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 prostate and peri-prostate tissue (i.e. prostatic bed), and in soft tissue to align and monitor the treatment 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 17G 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 Beacon Care Package - Soft Tissue (17G). The device is single use and provided sterile.

AI/ML Overview

This document is a 510(k) summary for the Permanent Beacon Transponder Soft Tissue Beacon Transponder, provided in the Beacon Care Package - Soft Tissue (17G). It compares the new device to its predicate, the Beacon Care Package - Soft Tissue (14G) (K140823).

Here's an analysis of the provided text in relation to acceptance criteria and study information:

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

The document does not explicitly state acceptance criteria or device performance in quantifiable metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The core "acceptance criteria" here is that the new device (17G) is "No Change" or equivalent to the predicate device (14G) for specified characteristics.

Feature/Specification	Predicate Device (14G)	New Device (17G)	"Acceptance Criteria"/Comparison	Reported Device Performance (Implicit)
Product Code	IYE	No Change	Equivalent	IYE
Transponder Frequencies	300kHz, 400kHz, 500kHz	No Change	Equivalent	300kHz, 400kHz, 500kHz
Transponder dimensions	1.8mm (dia) x 8.5mm (length)	1.3 mm (dia) x 8.7 mm (length)	Change (Smaller diameter, slightly longer)	1.3 mm (dia) x 8.7 mm (length)
Patient Contacting Material	Glass	No Change	Equivalent	Glass
Introducer Needle	304 Stainless Steel, 14G Cannula	304 Stainless Steel, 17G Cannula	Change (Smaller gauge, 17G)	304 Stainless Steel, 17G Cannula
Labeling	General for soft tissue and specific for prostate/prostatic bed	No Change	Equivalent	As predicate
Sterile Barrier	Mylar/Tyvek Pouch, Double Barrier	No Change	Equivalent	Mylar/Tyvek Pouch, Double Barrier
Sterilization Method	Gamma Radiation	No Change	Equivalent	Gamma Radiation
MR Safety	MR Conditional	No Change	Equivalent	MR Conditional
Shelflife	2 Years	No Change	Equivalent	2 Years
Calypso System	For use with v3.0 or higher	No Change	Equivalent	For use with v3.0 or higher

The explicit performance data or "acceptance criteria" for metrics like accuracy, precision, or localization capabilities are not present in this summary because the submission is for substantial equivalence based on technological characteristics being largely the same, with justifiable changes (e.g., smaller introducer needle and transponder). The assumption is that the performance established for the predicate device (K140823) carries over or is not adversely affected by the minor changes.

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

This document does not contain any information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). This is a 510(k) summary focused on device description and comparison to a predicate, not a detailed clinical study report.

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)

This document does not contain any information about experts used to establish ground truth or their qualifications.

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

This document does not contain any information about an adjudication method.

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

This document does not contain any information about an MRMC study or AI assistance. The device is a physical fiducial marker used with a radiation therapy system (Calypso System), not an AI-powered diagnostic tool.

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

This document describes a physical medical device (fiducial marker) used in conjunction with a radiation therapy system. It is not an algorithm-only device, so a standalone algorithm performance study is not applicable and not mentioned.

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

This document does not describe the type of ground truth used. As it's a 510(k) summary for a physical device and not a clinical study, this information is not expected here.

8. The sample size for the training set

This document does not contain any information about a training set or its sample size.

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

This document does not contain any information about how ground truth for a training set was established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2015

Varian Medical Systems, Inc. % Ms. Marcia Page Director Quality Assurance and Regulatory Affairs 2101 4th Avenue, Suite 100 SEATTLE WA 98121

Re: K152761

Trade/Device Name: Permanent Beacon Transponder Soft Tissue Beacon Transponder Beacon Care Package - Soft Tissue (17G) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 16, 2015 Received: November 17, 2015

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. 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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ocks

Robert Ochs, Ph.D. 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) K152761

Device Name Permanent Beacon Transponder Soft Tissue Beacon Transponder Beacon Care Package - Soft Tissue (17G)

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

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

Date of preparation:	22 September 2015
Submitter information:	Varian Medical Systems2101 Fourth Avenue, Suite 100Seattle, WA 98121 USAPhone: 206-254-0600Fax: 206-254-0606
Contact:	Marcia A PageDirector Quality Assurance and Regulatory Affairs
Device trade name:	Permanent Beacon® Transponder, orSoft Tissue Beacon transponder, provided in theBeacon® Care Package - Soft Tissue (17G)
Common name:	Fiducial marker
Classification:	CFR 892.5050Class IIProduct code – IYE
Classification name:	Medical charged-particle radiation therapy system
Predicate device:	Beacon Care Package - Soft Tissue (14G) (K140823

Device Description:

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

Feature/Specification	BCP-Soft Tissue (14G)K140823	BCP-Soft Tissue (17G)This Submission
Product Code	IYE	No Change
TransponderFrequencies	300kHz400kHz500kHz	No Change
Transponder dimensions	1.8mm (dia) x8.5mm (length)	1.3 mm (dia) x8.7 mm (length)
Patient ContactingMaterial	Glass	No Change
Introducer Needle	304 Stainless Steel14G Cannula	304 Stainless Steel17G Cannula
Labeling	General for soft tissue andspecific forprostate/prostatic bed	No Change
Sterile Barrier	Mylar/Tyvek PouchDouble Barrier	No Change
Sterilization Method	Gamma Radiation	No Change
MR Safety	MR Conditional	No Change
Shelflife	2 Years	No Change
Calypso System	For use with v3.0 or higher	No Change

Technological Characteristics – See device comparison table below

Regulation Number and Section

N/A