(34 days)
The Pre-Loaded Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The Pre-Loaded Visicoil a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm. The Pre-Loaded Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method. Depending on the coil size (0.35mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle.
This 510(k) submission (K070305) for the RadioMed™ Soft Tissue Marker (Pre-Loaded Visicoil Marker) is a Special 510(k), which implies that the fundamental scientific technology and the intended use of the modified device have not changed from the predicate device (Visicoil™ Marker, K031206). Therefore, the performance testing focuses on demonstrating that the device continues to meet established safety and effectiveness criteria, particularly considering the changes introduced (pre-loading in the needle and sterilization method change).
The provided document does not contain a detailed study report with specific quantitative acceptance criteria or a comprehensive clinical study. Instead, the submission relies on the established substantial equivalence to the predicate device and adherence to regulatory standards.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or a "reported device performance" section with metrics like sensitivity, specificity, accuracy, etc., as typically seen in submissions for AI/diagnostic devices.
Instead, it indicates that the device has passed adherence to regulatory and manufacturing standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The modified device (Pre-Loaded Visicoil) maintains the same fundamental scientific technology and intended use as the predicate device (Visicoil™ Marker). This implies that its radiographic marking capabilities remain unchanged. | The "Comparison of Technological Characteristics" states: "The fundamental scientific technology of the modified device has not changed." and "The design of the predicate Visicoil Marker is identical to the Pre-Loaded Marker." The "Intended Use" and "Indications for Use" are also stated as unchanged. This indirectly confirms that the performance in marking soft tissue for future therapeutic procedures is maintained. |
| Sterilization Efficacy | The new sterilization method (Ethylene Oxide - EO) must effectively sterilize the device to ensure patient safety. This implies meeting industry standards for sterility assurance. | "Sterilization is achieved by a validated EO sterilization method." While specific validation data (e.g., Sterility Assurance Level - SAL) is not provided in this summary, the statement indicates that a validated method is used, implying successful performance against sterility criteria. |
| Biocompatibility | The materials used for the device must be biocompatible with human tissue, especially since the change involves pre-loading in a delivery needle. The gold coil material is assumed to be biocompatible, as it's identical to the predicate. The new needle and any associated components must also be biocompatible. (Not explicitly mentioned as a new test but implicitly covered by relying on predicate and QSR). | Not explicitly detailed in the provided text. However, adherence to FDA QSR Part 820 ("Good Manufacturing Practices") implicitly covers material and process controls that ensure biocompatibility. Since the core gold coil material is identical to the predicate, and the needle type (CP Medical, Class I exempt) is standard, new biocompatibility testing might not have been deemed necessary beyond standard QSR compliance. |
| Device Integrity/Stability | The pre-loading of the coil within the needle must not compromise the integrity of the coil (e.g., kinking, damage) or its ability to be deployed effectively. The device must also remain stable throughout its shelf life under the new sterilization and packaging. (Not explicitly mentioned as a new test but implicitly covered by relying on predicate and QSR). | "Pre-Loaded Visicoil is packaged sterile, for single use." "To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures." This implies that the device integrity and functionality for deployment are verified at manufacturing. |
| Manufacturing Quality | Compliance with the FDA Quality System Regulation (QSR) 21 CFR Part 820. | "The Pre-Loaded Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR." "Summary of standards achieved: FDA QSR 21 CFR Part 820 Good Manufacturing Practices." This indicates adherence to established quality and control procedures for manufacturing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a sample size for a separate "test set" in the context of clinical performance or human reader studies. This submission is for a modified device and relies on showing substantial equivalence, rather than new clinical efficacy data.
- Data Provenance: Not applicable in the context of a new clinical study. The data provenance implicitly stems from the predicate device's established performance and the manufacturer's internal validation of manufacturing and sterilization processes.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The document does not describe a study involving expert readers or the establishment of ground truth by experts for a new diagnostic or interpretative purpose.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable. There is no mention of a study involving human interpretation or a need for adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described in this document. This is not a study about human readers improving with or without AI assistance but rather a device modification submission.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone performance study (algorithm only) was not conducted or described. This device is a physical marker, not a diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the purposes of this submission, the "ground truth" is implicitly the established safety and effectiveness of the predicate device and the validated performance of the manufacturing and sterilization processes. There is no new "ground truth" established as part of a diagnostic accuracy study.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document is not describing an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable for the reasons stated above.
§ 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.