(41 days)
Not Found
No
The summary describes a system for patient localization using electromagnetic and optical technology and mentions software and hardware updates for gating capabilities. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML models, or image processing which is often a domain for AI/ML in medical devices.
No.
The device is used as an adjunct in treatment planning and radiation therapy to monitor patient position, and its transponders mark tissue for future therapeutic procedures, but it does not directly perform a therapeutic intervention.
No
The device is described as a localization system used as an adjunct in treatment planning and radiation therapy to align and monitor patient position, and the Beacon transponders are used to mark soft tissue. This indicates a role in therapeutic procedures and patient positioning, not diagnosis.
No
The device description explicitly states that the modification includes "updated computer software and hardware."
Based on the provided information, the Calypso 4D Localization System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Calypso System's Intended Use: The Calypso System is intended for use in vivo (within the living body) as an adjunct in treatment planning and radiation therapy to align and monitor the patient's position. It uses implanted transponders and external electromagnetic and optical technology.
- No Specimen Examination: The system does not examine specimens derived from the human body. It interacts directly with the patient's body and implanted devices.
Therefore, the Calypso 4D Localization System falls under the category of a medical device used for treatment planning and delivery, not an In Vitro Diagnostic.
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 (i.e., prostatic bed).
Product codes (comma separated list FDA assigned to the subject device)
LHN, IYE
Device Description
The Calypso System with the Dynamic Edge™ Gating modification enables the Calypso System to interface with radiation therapy systems configured with gating capabilities via an interface to external systems. This modification includes updated computer software and hardware.
All other features of the Calypso System remain as cleared by K060906 and K080726.
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 (i.e., prostatic bed).
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)
The Calvoso System has undergone performance testing, including design verification and validation, software verification and validation, electromagnetic compatibility as well as other assessments to demonstrate that the system meets its intended use, is safe and effective, and performs comparably to the predicate device.
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.
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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.
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6.0 Summary of Safety and Effectiveness
SEP 3 0 2010
This 510(k) Summary of Safety and Effectiveness is provided in accordance with 21 CFR 807.92.
Date of preparation: August 19, 2010
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
- Device trade name: Calypso® System with Dynamic Edge™ Gating
Patient localization system Common name:
Regulation name: Medical charged-particle radiation therapy system
- CFR 892.5050 Regulation: Class II Product code – LHN, IYE
- Predicate devices: Calypso® 4D Localization System (K060906; K080726)
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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 (i.e., prostatic bed).
Device Description:
The Calypso System with the Dynamic Edge™ Gating modification enables the Calypso System to interface with radiation therapy systems configured with gating capabilities via an interface to external systems. This modification includes updated computer software and hardware.
All other features of the Calypso System remain as cleared by K060906 and K080726.
Summary of Technological Characteristics:
As described in K060906 and K080726, the Calypso System with the gating interface option utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target.
Summary of Performance Testing:
The Calvoso System has undergone performance testing, including design verification and validation, software verification and validation, electromagnetic compatibility as well as other assessments to demonstrate that the system meets its intended use, is safe and effective, and performs comparably to the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.
OCT 2 1 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ed Vertatschitsch Chief Executive Officer Calypso Medical Technologies, Inc. 2101 4th Avenue, Suite 500 SEATTLE WA 98121
Re: K102373
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: LHN Dated: September 22, 2010 Received: September 23, 2010
Dear Mr. Vertatschitsch:
This letter corrects our substantially equivalent letter of September 30, 2010.
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 (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 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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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5.0 Indications for Use Statement
SEP 30 2010
510(k) Number (if known): _ |くし2373
Calypso 4D Localization System Device Name:
Indication 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 (i.e., prostatic bed).
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Bvaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K.K102373
Section 5.0