(159 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Antimicrobial Activity (in-vitro): Reduction in concentration of tested bacteria and fungi. | At the highest concentration (0.15 grams), the Clo-SurPLUS P.A.D. reduced the concentration of both bacteria and fungi (Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Enterococcus faecium, Streptococcus pyogenes, Candida albicans, and Aspergillus niger) over a 24-hour period in the in-vitro study. |
| Clinical Performance (hemostasis, wound healing, bacterial barrier): (Not explicitly defined in terms of specific thresholds or metrics for this 510(k) submission based on clinical data). | The device is intended for local management of bleeding wounds, bacterial barrier, and promotion of rapid hemostasis. The in-vitro study demonstrated antibacterial activity. The clinical significance of the in-vitro findings is unknown. |
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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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.
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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.
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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
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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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IV. 510(k) SUMMARY
| Submitted by: | Scion Cardio-Vascular, Inc. |
|---|---|
| 14256 S.W. 119th Avenue | |
| Miami, FL 33186 | |
| Phone: (305) 259-8880Fax: (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),
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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
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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.
N/A