(42 days)
The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.
The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.
The provided document K071550 describes the CP Medical Pre-waxed Needles with Gold Fiduciary Markers. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive standalone performance evaluation.
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert contributions, adjudication methods, and MRMC studies, which are typical for AI/CAD device submissions, is not applicable or available in this document. The submission relies on design verification and a comparison of materials and packaging to a predicate device.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly defined in terms of specific performance metrics with acceptance criteria. The submission focuses on substantial equivalence to the predicate device (Best Radiopaque Marker, K043117) rather than setting and meeting de novo performance targets. The "acceptance criteria" here implicitly relate to demonstrating equivalent materials, packaging, and the intended function through design verification.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence to Predicate Device | The CP Medical Pre-waxed Needles with Gold Fiduciary Markers use equivalent materials to the Best Radiopaque Marker (K043117). (No specific material specifications or performance metrics provided.) |
| Packaging Equivalence to Predicate Device | The CP Medical Pre-waxed Needles with Gold Fiduciary Markers use equivalent packaging to the Best Radiopaque Marker (K043117). (No specific packaging validation results provided, only statement of equivalence.) |
| Sterilization Validation | Sterilization validation activities were performed. (Specific validation results or acceptance criteria for sterilization are not detailed beyond the statement of completion.) |
| Package Validation | Package validation activities were performed. (Specific validation results or acceptance criteria for package integrity are not detailed beyond the statement of completion.) |
| Product Integrity (Needles) | Product integrity for the pre-waxed needles component was "previously performed." (References K024372 and states no new testing required for this component.) Specifics of this prior testing or its acceptance criteria are not provided in this document. |
| Intended Use Fulfillment (Localization for Radiation Therapy) | The device is designed for interstitial placement of gold seed markers, which serve as localization devices for radiation therapy, functionally equivalent to the predicate device. (No specific clinical performance metrics provided.) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of a typical AI/CAD performance study. The submission for this type of device (implantable marker/needle) focuses on engineering design verification rather than clinical test set performance. No "test set" of patient data (images, pathology, etc.) was used for evaluating algorithm performance. The "testing and verification activities" refer to engineering and manufacturing tests (sterilization, packaging, product integrity).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. There was no test set requiring expert ground truth establishment for this device submission.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for an implantable radiographic marker and needle device, which does not involve human readers interpreting imaging with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical instrument, not an algorithm, so standalone performance in the context of AI is not applicable.
7. The Type of Ground Truth Used
Not applicable in the context of AI/CAD ground truth. The "ground truth" for this submission is whether the physical device meets engineering specifications and is equivalent to the predicate device in materials, packaging, and intended use. This is established through design verification rather than expert consensus on clinical data or pathology reports.
8. The Sample Size for the Training Set
Not applicable. This device submission does not involve a "training set" as it's not an AI/CAD system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this device.
Summary of Approach:
The K071550 submission for the CP Medical Pre-waxed Needles with Gold Fiduciary Markers followed a substantial equivalence pathway to a legally marketed predicate device (Best Radiopaque Marker, K043117). The primary evidence presented involved:
- Comparison of materials and packaging: Stating that they are equivalent to the predicate device.
- Design Verification: Confirming that engineering design inputs were achieved through activities like sterilization validation and package validation. Product integrity for the needle component was referenced as previously performed (K024372).
This type of submission does not involve the detailed performance studies or data sets typically associated with AI/CAD devices, as the product is a conventional medical instrument.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.