(92 days)
Not Found
No
The summary describes a physical dressing with an antimicrobial agent and does not mention any computational or analytical functions that would typically involve AI/ML.
No
Explanation: The device is an antimicrobial dressing intended to cover and protect catheter sites and secure devices. While it prevents infection, its primary use is not to treat a disease or condition therapeutically, but rather to serve as a protective and preventative measure.
No
Explanation: The device is an IV dressing intended to cover and protect catheter sites and secure devices, and act as an antimicrobial. It does not perform any diagnostic functions.
No
The device description clearly states it is a physical dressing with integrated Chlorhexidine Gluconate (CHG), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cover and protect catheter sites and to secure devices to the skin." This is a topical application for wound care and device securement.
- Device Description: The device is a "transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG)." This describes a physical barrier with an antimicrobial agent, not a test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This dressing does not fit that description.
N/A
Intended Use / Indications for Use
The ChloraShield IV Dressing with CHG Antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Sterility testing was conducted to verify the change to the packaging material did not negatively impact the sterility assurance level. The sterility assurance level within the original 510(k) submission was 10 ° and testing confirmed that the revised packaging achieved a sterility assurance level of 10 * thus there was no impact to the sterility. In addition to the sterility testing, the seal strength was verified. In summary, the following performance tests were performed as part of verification/validation activities:
- . Seal Strength
- Bubble Leak Test
- Sterility
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.
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
MAR 1 3 2014
K133764 page 1 of 2
Special 510(k) Summary
Avery Dennison Belgie, b.v.b.a. ChloraShield IV Dressing with CHG antimicrobial
1. Submitter Information
| Name: | Avery Dennison Belgie, bvba |
|---|---|
| Address: | Tieblokkenlaan 1 |
| Turnhout, Belgium B-2300 | |
| Telephone Number: | 1-312-629-4608 |
| Contact Person: | Lisa Bartakovics |
| Telephone Number: | 1-312-629-4608 |
| Email: | Lisa.Bartakovics@averydennison.com |
December 10, 2013 Date Prepared:
2. Device Name
| Trade Name: | ChloraShield IV Dressing with CHG Antimicrobial |
|---|---|
| Common Name: | Dressing, Wound, Drug |
| Classification Name: | Unclassified |
3. Predicate Device(s)
- K113836, Benehold CHG Transparent Film Dressing .
4. Device Description
The ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
5. Indications for Use
The ChloraShield IV Dressing with CHG antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.
The Indications for Use have not been altered and are the same as those listed within the original 510(k) application (K113836).
| Avery Dennison Belgie, b.v.b.a. | |
|---|---|
| Special 510(k) Submission: ChloraShield IV Dressing with CHG antimicrobial | Page: 1 of 2 |
1
K133764 page 2 of 2
6. Technological Characteristics and Substantial Equivalence
The change in the packaging material does not affect the substantial equivalence of the device per submission K113836. Although the packaging has been modified, the fundamental technology of the finished device has not been altered. The inclusion of CHG as a preservative within the adhesive of the dressing, which is the fundamental scientific technology, is unaffected by the change to the packaging. In addition, the performance, functionality and manufacturing methods remain unchanged.
7. Performance Testing
Sterility testing was conducted to verify the change to the packaging material did not negatively impact the sterility assurance level. The sterility assurance level within the original 510(k) submission was 10 ° and testing confirmed that the revised packaging achieved a sterility assurance level of 10 * thus there was no impact to the sterility. In addition to the sterility testing, the seal strength was verified. In summary, the following performance tests were performed as part of verification/validation activities:
- . Seal Strength
- Bubble Leak Test
- Sterility ●
8. Conclusion
Testing demonstrates that the change in the packaging material does not affect the technological characteristics of the device or the intended use as listed within the original submission (K113836). The method of sterilization, gamma, remains unchanged. Furthermore, there has been no decrease in the sterility assurance level of the ChloraShield IV Dressing with CHG antimicrobial thus the proposed change in the packaging of the device is equivalent to that of the original submission.
| Avery Dennison Belgie, b.v.b.a. | ||
|---|---|---|
| Special 510(k) Submission: ChloraShield IV Dressing with CHG antimicrobial | Page: | 2 of 2 |
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
March 13, 2014
Avery Dennison Belgie, bvba Ms. Lisa Bartakovics Director of Global Regulatory Affairs Tieblokkenlaan 1 Turnhout, Belgium B-2300
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K133764
Trade/Device Name: ChloraShield IV Dressing with CHG Antimicrobial Regulatory Class: Unclassified Product Code: FRO Dated: February 10, 2014 Received: February 12, 2014
Dear Ms. Bartakovics:
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 10 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 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.
3
Page 2 - Ms. Lisa Bartakovics
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K133764 510(k) Number (if known):
Device Name: ChloraShield IV Dressing with CHG Antimicrobial
Indications for Use:
The ChloraShield IV Dressing with CHG Antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number