(89 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological effects of a topical cream, with no mention of AI or ML technologies.
Yes.
The device is intended for "management of minor burns and abrasions" and "to provide a moist wound environment that is supportive of healing," which are therapeutic claims.
No
Explanation: The device, Neutrogena MD™ Cream with Glycerin, is described as a hydrogel wound dressing intended for the management of minor burns and abrasions by providing a moist wound environment supportive of healing. Its function is therapeutic (to support healing), not diagnostic (to identify or determine the nature of a disease or condition).
No
The device description clearly states it is a hydrogel wound dressing, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of minor burns and abrasions associated with resurfacing procedures, applied topically to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a hydrogel wound dressing. This is a physical product applied to the body for healing purposes.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
- Performance Studies: The performance studies focus on safety and suitability for wound management, not on diagnostic accuracy or performance.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used in vivo (on the body) for therapeutic wound management.
N/A
Intended Use / Indications for Use
Neutrogena MD™ Cream with Glycerin is intended for use in the management of minor burns and abrasions associated with resurfacing procedures, such as dermabrasion, chemical resurfacing, or laser resurfacing, in order to provide a moist wound healing environment that is supportive of healing.
For external use only. Not intended for use on 3rd degree burns.
Product codes
MGQ
Device Description
Neutrogena MD™ Cream with Glycerin is a hydrogel wound dressing composed primarily of water and glycerin.
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)
Neutrogena MD™ Cream with Glycerin has been evaluated through in vitro tests and animal safety studies. This data is consistent in indicating that this product is safe for use as a topical wound management product. The categories of preclinical safety tests and the safety test conclusions are as follows:
- Cytotoxicity USP Agar Diffusion
- product met the requirements of the USP
- Primary Skin Irritation In Rabbits
- product is not classified as a primary irritant or as a corrosive
- Delayed Contact Hypersensitivity in Guinea Pigs
- product is not a sensitizer
Neutrogena MD™ Cream with Glycerin has also been evaluated in the following clinical studies:
- Appa, Y. and L. Hemingway. May 10, 1994. Dry skin healing. A controlled double-blind clinical evaluation of cream and liquid moisturizers. Research and Development Department Report. Neutrogena Corporation, Los Angeles, CA.
- Goldman, M. 1998. Preliminary results from: The Effect of an Integrative Wound Management Regimen for Skin
- Following Facial Resurfacing Procedures (GS9710.01/A1)
- product is "... suitable for use in resurfacing procedures".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Page 5 of 9
OCT 21 1998
510(k) SUMMARY
Neutrogena MD™ Cream with Glycerin (79 MGQ)
- SUBMITTER'S NAME 1.
-
- CONTACT PERSON AT NEUTROGENA
- ന് DATE THAT 510(k) SUMMARY WAS PREPARED
-
- NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary)
- ક. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
- ર. DESCRIPTION OF THE DEVICE
-
- INTENDED USE OF THE DEVICE
-
- TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES
-
- SUMMARY OF SAFETY STUDIES AND CONCLUSIONS FROM SAFETY STUDIES
| SUBMITTER'S NAME |
|---|
| NEUTROGENA CORPORATION |
| 5760 West 96th Street |
| Los Angeles, CA 90045 |
| Telephone: (310) 642-1150 |
| Fax: (310) 337-2156 |
| 2. | CONTACT PERSON AT NEUTROGENA CORPORATION |
|---|---|
| Dr. Yohini Appa | |
| Director Claims, Safety/Regulatory Affairs | |
| Telephone: (310) 337-5585 | |
| Fax: (310) 216-5399 |
...
1
Page 7 of 9
page 2 of 4
| 4. NAME OF THE MEDICAL DEVICE | |
|---|---|
| Classification name | Dressing, wound and burn, hydrogel |
| (Surgery 79 MGQ) | |
| Common / usual name | Hydrogel dressing |
| Proprietary name | Neutrogena MD™ Cream |
| with Glycerin |
EGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
- SoloSite Dermal Wound Gel (Smith & Nephew, K932263)
- · Spand-Gel Wound Gel (K864124, Medi-Tech International)
DESCRIPTION OF THE DEVICE 6.
Neutrogena MD™ Cream with Glycerin is a hydrogel wound dressing composed primarily of water and glycerin.
1.
Neutrogena MD™ Cream with Glycerin is intended for use in the management of minor burns and abrasions associated with resurfacing procedures, such as dermabrasion, chemical resurfacing, or laser resurfacing, in order to provide a moist wound healing environment that is supportive of healing.
For external use only. Not intended for use on 3rd degree burns.
2
Page 8 of 9
510(k) SUMMARY Neutrogena MD™ Cream with Glycerin
page 3 of 4
TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES ...........
Neutrogena MD™ Cream with Glycerin, Solosite (K932263) and Spand-Gel (K864124) are all formulated to help maintain a moist wound healing microenvironment.
Neutrogena MD™ Cream with Glycerin, Solosite (K932263) and Spand-Gel (K864124) are all hydrogels composed primarily of glycerin and water.
While other hydrogel products (e.g., Vigilon [Bard] and Cutinova Gel-Film [Beiersdorf]) include an occlusive backing, Neutrogena MD™ Cream with Glycerin, Solosite (K932263) and Spand-Gel (K864124) are all packaged in plastic tube dispensers.
Neutrogena MD™ Cream with Glycerin, Solosite (K932263) and Spand-Gel (K864124) all contain similar preservative systems (methylparaben/propylparaben).
Spand-Gel contains a small amount of absorbent polycarbonate beads that gives it an absorbent property.
3
Page 9 of 9
982577
510(k) SUMMARY Neutrogena MD™ Cream with Glycerin
page 4 of 4
SUMMARY OF SAFETY STUDIES AND CONCLUSIONS FROM SAFETY STUDIES
Neutrogena MD™ Cream with Glycerin has been evaluated through in vitro tests and animal safety studies. This data is consistent in indicating that this product is safe for use as a topical wound management product. The categories of preclinical safety tests and the safety test conclusions are as follows:
- · Cytotoxicity USP Agar Diffusion
- · product met the requirements of the USP
- · Primary Skin Irritation In Rabbits
- ▷ product is not classified as a primary irritant or as a corrosive
- · Delayed Contact Hypersensitivity in Guinea Pigs
- ▷ product is not a sensitizer
Neutrogena MD™ Cream with Glycerin has also been evaluated in the following clinical studies:
- · Appa, Y. and L. Hemingway. May 10, 1994. Dry skin healing. A controlled double-blind clinical evaluation of cream and liquid moisturizers. Research and Development Department Report. Neutrogena Corporation, Los Angeles, CA.
- · Goldman, M. 1998. Preliminary results from: The Effect of an Integrative Wound Management Regimen for Skin
- Following Facial Resurfacing Procedures (GS9710.01/A1)
- product is "... suitable for use in resurfacing procedures".
4
Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Yohini Appa, Ph.D. Neutrogena Corporation 5760 West 96th Street Los Angeles, California 90045
Re: K982577 Trade Name: Neutrogena MD™ Cream with Glycerin Regulatory Class: Unclassifed Product Code: MGQ Dated: July 24, 1998 Received: July 24, 1998
Dear Dr. Appa:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
5
Page 2 - Dr. Yohini Appa
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 (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
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,
S. John M. White, Ph.D., M.D.
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
6
INDICATIONS FOR USE STATEMENT
K982577 510(k) Number (if known):
Neutrogena MD™ Cream with Glycerin Device Name:
Indications For Use:
Neutrogena MD™ Cream with Glycerin is intended for use in the management of minor burns and abrasions associated with resurfacing procedures, such as dermabrasion, chemical resurfacing, or laser resurfacing, in order to provide a moist wound environment that is supportive of healing.
For external use only. Not intended for use on 3rd degree burns.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODD)
OR
Prescription Use
(per 21 CFR 801.109) $\checkmark$
Over-The-Counter Use
to co.leef
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982577