(245 days)
Not Found
No
The device description and intended use clearly indicate a topical emulsion for wound management, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device, AVO Cream Topical Emulsion, is a wound dressing emulsion applied topically to manage various skin injuries and conditions by providing a moist environment and isolating the wound. This makes it a wound care product, not a therapeutic device in the sense of actively treating or curing a disease through complex mechanisms or intervention. Its function is supportive to the healing process.
No
This device is a topical emulsion intended for wound management and healing, not for diagnosing medical conditions. It provides a moist environment for healing and isolates wounds from contamination.
No
The device description clearly states it is a "Topical Emulsion," which is a physical substance applied to the skin, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a topical emulsion for the dressing and management of various types of wounds and burns. This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces that it's a water-based emulsion applied to wounds to create a moist environment for healing and protection. This is consistent with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
- Predicate Device: The predicate device (Biafine® Wound Dressing Emulsion) is also a wound dressing, further indicating the device's therapeutic nature.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. AVO Cream Topical Emulsion does not fit this description.
N/A
Intended Use / Indications for Use
AVO Cream Topical Emulsion is indicated for use in:
- Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers ●
- Superficial wounds
- 1st and 2nd degree burns, including sunburns .
- Dermal donor and graft site management .
- Radiation dermatitis .
- Minor abrasions .
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
Device Description
AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
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)
Functional and performance testing has been conducted to assess the safety and efficacy of AVO Cream Topical Emulsion and the results are satisfactory.
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
Trigen Laboratories, Inc. Wound Dressing
NOV 1 8 2011 K110762
page 1 of 2
510(k) SUMMARY
(in accordance with 21 CFR 807.87(b) and 21 CFR 807.92)
AVO Cream Topical Emulsion
1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
RRI Group, Inc. 248 Latitude Lane, Suite 104 Lake Wylie, SC 29710
Phone: (803) 831-7657 (803) 831-1494 Fax:
Contact Person: Lara Noah lnoah@rriint.com
Date Prepared: May 26, 2011
- Name of Device and Name/Address of Sponsor 2.
AVO Cream Topical Emulsion
Trigen Laboratories, Inc. 2400 Main Street Ext., Suite 6 Sayreville, NJ 08872
Common or Usual Name
Dressing, Wound & Burn, Hydrogel w/drug biologic
Classification Name
Device Unclassified Review Panel General & Plastic Surgery Product Code MGQ Unclassified Reason Pre-Amendment Submission Type 510(k)
-
- Substantial Equivalent Devices:
Trigen Laboratories Inc. believes that AVO Cream Topical Emulsion is substantially equivalent to the currently marketed device, Biafine® Wound Dressing Emulsion (Radiodermatitis Emulsion) cleared under K964240.
- Substantial Equivalent Devices:
1
Trigen Laboratories, Inc. Wound Dressing
K110762
page 2 of 2
-
Device Description: 4.
AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination. -
Intended Use Indications for Use: ഗ്
AVO Cream Topical Emulsion is indicated for use in: -
Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
-
Superficial Wounds
-
· 1st and 2nd Degree Burns, including Sunburns
-
· Dermal Donor and Graft Site Management
-
Radiation Dermatitis
-
Summary of the Technological Characteristics of the Device Compared to the Predicate Device(S): 6.
All products referenced are non-sterile emulsions that are applied topically to relieve the symptoms of various dermatoses.
7. Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of AVO Cream Topical Emulsion and the results are satisfactory.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Trigen Laboratories, Inc. % RRI Group, Inc. Ms. Lara Noah 248 Latitutde Lane, Suite 104 Lake Wylie, South Carolina 29710-1457
Re: K110762
Trade/Device Name: AVO Cream Topical Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: October 17, 2011 Received: October 18, 2011
Dear Ms. Noah:
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
NOV 1 8 2011
3
Page 2 - Ms. Lara Noah
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
for Pete Shumway/
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): K110762
Device Name: AVO Cream Topical Emulsion
Indications For Use:
AVO Cream Topical Emulsion is indicated for use in:
- Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers ●
- Superficial wounds
- 1st and 2nd degree burns, including sunburns .
- Dermal donor and graft site management .
- Radiation dermatitis .
- Minor abrasions .
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Daniel Kaczynski NKM
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K110762