CLO-SURPLUSP.A.D.

K032986 · Scion Cardio-Vascular, Inc. · QSY · Mar 1, 2004 · SU

Device Facts

• Record ID: K032986
• Device Name: CLO-SURPLUSP.A.D.
• Applicant: Scion Cardio-Vascular, Inc.
• Product Code: QSY · SU
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Clo-SurPLUS P.A.D. is a sterile, non-woven topical hemostasis pad; composed of poly-D-glucosamine and poly-N-acetylglucosamine (chitosan derivative). Device functions as a physical dressing to manage bleeding and provide an antimicrobial barrier. Applied topically to wounds; used by clinicians or patients to control bleeding from lacerations, abrasions, nose bleeds, and vascular access sites. Hemostatic and antibacterial properties derived from natural biological characteristics of chitosan. Sterile, single-use, foil-pouch packaging.

Clinical Evidence

Bench testing only. In-vitro study performed to assess antimicrobial properties against bacteria (E. coli, P. aeruginosa, S. aureus, B. subtilis, E. faecium, S. pyogenes) and fungi (C. albicans, A. niger) over 24 hours. Results showed reduction in organism concentration at 0.15g concentration compared to positive control. Clinical significance of in-vitro findings is unknown.

Technological Characteristics

Non-woven pad composed of poly-D-glucosamine and poly-N-acetylglucosamine (chitosan). Biocompatible, biodegradable, hemostatic, and antimicrobial. Sterilized via E-beam radiation to 10^-6 SAL. Form factor is a topical pad.

Indications for Use

Indicated for all patients for local management of bleeding wounds and as a bacterial barrier. Specifically indicated for hemostasis in patients post-hemodialysis and patients on anticoagulation therapy. Applicable to lacerations, abrasions, nose bleeds, and skin puncture sites from vascular procedures, percutaneous catheters, or tubes.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Advanced Medical Solutions, LTD. Antimicrobial Dressing (K024298)
• Perclose, Inc. ChitoSeal (K021062)
• T-Scientific, Inc. T-PAD (K030334)
• Marine Polymer Technologies SyvekPatch (K984177)

Submission Summary (Full Text)

{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, [e-mail].

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

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: [phone]<br>Fax: [phone] |

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
- Perclose, Inc. K021062 ChitoSeal .
- T-Scientific, Inc. K030334 T-PAD .
- Marine Polymer Technologies K984177 -. SyvekPatch

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.