(103 days)
No
The device description and intended use focus on the physical properties and antimicrobial agent of the dressing, with no mention of AI or ML capabilities.
No.
The device is a dressing intended to protect wounds and inhibit microbial growth, not to treat a disease or condition itself.
No
The device is a post-operative dressing intended to cover and protect wounds and inhibit microbial growth, not to diagnose a condition or disease.
No
The device is a physical dressing with an integrated chemical agent (CHG), not a software program.
Based on the provided information, the ReliaTect™ Post-Op Dressing with CHG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to cover and protect wounds and inhibit microbial growth on the wound surface and within the dressing. This is a topical application for wound management.
- Device Description: It's a transparent adhesive dressing with an antiseptic agent (CHG). This describes a physical barrier and a chemical agent applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The ReliaTect™ dressing does not perform any such analysis of biological specimens.
- Performance Studies: The performance studies described (antimicrobial efficacy, wound healing in animals) are relevant to a wound dressing, not an IVD device.
In summary, the ReliaTect™ Post-Op Dressing with CHG is a wound care product, not an IVD.
N/A
Intended Use / Indications for Use
The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.
ReliaTect™ may also be used to cover and secure a primary dressing.
ReliaTect™ inhibits microbial growth within the dressing and prevents external contamination.
Product codes
FRO
Device Description
The ReliaTect™ Post-Op Dressing with CHG is a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial activity.
In vitro testing (barrier and log reduction) demonstrates the ReliaTect™ Post-Op Dressing with CHG provides an effective barrier against external contamination including fluids (waterproof) and a variety of gram-positive bacteria, gramnegative bacteria, and yeast within the dressing including: Staphylococcus aureus, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Escherichia coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella pneumonia, and Candid albicans. Reduction in the colonization or microbial growth on the device has not been shown to correlate with a reduction in infections in patients. Clinical studies to evaluate reduction in infection have not been performed.
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
Bench testing studies, including antimicrobial efficacy, demonstrate the two devices have comparable performance. The Intended Use of the ReliaTect™ is equivalent to the SurgiClear™ device.
Performance testing was completed on various characteristics to ensure product requirements were satisfied as well as for comparison aqainst the predicate product. The acceptance criteria were met for all characteristics and comparison against the predicate demonstrated equivalent performance. Performance tests included:
- Fluid Handling Capacity
- Static Absorption
- Moisture Vapor Transmission Rate
- Peel Adhesion to Polyethylene
- Liner Release
- Antimicrobial Effectiveness
- Transparency
- Peel Adhesion to Sutures
Antimicrobial effectiveness testing performed demonstrates that the presence of CHG within the dressing inhibits microbial growth within the dressing.
The ReliaTect™ Post-Op Dressing with CHG was subjected to a wound healing evaluation through a porcine study. The objective of this study was to evaluate the wound healing impact of the Post-Op dressing with an active antimicrobial agent on full thickness incisional wounds in Yucatan miniature swine. Results of the study demonstrate the ReliaTect™ Post-Op Dressing and the predicate device achieved equivalent performance.
Key Metrics
Not Found
Predicate Device(s)
Covalon SurgiClear™ K121819
Reference Device(s)
Avery Dennison Benehold CHG Transparent Film . Dressing K113836
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2017
Avery Dennison Corporation Ms. Lisa Bartakovics Director of Global Regulatory Affairs 7100 Lindsay Dr., Bldg. 14 Mentor, Ohio 44060
Re: K163529
Trade/Device Name: Reliatect Post-op Dressing With CHG (8cm X 15cm), Reliatect Postop Dressing With CHG (10cm X 25cm)
Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2017 Received: February 23, 2017
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 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.
1
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
EPARTMENT OF HEALTH AND HUMAN SERVIC
Food and Drug Administration
lications for
Expiration Date
ration Date: January 31, 20
PRA Statement below.
Approved: OMB No. 0910-0120
IS1052
Device Name
The ReliaTect™ Post-Op Dressing with t
Indications for Use (Describe)
ndication for Use (Describe)
The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous media
levices such as drains, chest tube
ReliaTect™ may also be used to cover and secure a primary dress
iiaTect™ inhibits microbial growth within the dressing and prevents external contamin
ype of Use (Select one or both, as applicable
Over-The-Counter Use (21 CFR 801 Subpart ■ Prescription Use (Part 21 CFR 801 Subpart D)
ONTINUE ON A SEPARATE PAGE IF NEED
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
Avery Dennison Corporation ReliaTect™ Post-Op Dressing with CHG
1. Submitter Information
| Name: | Avery Dennison Corporation |
|---|---|
| Address: | 7100 Lindsay Drive |
| Mentor, Ohio 44060 | |
| Telephone Number: | + 1 (440) 534-6000 |
| Contact Person: | Lisa Bartakovics |
| Telephone Number: | +1 (312) 206-6159 |
| Email: | Lisa.Bartakovics@averydennison.com |
2. Device Name
| Trade Name: | ReliaTect™ Post-Op Dressing with CHG |
|---|---|
| Common Name: | Dressing, Wound, Drug |
| Classification Name: | Unclassified |
| Product Code: | FRO |
3. Predicate Device(s)
- Predicate Device- Covalon SurgiClear™ K121819 ●
- Reference Device- Avery Dennison Benehold CHG Transparent Film . Dressing K113836
4. Device Description
The ReliaTect™ Post-Op Dressing with CHG is a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial activity.
In vitro testing (barrier and log reduction) demonstrates the ReliaTect™ Post-Op Dressing with CHG provides an effective barrier against external contamination including fluids (waterproof) and a variety of gram-positive bacteria, gramnegative bacteria, and yeast within the dressing including: Staphylococcus aureus, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Escherichia coli, Pseudomonas aeruginosa,
4
Enterobacter aerogenes, Klebsiella pneumonia, and Candid albicans. Reduction in the colonization or microbial growth on the device has not been shown to correlate with a reduction in infections in patients. Clinical studies to evaluate reduction in infection have not been performed.
5. Indications for Use
The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.
ReliaTect™ may also be used to cover and secure a primary dressing.
ReliaTect™ inhibits microbial growth within the dressing and prevents external contamination.
6. Technological Characteristics and Substantial Equivalence
The ReliaTect™ Post-Op Dressing with CHG is substantially equivalent to the commercially available Covalon SurgiClear™ device (K121819). Bench testing studies, including antimicrobial efficacy, demonstrate the two devices have comparable performance. The Intended Use of the ReliaTect™ is equivalent to the SurgiClear™ device.
7. Performance Testing
Performance testing was completed on various characteristics to ensure product requirements were satisfied as well as for comparison aqainst the predicate product. The acceptance criteria were met for all characteristics and comparison against the predicate demonstrated equivalent performance. Performance tests included:
- . Fluid Handling Capacity
- Static Absorption
- . Moisture Vapor Transmission Rate
- Peel Adhesion to Polyethylene .
- . Liner Release
- . Antimicrobial Effectiveness
- Transparency ●
- Peel Adhesion to Sutures .
Antimicrobial effectiveness testing performed demonstrates that the presence of CHG within the dressing inhibits microbial growth within the dressing.
5
8. Animal Study
The ReliaTect™ Post-Op Dressing with CHG was subjected to a wound healing evaluation through a porcine study. The objective of this study was to evaluate the wound healing impact of the Post-Op dressing with an active antimicrobial agent on full thickness incisional wounds in Yucatan miniature swine. Results of the study demonstrate the ReliaTect™ Post-Op Dressing and the predicate device achieved equivalent performance.
9. Conclusion
The ReliaTect™ Post-Op Dressing with CHG is substantially equivalent to the Covalon SurgiClear™ device. Bench and Animal performance testing, including antimicrobial effectiveness, demonstrate the two devices are substantially equivalent for their intended use.