(61 days)
Not Found
No
The description focuses on electromagnetic and optical technology for localization and tracking, with no mention of AI or ML algorithms for data processing or decision-making.
No
The device is described as an "adjunct in treatment planning and radiation therapy" and is used to "align and monitor the patient's position relative to the isocenter." It localizes and tracks a treatment target but does not directly treat the disease or condition. The Beacon® transponders are used to "mark soft tissue for future therapeutic procedures," indicating the therapeutic action is separate.
No
The device is used for patient alignment and monitoring during radiation therapy, not for diagnosing a disease or condition. The Beacon transponders are used to mark tissue for future therapeutic procedures, and the system localizes the treatment target, which implies a disease has already been diagnosed and treatment planned.
No
The device description explicitly states the system utilizes "non-ionizing electromagnetic and optical technology" and detects signals from "passive implanted markers, called Beacon transponders." This indicates the system includes hardware components beyond just software.
Based on the provided information, the Calypso® 4D Localization System is not an IVD (In Vitro Diagnostic) device.
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.
- Calypso System Function: The Calypso System works by detecting electromagnetic signals from implanted markers (Beacon transponders) within the patient's body. It is used for localization and monitoring of a treatment target during radiation therapy, which is an in-vivo procedure.
- No Sample Analysis: The system does not analyze biological samples taken from the patient.
Therefore, the Calypso System falls under the category of a medical device used for treatment planning and delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.
Permanent Beacon® transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue.
Product codes
IYE
Device Description
The Calypso 4D Localization System (Calypso System) utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and the peri-prostatic 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)
Performance testing demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Ko 80726
510(K) SUMMARY OF SAFETY & EFFECTIVENESS 5.0
MAY 1 4 2008
This 510(k) Summary of Safety and Effectiveness is provided in accordance with 21 CFR 807.92.
March 13, 2008 Date of preparation:
Submitter information:
Calypso® Medical Technologies, Inc. 2101 Fourth Avenue, Suite 500 Seattle, WA 98121
Phone: 206-254-0600 Fax: 206-254-0606
- Sue Ridge Contact: Regulatory Affairs/Quality Systems Manager
- Calypso® 4D Localization System Device trade name:
- Patient localization system Common name:
Accelerator, Linear, Medical Classification name:
- CFR 892.5050 Classification: Class II Product code - IYE
- Calvoso® 4D Localization System Predicate devices: (K060906)
RadioMed™ Soft Tissue Marker (K031206)
Indications for Use:
The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.
Permanent Beacon® transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue.
1
Device Description:
The Calypso 4D Localization System (Calypso System) utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.
Summary of Performance Testing:
Performance testing demonstrated substantial equivalence.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Ms. Sue Ridge Regulatory Affairs/Quality Systems Manager Calypso Medical Technologies, Inc. 2101 Fourth Avenue, Suite 500 SEATTLE WA 98121
Re: K080726
Trade/Device Name: Calypso 4D Localization System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 13, 2008 Received: March 19, 2008
Dear Ms. Ridge:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.
3
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 Ant 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 liusting (21 CFR Part 807); labeling (21 CFR Part 801); 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 100-1050,
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device of your device to results your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance a one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Shall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html U
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Calypso® 4D Localization System
Indications For Use:
The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Beacon® transponders are indicated for use to radiographically and electromagnetically marks soft tissue for future therapeutic procedures.
Permanent Beacon® transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Armi N. Whang
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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