(413 days)
Not Found
No
The summary describes a hydrogel sheet for scar management and does not mention any AI or ML components or functionalities.
Yes
The intended use statement explicitly states that Avogel® is "intended for use in the management of hypertrophic scars," indicating a therapeutic purpose.
No.
Explanation: The "Intended Use" states that Avogel is "intended for use in the management of hypertrophic scars." Management implies treatment or care, not the identification or diagnosis of a condition. The device description also indicates it is a physical sheet (hydrogel with a polyurethane film backing) which is consistent with a treatment rather than a diagnostic tool.
No
The device description explicitly states that Avogel® is a "sheet of hydrogel with a polyurethane film backing," indicating it is a physical product, not software.
Based on the provided information, Avogel® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the management of hypertrophic scars." This describes a therapeutic or management function applied directly to the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a "sheet of hydrogel with a polyurethane film backing." This is a physical dressing applied externally.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on clinical improvement (reduction in firmness, pruritus, pain, tenderness) and molecular changes within the scar tissue itself, not on a diagnostic test's performance.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures. Avogel® does not fit this description.
N/A
Intended Use / Indications for Use
Avogel® is intended for use in the management of hypertrophic scars.
Product codes (comma separated list FDA assigned to the subject device)
MGO, MDA, MGQ
Device Description
Avogel® is a sheet of hydrogel with a polyurethane film backing.
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)
Clinical and molecular testing has shown equivalent clinical improvement using silicone and hydrogel dressings with reduction in firmness, pruritus, pain and tenderness. Molecular testing showed increased levels of IL-8, bFGF and GMCSF mRNA; while mean TGFB and fibronectin mRNA decreased after treatment with both dressings. Both silicone and hydrogel dressing offered treatment for hypertrophic scars that was monitored at the clinical and molecular level with equivalent outcomes.
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
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
AVOCET
JUN
510(k) SUMMARY K981353 SUBJECT: PREMARKET NOTIFICATION [510(k)] SUBMISSION
IDENTIFICATION 1-
Date:
May 27, 1999
Applicant: Address:
Avocet Polymer Technologies, Inc. 1112 Church Street Huntsville, AL 35801
Applicant Telephone: Applicant Fax:
256/533-4201 256/533-4805
Contact:
Mary Capelli-Schellpfeffer Tel. 256/533-4201 Fax 256/533-4805
NAME OF THE MEDICAL DEVICE 2.
Proprietary name: Common/usual name: Classification name; Regulation number: Medical specialty: Product code:
Avogel® Hydrogel Dressing, Wound and Burn, Hydrogel 878.4022 General & Plastic Surgery MGO
SUBSTANTIALLY EQUIVALENT PRODUCTS র্পা
| Silastic Soft Sheeting | Dow Corning
P.O. Box 100
Arlington, TN 38002
K894226 |
|------------------------------|----------------------------------------------------------------------------|
| Cica-Care Silicone Gel Sheet | Smith & Nephew
11775 Starkley Rd.
Largo, FL 34649
K935803 |
| NovaGel Sheeting | Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul, MN 55110
K963128 |
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05
510(k) SUMMARY K981353, Page 2
DEVICE DESCRIPTION বাঁ
Avogel® is a sheet of hydrogel with a polyurethane film backing.
INTENDED USE ળી
Avogel® is intended for use in the management of hypertrophic scars.
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE کے COMPARED TO THE PREDICATE DEVICE
The device is indicated for surface dressing of intact and uninfected scarred skin identical to the predicate devices. The device offers user flexibility as it can be worn under a simple bandage, paper tape, ace wrap or flexnet as desired by the patient. The device may be worn without attachment by adhesives or wraps.
As with the predicate devices, the barrier function of healed skin is expected to be intact. Avogel® and the predicate devices provide similar physical, thermal and mechanical properties.
Clinical and molecular testing has shown equivalent clinical improvement using silicone and hydrogel dressings with reduction in firmness, pruritus, pain and tenderness. Molecular testing showed increased levels of IL-8, bFGF and GMCSF mRNA; while mean TGFB and fibronectin mRNA decreased after treatment with both dressings. Both silicone and hydrogel dressing offered treatment for hypertrophic scars that was monitored at the clinical and molecular level with equivalent outcomes.
The limited indication statement of Avocet Polymer Technologies Gel does not raise new issues of safety in comparison to the predicate device. The barner function of treated skin is expected to be intact during Avogel® use. This submission does not claim intended use for wound exudate absorption. Avogel® is not intended to be placed over open wounds. Avogel® is not intended to be placed in direct contact with body fluids (either from eyes, internally or from open wounds).
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 1999
Mary Capelli-Schellpfeffer, MD, MPA Director Avocet Polymer Technologies, Inc. 1112 Church Street Huntsville, Alabama 35801
Re: K981353
Trade Name: Avogel® Regulatory Class: Unclassified Product Code: MDA and MGQ Dated: March 25, 1999 Received: March 26, 1999
Dear Dr. Capelli-Schellpfeffer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Mary Capelli-Schellpfeffer
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
@03
510(k) Number: K981353
Device Name: Avogel®
Indications for Use:
Avogel® is intended for use in the management of hypertrophic scars.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981353