(271 days)
Not Found
No
The device description and performance studies focus on the physical and antimicrobial properties of a transparent film dressing, with no mention of AI or ML technologies.
No.
A therapeutic device is one that treats a disease or condition. This device is a dressing intended to cover and protect catheter sites and to secure devices to the skin, with an antimicrobial agent to prevent infection, but it does not directly treat a disease or condition.
No
The device is a film dressing used to cover and protect catheter sites and secure devices, and is not designed to diagnose any condition or disease.
No
The device description clearly indicates it is a physical dressing made of transparent film with adhesive containing Chlorhexidine Gluconate, which is a hardware component.
Based on the provided information, the BeneHold CHG Transparent Film Dressing is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to cover and protect catheter sites and secure devices to the skin. This is a physical barrier and securing function applied externally to the body.
- Device Description: The description focuses on the physical properties of the dressing (transparent film, adhesive, CHG content, barrier properties, breathability) and its function as a protective covering and securing device.
- Mechanism of Action: The CHG provides an antimicrobial effect in the dressing and acts as a barrier to prevent external contamination from reaching the site. It does not analyze or test samples taken from the body.
- Performance Studies: The performance studies listed evaluate the physical and antimicrobial properties of the dressing itself, not its ability to diagnose a condition based on analysis of biological samples.
In Vitro Diagnostics (IVDs) are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
The BeneHold CHG Transparent Film Dressing does not fit this definition. It is a topical medical device used for wound care and securing purposes.
N/A
Intended Use / Indications for Use
The BeneHold CHG Transparent Film Dressing 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
FRO
Device Description
The BeneHold CHG Transparent Film Dressing is used to cover and protect catheter sites and to secure devices to the skin. The dressing consists of a transparent film with an acrylic adhesive which contains Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and yeast, and protects the IV site from outside contamination. The dressing absorbs between 8 and 21 ml of fluid depending on the dressing size. In vitro testing (barrier, kill time and log reduction) demonstrates that the BeneHold CHG Transparent Film Dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria, yeast and fungus in the dressing. BeneHold CHG Transparent Film Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (for catheter sites)
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)
The BeneHold CHG Transparent Film Dressing was evaluated to assure conformance to design specifications. The following performance tests were performed:
- Fluid Handling Capacity
- Static Absorption
- Moisture Vapor Transmission Rate
- Peel Adhesion
- Liner Release
- Final Tack
- Seal Strength
- Die Migration
- CHG/PCA Content
- Antimicrobial Effectiveness
- Bacterial/Viral Barrier
- Sterility
The BeneHold CHG Transparent Film Dressing was also evaluated for safety concerns relative to biocompatibility. The evaluations showed that there irritation is negligible, and that there is no evidence the device causes cell lysis or toxicity, nor is there evidence of delayed dermal contact sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K113836
p1/2
510(k) Summary
Avery Dennison Belgie, BVBA · BeneHold CHG Transparent Film Dressing
1. Submitter Information
| Name: | Avery Dennison Belgie, BVBA |
|---|---|
| Address: | Tieblokkenlaan 1 |
| Turnhout, Belgium B-2300 | |
| Telephone Number: | 1-312-629-4608 |
Contact Person: Jerzy Wojcik Telephone Number: . 1-312-629-4608 Email: jerzy.wojcik@averydennison.com
Date Prepared:
December 27, 2011
2. Device Name
| Trade Name: | BeneHold CHG Transparent Film Dressing |
|---|---|
| Common Name: | Dressing, Wound, Drug |
| Classification Name: | Unclassified |
3. Predicate Device(s)
- K063458, 3M Tegaderm CHG Dressing
বঁ Device Description
The BeneHold CHG Transparent Film Dressing is used to cover and protect catheter sites and to secure devices to the skin. The dressing consists of a transparent film with an acrylic adhesive which contains Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and yeast, and protects the IV site from outside contamination. The dressing absorbs between 8 and 21 ml of fluid depending on the dressing size. In vitro testing (barrier, kill time and log reduction) demonstrates that the BeneHold CHG Transparent Film Dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria, yeast and fungus in the dressing. BeneHold CHG Transparent Film Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
| Avery Dennison Belgie, BVBA | Section: 5 |
|---|---|
| Traditional 510(k) Submission: BeneHold CHG Transparent Film Dressing | Page: 1 of 2 |
1
K113836
r2/
5. Indications for Use
The BeneHold CHG Transparent Film Dressing 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.
6. Technological Characteristics and Substantial Equivalence
Both the BeneHold CHG Transparent Film Dressing and 3M Tegaderm CHG Dressing are wound dressings used to cover and protect catheter sites and secure devices to the skin via adhesion of the dressing to the skin.
7. Performance Testing
The BeneHold CHG Transparent Film Dressing was evaluated to assure conformance to design specifications. The following performance tests were performed:
- Fluid Handling Capacity �
- . Static Absorption
- Moisture Vapor Transmission Rate .
- . Peel Adhesion
- Liner Release ●
- Finat Tack .
- Seal Strength .
- . Die Migration
- CHG/PCA Content
- Antimicrobial Effectiveness .
- Bacterial/Viral Barrier ●
- Sterility .
The BeneHold CHG Transparent Film Dressing was also evaluated for safety concerns relative to biocompatibility. The evaluations showed that there irritation is negligible, and that there is no evidence the device causes cell lysis or toxicity, nor is there evidence of delayed dermal contact sensitization.
8. Conclusion
Testing indicates that the BeneHold CHG Transparent Film Dressing is substantially equivalent in terms of both indications for use and technology to the predicate product.
| Avery Dennison Belgie, BVBA | Section: | 5 |
|---|---|---|
| Traditional 510(k) Submission: BeneHold CHG Transparent Film Dressing | Page: | 2 of 2 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Avery Dennison Belgie, BVBA % Avery Dennison Corporation Mr. Jerzy Wojcik Manager, Regulatory Affairs 20 North Wacker Drive, Suite 2240 Chicago, Illinois 60606
SEP
24
2012
Re: K113836
Trade/Device Name: BeneHold CHG Transparent Film Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 14, 2012 Received: September 18, 2012
Dear Mr. Wojcik:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Mr. Jerzy Wojcik
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.html 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mach H. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: BeneHold CHG Transparent Film Dressing
Indications for Use:
The BeneHold CHG Transparent Film Dressing 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 x
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number