(182 days)
Not Found
No
The device description and performance studies focus on the material properties and biological effects of the hydrogel, with no mention of AI or ML.
Yes
The intended use of the Gentell hydrogel is to treat various types of wounds (pressure ulcers, venous ulcers, 1st & 2nd degree burns) by providing a moist healing environment, which is a therapeutic action.
No
The device description indicates it is a primary wound dressing intended to provide a moist healing environment, not to diagnose a condition. The "Intended Use / Indications for Use" section lists wound types it treats, not conditions it diagnoses.
No
The device description clearly states it is a hydrogel, which is a physical substance (a wound dressing), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for treating various types of wounds (pressure ulcers, venous ulcers, burns). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing (hydrogel) applied directly to the wound to create a moist healing environment. This is a topical treatment, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
- Predicate Devices: The listed predicate devices are also wound dressings, further supporting its classification as a therapeutic device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Pressure ulcers, stage II, III & IV wounds
- Venous ulcers
- 1st & 2nd degree bums
Product codes
MGQ
Device Description
Gentell hydrogel is an amorphous gel formed with a high molecular weight hydrophilic polymer, water and aloc vera. This primary wound dressing is intended to provide a moist healing environment. Gel may be removed by gentle irrigation, reducing the potential of tissue damage. Gentell hydrogel is supplied in a multidose cight ounce trigger spray boule and a four ounce tube. This product is not terminally sterilized and bioburden reduction/stasis is achieved through preservation.
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
Testing consistent with the Tripartite Biocompatibility Guidance for Medical Devices includes: irritation, sensitization, cytotoxicity and preservative effectiveness test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510 (k) Summary
Safety and Effectiveness
Summary:
Common Namc:
Corespondent:
Prepared:
AUG 12 200
Gentell Hydrogel Wound Dressing
79 MGO Dressing Classification Name
Hydrogel Wound Dressing
Demetrius Trihoulis
January 29, 1999
Gentell hydrogel is an amorphous gel formed with a high molecular weight hydrophilic polymer, water and aloc vera. This primary wound dressing is intended to provide a moist healing environment. Gel may be removed by gentle irrigation, reducing the potential of tissue damage.
Gentell hydrogel is supplied in a multidose cight ounce trigger spray boule and a four ounce tube. This product is not terminally sterilized and bioburden reduction/stasis is achieved through preservation.
Testing consistent with the Tripartite Biocompatibility Guidance for Medical Devices includes: irritation, sensitization, cytotoxicity and preservative effectiveness test.
Gentell hydrogel wound and burn dressing is similar in design, composition and function to Carrington Dermal Wound Gel (K894541) manufactured by Carrington Laboratorics, Inc., and Eutra Gcl for Wound Dressing (K932291) manufactured by Swiss American Products, Inc.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Gentell, Inc. C/O Mark L. Itzkoff Duane, Morris & Heckscher LLP 1667 K Street N.W., Suite 700 Washington, D.C. 20006
K990440 Re : Trade Name: Gentell Hydrogel Spray Gel, Appligard Squeeze Requlatory Class: Unclassified Product Code: MGQ Dated: June 11, 1999 Received: June 15, 1999
Dear Mr. Itzkoff:
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 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). 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 requlations 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 requirements, 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.
2
Page 2 & Mr. Mark L. Itzkoff
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, "Misbrandinq by reference to premarket notification" Other general information on your (21CFR 807.97). 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
F. O. Cliffor
a Celia M. Witten, M.D., Ph.D. Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K99042K
Page
of
Indications for Use Statement 510(k) Number (if known):
Device Name:
Indications For Use:
510(k) Number: Device Name:
. K990440 Gentell Hydrogel Spray Gcl Appligard Squeeze Gel
Indications for Use:
- · Pressure ulcers, stage II, III & IV wounds
- Venous ulcers
- · 1st & 2nd degree bums
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990440 |
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | -------------- | ---- | ---------------------- |
(Optional Format 1-2-96)