this context, evaluating the system's ability to accurately track and gate. However, the document does not explicitly use the term "standalone study" in this manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for its performance testing. Given the nature of the device (a localization and gating system), the "ground truth" for its accuracy and precision would likely be established through:

Physical phantoms and precise measurement systems: For validating the 3D localization accuracy of the Beacon transponders.
Simulated motion profiles: For validating the tracking and gating capabilities under controlled conditions.
Technical specifications and engineering measurements: For assessing compliance with electrical and EMC safety standards.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The Calypso System is described as utilizing non-ionizing electromagnetic and optical technology for localization and monitoring, which implies a deterministic algorithm based on physics principles rather than a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied, this information is not applicable and not provided.

Summary

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K123137: 510(K) SUMMARY

DEC 0 5 2012

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

Date of preparation:	04 October 2012
Revised Date:	05 November 2012
Submitter information:	Varian Medical Systems2101 Fourth Avenue, Suite 500Seattle, WA 98121Phone: 206-254-0600Fax: 206-254-0606
Contact:	Marcia A PageDirector Quality Assurance and Regulatory Affairs
Device trade name:	Calypso® SystemCalypso® System with Dynamic Edge™ Gating
Common name:	Patient localization system
Classification name:	Medical charged-particle radiation therapy system
Classification:	CFR 892.5050Class IIProduct code: IYE
Predicate devices:	Calypso System (K060906, K102373, K112768)

Device Description:

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Indications for Use:

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

Surface Beacon® transponders are indicated for temporary external placement on the skin, to monitor respiratory motion and other patient motion in real time during radiation therapy.

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Technological Characteristics – See device comparison table below

Feature and/orSpecification of theCalypso System	Cleared Calypso SystemFeature/Specification	Modified CalypsoSystem Feature/Specification
Infrared optical system	Cameras and infrared targetson array and BeaconTransponders	No change
Monitoring	Real Time Monitor patientmotion	No change
Tracking	Real Time Tracking Patientand Respiratory motion	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	EN60601-1: 1990 / A1:1993 /A2:1995EN 60601-1-1: 2001	EN60601-1 EN60601-1: 2005 +CORR. 1 (2006) +CORR. 2 (2007)
EMC Safety	EN60601-1-2 ed. 2.0	No Change

Summary of Performance Testing:

Results of software, hardware and system verification and validations testing demonstrate that the Calypso System satisfies the intended use as described above.

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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 features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple, yet recognizable, and represents the department's role in providing essential services to the American people.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 5. 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Ms. Marcia Page Director Quality Assurance and Regulatory Affairs Varian Medical Systems 2101 Fourth Avenue South, Suite 500 SEATTLE, WA 98121

Re: K123137

Trade/Device Name: Calypso® System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 4, 2012 Received: October 5, 2012

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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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/ReportaProblem/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,

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123137

Device Name: Calypso® System

Indications for Use:

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

Surface Beacon® transponders are indicated for temporary external placement on the skin. to monitor respiratory motion and other patient motion in real time during radiation therapy.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR -

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

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.