(87 days)
Not Found
No
The description focuses on electromagnetic and radiographic fiducial markers and their use with existing radiation therapy systems, with no mention of AI or ML for localization or monitoring.
No.
The device is described as an adjunct in treatment planning and radiation therapy, used to align and/or monitor a patient's position and electromagnetically mark soft tissue for future therapeutic procedures, rather than directly providing therapy itself.
No
The device is described as an "adjunct in treatment planning and radiation therapy" used to "align and/or monitor the patient's position relative to the isocenter of a radiation therapy system" and to electromagnetically mark soft tissue for "future therapeutic procedures." It is a fiducial marker, not a device that diagnoses a condition or disease.
No
The device description explicitly details a physical, implantable hardware component (Soft Tissue Beacon Transponder) and its associated introducer needle. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Calypso system and Beacon transponders are used for in vivo (within the living body) localization and monitoring of a patient's position during radiation therapy. They are implanted in the body and interact with external systems to guide treatment.
- Intended Use: The intended use clearly states it's for "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." This is a therapeutic and positioning function, not a diagnostic test performed on a sample.
- Device Description: The description details an implanted fiducial marker and its use with imaging and electromagnetic systems for localization, not for analyzing biological samples.
Therefore, the Calypso system and Soft Tissue Beacon Transponders fall under the category of medical devices used for treatment guidance and positioning, not for in vitro diagnostic testing.
N/A
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, 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.
Product codes
IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV x-ray, fluoroscopy, CT, ultrasound
Anatomical Site
prostate and peri-prostatic tissue (i.e., prostatic bed), and in soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060906, K080726, K123137, K071614, K071673
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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
Page 1 of 5
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 )
1
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.
2
| Item/Characteristic | Permanent Beacon
Transponder with Expanded
Indications | Permanent Beacon
Transponder
(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 target
localization | Radiotherapy target
localization | Radiotherapy target
localization | Radiotherapy target
localization |
| Indications for use
statement
(bold emphasis added
only as an aid to the
reader) | 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 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 fiducial markers are
intended to be implanted into
the body to accurately
visualize and constitute the
reference frame for
stereotactic radiosurgery and
radiotherapy target
localization.
Specifically, they can be used
in intracranial diseases as
gliomas, neuromas,
meningiomoas, astrocytomas,
arteriovenous malformations,
and metastatic carcinomas.
Additionally, they can be used
in the body for treating
hepatic, pancreatic,
retroperitoneal, paraspinal,
skeletal, prostatic and breast
tumors. | The ONC Marker is indicated
for use to radiographically
mark soft tissue for future
therapeutic procedures. |
| | Implanted Beacon
transponders are indicated for
use to radiographically and
electromagnetically mark soft
tissue for future therapeutic
procedures. | 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,
including in the prostate and | Permanent Beacon
transponders are indicated for
implantation in the prostate
and the peri-prostatic tissue | |
| Item/Characteristic | Permanent Beacon
Transponder with Expanded
Indications | Permanent Beacon
Transponder
(predicate) | Gold Soft Tissue Marker
(predicate) | ONC Gold Seed Marker
(predicate) |
| | the peri-prostatic tissue (i.e.,
prostatic bed), to align and
monitor the treatment
isocenter in real time during
radiation therapy. | (i.e., prostatic bed) to align
and monitor the treatment
isocenter in real time during
radiation therapy. | | |
| Dimensions | Cylindrical | Cylindrical | Cylindrical | Cylindrical |
| Materials | 1.8 mm dia. x 8.5 mm length
Biocompatible-glass-
encapsulated electrical
circuit (primarily copper
and ferrite) | 1.8 mm dia. x 8.5 mm length
Biocompatible-glass-
encapsulated electrical
circuit (primarily copper
and ferrite) | 1.6 mm dia. x 3 mm length
Gold | 1.2 mm dia. x 10 mm length
Gold |
| Radiographic and
Ultrasound imaging | Radiopaque (kV x-rays,
fluoroscopy, CT);
Echogenic (ultrasound) | Radiopaque (kV x-rays,
fluoroscopy, CT);
Echogenic (ultrasound) | Radiopaque (kV x-rays, MV
x-rays, CT);
Echogenic (ultrasound) | No details provided but known
to be radiopaque and
echogenic |
| Means of radiotherapy
target localization | Used as electromagnetic
fiducial marker with Calypso
system | Used as electromagnetic
fiducial marker with Calypso
system | Used as radiographic fiducial
marker with radiographic
detector | Used as radiographic fiducial
marker with radiographic
detector |
| | Used as radiographic fiducial
marker with radiographic
detector | Used as radiographic fiducial
marker with radiographic
detector | | |
| MR status | MR conditional
Rigid, no attachments | MR conditional
Rigid, no attachments | MR conditional
Rigid, no attachments, knurled | MR conditional
Rigid, no attachments |
| Introducer needle gauge | 14G | 14G | 14G | 17G |
| Introducer needles
available | Provided with introducer
needles | Provided with introducer
needles | Provided with introducer
needles | Provided with introducer
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
Transponder with Expanded
Indications | Permanent Beacon
Transponder
(predicate) | Gold Soft Tissue Marker
(predicate) | ONC Gold Seed Marker
(predicate) |
| Biocompatibility | Biocompatibility was
evaluated per ISO 10993 | Biocompatibility evaluated per
ISO 10993 | Biocompatibility evaluated per
ISO 10993 | No information |
| Sterilization | Sterilization: gamma
irradiation | Sterilization: gamma
irradiation | Sterilization method: EtO | Sterilization method: EtO |
Table 7-1. Substantial Equivalence Comparison Table
. .
1
.
3
:
:
4
. . .
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.
6
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
7
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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