(21 days)
Not Found
No
The device description focuses on the chemical composition and intended use of a hydrogel wound dressing with added lidocaine, with no mention of AI or ML technologies.
Yes
The device is described as a hydrogel that "maintains a moist environment to support wound healing" and includes "4% Lidocaine HCL" to "help reduce the discomfort patients feel," indicating its use for treatment and pain relief of various wounds.
No
Explanation: The device is a wound dressing designed to support wound healing and reduce discomfort. It is not described as detecting, determining, or monitoring any physiological or pathological conditions.
No
The device description clearly states it is a hydrogel wound dressing, which is a physical substance applied to wounds, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of various types of wounds (pressure ulcers, venous stasis ulcers, diabetic ulcers, burns, incisions, cuts, and abrasions). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a hydrogel wound dressing with added lidocaine. It is applied topically to the wound to maintain a moist environment and reduce pain. This is a treatment, not a diagnostic test performed on a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
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.
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)
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.
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
Image /page/0/Picture/0 description: The image shows a logo for AMER Health Care, Corp. The logo is in black and white and features the company name in bold letters. The letters are stylized and have a textured appearance. The logo also includes a graphic element that resembles a stylized "X".
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
1
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.
PAGE 5.2
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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.
3
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
4
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