Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions
AmeriGel® Wound Dressing PLUS is a hydrogel that maintains a moist environment to support wound healing. We added 4% Lidocaine HCL to the formulation in our predicate device, AmeriGel® Wound Dressing. AmeriGel® Wound Dressing has been on the market for many years. With so many painful wounds, particularly venous stasis ulcers, we wanted to offer a wound gel that would help reduce the discomfort patients feel. Since AmeriGel® Wound Dressing has been doing so well for all these years, adding the 4% Lidocaine to the Polyethylene glycol (PEG) base will finally provide relief for those patients with painful wounds. When the Lidocaine was added to our formulation of Oakin (oak extract), Meadowsweet extract, water and Zinc acetate, the physical properties remained at a pH range of 7.0 - 7.2. Lidocaine HCL is well known to be GRASE (Generally regarded as safe and effective) and AmeriGel® Wound Dressing is also well known to be safe and effective, the combination of chemicals were found compatible, safe and effective.
This document (K092086) is a 510(k) summary for a medical device called "AmeriGel® Wound Dressing PLUS." It primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in a quantitative sense.
Therefore, many of the requested sections regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication, and comparative effectiveness studies are not applicable or not provided in the given document. This is common for 510(k) submissions, especially for devices undergoing minor modifications (like adding an existing drug component to a previously cleared base).
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided as a quantitative table.
- The acceptance criteria for this 510(k) submission are implicitly based on demonstrating that the new device, AmeriGel® Wound Dressing PLUS, performs at least as well as, and is as safe and effective as, its predicate devices (AmeriGel® Wound Dressing and Regenecare® Wound Gel).
- The reported "performance" is primarily a claim of substantial equivalence supported by the fact that:
- The formulation is identical to AmeriGel® Wound Dressing, except for the addition of 4% Lidocaine HCL.
- Lidocaine HCL is "well known to be GRASE (Generally regarded as safe and effective)."
- AmeriGel® Wound Dressing is "well known to be safe and effective" and has been marketed for almost ten years without adverse events.
- Physical properties (pH range of 7.0 - 7.2) remained compatible after adding Lidocaine.
- Biocompatibility was previously established for AmeriGel® Wound Dressing (dermal irritation test on rabbits, sensitization test on guinea pigs, in-vitro cytotoxicity test).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No specific "test set" in the context of a performance study with a sample size is mentioned in this 510(k) summary. The submission relies on the established safety and efficacy of its components and predicate devices.
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. No expert review committee or ground truth establishment relevant to an AI/diagnostic device performance study is described. The "ground truth" here is the established safety and efficacy of the individual components (Lidocaine HCL, AmeriGel® Wound Dressing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is mentioned as there was no specific performance study requiring such a process.
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 device is a medicated wound gel, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medicated wound gel, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on:
- Prior regulatory classifications and approvals: Lidocaine HCL is GRASE (Generally Regarded As Safe and Effective).
- Long-standing market history and absence of adverse events: AmeriGel® Wound Dressing has been on the market for almost ten years without reported adverse events, providing real-world outcomes data as evidence of its safety and effectiveness.
- Bench testing: Biocompatibility tests (dermal irritation, sensitization, in-vitro cytotoxicity) performed previously on the predicate device.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this type of device.
In summary:
This 510(k) relies on demonstrating substantial equivalence to predicate devices and the established safety and efficacy of its components, rather than presenting a de novo clinical study with quantitative performance metrics for "acceptance criteria" in the way one might expect for a novel diagnostic or AI device. The "study" proving the device meets criteria is implicitly the regulatory history and proven safety record of the existing ingredients and base product.
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K092086
Page 107
510(k) Summary
JUL 30 2008
Date Prepared: July 08, 2009
Submitter's Information:
Amerx Health Care Corporation 1300 S. Highland Ave. Clearwater, FL 33756 www.amerigel.com
Contact Information:
Art W. Simonetti, LPN Director of Research & Regulatory Affairs Phone: (727) 443-0530 Fax: (727) 447-5617 Toll-Free: (800) 448-9599 Email: aws@amerxhc.com
New Device Name:
Proprietary Name: Amerigel® Wound Dressing PLUS Common Name: Medicated Wound Gel Classification Name: Dressing, wound and burn, hydrogel w/drug and/or biologic Product Code: MGQ Regulatory Class: Unclassified
Predicate Device #1:
Trade/Device Name: Regenecare® Wound Gel (510(k) # K020540) Regulation Name: Hydrogel Wound Dressing Product Code: MGQ Regulatory Class: Unclassified
Predicate Device #2:
Trade/Device Name: AmeriGel® Wound Dressing (510(k) # K002136) Classification Regulation Name: Hydrogel Wound Dressing (21 CFR 878.4022) Regulatory Class: Class I, exempt Product Code: NAE
Bice 5
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Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text includes "k0", a symbol resembling a circled "Q", and the numbers "2086". Below this, the word "page" is written, followed by "2 of 2". The handwriting is somewhat cursive and has a casual, informal style.
Device Description:
AmeriGel® Wound Dressing PLUS is a hydrogel that maintains a moist environment to support wound healing. We added 4% Lidocaine HCL to the formulation in our predicate device, AmeriGel® Wound Dressing. AmeriGel® Wound Dressing has been on the market for many years. With so many painful wounds, particularly venous stasis ulcers, we wanted to offer a wound gel that would help reduce the discomfort patients feel. Since AmeriGel® Wound Dressing has been doing so well for all these years, adding the 4% Lidocaine to the Polyethylene glycol (PEG) base will finally provide relief for those patients with painful wounds. When the Lidocaine was added to our formulation of Oakin (oak extract), Meadowsweet extract, water and Zinc acetate, the physical properties remained at a pH range of 7.0 - 7.2. Lidocaine HCL is well known to be GRASE (Generally regarded as safe and effective) and AmeriGel® Wound Dressing is also well known to be safe and effective, the combination of chemicals were found compatible, safe and effective.
AmeriGel® Wound Dressing PLUS would be used to manage stage I - IV pressure ulcers, venous stasis ulcers, ulcerations caused by mixed vascular etiologies, Diabetic skin ulcers, First and second degree burns, post-surgical incisions, cuts and abrasions..
Technological Characteristics:
AmeriGel® Wound Dressing PLUS is identical in formulation to AmeriGel® Wound Dressing, except with the addition of the Lidocaine. Regenecare® Wound Gel has similar action of its formulation. The PEG base provides moisture similarly to the Aloe Vera in Regenecare®. As they are both classified as hydrogels, they also autolytically debride. Both predicate devices are packaged in plastic tubes, as will AmeriGel® Wound Dressing PLUS. Regenecare® is sterile and AmeriGel® Wound Dressing is not, nor will AmeriGel® Wound Dressing PLUS. Biocompatibility for AmeriGel® Wound Dressing was previously established by dermal irritation test on rabbits, a sensitization test on guinea pigs, and In-vitro cytotoxicity test. Of course, AmeriGel® Wound Dressing has been marketed and used on humans for almost ten years without any adverse events.
Substantial Equivalence:
The claim of substantial equivalence of AmeriGel® Wound Dressing PLUS to the predicate devices is based on the comparison of the intended use, product technical characteristics and performance. Accordingly, Amerx Health Care Corporation concluded that AmeriGel® Wound Dressing PLUS is safe and effective for its intended use, and will perform at least as well as the legally predicate devices.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IJUL 3 0 2009
Amerx Health Care Corporation % Mr. Art W. Simonetti, LPN Director of Research & Clinical Affairs 1300 S. Highland Avenue Clearwater, Florida 33756-6519
Re: K092086
Trade/Device Name: AmerGel® Wound Dressing PLUS Regulatory Class: Unclassified Product Code: FRO Dated: July 8, 2009 Received: July 9, 2009
Dear Mr. Simonetti:
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.
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 of medical device-related 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.
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Page 2 - Mr. Art W. Simonetti, LPN
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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Othms Df
Dep.
Mark N. Melkerso 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: K092086
Device Name: AmeriGel® Wound Dressing PLUS
Indications for Use:
Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions
Prescription Use (21 CFR 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keene furmxm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092086
N/A