Search Results

· The SchurSign Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Device Description

SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI).

The proposed SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location.

The proposed SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate.

The proposed SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker.

The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.

SchurSign is available in seven different sizes:

Model	Diameter (mm)	Length (mm)
SchurSign 1.5-5	1.5	5
SchurSign 1.5-8	1.5	8
SchurSign 2.0-5	2.0	5
SchurSign 2.0-8	2.0	8
SchurSign 2.0-10	2.0	10
SchurSign 2.5-10	2.5	10
SchurSign 3.0-10	3.0	10

AI/ML Overview

The provided text describes the SchurSign Tissue Marker and its comparison to a predicate device, Beacon Tissue Marker, to demonstrate substantial equivalence for FDA clearance. However, the document focuses on biocompatibility testing, imaging visibility (in vitro and in vivo), and overall device equivalence rather than the performance of an AI/algorithm-based diagnostic device.

Therefore, many of the requested points regarding AI/algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, types of ground truth for AI) are not applicable or not present in this document because the SchurSign Tissue Marker is a physical medical device, not an AI software.

Below is a summary of the information that is available in the document, framed as closely as possible to your request.

Acceptance Criteria and Study for SchurSign Tissue Marker

The document describes the acceptance criteria and studies conducted to demonstrate the substantial equivalence of the SchurSign Tissue Marker to its predicate device, the Beacon Tissue Marker (K130763). This is primarily focused on physical and biocompatibility performance, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the biocompatibility tests according to ISO standards and a demonstration of equivalent imaging visibility to the predicate. The "reported device performance" section focuses on the results of these tests and the conclusion of substantial equivalence.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Cytotoxicity	No cytotoxic potential to L-929 mouse fibroblast cells.	Test article extract showed no cytotoxic potential.
Acute Systemic Toxicity	No mortality or evidence of systemic toxicity from extracts in mice.	No mortality or evidence of systemic toxicity.
Sensitization	No delayed sensitization in guinea pig.	Not considered a sensitizer.
Irritation/Intracutaneous	Difference between test extract mean score and control blank mean score = 0.0.	Met requirements; difference was 0.0.
Subacute Toxicity	No evidence of systemic toxicity 4 weeks post-implantation in rat.	No evidence of systemic toxicity.
Implantation	Macroscopic reaction not significant compared to negative control; microscopic reaction not significant compared to negative control.	Macroscopic reaction not significant; microscopic reaction moderate.
Pyrogenicity	Non-pyrogenic according to US Pharmacopoeia.	Judged as non-pyrogenic.
Genotoxicity	Non-mutagenic in bacterial reverse mutation study.	Considered to be non-mutagenic.
Chemical Characterization	Neither components nor potential leachables pose a risk.	Concluded no risk to patient.
Imaging Visibility	Equivalent visibility to predicate device on X-ray, mammography, ultrasound, and MRI.
In Vitro (Ultrasound)	Equivalent to Beacon in ex vivo ultrasound imaging of chicken breast.	Equivalent to Beacon.
In Vivo (X-ray, Ultrasound, Histopathology)	Demonstrates localization and biological response equivalent to predicate.	Performance equivalent to predicate device; histopathology conducted.
Substantial Equivalence	Same intended use and similar characteristics/functional properties as predicate; any differences do not raise new safety/performance questions.	Concluded to be substantially equivalent in design and function to Beacon.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for each biocompatibility test or imaging study. The studies refer to "mice," "guinea pig," "rat," and "swine" without specific numbers for each group. For the in vitro imaging, it mentions "chicken breast."
Data Provenance: The studies were conducted as part of the regulatory submission, implying they were performed by or for the manufacturer. The location (country of origin) of these tests is not specified, but the manufacturer is based in Germany. The studies are prospective in nature, designed specifically for this regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This device is a physical tissue marker, not an AI/algorithmic diagnostic device requiring expert interpretation for ground truth establishment. Biocompatibility results are typically determined by laboratory assays and pathologist evaluation of tissue samples, not a consensus of clinical experts in the manner described for AI. The swine study involved histopathology, which would be interpreted by pathologists, but details on the number or qualifications are not provided.

4. Adjudication Method for the Test Set

Not Applicable. No expert adjudication method (like 2+1, 3+1) is mentioned as it's not relevant for the type of device and studies conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is specifically for evaluating the effectiveness of AI or diagnostic systems with human readers. The SchurSign Tissue Marker is a passive marker device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. The device is not an algorithm.

7. The Type of Ground Truth Used

Biocompatibility: Ground truth is based on established biological and chemical assay readouts (e.g., cell viability in cytotoxicity, observed reactions in sensitization tests, macroscopic/microscopic findings in implantation) as per ISO and USP standards.
Imaging Visibility: Ground truth is the physical presence and visibility of the marker in anatomical models (ex vivo chicken breast) and living tissue (in vivo swine), confirmed by direct observation on imaging modalities (X-ray, ultrasound) and potentially post-mortem examination or histopathology.
Histopathology: Ground truth is established by pathological examination of tissue samples from the swine study.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set exists for this device.

Ask a Question

Ask a specific question about this device

Page 1 of 1