← Product Code FRO · K110762 # AVO BARRIER TOPICAL EMULSION (K110762) _Trigen Laboratories, Inc. · FRO · Nov 18, 2011 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K110762 ## Device Facts - **Applicant:** Trigen Laboratories, Inc. - **Product Code:** FRO - **Decision Date:** Nov 18, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended 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. ## Device Story AVO Cream Topical Emulsion is a water-based topical emulsion for wound management. Applied by clinicians or patients to wound sites; provides moist environment for healing; isolates wound from external contamination and germs. Intended for superficial wounds, burns, ulcers, and radiation dermatitis. No complex processing or electronic components; functions as a physical barrier dressing. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Water-based topical emulsion. Non-sterile. Functions as a physical barrier/dressing to maintain moist wound environment. ## Predicate Devices - Biafine® Wound Dressing Emulsion ([K964240](/device/K964240.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) - 3. 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. {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 --- **Source:** [https://fda.innolitics.com/device/K110762](https://fda.innolitics.com/device/K110762) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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