(206 days)
- Intended to be used as a universal diaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
- Intended for use by a qualified/trained doctor or technologist on both and pediatric subjects taking diagnostic and fluoroscopic exposures of the whole body, skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in prone or supine position.
The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis and treatment.
This 510(k) submission (K133553) describes a modification to an existing device, the KALARE (DREX-KL80), which involves the addition of a previously cleared Flat Panel Detector (FPD). As such, the study performed is a justification of substantial equivalence rather than a detailed performance study against specific acceptance criteria for a novel device.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | The device is designed and manufactured under Quality System Regulations (21 CFR § 820 and ISO 13485). |
| Conforms with applicable parts of IEC60601-1, IEC 60601-2-7, IEC60601-2-28, and IEC 60601-2-32 standards. | |
| Meets all requirements of the Federal Diagnostic Equipment Standard (21 CFR §1020). | |
| Effectiveness | Bench testing: Confirmed that the installation of the detector met the stated specifications of the component manufacturer. |
| Comparative Testing: Image quality, artifacts, and motion/dynamic capabilities were compared between the predicate device and the modified device. | |
| Conclusion: The testing demonstrated that substantial equivalence to the predicate device could be proven without the use of clinical images. | |
| Indications for Use Unchanged | The modifications incorporated into the KALARE do not change the indications for use or the intended use of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense of a clinical test set. The study primarily involved bench testing and comparative non-clinical performance evaluations.
- Data Provenance: The testing was conducted in accordance with applicable standards published by the International Electromechanical Commission (IEC). The device's manufacturing site is in Japan (Toshiba Medical Systems Corporation). The specific location or "provenance" of the bench testing is not explicitly stated beyond "Testing of the modified system was conducted...". The study type is a verification and validation study focused on demonstrating substantial equivalence through non-clinical means.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided because the study did not involve a clinical test set with a need for expert-established ground truth. The evaluation was primarily technical and comparative against the predicate device's established performance and component specifications.
4. Adjudication Method for the Test Set
- Not applicable, as no external expert adjudication of clinical cases was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "The conclusion of this testing demonstrated that substantial equivalence to the predicate device could be proven without the use of clinical images."
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done for a new or modified algorithm. The device is an X-ray system that incorporates a (modified) detector, not an AI algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this submission would be defined by the technical specifications of the previously cleared FPD component, the established performance characteristics of the predicate device, and the applicable industry standards (IEC, 21 CFR §1020). The testing aimed to show that the new configuration met these technical and performance benchmarks.
8. Sample Size for the Training Set
- Not applicable. This is a submission for a modification to a medical device (an X-ray system), not for a machine learning or AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no training set for an AI algorithm.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.