(27 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Hemostasis (rapid control of bleeding) | Intended for the local management of bleeding wounds and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. |
| Bacterial Barrier | Intended to provide a barrier to bacterial penetration of the dressing in all patients. Has demonstrated in-vitro antibacterial activity for up to 144 hours (6 days) in certain strains (Escherichia Coli, Staphylococcus Aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, Bacillus cereus, Enterococcus faecium, Candida Albicans and Asperigillus brasiliensis). |
| Wound Healing Environment | Provides an optimal wound healing environment. |
| Biocompatibility | Enabled by a proprietary formulation of poly-D-glucosamine and poly-N-acetylglucosamine. |
| Biodegradability | Enabled by a proprietary formulation of poly-D-glucosamine and poly-N-acetylglucosamine. |
| Sterility | Sterile, packed in a foil pouch and sterilized by E-beam radiation to a 10^-6^ SAL. |
| Equivalence to Predicate Device | The technological characteristics of the modified Clo-SurPLUS PAD™ are the same as the predicate device (Scion Cardio-Vascular, Inc, K092552, CLO-SURPLUS P.A.D.). Works in the same manner as the approved predicate device. |
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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