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The Scion Cardio-Vascular Clo-SurPUS P.A.D. is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy.

The dressing is indicated for the following wounds: lacerations, nose bleeds, surgical debridement sites, skin surface puncture sites, vascular sites, and sites involving percutaneous catheters, tubes and pins.

The Scion Cardio-Vascular Clo-SurPLUS PADTM is a soft, nonwoven topical pad that provides an optimal wound healing environment, combining an effective antibacterial barrier activity with exudates management.

An optional slit Clo-SurfLUS PAD™ allows for easier placement of the dressing around pins and tubes.

Clo-Sur PLUS PADTM has demonstrated in-vitro antibacterial activity for up to 144 hours (6 days) in certain strains shown to be detrimental to wound healing such as: Escherichia Coli, Staphylococcus Aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, Bacillus cereus, Enterococcus faecium, Candida Albicans and Asperigillus brasiliensis.

Clo-SurPLUS PAD™ is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10°6 SAL.

Here's a breakdown of the requested information based on the provided text. However, it's important to note that the document is a 510(k) premarket notification letter and summary for a medical device (Clo-SurPLUS P.A.D.), not a study report. Therefore, much of the requested information regarding detailed study design, acceptance criteria, and specific performance metrics isn't typically included in this type of FDA communication.

The device is the Scion Cardio-Vascular Clo-SurPLUS P.A.D., a topical hemostasis pad.

1. Table of Acceptance Criteria and Reported Device Performance

This document primarily describes the device's intended use and its substantial equivalence to a predicate device, rather than presenting a formal study with explicit acceptance criteria and corresponding performance metrics for a new claim. The "performance" mentioned relates to its characteristics and in-vitro antibacterial activity.

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

This document does not specify a "test set" sample size in the context of a clinical study for performance evaluation against acceptance criteria. The information provided is primarily about the device's characteristics and indications for use, often supported by in-vitro or pre-clinical data (like the antibacterial activity) and demonstrating substantial equivalence to a predicate.

• Sample Size: Not specified for a clinical test set.
• Data Provenance: The antibacterial activity is stated as "in-vitro." Other claims are based on the known properties of the material (poly-D-glucosamine and poly-N-acetylglucosamine) supported by "scientific literature" gathered "over a period of decades by scientists from around the world." There is no mention of country of origin for specific clinical data or whether it's retrospective or prospective.

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

This information is not provided in the document. The FDA 510(k) process for this device relies on demonstrating substantial equivalence to a predicate device and presenting data (like in-vitro studies) that support its stated characteristics and intended use. It does not mention a specific "test set" and ground truth established by experts in the context of a new clinical or comparative study for this submission.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a clinical study with a test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not indicate that an MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. This device is a topical hemostasis pad.

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

Not applicable. This device is a physical medical device (a pad), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the in-vitro antibacterial activity mentioned, the ground truth would be established through standard microbiological assays, detecting the reduction or inhibition of bacterial growth. For claims of biocompatibility, biodegradability, and hemostatic activity, the ground truth relies on the established scientific understanding and published research on chitosan-derived materials (poly-D-glucosamine and poly-N-acetylglucosamine). There is no mention of pathology or outcomes data as a 'ground truth' for this specific 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. This document is for a physical medical device, not an AI or algorithm-based device that would have a training set.

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

Not applicable. As above, there is no training set for this type of device.

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I apologize, but the document provided is a letter from the FDA to Scion Cardio-Vascular, Inc. regarding an administrative change to a previous substantial equivalence determination. It discusses a change in product codes for the Clo-SurPLUS P.A.D. device.

This document does not contain any information about:

• Acceptance criteria for the device
• Device performance data
• Details of any studies conducted (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

Therefore, based solely on the provided text, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

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The M-BolusTM Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.

M-BOLUSTM Embolic Microspheres are made out of a biocompatible, non-degradable and non-absorbable synthetic polymer called Polyvinyl Alcohol (PVA). The M-BOLUSTM Embolic Microspheres are precisely manufactured spheres, with a smooth and lightly porous surface with hydrophilic characteristics. The M-BOLUSTM Embolic Microspheres, which are supplied in a hydrated state (0.9% Sodium Chloride), are soft and flexible allowing them to be compressed/deformed as they travel through the lumen of a delivery catheter or the vasculature. The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres are substantially equivalent to the predicate devices.

The provided text is a 510(k) summary for the M-BOLUS™ Embolic Microspheres. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way one would for a novel device or AI algorithm.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission. This document is a premarket notification for a medical device that claims substantial equivalence to an already approved device.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or detailed performance results in the format of a table as typically seen for AI/software-based devices. The basis for acceptance is stated as "substantial equivalence" to a predicate device.

2. Sample size used for the test set and the data provenance

Not applicable. This device is a physical embolic microsphere, not an AI algorithm. There is no "test set" of data in the typical sense for an AI model. Biocompatibility testing was mentioned, but no sample sizes or data provenance for that testing are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" to be established by experts for a physical device like embolic microspheres in this context. The evaluation is based on material properties, design, and intended use as compared to a predicate device.

4. Adjudication method for the test set

Not applicable. There is no "test set" and thus no adjudication method needed for expert consensus.

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

Not applicable. This device is a physical medical device (embolic microspheres), not an AI algorithm intended for use by human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

Not applicable. As this is a physical device, the "ground truth" concept in the context of expert consensus or pathology for diagnostic AI is not relevant. The substantial equivalence claim is based on comparing the device's technical characteristics, materials, and intended use to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable. This is not an AI algorithm that requires a training set or ground truth for its development.

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The Scion Cardio-Vascular Clo-SurPLUS P.A.D., is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites for vascular procedures, percutaneous catheters or tubes.

The Scion Cardio-Vascular Clo-SurPLUS P.A.D. is a soft, non-woven pad that provides an optimal wound-healing environment, combining an effective antibacterial barrier activity with exudates management. Clo-SurPLUS P.A.D. has demonstrated in-vitro antibacterial activity meant to prevent microbial colonization and penetration of the dressing. Clo-SurPLUS P.A.D. is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.

The provided text describes a 510(k) submission for the Scion Cardio-Vascular Clo-SurPLUS P.A.D., which is a topical hemostasis pad. The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically involves demonstrating that the new device has similar technological characteristics and performs as safely and effectively as the predicate.

The document discusses an in-vitro study conducted to demonstrate the effectiveness of the Clo-SurPLUS P.A.D. as an antimicrobial substance. However, it explicitly states: "The clinical significance of the findings in this vitro study is unknown." This indicates that no clinical study (human trials) was performed to establish clinical performance or acceptance criteria in a real-world setting for this particular 510(k) submission.

Therefore, many of the requested details, such as specific acceptance criteria for clinical performance, sample sizes for test sets (clinical), ground truth methodologies, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not present in this document because a clinical performance study was not the basis of this 510(k) submission. The equivalence was primarily based on the device's technological characteristics and its in-vitro antimicrobial activity.

Here's a breakdown of the information available based on your request, highlighting what is provided and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set (in-vitro study): The sample size for the in-vitro antimicrobial study involved challenging three product concentrations of Clo-SurPLUS P.A.D. with a 10^5 CFU/mL concentration of eight different organisms (bacteria and fungi). This is an in-vitro (laboratory) study, not a clinical test set.
• Data Provenance: In-vitro laboratory data. The country of origin is not specified but is typically internal to the manufacturer or a contract lab. The study was conducted as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable for the in-vitro antimicrobial study. Ground truth in such a study is established by standard microbiological techniques and quantification of microbial growth/reduction, not by expert consensus in a clinical sense.

4. Adjudication method for the test set

• Not applicable as it was an in-vitro quantitative assay, not a clinical trial requiring adjudication of human observations or interpretations.

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, a MRMC comparative effectiveness study was not done. This device is a topical hemostasis pad, not an AI-powered diagnostic or interpretive device.

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

• Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the in-vitro antimicrobial study, the ground truth was established by quantitative microbiological assay measuring the concentration of various bacterial and fungal organisms over time. For the basis of the 510(k), the ground truth for substantial equivalence was established by comparing the technological characteristics of the Clo-SurPLUS P.A.D. to predicate devices based on existing scientific literature on poly-D-glucosamine and poly-N-acetylglucosamine.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable.

Summary of Device Rationale for 510(k) Clearance:

The 510(k) submission for the Clo-SurPLUS P.A.D. focused on establishing substantial equivalence to legally marketed predicate devices primarily through:

• Technological Characteristics: The device is described as a soft, non-woven pad made of poly-D-glucosamine and poly-N-acetylglucosamine (chitosan), noting its biocompatibility, biodegradability, hemostatic, and anti-infective properties, which are similar to existing literature and predicate devices.
• In-vitro Antimicrobial Activity: An in-vitro study demonstrated that the pad could reduce the concentration of various bacteria and fungi. However, the document explicitly states that the clinical significance of these in-vitro findings is unknown.
• Intended Use: The intended use for local management of bleeding wounds, bacterial barrier, and promotion of hemostasis aligns with the predicate devices.

This 510(k) summary does not describe a clinical study (i.e., human trials) to prove specific clinical acceptance criteria for the device's performance in patients. The clearance was based on in-vitro data and demonstrating similar technological characteristics and intended use to predicate devices already on the market.

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