(89 days)
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.
Neutrogena MD™ Cream with Glycerin is a hydrogel wound dressing composed primarily of water and glycerin.
The provided text describes the 510(k) summary for the Neutrogena MD™ Cream with Glycerin. This document focuses on demonstrating substantial equivalence to predicate devices and detailing safety studies, rather than defining specific performance acceptance criteria and a study to prove meeting those criteria in the way a diagnostic algorithm might.
Therefore, much of the requested information, such as quantitative acceptance criteria, test set sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable or not present in the provided document.
However, I can extract the information that is available and indicate what is not present based on the document's content.
Device: Neutrogena MD™ Cream with Glycerin (Type: Hydrogel wound dressing)
Intended Use: Management of minor burns and abrasions associated with resurfacing procedures (dermabrasion, chemical resurfacing, laser resurfacing) to provide a moist wound healing environment. For external use only. Not intended for use on 3rd degree burns.
Reason for lack of detailed performance criteria and study: This 510(k) submission is for a medical device (a topical hydrogel dressing), not an AI/diagnostic algorithm. The evaluation focuses on safety and substantial equivalence to existing predicate devices based on formulation, intended use, and pre-clinical/clinical safety assessments. Therefore, the types of performance metrics and study designs typically used for AI diagnostics (sensitivity, specificity, ROC curves, multi-reader studies, etc.) are not relevant or included here.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not define specific quantitative "acceptance criteria" in the format of a diagnostic algorithm (e.g., target sensitivity/specificity). Instead, the "acceptance" is based on meeting safety standards and demonstrating substantial equivalence to predicate devices. The "performance" is described in terms of safety study conclusions and clinical observations.
| Acceptance Criteria Category (Implied) | Reported Device Performance / Conclusion from Study |
|---|---|
| Safety - Cytotoxicity | Product met the requirements of the USP (United States Pharmacopeia) for Cytotoxicity USP Agar Diffusion. Conclusion: Biocompatible, not cytotoxic. |
| Safety - Primary Skin Irritation | Product is not classified as a primary irritant or as a corrosive in rabbits. Conclusion: Non-irritating. |
| Safety - Delayed Contact Hypersensitivity | Product is not a sensitizer in guinea pigs. Conclusion: Not a sensitizer. |
| Clinical Suitability for Intended Use | Product is "...suitable for use in resurfacing procedures." (Based on preliminary results from "The Effect of an Integrative Wound Management Regimen for Skin Following Facial Resurfacing Procedures (GS9710.01/A1)"). Conclusion: Supports the intended use in specified wound management. |
| Substantial Equivalence | Demonstrated substantial equivalence to SoloSite Dermal Wound Gel (K932263) and Spand-Gel Wound Gel (K864124) based on: - Formulation (primarily water and glycerin) - Intended use (moist wound healing microenvironment) - Packaging (plastic tube dispensers, not occlusive backing) - Preservative systems (similar methylparaben/propylparaben) (Spand-Gel note about absorbent polycarbonate beads indicates a minor difference but not one that negates equivalence based on the overall assessment). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for either the preclinical animal studies or the clinical studies. For the "Dry skin healing" study, it's a "controlled double-blind clinical evaluation," implying human subjects, but the number is not provided. For the "integrative wound management regimen" study, it's a "preliminary results" report, again with no sample size specified.
- Data Provenance:
- Preclinical studies (Cytotoxicity, Skin Irritation, Hypersensitivity) are laboratory-based and animal studies, not human data with country of origin.
- The "Dry skin healing" clinical study (Appa, Y. and L. Hemingway, 1994) was conducted by "Neutrogena Corporation, Los Angeles, CA," suggesting US origin.
- The "integrative wound management regimen" clinical study (Goldman, M. 1998) is also a clinical study, but no specific location is given beyond the researcher's name and year.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. The "ground truth" here is established through scientific testing methods (e.g., USP standards for cytotoxicity, animal models for irritation/sensitization, clinical observation for suitability), not through expert consensus on diagnostic images or similar data. The clinical studies would have involved medical professionals, but their specific role in "establishing ground truth" in a diagnostic sense is not relevant.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for diagnostic interpretations, not for evaluating properties of a wound dressing. The "controlled double-blind clinical evaluation" suggests a methodology to minimize bias in clinical assessment, but not an adjudication of "ground truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document does not mention an MRMC comparative effectiveness study. This type of study is typically relevant for evaluating the impact of AI on human diagnostic accuracy, which is not the scope of this medical device submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device (cream), not an algorithm. Its performance is inherent to its properties and application, not an independent algorithmic output.
7. Type of Ground Truth Used
- A combination of:
- In vitro and animal study results: For safety endpoints (cytotoxicity, irritation, sensitization), the "ground truth" is determined by meeting established scientific and regulatory standards (e.g., USP requirements) and observed biological responses in tested models.
- Clinical observation/outcome: For the clinical studies, the "ground truth" for usefulness is based on observed clinical outcomes or suitability for the intended use (e.g., providing a moist wound environment, suitability for resurfacing procedures). This aligns with "outcomes data" in a broader sense.
8. Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there is no "training set." The development of the cream would involve R&D and formulation testing, but this isn't structured as a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, this question is not relevant.
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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 CORPORATION5760 West 96th StreetLos Angeles, CA 90045 |
| Telephone: (310) 642-1150Fax: (310) 337-2156 |
| 2. | CONTACT PERSON AT NEUTROGENA CORPORATION |
|---|---|
| Dr. Yohini AppaDirector Claims, Safety/Regulatory Affairs | |
| Telephone: (310) 337-5585 | |
| Fax: (310) 216-5399 |
...
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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™ Creamwith 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.
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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.
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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".
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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.
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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
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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
N/A