FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave.

The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. 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.

The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.

AI/ML Overview

This document describes a 510(k) submission for the RadioMed™ Soft Tissue Marker, which is a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against acceptance criteria in a comprehensive study.

Based on the provided text, there is no specific acceptance criteria table or a study proving the device meets distinct performance criteria in terms of accuracy, sensitivity, specificity, etc. This is because 510(k) submissions for devices like markers often rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance testing mentioned is related to manufacturing standards and visibility, not a clinical effectiveness study with defined performance metrics.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Missing Information (Not Applicable to this 510(k) submission):

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices and manufacturing quality, not a comparison against specific clinical performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of a clinical performance study as described in the prompt.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical marker, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Information that is present or can be inferred:

Overview of Evidence Presented:

The submission focuses on comparing the RadioMed™ Soft Tissue Marker to existing predicate devices (RadioMed™ Marker, Implanter/Adjustable/Anderson's Marker, Extracranial Marker) to demonstrate substantial equivalence. The key aspects of this comparison are:

Intended Use: The intended use and indications for use have not changed from the predicate device.
- Intended Use: "RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures."
Technological Characteristics: The fundamental scientific technology of the modified device has not changed.
- Material: The material (metallic gold) is identical to the Anderson Marker (K940121) and Extracranial Marker, and is widely used in other approved medical devices with a "safe history of use." This obviates the need for additional biocompatibility testing.
- Design: The design is identical to the predicate RadioMed™ Marker (K022326) except for the outside diameter (OD) and material (gold vs. unspecified material in K022326). The new marker ranges in OD between 0.75mm and 1.2mm.
Performance Testing (Non-Clinical):
- Summary of standards achieved:
  - FDA QSR 21 CFR Part 820 Good Manufacturing Practices
  - AAMI Standard 11134-1994 Recommended practice for Steam Autoclave
- Visibility Studies: "Visibility Studies (see section H - Performance Testing)" are mentioned, implying that the marker's visibility under radiographic imaging was assessed. However, no specific data, acceptance criteria, or experimental setup for these visibility studies are provided in this summary.

Conclusion from a 510(k) Perspective:

The FDA's letter (K031206) confirms that they have "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the information provided in the 510(k) submission, primarily focusing on the safety and effectiveness as demonstrated through comparison to predicates and adherence to manufacturing and sterilization standards, rather than direct clinical performance against novel acceptance criteria.

In summary, for this specific 510(k) submission, the "acceptance criteria" and "study" are intrinsically linked to demonstrating substantial equivalence through comparison with predicate devices and adherence to established manufacturing and safety standards, rather than a clinical trial proving specific performance metrics of an AI algorithm.

Summary

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.