(157 days)
Not Found
No
The summary describes a dressing with an antimicrobial agent and does not mention any computational or analytical capabilities.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is an IV dressing intended to cover and protect catheter sites and secure devices, and includes an antimicrobial agent, which serves as a preservative within the dressing. It does not treat a therapeutic condition.
No
Explanation: The device description states its purpose is to cover and protect catheter sites and secure devices, and it contains an antiseptic. Its intended use does not involve detecting, monitoring, or predicting a medical condition.
No
The device description clearly states it is a physical dressing with integrated Chlorhexidine Gluconate (CHG), indicating it is a hardware 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 to "cover and protect catheter sites and to secure devices to the skin." This describes a device used on the body for physical protection and securing, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical components of the dressing and the antimicrobial properties of CHG within the dressing. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, the BD ChloraShield IV Dressing with CHG antimicrobial is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BD 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 IV catheters, other intravascular catheters and percutaneous devices.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The BD ChloraShield™ IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing integrated with 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)
Performance testing for the BD ChloraShield™ IV Dressing with CHG antimicrobial utilized the same test methodology as the predicate device within K113836. Since the CHG concentration, materials and method of manufacture remain unchanged per the predicate device, this Traditional 510(k) submission mirrors the requirements set forth in K113836. The compilation of laboratory and performance testing demonstrates that the BD ChloraShield™ IV Dressing with CHG antimicrobial is substantially equivalent to the predicate device in K113836. The resulting verification/ validation activities confirmed that the use of Ethylene Oxide sterilization met sterility requirements of 10° without compromising the performance of the device.
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
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three faces in profile, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2017
Avery Dennison Belgie BVBA Lisa Bartakovics Senior Director of Global Regulatory Affairs Tieblokkenlaan 1 Turnhout, B-2300 BE
Re: K170407
Trade/Device Name: BD Chlorashield IV Dressing With CHG Antimicrobial Regulatory Class: Unclassified Product Code: FRO Dated: June 13, 2017 Received: June 15, 2017
Dear Lisa 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 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170407
Device Name
BD ChloraShield IV Dressing with CHG antimicrobial
Indications for Use (Describe)
The BD 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 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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510(k) Summary - K170407
Avery Dennison België BVBA BD ChloraShield™ IV Dressing with CHG antimicrobial
1. Submitter Information
| Name: | Avery Dennison België 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 |
Date Prepared: February 07, 2017
2. Device Name
| Trade Name: | BD ChloraShield™ IV Dressing with CHG antimicrobial |
|---|---|
| Common Name: | Dressing, Wound, Drug |
| Classification Name: | Unclassified |
| Product Code: | FRO |
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 integrated with 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 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 are the same as those listed within the predicate 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 device cleared within K113836 was sterilized through gamma radiation.
Following a series of Engineering trials, it was determined that the BD ChloraShield™ IV Dressing with CHG antimicrobial could also be sterilized by Ethylene Oxide gas. Thus, a project was undertaken to demonstrate that the dressing manufactured by Avery Dennison was compatible with Ethylene Oxide sterilization. Therefore, the purpose of this Traditional 510(k) submission is to obtain clearance for the Ethylene Oxide sterilization of the BD ChloraShield™ IV Dressing with CHG antimicrobial.
Although the method of sterilization for the ChloraShield™ IV dressing has been modified, the Sterility Assurance Level (SAL) of the device remains 10°. The inclusion of CHG within the dressing, which is the fundamental scientific technology, is unaffected by the change in sterilization method. In addition, the performance, functionality and manufacturing methods remain unchanged.
7. Performance Testing
Performance testing for the BD ChloraShield™ IV Dressing with CHG antimicrobial utilized the same test methodology as the predicate device within K113836. Since the CHG concentration, materials and method of manufacture remain unchanged per the predicate device, this Traditional 510(k) submission mirrors the requirements set forth in K113836. The compilation of laboratory and performance testing demonstrates that the BD ChloraShield™ IV Dressing with CHG antimicrobial is substantially equivalent to the predicate device in K113836. The resulting verification/ validation activities confirmed that the use of Ethylene Oxide sterilization met sterility requirements of 106 without compromising the performance of the device.
8. Conclusion
Testing demonstrates that the change in sterilization method for the BD ChloraShield™ IV Dressing with CHG antimicrobial does not affect the required Sterility Assurance Level, technological characteristics, performance or the intended use as listed within the predicate submission (K113836). Furthermore, substantial equivalence to the predicate device was confirmed through sterility results, stability or shelf-life (including antimicrobial efficacy testing) and bench testing. Therefore, the change to the sterilization method of the finished device is acceptable and substantially equivalent to the design set forth within the predicate submission.
Traditional 510(k) Submission: BD ChloraShield™ IV Dressing with CHG Antimicrobial Avery Dennison België BVBA