(31 days)
The BD ChloraShield IV Dressing with CHG antimicrobial, per K152923, is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
The BD 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.
This document is a 510(k) premarket notification for a medical device called the "BD ChloraShield IV Dressing with CHG antimicrobial". It describes a special 510(k) application, which is used for modifications to a previously cleared device where the modification does not affect the indications for use or the fundamental scientific technology of the device.
The core purpose of this document is to demonstrate "substantial equivalence" to a predicate device (K113836, Benehold CHG Transparent Film Dressing) after a specific change: expanding the specification for Chlorhexidine Gluconate (CHG) content in the dressing.
There is no information in this document about the use of AI, machine learning, or any form of algorithmic performance that would necessitate the detailed acceptance criteria and study design requested in the prompt.
The "performance testing" section (Section 7) refers to:
- Antimicrobial efficacy testing to the requirements set forth within USP 51.
- Verification/validation activities confirming that the specification change was "well within the requirements".
- Antimicrobial efficacy test results demonstrating conformance.
This is a chemical/material performance study, not a performance study of an AI/ML diagnostic or assistive device. Therefore, I cannot extract the requested information regarding AI/ML performance, ground truth establishment, expert review, or MRMC studies, as those concepts are irrelevant to this specific device and its regulatory submission.
The prompt asks for acceptance criteria and study details related to an AI/ML device, which this document is clearly not about.
As such, I cannot fulfill the request in the way it is structured. I can only confirm that the document describes a regulatory submission for an IV dressing and indicates that performance testing involved antimicrobial efficacy testing, demonstrating the modified CHG specification still met the requirements of the original submission.
No information regarding AI/ML performance, ground truth, experts, or MRMC studies is present in the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2016
Avery Dennison Belgie, BVBA Ms. Lisa Bartakovics Director of Global Regulatory Affairs Tieblokkenlaan 1 Turnhout, Belgium B-2300
Re: K152923
Trade/Device Name: BD Chlorashield IV Dressing With CHG Antimicrobial Regulation Number: Unclassified Regulation Name: FRO Dated: September 29, 2015 Received: October 5, 2015
Dear Ms. Bartakovics:
This letter corrects our substantially equivalent letter of November 5, 2015.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152923
Device Name
BD ChloraShield IV Dressing with CHG antimicrobial
Indications for Use (Describe)
The BD ChloraShield IV Dressing with CHG antimicrobial, per K152923, is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Special 510(k) Summary K152923
Avery Dennison Belgie, BVBA BD ChloraShield IV Dressing with CHG antimicrobial
1. Submitter Information
| Name: | Avery Dennison Belgie, BVBA |
|---|---|
| Address: | Tieblokkenlaan 1Turnhout, Belgium B-2300 |
| Telephone Number: | 1-312-629-4608 |
| Contact Person: | Lisa Bartakovics |
|---|---|
| Telephone Number: | 1-312-629-4608 |
| Email: | Lisa.Bartakovics@averydennison.com |
Date Prepared: September 29, 2015
2. Device Name
| Trade Name: | BD 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 BD 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 BD ChloraShield IV Dressing with CHG Antimicrobial, per K152923, 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).
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6. Technological Characteristics and Substantial Equivalence
Avery Dennison submitted a 510k application for an IV Dressing containing Chlorhexidine Gluconate (CHG) within submission K113836. The 510k submission was cleared in 2012 under the principle that the CHG was considered a preservative within the device and thus met the requirements for "preservative effectiveness". The CHG specification within K113836 demonstrated antimicrobial efficacy testing well above those required.
Upon further review, it was determined that the CHG specification for the Avery Dennison IV Dressing could be expanded and still meet the requirements stated within submission K113836. Therefore, this Special 510k application was authored to expand the specification for CHG content.
Although the specification of the Chlorhexidine Gluconate 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 specification since antimicrobial efficacy testing continues to meet the stated requirements. In addition, the performance, functionality and manufacturing methods remain unchanged.
7. Performance Testing
Submission K113836 contained antimicrobial efficacy testing to the requirements set forth within USP 51. Therefore, any change to the specification of the CHG contained within the BD ChloraShield device must meet the requirements as stated within K113836. The modification of the specification was subjected to design controls. The resulting verification/ validation activities confirmed that the specification change was well within the requirements. Antimicrobial efficacy test results demonstrated conformance thus validating the acceptability of the proposed specification change.
8. Conclusion
Testing demonstrates that the change to the specification for CHG content does not affect the technological characteristics of the device nor the intended use as listed within the original submission (K113836). Conformance to the requirements set forth within the original submission was confirmed through antimicrobial efficacy testing. Therefore the proposed change to the specification of the finished device is acceptable and equivalent to the design set forth within the original submission.
N/A