(245 days)
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 .
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.
The provided text is a 510(k) summary for AVO Cream Topical Emulsion, a wound dressing. It declares substantial equivalence to a predicate device and states that functional and performance testing was conducted to assess safety and efficacy with satisfactory results. However, the document does not contain explicit acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the completion of the requested table and answers to points 2 through 9.
Here's an analysis of what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Explanation: The document states, "Functional and performance testing has been conducted to assess the safety and efficacy of AVO Cream Topical Emulsion and the results are satisfactory." This is a general statement and does not provide specific acceptance criteria (e.g., "wound healing time reduced by X%") or quantitative performance data to fill this table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided.
- Data provenance: Not provided. The document focuses on regulatory submission and substantial equivalence rather than a detailed study protocol or results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The document does not describe studies involving expert-established ground truth for a test set. The assessment of "safety and efficacy" would typically involve clinical or pre-clinical studies, but the details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (topical emulsion) and not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (topical emulsion) and not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. Given it's a wound dressing, "outcomes data" related to wound healing, safety (e.g., adverse events), and patient comfort would be expected, but the document does not specify what type of data served as "ground truth" for their internal "functional and performance testing."
8. The sample size for the training set
- Not applicable/Not provided. This document implies pre-clinical and possibly clinical testing for safety and efficacy, not a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary: The provided 510(k) summary is a regulatory document affirming substantial equivalence to an existing device (Biafine® Wound Dressing Emulsion, K964240). It states that functional and performance testing was performed with satisfactory results but does not include the detailed study information, acceptance criteria, or performance metrics requested. This level of detail is typically found in the full submission, not the summary intended for public disclosure.
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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:
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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.
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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
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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
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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
N/A