PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER

K140823 · Varian Medical Systems, Inc. · IYE · Jun 27, 2014 · Radiology

Device Facts

• Record ID: K140823
• Device Name: PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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 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 Story

Permanent Beacon transponder is a small, radiopaque, echogenic, electromagnetic fiducial marker; implanted via 14G introducer needle into or near tumor/radiation target. Device consists of sealed biocompatible-glass capsule containing passive electrical circuit. Used with Calypso System (3.0+) for electromagnetic localization or radiographic systems (kV x-ray, fluoroscopy, CT) for radiographic localization. Operates as fiducial marker to ensure accurate patient positioning relative to radiation therapy isocenter. Provides continuous, real-time localization data to clinicians during radiation therapy; enables precise alignment of radiation beams to target. Benefits include improved accuracy in radiation delivery and monitoring of target position.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing, biocompatibility evaluation per ISO 10993, and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Cylindrical fiducial marker (1.8 mm dia. x 8.5 mm length); biocompatible-glass encapsulated passive electrical circuit (copper/ferrite). Radiopaque (kV x-ray, fluoroscopy, CT) and echogenic (ultrasound). MR conditional. Sterilized via gamma irradiation. Single-use. Implanted via 14G needle.

Indications for Use

Indicated for patients requiring radiotherapy target localization. Used to mark soft tissue, specifically prostate and peri-prostatic tissue (prostatic bed), for real-time alignment and monitoring of treatment isocenter during radiation therapy.

Regulatory Classification

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.

Predicate Devices

• Calypso System with Beacon transponders (K060906, K080726, K123137)
• Gold Soft Tissue Marker (K071614)
• ONC Gold Seed Marker (K071673)

Submission Summary (Full Text)

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**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: [phone] Fax: [phone] 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:

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.

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

## 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 Beacon<br>Transponder with Expanded<br>Indications | Permanent Beacon<br>Transponder<br>(predicate) | Gold Soft Tissue Marker<br>(predicate) | ONC Gold Seed Marker<br>(predicate) |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| number | n/a | K060906, K080726, K123137 | K071614 | K071673 |
| product code | IYE | IYE | IYE | IYE |
| Intended use | Radiotherapy target<br>localization | Radiotherapy target<br>localization | Radiotherapy target<br>localization | Radiotherapy target<br>localization |
| Indications for use<br>statement<br>(bold emphasis added<br>only as an aid to the<br>reader) | The Calypso System is<br>intended for use as an adjunct<br>in treatment planning and<br>radiation therapy, to align<br>and/or monitor the patient's<br>position relative to the<br>isocenter of a radiation<br>therapy system. The Calypso<br>System provides accurate,<br>precise and continuous<br>localization of a treatment<br>isocenter by using two or<br>more Beacon transponders. | The Calypso System is<br>intended for use as an adjunct<br>in treatment planning and<br>radiation therapy, to align<br>and/or monitor the patient's<br>position relative to the<br>isocenter of a radiation<br>therapy system. The Calypso<br>System provides accurate,<br>precise and continuous<br>localization of a treatment<br>isocenter by using two or<br>more Beacon transponders. | The fiducial markers are<br>intended to be implanted into<br>the body to accurately<br>visualize and constitute the<br>reference frame for<br>stereotactic radiosurgery and<br>radiotherapy target<br>localization.<br><br>Specifically, they can be used<br>in intracranial diseases as<br>gliomas, neuromas,<br>meningiomoas, astrocytomas,<br>arteriovenous malformations,<br>and metastatic carcinomas.<br><br>Additionally, they can be used<br>in the body for treating<br>hepatic, pancreatic,<br>retroperitoneal, paraspinal,<br>skeletal, prostatic and breast<br>tumors. | The ONC Marker is indicated<br>for use to radiographically<br>mark soft tissue for future<br>therapeutic procedures. |
| | Implanted Beacon<br>transponders are indicated for<br>use to radiographically and<br>electromagnetically mark soft<br>tissue for future therapeutic<br>procedures. | Implanted Beacon<br>transponders are indicated for<br>use to radiographically and<br>electromagnetically mark soft<br>tissue for future therapeutic<br>procedures. | | |
| | | Permanent Beacon<br>transponders are indicated for<br>implantation in the body,<br>including in the prostate and | Permanent Beacon<br>transponders are indicated for<br>implantation in the prostate<br>and the peri-prostatic tissue | |
| Item/Characteristic | Permanent Beacon<br>Transponder with Expanded<br>Indications | Permanent Beacon<br>Transponder<br>(predicate) | Gold Soft Tissue Marker<br>(predicate) | ONC Gold Seed Marker<br>(predicate) |
| | the peri-prostatic tissue (i.e.,<br>prostatic bed), to align and<br>monitor the treatment<br>isocenter in real time during<br>radiation therapy. | (i.e., prostatic bed) to align<br>and monitor the treatment<br>isocenter in real time during<br>radiation therapy. | | |
| Dimensions | Cylindrical | Cylindrical | Cylindrical | Cylindrical |
| Materials | 1.8 mm dia. x 8.5 mm length<br>Biocompatible-glass-<br>encapsulated electrical<br>circuit (primarily copper<br>and ferrite) | 1.8 mm dia. x 8.5 mm length<br>Biocompatible-glass-<br>encapsulated electrical<br>circuit (primarily copper<br>and ferrite) | 1.6 mm dia. x 3 mm length<br>Gold | 1.2 mm dia. x 10 mm length<br>Gold |
| Radiographic and<br>Ultrasound imaging | Radiopaque (kV x-rays,<br>fluoroscopy, CT);<br>Echogenic (ultrasound) | Radiopaque (kV x-rays,<br>fluoroscopy, CT);<br>Echogenic (ultrasound) | Radiopaque (kV x-rays, MV<br>x-rays, CT);<br>Echogenic (ultrasound) | No details provided but known<br>to be radiopaque and<br>echogenic |
| Means of radiotherapy<br>target localization | Used as electromagnetic<br>fiducial marker with Calypso<br>system | Used as electromagnetic<br>fiducial marker with Calypso<br>system | Used as radiographic fiducial<br>marker with radiographic<br>detector | Used as radiographic fiducial<br>marker with radiographic<br>detector |
| | Used as radiographic fiducial<br>marker with radiographic<br>detector | Used as radiographic fiducial<br>marker with radiographic<br>detector | | |
| MR status | MR conditional<br>Rigid, no attachments | MR conditional<br>Rigid, no attachments | MR conditional<br>Rigid, no attachments, knurled | MR conditional<br>Rigid, no attachments |
| Introducer needle gauge | 14G | 14G | 14G | 17G |
| Introducer needles<br>available | Provided with introducer<br>needles | Provided with introducer<br>needles | Provided with introducer<br>needles | Provided with introducer<br>needles |
| 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 Beacon<br>Transponder with Expanded<br>Indications | Permanent Beacon<br>Transponder<br>(predicate) | Gold Soft Tissue Marker<br>(predicate) | ONC Gold Seed Marker<br>(predicate) |
| Biocompatibility | Biocompatibility was<br>evaluated per ISO 10993 | Biocompatibility evaluated per<br>ISO 10993 | Biocompatibility evaluated per<br>ISO 10993 | No information |
| Sterilization | Sterilization: gamma<br>irradiation | Sterilization: gamma<br>irradiation | Sterilization method: EtO | Sterilization method: EtO |

Table 7-1. Substantial Equivalence Comparison Table

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K140823
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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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

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