(62 days)
Not Found
No
The summary describes a passive fiducial marker and a system for electromagnetic and radiographic localization. There is no mention of AI or ML in the device description, intended use, or performance study sections.
No.
The device is used to align and/or monitor the patient's position relative to the isocenter of a radiation therapy system, and to mark soft tissue for future therapeutic procedures. It is an adjunct in treatment planning and radiation therapy, not a therapeutic device itself.
No
The Calypso system and Beacon transponders are described as an adjunct in treatment planning and radiation therapy, primarily for patient positioning and monitoring during treatment, not for diagnosing a disease or condition. They are used to mark tissue for therapeutic procedures and align/monitor the patient's position.
No
The device description explicitly details a physical, implantable hardware component (Soft Tissue Beacon Transponder) and its associated introducer needle. While the system utilizes software for localization, the core device being described and cleared is a hardware fiducial marker.
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 markers and a system that tracks their position.
- 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 application, not a diagnostic test performed on a sample.
- Device Description: The description details an implanted fiducial marker and an introducer needle, which are used within the body.
Therefore, the Calypso system and Beacon transponders fall under the category of medical devices used for treatment and positioning, not in vitro diagnostics.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic-based systems (e.g., kV x-ray, fluoroscopy, and CT)
Anatomical Site
prostate and peri-prostate 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
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.
1
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)
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.
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 Systems | |
| 2101 Fourth Avenue, Suite 100 | ||
| Seattle, WA 98121 USA |
Phone: 206-254-0600
Fax: 206-254-0606 | |
| Contact: | Marcia A Page
Director Quality Assurance and Regulatory Affairs | |
| Device trade name: | Permanent Beacon® Transponder, or
Soft Tissue Beacon transponder, provided in the
Beacon® Care Package - Soft Tissue (17G) | |
| Common name: | Fiducial marker | |
| Classification: | CFR 892.5050
Class II
Product code – IYE | |
| Classification name: | Medical charged-particle radiation therapy system | |
| Predicate device: | Beacon Care Package - Soft Tissue (14G) (K140823 | |
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.
4
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.
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 |
| Transponder
Frequencies | 300kHz
400kHz
500kHz | No Change |
| Transponder dimensions | 1.8mm (dia) x
8.5mm (length) | 1.3 mm (dia) x
8.7 mm (length) |
| Patient Contacting
Material | Glass | No Change |
| Introducer Needle | 304 Stainless Steel
14G Cannula | 304 Stainless Steel
17G Cannula |
| Labeling | General for soft tissue and
specific for
prostate/prostatic bed | No Change |
| Sterile Barrier | Mylar/Tyvek Pouch
Double 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