(61 days)
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.
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.
The provided 510(k) summary for the Calypso® 4D Localization System (K080726) does not contain detailed information about specific acceptance criteria and a study proving that the device meets these criteria. The document states "Performance testing demonstrated substantial equivalence," but it lacks the specific data, methodology, and results required to answer many of your questions.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| (e.g., Accuracy, Precision, Response Time, etc., with quantitative thresholds) | (e.g., Achieved accuracy of X, precision of Y, etc.) |
Explanation: The document does not list any specific performance metrics or thresholds that the device was required to meet. It broadly states "Performance testing demonstrated substantial equivalence," but no details on what was tested or the results are provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Information not provided. The document does not mention any test set sample sizes, data provenance (country of origin), or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Information not provided. The document does not describe any human expert involvement in establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Information not provided. Since no expert review or test set is described, no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a patient localization system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The primary function is to track the physical position of a treatment target. The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's core function is "algorithm only" in the sense that it automatically detects and tracks transponders. However, the document does not explicitly provide data from a "standalone" performance study in the way this question is typically asked for AI diagnostic tools (i.e., comparing algorithm output to ground truth without human intervention). The "performance testing" mentioned is likely related to the system's ability to accurately and precisely localize the transponders.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information not provided. The document does not specify how "ground truth" was established for any performance testing. For a localization system, ground truth would likely involve highly accurate physical measurement systems.
8. The sample size for the training set
Information not provided. This device is not described as a machine learning/AI predictive model that would typically have a "training set" in the conventional sense. Its function relies on detecting electromagnetic signals from transponders, not on learning patterns from a large dataset.
9. How the ground truth for the training set was established
Information not provided. As mentioned above, a training set in the AI context is not applicable here given the device's description.
In summary, the provided 510(k) summary is very high-level and focuses on the regulatory aspects of substantial equivalence, rather than providing detailed technical performance study results and methodologies. For a device of this nature (a localization system), the performance testing would typically involve evaluating accuracy, precision, and response time under various conditions (e.g., different transponder configurations, distances, and potential interference). However, these details are not present in this document.
{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
Page 1 of __
§ 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.