Search Results

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

The proposed Beacon Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The proposed Beacon Tissue Marker is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. The proposed Beacon Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

The proposed Beacon Tissue Marker is comprised of Oxford Performance Materials (OPM) OXPEKK-IG200 filled with Barium Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.

The delivery system is a sterile, single patient use, pre-loaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, tabs to retain the tissue marker, and a tip cover. 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 Beacon Tissue Marker delivery system is used to place the Beacon Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a beveled 12 cm / 14 gauge needle with 1 cm depth marks and a plunger.

Here's an analysis of the acceptance criteria and study for the Beacon Tissue Marker, based on the provided 510(k) summary:

Device: Beacon Tissue Marker™ (Implantable Clip)

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not specify the exact sample sizes used for each of the non-clinical tests (e.g., deployment force, marker expulsion, etc.). It only broadly states that "All testing met pre-defined acceptance criteria."

The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given that this is a non-clinical, bench-top testing summary, it would typically be prospective testing conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the 510(k) summary. The testing described for this device is non-clinical, engineering-based performance testing (e.g., deployment force, bond strength, dimensions). There is no mention of medical image interpretation or human subject studies that would require experts to establish a "ground truth" for diagnostic or clinical performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which are not described in the non-clinical testing for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it relevant for the type of device and testing described. MRMC studies are used to assess the impact of a medical device (often AI-assisted diagnostic tools) on human reader performance in interpreting medical images or data. The Beacon Tissue Marker is an implantable clip for marking soft tissue, and its performance is evaluated through engineering and biocompatibility testing, not clinical diagnosis or interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

No. A standalone algorithm performance study was not done. This device is a physical implantable marker and does not involve any algorithms or artificial intelligence for its function or evaluation in the context of this 510(k) summary.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical testing consisted of engineering specifications and predefined performance thresholds. For example:

• Deployment force might have a specified range (e.g., 5N-15N).
• Marker retention might be evaluated by ensuring the marker does not prematurely release under specified forces.
• Dimensions would be compared against design specifications.
• Package integrity would be assessed against industry standards for sterility barrier and leak protection.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical device testing.

8. Sample Size for the Training Set

This information is not applicable and not provided. Since the device does not involve algorithms or AI, there is no "training set" in the context of machine learning. The testing performed is to validate the physical and functional aspects of the device against engineering requirements.

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

This information is not applicable (as there is no training set).

Ask a specific question about this device

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

The proposed Beacon Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The proposed Beacon Tissue Marker is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. The proposed Beacon Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

The proposed Beacon Tissue Marker is comprised of Oxford Performance Materials (OPM) OXPEKK-IG200 filled with Barium Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.

The proposed Beacon Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the Beacon 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 Beacon Tissue Marker delivery system is used to place the Beacon Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a beveled 12 cm / 14 gauge needle with 1 cm depth marks and a plunger.

The provided document is a 510(k) summary for the Beacon Tissue Marker, which describes a device modification. It states that the purpose of the submission is to seek clearance for a modification to an already cleared tissue marker to be inserted into an already cleared delivery system.

Therefore, this document does not describe a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to pre-existing predicate devices based on the modification of components already cleared by the FDA. The submission largely relies on the prior clearance of its constituent parts and asserts that the combined device does not raise new questions of safety or efficacy.

As a result, I cannot provide the specific details requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies would typically be conducted for novel devices or significant modifications, which is not the case described here.

The document indicates that the change is the combination of:

• KMD-Mark1 Tissue Marker (K093473) - already cleared
• BiomarC® Tissue Marker delivery system (K063193) - already cleared

The document states: "Scion Medical Technologies, LLC believes that the proposed Beacon Tissue Marker... does not raise any new or significant questions of safety and efficacy and is substantially equivalent to the predicate Kent Medical Devices, Inc. KMD-Mark1 Tissue Marker (K093473)... and the predicate Carbon Medical Technologies, Inc. BiomarC Tissue Marker (K063193)."

This type of submission often relies on a comparison of technical characteristics and existing performance data of the predicate devices rather than new, extensive clinical studies for the combined product.

Ask a specific question about this device

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.q., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated control unit handle (the CASSI II handle), a valve block, battery, cryogen, a biopsy needle (CASSI QuadPoint comprised of a sticking needle and cutting cannula/piston assembly), and a sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CASSI™ II Rotational Core Biopsy System, addressing your requested points:

The provided document is a 510(k) summary for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this 510(k) submission is for an updated branding and packaging configuration, along with minor modifications, of an already cleared predicate device (Sanarus CASSI™ II Rotational Core Biopsy System K051581). Therefore, the regulatory decision is based on substantial equivalence to that predicate device, not on new performance studies establishing new acceptance criteria.

The core argument in this 510(k) is that the modified device "do[es] not raise any new or significant questions of safety and efficacy and are substantially equivalent to the predicate Sanarus CASSI II Rotational Core Biopsy System." This implies that the original predicate device would have had studies and acceptance criteria to demonstrate its safety and efficacy, but those details are not present in this document.

Therefore, I cannot populate most of your requested information based on the provided text. However, I can explain why for each point:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not applicable. No new performance study data is described in this 510(k) summary.
• Data provenance: Not applicable. No new performance study data is described in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No new performance study requiring ground truth establishment is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No new performance study requiring adjudication is described in this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This device is a biopsy system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a biopsy system, not an algorithm, and the submission does not describe a standalone performance study.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. No new performance study requiring ground truth is described in this 510(k) summary.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/algorithmic device and no new performance study data is presented.

9. How the ground truth for the training set was established

• Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of what the document does indicate:

• Device: CASSI™ II Rotational Core Biopsy System with the CASSI QuadPoint™ Disposable
• Purpose of Submission: Seek clearance for updated branding and packaging, and summarize minor modifications to the predicate device (Sanarus CASSI™ II Rotational Core Biopsy System, K051581).
• Conclusion: The manufacturer believes the modified device is substantially equivalent to the predicate and does not raise new safety or efficacy questions.
• Indications for Use: Obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors, and breast abnormalities). Not intended for use in bone.
• Classification: Class II, 21 CFR 876.1075 (Gastroenterology-urology biopsy instrument).

Ask a specific question about this device