(159 days)
Not Found
No
The document describes a topical hemostasis pad and its in-vitro antimicrobial testing, with no mention of AI or ML technology.
Yes
The device is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration, which are therapeutic actions.
No
The device is described as a hemostasis pad intended for local management of bleeding wounds and to provide a barrier to bacterial penetration, not for diagnosing conditions.
No
The device description clearly states it is a "soft, non-woven pad" and a "sterile topical hemostasis pad," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the local management of bleeding wounds and providing a bacterial barrier. This is a direct therapeutic application to the patient's body surface.
- Device Description: The device is a topical pad applied to the wound.
- Lack of In Vitro Diagnostic Function: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease. This device does not perform any such examination of specimens. While it has demonstrated in-vitro antibacterial activity, this is a characteristic of the device itself, not a diagnostic test performed on a patient sample.
- Performance Study: The performance study described is an in-vitro study to demonstrate the antimicrobial properties of the device, not a diagnostic test on patient samples.
Therefore, the Scion Cardio-Vascular Clo-SurPLUS P.A.D. is a topical medical device intended for wound management and hemostasis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, LYA, FRO
Device Description
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.
An in-vitro study was performed to demonstrate the effectiveness of the Clo-Sur P.A.D., to act as an antimicrobial substance against bacteria and fungi. The test protocol as designed assessed by quantitative assay the antimicrobial properties of the Clo-Sur P.A.D. over a defined 24-hour time frame.
To determine the effectiveness of the Clo-Sur P.A.D., three product concentrations were prepared and challenged with a 10° CFU/mL concentration of each of the following organisms: Escherichia coli (ATCC 8739), Pseudomonas aeuroginosa (ATCC 9027). Staphylococcus aureus (ATCC 6538), Bacillus subtilis (ATCC 6633), Enterococcus faecium (ATCC 15335), Streptococcus pyogenes (ATCC 12347), Candida albicans (ATCC 10231) and Aspergillus niger (ATCC 16404). The test solutions were then samples at time points of 0, 4 and 24 hours to determine the organism concentration. A positive control was run in parallel with each of the organism to determine the organism growth profile without the presence of the test article.
The study demonstrated that at the highest concentration of 0.15 grams, the Clo-Sur P.A.D. reduced the concentration of both bacteria and fungi over the 24-hour course of the study.
The clinical significance of the findings in this vitro study is unknown.
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 Scion Cardio-Vascular Clo-SurPLUS P.A.D., a soft, non-woven pad made of a proprietary formulation of poly-D-glucosamine and poly-N- acetylglucosamine derived from chitosan. The natural biological property of this material gives the Clo-SurPLUS P.A.D. 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-acetylglucosamine have been reported. The studies represent research on the safety and use of these materials. which has been published over a period of decades by scientists from around the world. This large body of 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 Clo-SurPlus P.A.D. are the same as the predicate devices. The Scion Cardio-Vascular C/o-Surfus® P.A.D. works in the same manner as the approved predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface puncture sites for vascular procedures; wounds including lacerations, abrasions, nose bleeds.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An in-vitro study was performed to demonstrate the effectiveness of the Clo-Sur P.A.D., to act as an antimicrobial substance against bacteria and fungi.
Test protocol: quantitative assay of antimicrobial properties over a defined 24-hour time frame.
Sample size: Not explicitly stated for specific organisms, but three product concentrations were prepared and challenged with 10^0 CFU/mL concentration of each of the following organisms: Escherichia coli (ATCC 8739), Pseudomonas aeuroginosa (ATCC 9027), Staphylococcus aureus (ATCC 6538), Bacillus subtilis (ATCC 6633), Enterococcus faecium (ATCC 15335), Streptococcus pyogenes (ATCC 12347), Candida albicans (ATCC 10231) and Aspergillus niger (ATCC 16404).
Key results: The study demonstrated that at the highest concentration of 0.15 grams, the Clo-Sur P.A.D. reduced the concentration of both bacteria and fungi over the 24-hour course of the study. The clinical significance of the findings in this vitro study is unknown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K024298, K021062, K030334, K984177
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Scion Cardio-Vascular, Inc. Ramon Augusto Paz Director of Quality Assurance & Regulatory Affairs 14256 SW 119 Avenue Miami. Florida 33186
June 11, 2023
Re: K032986 Trade/Device Name: Clo-SurPlus P.A.D. Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Ramon Augusto Paz:
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 March 1, 2004. 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.
Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. It also lists OHT4: Office of Surgical and Infection Control Devices. The signature block concludes with Office of Product Evaluation and Quality Center for Devices and Radiological Health.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ramon Augusto Paz Director of Quality Assurance & Regulatory Affairs Scion Cardio-Vascular, Inc. 14256 SW 119 Avenue Miami, Florida 33186
Re: K032986
Trade/Device Name: Clo-Sur Plus P.A.D. Regulatory Class: Unclassified Product Code: FRO Dated: December 17, 2003 Received: December 19, 2003
Dear Mr. Paz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ramon Augusto Paz
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
VI. Indications for Use
K032986 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
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.
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)
Miriam C. Provost
livision Sign-Division of General, Restorative. and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K032986
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Image /page/4/Picture/1 description: The image shows handwritten text. The text at the top reads "K032986". Below that, the text reads "page 1/3". The handwriting appears to be in black ink on a white background.
IV. 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 Ramon Augusto Paz
Person:
Date Prepared: February 18, 2004
Proprietary Name:
Common
Name:
Name:
Predicate
Device:
Scion Cardio-Vascular Clo-Sur Cus P.A.D.TM
Topical Hemostasis Pad
Classification: Unclassified
Classification Topical Wound Dressing Pad
- Advanced Medical Solutions, LTD. K024298 -. Antimicrobial Dressinq
The Scion Cardio-Vascular Clo-SurPLUS P.A.D. is a soft, Device Description: 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.
An in-vitro study was performed to demonstrate the effectiveness of the Clo-Sur P.A.D., to act as an antimicrobial substance against bacteria and fungi. The test protocol as designed assessed by quantitative assay the antimicrobial properties of the Clo-Sur P.A.D. over a defined 24-hour time frame.
To determine the effectiveness of the Clo-Sur P.A.D., three product concentrations were prepared and challenged with a 10° CFU/mL concentration of each of the following organisms: Escherichia coli (ATCC 8739),
5
K032986 Page 2/3
Pseudomonas aeuroginosa (ATCC 9027). Staphylococcus aureus (ATCC 6538), Bacillus subtilis (ATCC 6633), Enterococcus faecium (ATCC 15335), Streptococcus pyogenes (ATCC 12347), Candida albicans (ATCC 10231) and Aspergillus niger (ATCC 16404). The test solutions were then samples at time points of 0, 4 and 24 hours to determine the organism concentration. A positive control was run in parallel with each of the organism to determine the organism growth profile without the presence of the test article.
The study demonstrated that at the highest concentration of 0.15 grams, the Clo-Sur P.A.D. reduced the concentration of both bacteria and fungi over the 24-hour course of the study.
The clinical significance of the findings in this vitro study is unknown.
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.
Intended Use: The Scion Cardio-Vascular C/o-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., a soft, Technological non-woven pad made of a proprietary formulation of Characteristics: poly-D-glucosamine and poly-N- acetylglucosamine derived from chitosan. The natural biological property of this material gives the Clo-SurPLUS P.A.D. 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-acetylglucosamine have been reported. The studies represent research on the safety and use of these materials. which has been published over a period of decades by scientists from around the world. This large body of 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
6
K032986 Page 3/3
dressing, namely biocompatibility, biodegradability, hemostatic activity, anti-infectional activity.
The technological characteristics of the Clo-SurPlus P.A.D. are the same as the predicate devices. The Scion
Cardio-Vascular C/o-Surfus® P.A.D. works in the same
manner as the approved predicate devices.