(62 days)
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.
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.
This document is a 510(k) summary for the Permanent Beacon Transponder Soft Tissue Beacon Transponder, provided in the Beacon Care Package - Soft Tissue (17G). It compares the new device to its predicate, the Beacon Care Package - Soft Tissue (14G) (K140823).
Here's an analysis of the provided text in relation to acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or device performance in quantifiable metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The core "acceptance criteria" here is that the new device (17G) is "No Change" or equivalent to the predicate device (14G) for specified characteristics.
| Feature/Specification | Predicate Device (14G) | New Device (17G) | "Acceptance Criteria"/Comparison | Reported Device Performance (Implicit) |
|---|---|---|---|---|
| Product Code | IYE | No Change | Equivalent | IYE |
| Transponder Frequencies | 300kHz, 400kHz, 500kHz | No Change | Equivalent | 300kHz, 400kHz, 500kHz |
| Transponder dimensions | 1.8mm (dia) x 8.5mm (length) | 1.3 mm (dia) x 8.7 mm (length) | Change (Smaller diameter, slightly longer) | 1.3 mm (dia) x 8.7 mm (length) |
| Patient Contacting Material | Glass | No Change | Equivalent | Glass |
| Introducer Needle | 304 Stainless Steel, 14G Cannula | 304 Stainless Steel, 17G Cannula | Change (Smaller gauge, 17G) | 304 Stainless Steel, 17G Cannula |
| Labeling | General for soft tissue and specific for prostate/prostatic bed | No Change | Equivalent | As predicate |
| Sterile Barrier | Mylar/Tyvek Pouch, Double Barrier | No Change | Equivalent | Mylar/Tyvek Pouch, Double Barrier |
| Sterilization Method | Gamma Radiation | No Change | Equivalent | Gamma Radiation |
| MR Safety | MR Conditional | No Change | Equivalent | MR Conditional |
| Shelflife | 2 Years | No Change | Equivalent | 2 Years |
| Calypso System | For use with v3.0 or higher | No Change | Equivalent | For use with v3.0 or higher |
The explicit performance data or "acceptance criteria" for metrics like accuracy, precision, or localization capabilities are not present in this summary because the submission is for substantial equivalence based on technological characteristics being largely the same, with justifiable changes (e.g., smaller introducer needle and transponder). The assumption is that the performance established for the predicate device (K140823) carries over or is not adversely affected by the minor changes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not contain any information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). This is a 510(k) summary focused on device description and comparison to a predicate, not a detailed clinical study report.
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)
This document does not contain any information about experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This document does not contain any information about an adjudication method.
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
This document does not contain any information about an MRMC study or AI assistance. The device is a physical fiducial marker used with a radiation therapy system (Calypso System), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a physical medical device (fiducial marker) used in conjunction with a radiation therapy system. It is not an algorithm-only device, so a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This document does not describe the type of ground truth used. As it's a 510(k) summary for a physical device and not a clinical study, this information is not expected here.
8. The sample size for the training set
This document does not contain any information about a training set or its sample size.
9. How the ground truth for the training set was established
This document does not contain any information about how ground truth for a training set was established.
§ 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.