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.

Anchored Beacon transponders are indicated for permanent implantation in small airways in the lung to align and/or monitor the internal position of targets that move with respiratory and other patient motion in real time during radiation therapy.

Device Description

The Anchored Beacon® transponder is a small passive implant, intended for permanent implantation in small airways in the lung. It is provided pre-loaded in a single-use delivery catheter for bronchoscopic implantation in a lung airway.

The Anchored Transponder is comprised of a Permanent Beacon Transponder (glassencapsulated electrical circuit) coupled to a stability feature (self-expanding 5-legged structure in a shell assembly). When implanted in a small diameter airway, the anchor legs of the stability feature expand independently to contact the airway wall.

When used with the Calypso® System, the Anchored Transponder signals enable realtime, objective measurement of the location of the treatment target in four dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to radiation therapy and/or to monitor the position of the treatment target during treatment.

AI/ML Overview

The provided document is a 510(k) summary for the Anchored Beacon® Transponder. It describes the device, its intended use, and a summary of the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not explicitly detail acceptance criteria in a table format or provide a comprehensive study report with quantitative performance metrics that would directly address all the requested points.

Based on the information available in the document, here's what can be extracted and inferred regarding the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Bench testing was performed and demonstrated: (1) the Anchored transponder satisfied the established performance requirements, including related to use in the lung". However, the specific quantitative acceptance criteria for these performance requirements (e.g., specific thresholds for localization accuracy, stability, or drift) are not provided in the document. Similarly, the exact reported device performance values against these established criteria are not explicitly stated in a quantitative manner.

We can infer the types of performance evaluated, but not the specific metrics or acceptance thresholds.

Performance Characteristic	Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Localization	Ability to be localized for patient position monitoring.	"the Anchored transponders can be localized to monitor patient position"
Positional Stability	Stability of the transponder in the airway for monitoring.	"the Anchored transponder is positionally stable in the airway" and "equivalence of stability over time" when compared to commercially-available fiducial markers.
Safety	Safe as a permanent implant in the lung.	"the Anchored transponder is safe as a permanent implant in the lung," "biocompatibility testing ... supports safety," and "presence of the transponders is unassociated with radiographic pulmonary abnormalities attributable to the transponder." Also, "safety profile is consistent with the original study patient data."
Biocompatibility	Biocompatible with the human body for permanent implantation.	"biocompatibility testing in conformance with ISO 10993 supports safety of the Anchored transponder materials and the delivery catheter materials."
Packaging & Sterility	Provides protection and a sterile barrier.	"the packaging provides protection and a sterile barrier."
Functionality	Satisfaction of "established performance requirements" related to lung use.	"the Anchored transponder satisfied the established performance requirements, including related to use in the lung." (Specific quantitative performance not provided, but implies successful operation as intended).

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

Sample Size: "69-patient cohort"
Data Provenance: The document states "Clinical study data obtained in lung cancer patients undergoing radiation therapy (69-patient cohort)". It doesn't explicitly state the country of origin, but it implies a prospective clinical study context. It is not explicitly stated if it was retrospective or prospective, but the phrasing "obtained in" and "undergoing" suggests a prospective collection of data for the purpose of the study.

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

The document does not provide any information about the number of experts used to establish ground truth or their qualifications. The clinical study primarily evaluates the device's ability to be localized, its stability, and its safety, which would likely rely on direct measurement, imaging, and clinical follow-up rather than expert consensus on an independent "ground truth" per se.

4. Adjudication Method for the Test Set

The document does not provide any information about an adjudication method. Given the nature of the device (a physical fiducial marker for real-time tracking), the "ground truth" would likely be derived from direct instrumental measurements or clinical observations rather than subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The clinical study compared the stability of the anchored transponders in a subset of study patients to "a matched cohort of patients with commercially-available fiducial markers implanted in lung (including the predicate, the superlock Cobra)". This is a comparative study, but it's focused on the device's performance (stability) rather than human reader improvement with or without AI assistance. The device itself is a passive marker, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a physical transponder, not an algorithm or AI. Its performance is evaluated in conjunction with the Calypso System (which includes hardware and software to track the transponders). Therefore, the concept of a "standalone" algorithm performance study without human-in-the-loop is not directly applicable in the way it would be for a diagnostic AI. The "localization" and "stability" assessment can be considered analogous to a standalone performance in that it evaluates the device and system's objective measurement capabilities.

7. Type of Ground Truth Used

The ground truth used in the studies described appears to be based on:

Real-time localization data: objective measurements from the Calypso System.
Clinical observation and follow-up: for safety, monitoring of patient position, and positional stability.
Radiographic assessment: for detecting pulmonary abnormalities attributable to the transponder.
Biocompatibility testing: in conformance with ISO 10993 standards, involving scientific testing rather than expert consensus on a clinical case.

It is not explicitly stated as pathology or outcomes data in the sense of disease progression or diagnosis, but rather related to the physical behavior and clinical impact of the implanted device.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This device is a physical fiducial marker, not a machine learning algorithm that requires a separate training set. The descriptions of "bench testing" and "clinical study data" refer to validation and verification, not training data for an algorithm.

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

As there is no mention of a training set for an algorithm, this question is not applicable based on the provided document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.

April 6, 2018

Varian Medical Systems, Inc. % Lisa Levine, Ph.D. Director, Clinical and Pre-Market Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K170570

Trade/Device Name: Anchored Beacon® Transponder Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 21, 2018 Received: March 23, 2018

Dear Dr. Levine:

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170570

Device Name

Anchored Beacon® transponder, Anchored transponder, Beacon Care Package - Lung

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------	----------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

varian

510(k) Summary
Submitter's name:	Varian Medical Systems Inc 3100 Hansen Way Palo Alto, CA 94304 USA
Contact person:	Lisa Levine, PhD Director, Clinical and Pre-Market Regulatory Affairs Phone: 206-254-0600 Fax: 206-254-0606
Date summary prepared:	March 21, 2018
Trade name(s):	Anchored Beacon® transponder Anchored transponder Beacon® Care Package - Lung
Common name:	Fiducial marker
Classification name:	Medical charged-particle radiation therapy system
Classification number:	CFR 892.5050
Class:	Class II
Product code:	IYE
Predicate:	Permanent Beacon transponder (K140823)

Device description:

{4}------------------------------------------------

Intended use/Indications for use:

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, and continuous localization of a treatment isocenter by using two or more Beacon transponders.

Predicate discussion:

This 510(k) notification is for a new Beacon transponder called the Anchored Beacon transponder, designed to be permanently implanted in the lung. The selected predicates are the following fiducial markers: the Soft Tissue Transponder 14G (K140823) and the superlock cobra marker (K120796). A comparison of the similarities and differences of the intended use/indications for use, technology, and other characteristics between the new device and the predicates is shown in the table below and discussed in the text following the table.

{5}------------------------------------------------

	New Device:	Predicate #1:	Predicate #2:
Item	Anchored Beacon	Soft Tissue transponder	superlock cobra marker
	transponder	(K140823)	(K120796)
Intendeduse/indications for use	The Calypso System isintended for use as anadjunct in treatmentplanning and radiationtherapy, to align and/ormonitor the patient'sposition relative to theisocenter of a radiationtherapy system. TheCalypso System providesaccurate, precise, andcontinuous localization ofa treatment isocenter byusing two or more Beacontransponders.	The Calypso System isintended for use as anadjunct in treatmentplanning and radiationtherapy, to align and/ormonitor the patient'sposition relative to theisocenter of a radiationtherapy system. TheCalypso System providesaccurate, precise, andcontinuous localization ofa treatment isocenter byusing two or more Beacontransponders.	The superDimensionsuperLock Cobra isintended to be used toradiographically mark softtissue for future surgical ortherapeutic purposes.
	Anchored Beacontransponders are indicatedfor permanentimplantation in smallairways in the lung toalign and/or monitor theinternal position of targetsthat move with respiratoryand other patient motion inreal time during radiationtherapy.	Implanted Beacontransponders are indicatedfor use to radiographicallyand electromagneticallymark soft tissue for futuretherapeutic procedures.Permanent Beacontransponders are indicatedfor implantation in thebody, specifically in theprostate and peri-prostatictissue (i.e., prostatic bed),and in soft tissue to alignand monitor the treatmentisocenter in real timeduring radiation therapy
Item	New Device:Anchored Beacontransponder	Predicate #1:Soft Tissue transponder(K140823)	Predicate #2:superlock cobra marker(K120796)
Technology(design andmaterials)	The anchored transponderis constructed by adding aself-expanding nitinolstabilization feature toPredicate #1. Theunconstrained diameter ofthe nitinol stabilizationfeature is approximately 5mm.	Cylinder consisting ofsmall electrical circuitencased in biocompatibleglass.No stabilization feature.	Gold cylinder with self-expanding nitinolstabilization feature. Theunconstrained diameter ofthe nitinol stabilizationfeature is 4.1 mm.
Permanentimplant	Yes	Yes	Yes
Sterility	Provided sterile (radiationsterilized).	Provided sterile (radiationsterilized).	Provided sterile (radiationsterilized).
Single use	Yes	Yes	Yes

{6}------------------------------------------------

The new device and the two predicates are intended to be used as fiducial markers. The Anchored transponder is intended for implantation in small airways in the lung, while the predicates are intended for implantation in soft tissue, and additionally in the prostate/prostatic bed for Predicate #2.

The Anchored transponder is constructed by adding a self-expanding nitinol stabilization feature to Predicate #1, so both the new transponder and Predicate #1 have this predicate in common. The Anchored transponder and Predicate #2 both have a cylindrical body with an attached self-expanding nitinol stabilization feature. The stabilization features prevent migration based on the same principle: the stabilization features expand against the surrounding tissue and hold the fiducial marker in place. The unconstrained diameters of the two stabilization features are similar.

The new device and the two predicates are permanent implants, provided radiation sterilized for single use.

Bench testing was performed and demonstrated: (1) the Anchored transponder satisfied the established performance requirements, including related to use in the lung; (2) biocompatibility testing in conformance with ISO 10993 supports safety of the Anchored transponder materials and the delivery catheter materials; and (3) the packaging provides protection and a sterile barrier.

Clinical study data obtained in lung cancer patients undergoing radiation therapy (69patient cohort) showed the Anchored transponders can be localized to monitor patient

{7}------------------------------------------------

position, that the Anchored transponder is positionally stable in the airway, and that the Anchored transponder is safe as a permanent implant in the lung.

A long-term follow-up analysis comparing the stability of the anchored transponders in a subset of study patients to a matched cohort of patients with commercially-available fiducial markers implanted in lung (including the predicate, the superlock Cobra) showed equivalence of stability over time.

An analysis was performed of the long term radiographic changes in a separate cohort of patients treated with implanted anchored transponders who had undergone thoracic radiotherapy. The analysis shows that the presence of the transponders is unassociated with radiographic pulmonary abnormalities attributable to the transponder. Analysis of the clinical safety of the device in this expanded cohort confirms the safety profile is consistent with the original study patient data.

The clinical data show that the Anchored transponders can be localized to monitor patient position, that the Anchored transponder is positionally stable in the airway, and that the Anchored transponder is safe as a permanent implant in the lung.

Overall, the bench, biocompatibility, and clinical testing have demonstrated the Anchored transponder to be safe and effective for use in the lung.

After comparing the devices and considering the bench, biocompatibility, and clinical data, no new questions of safety and effectiveness are raised.

Thus, the new device is shown to be substantially equivalent to the predicates.

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.