(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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Scion Cardio-Vascular, Inc. c/o C2C Development, LLC Craig Pagan 1050 W NASA Boulevard, Suite 136 Melbourne, Florida 32901
July 28, 2023
Re: K112961 Trade/Device Name: Clo-SurPLUS P.A.D. Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Craig Pagan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 31, 2011 and correction letter dated May 1, 2012. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely.
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Scion Cardio-Vascular, Inc. % C2C Development, LLC Mr. Craig Pagan 1050 W NASA Boulevard, Suite 136 Melbourne, Florida 32901
Re: K112961 Trade/Device Name: Clo-Sur-LUS P.A.D. Regulatory Class: Unclassified Product Code: FRO Dated: September 29, 2011
Received: October 4, 2011
MAY 1 2012
Dear Mr. Pagan:
This letter corrects our substantially equivalent letter of October 31, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Craig Pagan
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mada M Millan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5 - INDICATIONS FOR USE STATEMENT
112961 510(k) Number:
Clo-Surplus P.A.D. Device Name:
INDICATIONS:
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.
Prescription Use _ > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danill Ksomefu MXM
(Division Sign Off)
(Division Sign-Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K112961
Page 1 of 1
Scion Cardio-Vascular, Inc. Special 510(k) Submission - Modified Clo-Sur PLUS PAD
Page 18 of 47
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K112961
page 1 of 2
OCT 3 1 2011
SECTION 6 - 510(k) SUMMARY
Submitted by:
Scion Cardio-Vascular, Inc. 14256 S.W. 119th Avenue Miami, FL 33186 Phone: (305) 259-8880 Fax: (305) 259-8878
Contact Person:
Lou Rose 14256 S.W. 119th Avenue Miami, FL 33186 Phone: (305) 259-8880 Ext 103 Fax: (305) 259-8878
Date Prepared:
September 14, 2011 Clo-Surpl.us PAD™
Proprietary Name:
Common Name:
Classification:
Classification Name:
Predicate Device:
Device Description:
Intended Use:
Topical Hemostasis Pad
Unclassified
Topical Wound Dressing Pad
Scion Cardio-Vascular, Inc, K092552, CLO-SURPLUS P.A.D.,
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.
The Scion Cardio-Vascular Clo-Sur-Lus 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
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K112961
page 2 of 2
in patients following hemodialysis and for those on anticoagulation therapy.
The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites, and sites involving percutaneous catheters, tubes and pins.
Technological Characteristics
The Scion Cardio-Vascular Clo-SurPLUS PADTM is a soft, nonwoven pad made of a proprietary formulation of poly-Dglucosamine and poly-N-acetylglucosamine derived from chitosan. The natural biological properties of this material gives the Clo-Sur-LUS PADTM an advantage as an effective bacterial barrier while providing for an optimal wound healing environment.
Several biomedical applications of poly-D-glucosamine and poly-N-acetyglucosamine have been reported. The studies represent research on the safety and use of these materials, which have been published over a period of decades by scientists from around the world. The scientific literature satisfies the requirement that a general recognition of safety requires common knowledge about the substance throughout the scientific community. This formulation has many useful and advantageous properties in their application as a wound dressing, namely biocompatibility, biodegradability, hemostatic activity, anti-infectional activity.
The technological characteristics of the modified Clo-SurPLus PAD™ are the same as the predicate device. The Scion Cardio-Vascular modified Clo-SuPLUS PAD™ works in the same manner as the approved predicate device.
Scion Cardio-Vascular, Inc. Special 510(k) Submission - Modified Clo-Sur PLUS PAD
N/A