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.

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 body, specifically in the prostate and peri-prostatic tissue (i.e., prostatic bed), and in soft tissue to align and monitor the treatment isocenter in real time during radiation therapy.

Device Description

The Soft Tissue Beacon Transponder is a small, radiopaque, echogenic, electromagnetic fiducial marker designed for permanent implantation and intended for radiotherapy target localization to ensure accurate positioning for radiation therapy. It consists of a sealed biocompatible-glass capsule containing a small, passive electrical circuit. The Soft Tissue Beacon Transponder may be used with the Calypso System (3.0 or later) as an electromagnetic fiducial marker, or with radiographic-based systems (e.g., kV x-ray, fluoroscopy, and CT) as a radiographic fiducial marker.

Each transponder is implanted with a separate 14G introducer needle (introducer) in or near the tumor or intended radiation target. Three Soft Tissue Beacon Transponders and three single-use introducers are provided in each Soft Tissue Beacon Care Package. The device is single-use and provided sterile.

AI/ML Overview

This document is a 510(k) summary for Varian Medical Systems' Soft Tissue Beacon Transponder, detailing its substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria with reported performance metrics, expert qualifications, or detailed study design. The document focuses on regulatory approval based on equivalence, not on a performance study against predefined criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. The document outlines indications for use and device characteristics, but it does not present specific acceptance criteria (e.g., minimum accuracy thresholds, signal strength requirements) or a study reporting performance against such criteria. The entire document is a substantial equivalence comparison, not a performance study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. No performance study or test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be extracted. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be extracted. No adjudication method for a test set is described.

5. 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

Cannot be extracted. No MRMC study is mentioned. This device is a fiducial marker, not an AI-assisted diagnostic tool.

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

Cannot be extracted. The device is a physical fiducial marker, not an algorithm. Its function is to be implanted and tracked by a separate system (Calypso System or radiographic systems). Standalone algorithm performance is not applicable.

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

Cannot be extracted. No ground truth for a performance study is described.

8. The sample size for the training set

Cannot be extracted. As this is a physical medical device (fiducial marker) and not a machine learning algorithm, the concept of a "training set" in this context does not apply.

9. How the ground truth for the training set was established

Cannot be extracted. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "i" that extends above the other letters. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of trust and reliability.

JUN 27 2014

K140823
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510(k) Summary

Submitter information: Varian Medical Systems 2101 4th Ave., Suite 100 Seattle, WA 98121 Phone: 206-254-0600 Fax: 206-577-4597 Contact person: Lisa Levine, PhD Director, Clinical and Pre-Market Regulatory Affairs Date summary prepared: March 28, 2014 Permanent Beacon transponder or Trade name: Soft Tissue Beacon transponder, provided in the Soft Tissue Beacon Package Common name: Fiducial marker Classification name: Medical charged-particle radiation therapy system Classification number: CFR 892.5050 Class: Class II Product code: IYE Predicates: Calypso System with Beacon transponders (K060906, K080726, K123137) Gold Soft Tissue Marker (K071614) ONC Gold Seed Marker (K071673 )

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Device description:

Indications for use:

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

Substantial equivalence:

The subject device has the same intended use as the predicates. The technological characteristics of the subject device are supported by the technological characteristics of the predicates. The subject device is as safe and effective as the predicates. There are no different questions of safety or effectiveness. Thus, the subject device is substantially equivalent.

The substantial equivalence table is shown on the next page for reference.

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Item/Characteristic	Permanent BeaconTransponder with ExpandedIndications	Permanent BeaconTransponder(predicate)	Gold Soft Tissue Marker(predicate)	ONC Gold Seed Marker(predicate)
number	n/a	K060906, K080726, K123137	K071614	K071673
product code	IYE	IYE	IYE	IYE
Intended use	Radiotherapy targetlocalization	Radiotherapy targetlocalization	Radiotherapy targetlocalization	Radiotherapy targetlocalization
Indications for usestatement(bold emphasis addedonly as an aid to thereader)	The Calypso System isintended for use as an adjunctin treatment planning andradiation therapy, to alignand/or monitor the patient'sposition relative to theisocenter of a radiationtherapy system. The CalypsoSystem provides accurate,precise and continuouslocalization of a treatmentisocenter by using two ormore Beacon transponders.	The Calypso System isintended for use as an adjunctin treatment planning andradiation therapy, to alignand/or monitor the patient'sposition relative to theisocenter of a radiationtherapy system. The CalypsoSystem provides accurate,precise and continuouslocalization of a treatmentisocenter by using two ormore Beacon transponders.	The fiducial markers areintended to be implanted intothe body to accuratelyvisualize and constitute thereference frame forstereotactic radiosurgery andradiotherapy targetlocalization.Specifically, they can be usedin intracranial diseases asgliomas, neuromas,meningiomoas, astrocytomas,arteriovenous malformations,and metastatic carcinomas.Additionally, they can be usedin the body for treatinghepatic, pancreatic,retroperitoneal, paraspinal,skeletal, prostatic and breasttumors.	The ONC Marker is indicatedfor use to radiographicallymark soft tissue for futuretherapeutic procedures.
	Implanted Beacontransponders are indicated foruse to radiographically andelectromagnetically mark softtissue for future therapeuticprocedures.	Implanted Beacontransponders are indicated foruse to radiographically andelectromagnetically mark softtissue for future therapeuticprocedures.
		Permanent Beacontransponders are indicated forimplantation in the body,including in the prostate and	Permanent Beacontransponders are indicated forimplantation in the prostateand the peri-prostatic tissue
Item/Characteristic	Permanent BeaconTransponder with ExpandedIndications	Permanent BeaconTransponder(predicate)	Gold Soft Tissue Marker(predicate)	ONC Gold Seed Marker(predicate)
	the peri-prostatic tissue (i.e.,prostatic bed), to align andmonitor the treatmentisocenter in real time duringradiation therapy.	(i.e., prostatic bed) to alignand monitor the treatmentisocenter in real time duringradiation therapy.
Dimensions	Cylindrical	Cylindrical	Cylindrical	Cylindrical
Materials	1.8 mm dia. x 8.5 mm lengthBiocompatible-glass-encapsulated electricalcircuit (primarily copperand ferrite)	1.8 mm dia. x 8.5 mm lengthBiocompatible-glass-encapsulated electricalcircuit (primarily copperand ferrite)	1.6 mm dia. x 3 mm lengthGold	1.2 mm dia. x 10 mm lengthGold
Radiographic andUltrasound imaging	Radiopaque (kV x-rays,fluoroscopy, CT);Echogenic (ultrasound)	Radiopaque (kV x-rays,fluoroscopy, CT);Echogenic (ultrasound)	Radiopaque (kV x-rays, MVx-rays, CT);Echogenic (ultrasound)	No details provided but knownto be radiopaque andechogenic
Means of radiotherapytarget localization	Used as electromagneticfiducial marker with Calypsosystem	Used as electromagneticfiducial marker with Calypsosystem	Used as radiographic fiducialmarker with radiographicdetector	Used as radiographic fiducialmarker with radiographicdetector
	Used as radiographic fiducialmarker with radiographicdetector	Used as radiographic fiducialmarker with radiographicdetector
MR status	MR conditionalRigid, no attachments	MR conditionalRigid, no attachments	MR conditionalRigid, no attachments, knurled	MR conditionalRigid, no attachments
Introducer needle gauge	14G	14G	14G	17G
Introducer needlesavailable	Provided with introducerneedles	Provided with introducerneedles	Provided with introducerneedles	Provided with introducerneedles
Single-use	For single-use	For single-use	For single-use	For single-use
Sterility	Provided sterile	Provided sterile	Provided sterile	Provided sterile
	For permanent implantation	For permanent implantation	For permanent implantation	For permanent implantation
Item/Characteristic	Permanent BeaconTransponder with ExpandedIndications	Permanent BeaconTransponder(predicate)	Gold Soft Tissue Marker(predicate)	ONC Gold Seed Marker(predicate)
Biocompatibility	Biocompatibility wasevaluated per ISO 10993	Biocompatibility evaluated perISO 10993	Biocompatibility evaluated perISO 10993	No information
Sterilization	Sterilization: gammairradiation	Sterilization: gammairradiation	Sterilization method: EtO	Sterilization method: EtO

Table 7-1. Substantial Equivalence Comparison Table

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K140823
Page 5 of 5

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

June 27, 2014

Varian Medical Systems, Inc. % Lisa Levine, Ph.D. Director, Clinical and Pre-Market Regulatory Affairs 2101 4th Avenue, Suite 100 SEATTLE WA 98121

Re: K140823

Trade/Device Name: Permanent and Soft Tissue Beacon Transponder Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 31, 2014 Received: April 1, 2014

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

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Page 2-Lisa Levine, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

for

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 Form

510(k) Number (if known): K140823

Device Name: Permanent Beacon® Transponder

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

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

Michael D. DiHara

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K140823

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.